The American Journal of Cardiology

Transcription

The American Journal of Cardiology
Volume 96, Issue 7, Supplement 1, Pages 1-214 (3 October 2005)
Optimal Dianosis and Therapy •
Pages 1-2
1.
2.
3.
Antithrombin Alternatives: Low Molecular Weight Heparins, Direct
ANtithrombins, Xa Inhibitors and More •
Pages 3-4
Distal Protection and Thrombectomy Devises in the Coronary and Peripheral
Circulations •
Pages 5-6
4.
Drug-Eluting Stents “Next Generation” Basic Science Workshop •
Pages 7-8
5.
Cardiovascular Genetics, Genomics, and Proteomics •
Pages 9-10
6.
Interventional Heart Failure: Recent Developments and New Directions •
Pages 11-12
7.
Molecular Cardiology I: New Frontiers in Cardiovascular Angiogenesis •
Pages 13-14
8.
Platelet Inhibition I: New Insights into Aspirin and Thienopyridine Utilization
•
Pages 15-16
9.
Endovascular •
Pages 17-20
10.
The 3rd SCA&I Imaging Symposium •
Pages 21-22
11.
Interventional Pathobiology: Insights and Clinical Implications •
Pages 23-24
12.
13.
14.
Molecular Cardiology II: Myocardial Regeneration and Repair •
Pages 25-26
The 6th Annual Microvascular Reperfusion and Primary Angioplasty
Sympsoium: Advancing the Frontiers of Acute Myocardial Infarction
Therapy •
Pages 27-28
Platelet Inhibition II: New Insights into Glycoprotein IIb/IIIa Antagonist
Utilization •
Pages 29-30
15.
Diabetes and Cardiovascular Disease: Attacking the Epidemic •
Pages 31-32
16.
Coronary Stent Design and New Clinical Trial Insights •
Pages 33-34
17.
18.
19.
20.
21.
22.
Plaque Modification and Debulking in the Drug-ELuting Stent Era:
Atherectomy, Atherotomy, and Laser •
Pages 35-36
Chronic Total Occlusions: Exploring the Final Frontier •
Pages 37-38
Translational Research: Migrating Therapeutic Discoveries from the Bench
to Bedside •
Pages 39-40
EuroPCR Special Session: Interventional Insights from Europe •
Pages 41-42
Vulnerable Plaque: Pathophysiology, Detection and Therapeutic
Intervention •
Pages 43-44
The Drug-Eluting Stent Summit IV (A) •
Pages 45-46
23.
Cutting Edge Strategies in Acute Coronary Syndrome and Acute Myocardial
Infarction •
Pages 47-48
24.
Structural Heart Disease: Diagnosis and Interventional Approaches •
Pages 49-50
25.
Innovative Devices and Futuristic Therapies •
Pages 51-52
26.
The Drug-ELuting STent Summit IV (B) •
Pages 53-54
27.
Acute Myocardial Infarction •
Pages 55-66
28.
Angiogenesis, Myogenesis, and Cell Therapies •
Pages 67-73
29.
Atheroablation, Thrombectomy and Distal Protection •
Pages 74-78
30.
Bifurcation Lesions •
Pages 79-83
31.
Carotid Angiography and Intervention •
Pages 84-88
32.
Structural Heart Disease •
Pages 89-94
33.
Treatment of In-Stent Restenosis •
Pages 95-98
34.
Valvular Heart Disease •
Pages 99-100
35.
Vascular Access and Complications •
Pages 101-103
36.
Acute Coronary Syndromes •
Pages 104-106
37.
Cardiovascular Disease Risk Factors •
Pages 107-114
38.
Contrast Nephropathy and Contrast Agents •
Pages 115-118
39.
Coronary Intervention, Restenosis and Complications •
Pages 119-127
40.
Drug Eluting Stents I •
Pages 128-134
41.
Drug Eluting Stents in Diabetic Patients •
Pages 135-139
42.
Endovascular Interventions •
Pages 140-148
43.
Interventional Pharmacology •
Pages 149-156
44.
Miscellaneous •
Pages 157-160
45.
Chronic Total Occlusions •
Pages 161-165
46.
Drug Eluting Stents Comparisons •
Pages 166-169
47.
Drug ELuting Stent Complications •
Pages 170-175
48.
Drug Eluting Stents II •
Pages 176-185
49.
Drug Eluting Stent Restenosis •
Pages 186-191
50.
Imaging and Physiology •
Pages 192-200
51.
Left Main Coronary Intervention •
Pages 201-207
52.
New Drug Eluting Stents •
Pages 208-211
53.
Stent Design and Technologies •
Pages 212-213
MONDAY 10/17/05 10:20 AM-11:20 AM (Room 145AB)
The 4th Annual TCT Inflammation Summit: Expanding Horizons for
Optimal Diagnosis and Therapy
Room 145AB
Monday, October 17, 2005, 10:20 am - 11:20 am
(Abstract Nos. 1-4)
TCT-1
Prognostic Value of Serum Inflammatory and Necrosis Biomarkers
Elevation in the Clinical Late Outcome after Elective Percutaneous
Coronary Intervention: 3-Year Results
Marinella P Centemero, Amanda Sousa, Ibraim Pinto, Rodolfo Staico,
Alexandre Abizaid, Fausto Feres, Luiz F Tanajura, Nivea Salvarani,
Camila Sarteschi, Aurea Chaves, Luiz A Mattos, J. Eduardo Sousa
Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil
Background: Serum necrosis biomarkers elevation (NM) may occur in 10 to
40% of patients (P) undergoing successful percutaneous coronary intervention
(PCI) and this has been associated with major adverse cardiac events
(MACE) at late follow-up. Recently, studies have shown that inflammatory
markers (IM), such as CRP, may also rise after PCI and thus could be related
to worse outcome. Purpose: To evaluate the incidence of NM and IM
elevation after PCI and to analyse its correlation to MACE at late follow-up.
Methods: We measured the IM (hs-CRP) and NM (CKMB / Troponin T)
in 199 P who underwent elective coronary stenting (ECS) from 8/2001
to 02/2002.Blood samples were collected before the procedure and twice
after PCI: 6-8 hrs and 14-18hrs.The clinical impact of such information
was evaluated by means of Kaplan-Meier event-free survival (EFS)
curves and Cox regression model. The mean follow-up was 3 years.
Results: Mean age was 60.3 ± 10.1 yrs, 33% were diabetics and the mean
LVEF was 49 ± 10%. Procedural success was achieved in 193 P (97%) with
one in-hospital MACE: a non-Q wave MI (CKMB> 3 times normal value).
Late results are in the table:
Elevated Biomarker CKMB (> 10 IU/l)
Pre-PCI
0
Post-PCI
6%
EFS (1 year)
MB (-): 85%
MB (+): 60%
p
0.025
EFS (3 years)
MB (-): 79%
MB (+): 50%
p
0.014
Troponin T (>0.1 ng/ml) CRP (> 3 mg/l)
7.5%
61.4%
23%
83.3%
TnT (-): 85%
CRP (-): 87%
TnT (+): 80%
CRP (+): 83%
0.39
0.59
TnT (-): 79%
CRP (-): 83%
TnT (+): 70%
CRP (+): 77%
0.33
0.44
Cox regression analysis identified the independent predictors of late MACE:
diabetes (OR: 2.09; p = 0.023) and CKMB rise after ECS (OR: 3.32; p = 0.012).
Conclusions: 1) Periprocidure NM and IM elevation was frequent; 2)
however freedom from MACE at 1 and 3 years was significantly impaired
only in P with CKMB rise post-ESC; 3) diabetes was also an independent
predictor of late outcome in this P.
TCT-2
Soft Plaque and Elevated Pre-Procedural C-Reactive Protein are
Associated with Higher Incidence Rate of In-Stent Restenosis after
Coronary Artery Stenting
Young Joon Hong, Myung Ho Jeong, Ju Han Kim, Weon Kim, Young Keun
Ahn, Jeong Gwan Cho, Jong Chun Park, Jung Chaee Kang
Chonnam National University Hospital, Gwangju, Republic of Korea
Background: Although various predictors relating to in-stent restenosis
(ISR) have been demonstrated, the relation between the parameters of
intravascular ultrasound (IVUS) and inflammatory markers and ISR have
not been reported. The aim of this study was to evaluate the predictive factors
of ISR after stent implantation in patients with coronary artery disease.
Methods: This study included 120 patients who underwent stent
implantation for angiographically significant stenosis. Patients were
divided into a soft plaque group (n=50) and non-soft plaque group
(n=70) on the basis of pre-intervention plaque morphology. All
patients underwent angiographic and IVUS follow-up at 6 months.
Results: The baseline C-reactive protein (CRP) level was significantly
higher in the soft plaque group. The follow-up minimal lumen diameter
was significantly smaller in the soft plaque group. The pre-intervention
remodeling index was significantly higher in the soft plaque group
and the positive remodeling was more frequently observed in the soft
plaque group. Soft plaques were detected in 70% of the ISR group and,
in contrast, in only 30% of the non-ISR group. And ISR was observed
in 42% of soft plaque group, in contrast, in only 13% of non-soft plaque
group. The neointima area was significantly larger in the soft plaque
group (3.7±1.5mm2 vs. 1.9±1.5mm2, p<0.001). In non-soft plaque group,
association between the baseline CRP level and ISR development was
not observed. However, when the analysis was confined to patients with
soft plaque, high CRP level was associated with ISR significantly (63%
vs. 10%, p<0.001). By multivariate analysis, combination of soft plaque
and elevated CRP was the most significant independent predictor of ISR.
Conclusions: Measuring pre-interventional plaque morphology by IVUS
and CRP levels may be helpful to predict ISR.
TCT-3
Coronary Levels of Inflammatory Markers at the Site of Ruptured
Plaque Predict Clinical Outcome in Acute Coronary Syndrome
Chun Liang1,2, Zonggui Wu1, Junbo Ge2
1
Department of Cardiology, Changzheng Hospital,SMMU, Shanghai,
China2Shanghai Institute of Cardiovascular Diseases, Zhongshan
Hospital, Fudan University, Shanghai, China
Background:Inflammation plays an essential role in the initiation
and progression of coronary atherosclerosis and in atherosclerotic
plaque rupture that culminates in acute coronary syndrome.It is still
undetermined which and to what extent markers of inflammation originate
locally from the site of plaque rupture. Moreover, the links between
the levels of local inflammation and clinical outcome are not clarified.
Methods:The study included 73 patients with acute coronary syndrome
who underwent intravascular ultrasound (IVUS) imaging of culprit lesion
in only 1 vessel disease. By IVUS results, we divided into 42 patients as
ruptured plaque group and 31 patients as non-ruptured plaque group, 11
patients with myocardial bridge in left anterior descending artery as control
group. PCI was performed using an over-the-wire angioplasty system.
Prior to crossing balloon catheter through the lesion, blood was drawn just
proximal to the lesion. After the catheter crossed the lesion, blood was also
drawn at just distal to the lesion. The levels of IL-6,MMP-9,sVCAM-1 and
tissue factor (TF) were measured by ELISA Kit. All patients were implanted
bare mental stent and followed up for 6 months by coronary angiography.
Results: As compared with non-ruptured plaque and control group,
MMP-9 and TF were higher in distal blood samples than in the proximal
blood samples in ruptured plaque group(MMP-9: 213 ± 58.7 vs 178
± 48.1ng/ml,TF: 283 ± 98 vs 217 ± 75.1 pmol/L,P<0.01). Thus, the
values of MMP-9 and TF showed the trans-lesional gradient (distal
value minus proximal value), but there were no difference in IL-6 and
sVCAM-1.The trans-lesional gradients of MMP-9 and TF were correlated
with the restenosis in stent after 6 months (r=0.82,0.77, P<0.001).
Conclusions :These results suggest that coronary levels of MMP-9 and TF
at the site of plaque rupture are sound markers of plaque instability and
predict the restenosis in stent.
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Oral
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TCT-4
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Paradoxical Rebound Platelet Activation after NSAIDS or COX-2
Inhibitors (NSADS/COXI) Withdrawal: Which Patients Are in Higher
Risk for Vascular Events?
Victor Serebruany1, Alex Malinin1, Deepak Bhatt2
1
HeartDrug Research, Towson, MD;2Cleveland Clinic, Cleveland, OH
Background: Several reports strongly indicate that use of COXI is associated
with the increased risk of cardiovascular events. Therefore, the lowest dose
for the shortest duration necessary is now recommended. Considering the
key role of platelets, and the fact that aspirin, and recently clopidogrel have
been implicated in the reduced vascular mortality, we thought to determine
the effect of NSAIDS/COXI therapy and withdrawal on platelet activity.
Methods: Platelet characteristics from 34 aspirin-naive volunteers
who were receiving NSAIDS/COXI inhibitors were compared with
138 drug-free controls. Platelets were assessed twice at baseline
(at least one month of NSAIDS/COXI), and after 14 days washout.
We employed ADP-induced conventional aggregometry, pointof-care Ultegra® analyzer, and whole blood flow cytometry.
Results: The demographics, clinical characteristics, and platelet activity
during NSAIDS/COXI were similar and unremarkable between groups
(Table, Figure). However, there was a highly significant (p=0.00001)
increase of aggregability (Figure), Ultegra analyzer readings (p=0.004),
and expression of GPIIb/IIIa (p=0.002), P-selectin (p=0.00001),
and PECAM-1 (p=0.003) after withdrawal from NSAIDS/COXI.
Conclusion: These data suggest that discontinuation, rather than continuous
therapy with NSAIDS /COXI may represent the highest risk to develop
vascular events. This hypothesis requires intensive testing in the crossover
randomized studies, and may justify more aggressive antiplatelet regimens
in patients after NSAIDS/COXI withdrawal.
2H
MONDAY 10/17/05 11:16 AM-12:16 PM (Room 146A)
Antithrombin Alternatives: Low Molecular Weight Heparins, Direct
Antithrombins, Xa Inhibitors and More
Room 146A
Monday, October 17, 2005, 11:16 am - 12:16 pm
(Abstract nos. 5-8)
TCT-5
Bivalirudin is as Safe and Effective as Heparin in Peripheral
Interventions
Omar Hallak, Lito Justo, Mike Broce, Abdul K Elhabyan, B D Lucas,
Hoda Kasem, Bernardo J Reyes
CAMC Institute, Charleston, WV
Background: Percutaneous peripheral interventions (PPI) are
increasing as the treatment of choice for peripheral vascular disease.
Bivalirudin, a thrombin-specific anticoagulant, overcomes many
of the limitations of heparin and has demonstrated comparable
efficacy
with
significantly
fewer
bleeding
complications.
Methods: An open-label, nonrandomized registry in patients undergoing PPI
of the renal, iliac, and femoral arteries with bivalirudin (0.75 mg/kg bolus/1.75
mg/kg/hr infusion) or heparin (1000-5000 U/kg/hr infusion) as the foundation
anticoagulant. The primary endpoint was procedural success (residual
stenosis ≤30%). Secondary endpoints included: death, myocardial infarction
(MI), urgent revascularization, amputation, and major and minor bleeding.
Results: A total of 105 patients were enrolled (bivalirudin=53; heparin=52).
Baseline demographics were comparable between groups. Patients were
pretreated with clopidogrel (~71%) and aspirin (~79%). Procedural success
was achieved in 97% and 96% of patients in the bivalirudin and heparin treated
groups, respectively. Event rates were low and similar between groups (Table 1).
Conclusion: Bivalirudin is as effective as heparin in providing protection
against ischemic events without sacrificing safety in patients undergoing
PPI. Results of this study add to the growing body of evidence supporting
the safety and efficacy of bivalirudin as the sole procedural anticoagulant in
percutaneous interventions.
Table 1 In-hospital Clinical Outcomes
Bivalirudin
n(%)
Death
0
MI
0
1(1.9)
Urgent revasc.
Amputation
0
Major Hemorrhage
1(1.9)
Minor Hemorrhage
3(5.7)
Heparin
n(%)
0
0
0
0
1(1.9)
9(17.3)
TCT-6
Combined Glycoprotein IIb/IIIa and Direct Thrombin Inhibition
with Eptifibatide and Bivalirudin in the Interventional Treatment of
Critical Limb Ischemia: A Safety and Feasibility Report
David E Allie1, Chris J Hebert1, Mitchell D Lirtzman1, Charles H Wyatt1,
V Antoine Keller1, Muhammad A Khan1, Peter S Fail2, Krishnamoorthy
Vivekananthan1, Sonja Ellis Allie1, Elena V Mitran1, Gary Chaisson2,
Samuel J Staff, III2, Adam A Allie1, Michael W McElderry1, Esmond A
Barker1, Craig M Walker2
1
Cardiovascular Institute of the South, Lafayette, LA;2Cardiovascular
Institute of the South, Houma, LA
Background: Glycoprotein (GP) IIb/IIIa inhibition combined with direct
thrombin inhibition (DTI) with bivalirudin (Angiomax, The Medicines
Company, Cambridge, MA) has shown decreased bleeding and ischemic
complications in percutaneous coronary interventions (PCI). PCI benefits
potentially applicable to critical limb ischemia (CLI) treatment include
improved efficacy in diabetes, small complex vessels, microembolism
reduction, and clinical outcomes. Peripheral vascular interventions (PVI)
have higher complications, more frequent reinterventions, and poorer
outcomes than PCI. In CLI, a high incidence of diabetes, renal insufficiency,
platelet dysfunction, hypercoagulability, inflammation, diffuse disease,
and thrombus make DTI and eptifibatide (Integrilin, Millennium
Pharmaceuticals, Cambridge, MA) an attractive combination treatment.
Methods: Between 7/1/01 and 8/1/04, 162 CLI patients underwent PVI
utilizing bivalirudin (0.75mg/kg bolus with 1.75mg/kg/hr infusion)
and eptifibatide (180 mcq/kg IV bolus and 2 mcq/kg/min for 12
hours) (group A) and were compared to a contemporary clinically
matched heparin (UFH) control group without IIb/IIIa’s (group B).
Results: (Table)
Bivalirudin/Integrilin UFH Control
P-Value
Group A
Group B
N = 162
N = 162
Procedural Success
156 (96.2%)
152 (93.8%) 0.3051
6 (3.7%)
9 (5.5%)
0.4277
VAC (Major)*
14 (8.6%)
20 (12.3%)
0.2768
VAC (Minor)**
Acute Thrombosis (<48 hours)
2 (1.2%)
4 (2.5%)
0.4098
Subacute Thrombosis (30 day)
3 (1.8%)
7 (4.3%)
0.1988
SRT < 2 hours
120 (74.1%)
31 (19.1%) <0.0001
LOS < 72 hours
112 (69.1%)
71 (43.8%) <0.0001
Vascular Closure Device
21 (13.0%)
29 (17.9%)
0.2186
Secondary re-intervention***
19 (11.7%)
26 (16.0%)
0.2608
Limb salvage***
150 (92.6%)
142 (87.6%) 0.1363
Mortality***
5 (3.09%)
7 (4.3%)
0.5563
Duplex Ultrasound***
28 (17.3%)
40 (24.7%)
0.1016
>50% restenosis (SFA-popliteal)
VAC = vascular access complications
*Any surgery, intracranial bleed, stroke, > 5 cm hematoma, pseudoaneurysm,
retroperitoneal hematoma, or > 2u procedural related blood transfusion
**Any other bleeding or hematoma < 5 cm
SFA = Superficial femoral artery
SRT = sheath removal time
LOS = length of stay
*** = 6 months
Variables
Conclusion: Combined eptifibatide and bivalirudin is a safe, feasible, and
theoretically advantageous anticoagulation and antiplatelet strategy in
treating CLI and may offer improved clinical and hemostasis outcomes. A
prospective randomized multicenter trial is warranted to evaluate efficacy.
TCT-7
Clinical Outcomes Among Acute Coronary Syndromes Patients
Requiring Coronary Artery Bypass Surgery: Results from the
SYNERGY Trial
Derek P B Chew1, Philip Aylward1, Harvey D White2, Yao Huang3, Rick
Becker3, Kenneth W Mahaffey3, James J Ferguson4, Robert M Califf3
1
Flinders Medical Centre, Adelaide, Australia2Green Lane Hospital,
Auckland, New Zealand3Duke Clinical Research Institute, Durham,
NC;4Texas Heart Institute, Houston, TX
Background: Patients with high-risk NSTE ACS managed with an
early invasive strategy often require CABG for revascularization.
The clinical outcomes among this cohort are not well characterized,
so we analyzed CABG procedures using SYNERGY data.
Methods: A total of 1793/9902 (18.1%) patients underwent postrandomization CABG without preceding PCI. Clinical endpoints
assessed were death or MI by 6 months, in-hospital bleeding, and
stroke at 30 days. As an exploratory analysis, outcomes by treatment
randomization to enoxaparin or unfractionated heparin (UFH) were
assessed. Analyses presented are unadjusted for potential differences
between treatment groups and post-randomization confounders.
Results: The median time to CABG from randomization was 90.5 (44.5166.6) hours. Patients undergoing CABG were more likely to be male (OR,
2.04; 95% CI, 1.79-2.33; p<0.001) and diabetic (OR, 1.33; 95% CI, 1.181.50; p<0.001) and less likely to have previously undergone CABG (OR,
0.25; 95% CI, 0.20-0.30; p<0.001). Patients undergoing CABG experienced a
substantial risk of clinical events regardless of treatment assignment. See table.
Conclusion: Despite advances in percutaneous revascularization, a sizable
proportion of high-risk ACS patients require CABG. Among these patients,
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CABG is associated with a substantial burden of death or MI and major
bleeding events. Unadjusted ischemic and bleeding outcomes following
initial treatment with enoxaparin appear to be similar to those observed
with UFH.
Death/MI
TIMI major bleeding
GUSTO severe bleeding
Transfusion
Stroke
Enoxaparin (n=919)
30.1
35.1
7.7
34.7
2.2
UFH (n=864)
32.3
33.1
6.1
33.0
2.3
p Value
0.21
0.28
0.16
0.45
0.82
TCT-8
Statins Inhibit Platelet PAR-1 Receptors: The PAR-1 Inhibition by
Statins (PARIS) Trial
Victor Serebruany1, Michael Miller2, Alex Malinin1, Alex Pokov1, David
Lowry3, Charles Hennekens4
1
HeartDrug Research, Towson, MD;2University of Maryland, Baltimore,
MD;3Midatlantic Cardiovascular, Towson, MD;4University of Miami,
Miami, FL
Background: Recent data from randomized trials of statins support the
hypothesis of pleiotropy. We investigated whether statins affect platelet PAR1 thrombin receptor by performing serial measurements of its activity, and
expression level by flow cytometry before and during treatment with statins.
Methods and Results: Seventy patients with metabolic syndrome
not taking antiplatelet agents were assigned at random to therapy with
one of the six statins (atorvastatin, fluvastatin, lovastatin, pravastatin,
rosuvastatin, and simvastatin) or to a no statin group. Platelet expression
of intact (SPAN-12 antibody), and cleaved (WEDE-15) PAR-1 thrombin
receptors were assessed at baseline, Week 4, and Week 6 by flow
cytometry. At baseline, there was no difference in receptor expression.
However, after 4 weeks of treatment all statins significantly inhibited
(46-55%) the activated epitope of PAR-1 expression and following 6
weeks there remained inhibition despite a slight rebound (22-37%). There
was also a delayed pattern of inhibition of the intact PAR-1 epitope.
Conclusions: All statins inhibit the activity and antigen level of the platelet
PAR-1 thrombin receptor which has a major role in regulating platelet
activity and thrombin formation. These data offer one plausible mechanism
for the recently demonstrated pleiotropic effects of statins that may
contribute to early clinical benefit.
4H
MONDAY 10/17/05 3:00 PM-4:00 PM (Room 145AB)
Distal Protection and Thrombectomy Devices in the Coronary and
Peripheral Circulations
Room 145AB
Monday, October 17, 2005, 3:00 pm - 4:00 pm
(Abstract nos. 9-12)
TCT-9
Lower MACE Can be Achieved in SVG PCI: Stenting in Saphenous
Vein Grafts with Distal Protection Using a Second Generation FilterBased Catheter--The Combined BLAZE I and BLAZE II Registries
David Cox1, Henry Lui2, Ronald Caputo3, Hans Bonnier4, Richard
Kovach5, A.Zaki Masud6, Bruce Brodie7, Thomas Stuckey7, Howard
Herrmann8, James Hermiller9, Alexandra Lansky10, Donald Cutlip11,
Griffeth Tully12, Gregg Stone10
1
Mid Carolina Cardiology, Charlotte, NC;2Apex Cardiology, Jackson,
TN;3St. Joseph’s Hospital, Syracuse, NY;4Eindhoven Hospital,
Netherlands, Netherlands Antilles5Our Lady of Lourdes, Camden,
NJ;6Buffalo General Hospital, Buffalo, NY;7Moses Cone Hospital,
Greensboro, NC;8University of Pennsylvania, Philadelphia, PA;9St.
Vincent’s Hospital and Health Center, Indianapolis, IN;10Columbia
University Medical Center and the Cardiovascular Research Foundation,
New York City, NY;11HCRI, Boston, MA;12BSC EPI, Mountain View, CA
Objectives: BLAZE I and BLAZE II were prospective, multicenter registries
designed to assess the safety and efficacy at 30 day follow-up of the FilterWire
EZTM (2.25-5.5mm) System in percutaneous treatment of saphenous vein
grafts with operator-defined reference vessel diameter of the distal landing
zone between 3.5-5.5mm in BLAZE I and 2.25-3.5mm in BLAZE II.
Methods: 221 patients underwent stenting of 229 saphenous vein graft
lesions using the FilterWire EZ System for distal protection, with 90 patients
enrolled in BLAZE I and 131 in BLAZE II. The FilterWire EZ (2.25-3.5mm)
device is similar to the FilterWire EZ (3.5-5.5mm) with respect to steerability,
crossing profile, and deployment but conforms to the smaller vessel diameter.
Entry criteria were deliberately identical to the randomized FIRE Trial
(using FilterWire EX) for both BLAZE Registries, except for the smaller
vessel size requirement in BLAZE II. The primary endpoint was MACE
defined as death, myocardial infarction (CPK-MB >3x normal), emergency
CABG, or target vessel revascularization within 30 days of index procedure.
Results: High-risk features of the study population included diabetes
in 43.9% of patients, prior MI in 59.3%, and thrombus on initial
angiography in 37.5%. Reference vessel diameter was 3.44mm in
BLAZE I and 2.83mm in BLAZE II. Device success was achieved in
98.2% of patients and final TIMI-3 flow was present in 100% of patients.
MACE at 30 days occurred in only 5.0% of patients, including death in
0%, myocardial infarction in 5.0% (0.45% Q-wave MI and 4.5% Non-Q
wave MI), emergency CABG in 0%, and target vessel revascularization
in 0%. All MACE events were in-hospital complications with no MACE
occurring after hospital discharge. No perforations or distal dissections
occurred and distal embolization occurred in only 1 patient (0.45%).
Conclusion: Distal protection during SVG PCI with the FilterWire EZ
(2.25-5.5mm) System is safe and reduces peri-procedural complications.
Compared to two large prior randomized studies demonstrating MACE
rates of approximately 10% using first-generation distal protection devices,
MACE at 30 days is reduced to 5.0% with technical improvements in this
second-generation filter.
TCT-10
Can We Predict Which Vein Grafts Need Distal Protection During
Percutaneous Coronary Intervention?
William J van Gaal1, Robin P Choudhury1, Italo Porto1, Keith M
Channon1, Adrian P Banning1, Vladimir Dzavik2, Leonard M Schwartz2,
Peter H Seidelin2, Rachael Ramsamujh2, Sanh Bui2, Daniel J Blackman1,2
1
John Radcliffe Hospital, Oxford, United Kingdom2Toronto General
Hospital, Toronto, ON, Canada
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BACKGROUND: Distal protection devices (DPDs) have been proven
to reduce distal embolization and improve outcome in unselected
patients undergoing saphenous vein graft (SVG) PCI. However, it
remains uncertain whether all patients undergoing SVG PCI should
have distal protection. We investigated whether clinical or angiographic
variables can predict distal embolization, and hence need for a DPD.
METHODS: 58 consecutive vein grafts undergoing PCI with a FilterWire
(FW) EX or EZ (Boston Scientific, MA) DPD were studied. Post-procedure
the FW was fixed in formalin, photographed, and embolic debris area
(mm2) quantified by semi-automated edge-detection analysis (ImagePro
Plus, Media Cybernetics, MD). Debris area was correlated with 45
clinical, procedural, qualitative, and quantitative angiographic parameters.
RESULTS: Embolic debris was identified in 57/58 cases (98%, mean
5.45mm2, range 0.17-25.1). There were no significant clinical, procedural,
or angiographic predictors of embolic debris area on univariate analysis. In
particular, debris area could not be predicted by clinical presentation, graft
age, graft degeneracy, angiographic evidence of thrombus/filling defect,
TIMI-flow pre-PCI, graft diameter, lesion length, or plaque volume (Table).
CONCLUSION: Distal embolization during vein graft PCI is universal.
Embolic load cannot be predicted by clinical or angiographic variables.
Distal protection should be used in all cases.
VARIABLE
Age of SVG (yrs)
Degenerate SVG
(>50% ectasia)
Angiographic thrombus/
filling defect
TIMI flow pre-PCI
Acute coronary syndrome
Reference lumen diameter
(mm)
Lesion length (mm)
Plaque volume
<10
≥10
Yes
No
Yes
No
<3
3
Yes
No
<3.5
3.5-4
4.1-4.5
>4.5
<10
10-20
20.1-30
>30
Quartile 1
Quartile 2
Quartile 3
Quartile 4
DEBRIS AREA
(mm2)
5.9 ± 4.9
6.4 ± 6.8
5.4 ± 5.6
6.9 ± 6.7
6.4 ± 6.3
6.4 ± 6.5
6.8 ± 7.0
5.9 ± 5.5
6.2 ± 6.4
7.1 ± 6.5
6.3 ± 7.8
5.2 ± 6.1
7.4 ± 7.4
7.0 ± 5.4
6.3 ± 9.3
6.2 ± 5.6
5.8 ± 6.8
7.3 ± 6.6
5.4 ± 6.6
5.0 ± 7.0
8.1 ± 5.7
6.5 ± 6.7
p
0.81
0.42
0.99
0.63
0.67
NS
NS
NS
TCT-11
Predictors of Distal Embolization during Direct Angioplasty for Acute
Myocardial Infarction
Massimo Napodano, Giuseppe Tarantini, Silvia Compagno, Chiara
Fraccaro, Enrico Favaretto, Sabino Iliceto, Angelo Ramondo
Dpt of Cardiac Thoracic and Vascular Sciences, Padova, Italy
Background: recent evidence suggests that distal embolization (DE)
occurs in up to 15% of patients treated with direct angioplasty, and
that it may lead to larger myocardial damage and worse prognosis.
However little is known about the predictors of this complication.
Methods and: in 400 consecutive patients underwent conventional
direct angioplasty baseline clinical characteristics, angiograhic
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morphologic features and quantitative coronary analysis of target
lesion, and perfusion characteristics of the infarct related artery (IRA)
were assessed in order to identify predictors of distal embolization.
Distal embolization was defined as distal filling defect with an
abrupt “cut-off” in one or more peripheral coronary branch of IRA.
Results DE occurred in 64 (16%) patients, of these 3 (4.7%) were discovered
at baseline angiography, 15 (23.4%) occurred after wire placement, 35
(54.7%) after balloon dilatation, and 11 (17.1%) after stent deployment.
There were no significant differences in baseline clinical characteristics.
DE occurred more often in the RCA (53.1% vs 29.4%, p < 0.0001). Patients
with DE had more often an occluded (TIMI < 2) IRA at baseline (87.5%
vs 66.2%, p = 0.001), type B2/C lesion (62.5% vs 38.5%, p = 0.006) and
higher TIMI thrombus score (4.6 vs 3.5, p < 0.0001), and longer lesions
length (p = 0.02). The “cut-off” pattern of occlusion in the IRA was detected
in 68.8% of patients with DE vs 35.3% of patients without DE (p < 0.0001).
There were no significant difference between groups in term of stent use
and stent/vessel ratio. Abciximab was administered more often in DE
group (p < 0.0001). At multivariate analysis “cut-off” occlusion pattern in
the IRA (OR 2.5), right coronary related-artery (OR 2.4), TIMI thrombus
score (OR 1.4), and lesion lenght (1.1) were independent predictors of DE.
Conclusions: Distal embolization during direct angioplasty occurred more
in the right coronary related artery and in presence of specific morphologic
features of high thrombus burden lesion. These findings provide useful
insight for selection of patients who may benefit from mechanical adjunctive
therapy to prevent distal embolization.
low rate of complications with all filter types. However, success rate was
relatively lower with ES whereas procedural time was shorter with FW.
TCT-12
Comparison of Three Filter Device Performance in Carotid Stenting:
A Randomized, Single Center Study
Piero Montorsi, Stefano Galli, Paolo Ravagnani, Daniela Trabattoni,
Franco Fabbiocchi, Alessandro Lualdi, Luca Grancini, Giuseppe
Calligaris, Stefano De Martini, Antonio L. Bartorelli
Centro Cardiologico Monzino, IRCCS, Milan, Italy
Background: Carotid artery stenting (CAS) with systematic
use of distal protection with filters is an expanding treatment
option for carotid artery stenosis. However, studies comparing
performance of different types of filters in CAS are lacking.
Purpose: To compare three different filter devices in CAS.
Methods: One-hundred and sixty-two consecutive pts with carotid artery
stenosis (> 50% if symptomatic and > 75% if asymptomatic) were randomized
to three different filters: Emboshield (ES, n=46); FilterWire EZ (FW, n=57)
or Spider (SP n=59). The primary endpoint was filter success (lesion crossing,
filter positioning and retrieval without cross-over and any angiographic
complications). Secondary endpoints were procedural success and incidence
of death, MI, major and minor stroke within 30 days after the procedure.
Results: Groups were similar as regard to clinical, ultrasound, angiographic
and procedural characteristics. Filter performance and procedural results
are shown in the table:
Filter Success
-Lesion Crossing
-Filter Positioning
-Filter Retrival
-Cross-over
-Spasm
Debris in Filter
Procedural Success
Death, MI, Major Stroke
Minor Stroke
TIA
Procedural Time (min.)
ES
n=46 (%)
33 (72)*
42 (91)
45 (98)
45 (98)
2 (4.3)
8 (17)§
22 (48)
46 (100)
0 (0)
0 (0)
8 (17)#
24±5.7
FW
n=57(%)
52 (91)
54 (95)
56 (98)
57 (100)
1 (1.7)
2 (3.5)
22 (39)
57 (100)
0 (0)
0 (0)
1 (1.7)
20±5**
SP
n=59 (%)
54 (91)
56 (95)
57 (97)
59 (100)
1 (1.7)
1 (1.7)
26 (44)
57 (96.6)
0 (0)
2 (3.4)
2 (3.4)
24.7±7.7
p
0.01
0.77
0.85
0.98
0.28
0.005
0.63
0.34
1.0
0.33
0.005
0.002
Post-hoc
analysis:
*ES
vs
FW
and
SP;
§
ES
vs. FW and SP;# ES vs FW and SP; ** FW vs ES and SP.
Conclusions. CAS was accomplished with high procedural success and
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MONDAY 10/17/05 3:27 PM-4:27 PM (Room 146A)
Drug-Eluting Stents “Next Generation” Basic Science Workshop
Room 146A
TCT-13
Biocompatibility of a Novel Ultra-Thin Hydroxyapatite Stent Coating
in Normal Porcine Coronary Arteries
Greg L. Kaluza1, Fred J. Clubb, Jr.2, Daryl G. Schulz1, Juan F. Granada1,
Doug Smith3, Maurice Lien3, Tom Troczynski3, Arc W. Rajtar3, Albert E.
Raizner1
1
The Methodist Hospital Research Institute, Houston, TX;2Texas Heart
Institute, Houston, TX;3MIVI Technologies, Vancouver, BC, Canada
Background: Hydroxyapatite (HAp) is a native component of human
bones and teeth with a well-documented long-term biocompatibility
as a coating of biological implants. The present study examined
the potential of the HAp especially formulated as an ultra-thin
stent coating to provide a more natural alternative with improved
biocompatibility over currently used nonresorbable polymeric coatings.
Methods: In 10 miniswine, 20 coronary arteries were randomized to
receive HAp-coated 16mm Millennium Matrix stent or an identical
bare metal stent (BMS) oversized to 110% of arterial diameter and
followed up for 3 months. At termination, angiography and intravascular
ultrasound were performed, followed by harvesting arteries for histology.
Results: At 3 months, HAp-coated stents featured nearly identical % late
lumen loss (21±11%) as BMS (22±13%) and mean % area stenosis by IVUS
(HAp: 26±10% vs. BMS: 26±9%). In light microscopy, HAp-coated stents
showed exemplary biocompatibility, on par with their bare metal controls.
Low injury and inflammation parameters, complete endothelialization
and low neointimal growth were uniformly found (Table, means ± SD).
Conclusions: The microporous ultra-thin HAp coating with a potential for
drug elution shows promise of excellent long term biocompatibility and
makes an attractive candidate for next-generation stent coating. Further
research is warranted to characterize the drug elution capacity, ultrastructure
and metabolism of the HAp coating in the body.
Histology Parameter
Injury Score
Inflammation Score
Fibrin Score
Multinucleated Giant Cells
Intimal Thickness (μm)
Percent Area Stenosis
3-Month Histology Data
Bare Metal Stent
1.28 ± 0.13
1.00 ± 0.01
0.26 ± 0.09
0.15 ± 0.02
0.36 ± 0.18
31.0 ± 15.9
HAp-Coated Stent
1.19 ± 0.06
1.01 ± 0.01
0.25 ± 0.02
0.13 ± 0.04
0.35 ± 0.18
30.4 ± 15.3
TCT-14
Experimental Feasibility and Efficacy of a Novel Modular Segmented
Stent with In-situ Programmable Length and Drug Elution from a
Biodegradable Polymer Coating
Andrew J Carter1, Lori Gibson1, Scott Haller1, Anastasia Brodeur1, Robin
Collingwood1, Sarah Ross1, Philippe Marco2, Nicholas Chronos3, Fermin
Tio4, Keith Robinson3
1
Medical Device Research Laboratory, Kalamazoo, MI;2Xtent, Inc.,
Menlo Park, CA;3American Cardiovascular Research Institute, Atlanta,
GA;4University of Texas San Antonio, San Antonio, TX
Introduction: The Xtent Custom™ catheter system is a novel 6F
compatible device with a modular segmented stent that can be configured
in-situ to allow treatment of single or multiple coronary lesions of 4
mm to greater than 30 mm length. The purpose of this study was to
determine the feasibility to customize stent length in-situ and efficacy
of modular Biolimus A9 eluting stents in a porcine coronary model.
Methods: Balloon expandable cobalt alloy modular segmented stents
(Nine 4 mm segments, 36 mm total length) were coated with PLA and 17.9
μg/mm stent length of the rapamycin derivative Biolimus-A9 (Biosensors
Intl.). Eleven modular segmented Biolimus-A9 stents were evaluated in a
10 mm, 20 mm, or 30 mm lesion length simulation porcine coronary model.
Twenty-two Biolimus-A9 (n = 12) and bare metal (BMS) (n = 10) oversized
16 mm length modular segmented stents were implanted in the coronary
arteries of 10 swine. QCA and histological analysis was conducted to
characterize stent deployment morphology and to determine dose response.
Results: Eleven of 12 (92%) modular Biolimus-A9 eluting stents were
successfully deployed with coverage of the target region in the lesion
simulation model. The mean stent length was 27.2 ± 7.7 mm (7 ± 2 segments)
resulting in a stent to simulated lesion length of 1.6 ± 0.3 to 1. In the efficacy
studies, QCA demonstrated a similar baseline (2.59 ± 0.33 mm; 2.70 ± 0.14
mm; p = 0.81) and final MLD (3.03 ± 0.19 mm; 2.99 ± 0.19 mm; p = 0.75)
for the Biolimus-A9 and BMS, respectively. At 28-days, the in-stent MLD
was significantly greater for the Biolimus-A9 (2.35 ± 0.44 mm) as compared
with BMS (1.64 ± 0.53 mm; p = 0.02). The mean neointimal area was less
for the Biolimus-A9 (1.29 ± 0.45 mm2) as compared with BMS (2.53 ± 1.26
mm2, p = 0.0044) resulting in a 50% reduction of percent area stenosis for
the Biolimus-A9 (20.2 ± 9.1%) versus BMS (41.2 ± 20.3%, p = 0.004).
Conclusion: This novel modular segmented stent enables in-situ
customization of length and when coated with a biodegradable polymer
eluting the rapamycin derivative Biolimus-A9, inhibits neointimal formation
in the porcine coronary model. Further studies are necessary to determine
dose response, pharmacokinetics and long-term effects of this device.
TCT-15
Circulating Endothelial Progenitor Cells Predict Angiographic and
Intravascular Ultrasound Outcome following Percutaneous Coronary
Interventions: An Interim Analysis of the HEALING II Trial Using an
Endothelial Progenitor Cell Capturing Stent (Genous R Stent)
Henricus J Duckers1, J Aoki1, H.J. de Heer1, S. Rowland2, P den Heijer3,
B Rensing4, R de Winter5, M. Rau6, H Mudra7, S. Silber8, E. Benit9, S.
Verheye10, W. Wijns11, P.W.J.C. Serruys1
1
Thoraxcenter Rotterdam, Rotterdam, The Netherlands2OrbusNeich, Fort
Lauderdale, FL;3Amphia Ziekenhuis, Breda, The Netherlands4St.Antonius
Ziekenhuis, Nieuwegein, The Netherlands5Academic Medical Center,
Amsterdam, The Netherlands6Kerckhoff Herz Zentrum, Bad Nauheim,
Germany7Krankenhaus-Neuperlach, München, Germany8Kardiologische
Klinik Dr.Müller, München, Germany9Virga Jesse Ziekenhuis, Hasselt,
Belgium10Middelheim Ziekenhuis, Antwerp, Belgium11Onze Lieve Vrouwe
Gasthuis, Aalst, Belgium
Background: Endothelial progenitor cell (EPC) number and functional
properties are reduced in CAD patients with cardiovascular risk factors,
including diabetes and hyperlipidemia. As these cells may orchestrate the
vascular repair response following percutaneous intervention, EPC analysis
may identify patients most likely to benefit from EPC capture stent therapy.
Methods: The HEALING II clinical registry sought to define the
clinical safety and benefit of the Genous R stent, capable of capturing
circulating CD34+ progenitor cells in order to promote stent
reendothelialization and vascular repair response to prevent in-stent
restenosis and thrombosis. In 63 patients, EPC titer was correlated
to angiographic and IVUS outcome at 6 and 18 months follow-up.
Results: At interim analysis of 30 out of 63 patients, EPC titer strongly
correlated with QCA and QCU clinical outcome (Pearson, r=0.77).
EPC stent therapy in patients with normal or high levels of circulating
EPC resulted in reduced late loss (late lumen loss index 0.16±0.022
sem). Reduced EPC counts predicted poor QCA and QCU outcome
as well as TLR/TVR events, and were to a large extent restricted to
patients without statin therapy. Statin therapy was associated with a
2,5 fold increase of EPC level and improved angiographic outcome.
Conclusion: EPC titer predicts clinical outcome following PCI using an EPC
capturing stent, which may be augmented by statin therapy. We anticipate
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TCT-16
A Pimecrolimus and Paclitaxel Dual Drug Eluting Stent: A Synergistic
Response from Drugs with Different Mechanisms and Different
Release Kinetics from the COSTAR Stent Platform
Joseph Aragon1, Saibal Kar1, Ryan Berg1, Vladimir Royter1, Gregory
Cogert1, Neal Eigler1, John F Shanley2, Frank Litvack1
1
Cedars Sinai Medical Center, Los Angeles, CA;2Conor Medsystems,
Menlo Park, CA
Background: The COSTAR cobalt chromium stent is capable of
precise control of drug release kinetics. The stent has hundreds
of tiny holes laser drilled into the struts where drug and polymer
combinations can be deposited. We describe the results of the first
dual drug eluting stent with Pimecrolimus (PL), a potent antiinflammatory and Paclitaxel (PTX), a potent anti-proliferative agent.
Methods: Fifty COSTAR stents were implanted into 23 pigs with
a 1 to 1.2 balloon overstretch. Four groups are presented; Dual
drug (DD) stents containing15µg of PTX and 150µg of PL (PTX
and PL loaded in alternating reservoirs, n=8), PTX 30µg stents
(PTX fills all reservoirs, n=10), PL 300µg stents (PL fills all the
reservoirs,n=13) and Bare control stents (n=19). Quantitative coronary
angiography (QCA) and histomorphometry was performed at 28 days
Results: 22 animals survived to follow-up. There was no difference in preimplant characteristics in any of the groups. QCA at 28 days showed the DD
stents had the lowest late loss when compared to either the control, PL, or
PTX stents(table). Histomorphometric data is pending and will be presented.
Conclusion: Simultaneous, sustained release of two agents with
independent but potentially synergistic mechanisms of restenosis prevention
(anti-mitotic and anti-inflammatory) is possible. These data support the
hypothesis of enhanced potency with dual drug elution. Further analysis is
required but feasibility for the design and testing of novel DES paradigms
is established.
Table
Bare
PTX 30 µg
PL
Dual Drug
(PTX/PL)
p value
(ANOVA)
2.97±0.24
2.9±0.18
2.96±-0.19
2.88±0.22
p=NS
1.16±0.05
1.18±0.04
1.20±0.07
1.22±0.11
Late Loss
(mm)
1.02±0.46
0.51±0.32
0.74±0.40
0.33±0.35
Diameter
Stenosis %
29±15
10±12
16±13
11±10
p=NS
p<0.05 DD
COSTAR
30 vs. PL
and Bare
p<0.05 all
DES vs.
Bare
Pre-implant
Ref Diameter
(mm)
Balloon to
Artery Ratio
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Cardiovascular Genetics, Genomics, and Proteomics
Room 151AB
TCT-17
Recombinant Adeno-Associated Virus Serotype 1 Vector-Mediated the
Delivery of VEGF Gene in Mouse Ischemic Skeletal Muscles
Hua Yan1, Xiaobing Wu2, Yanhong Guo1, Wei Gao1
1
Peking University Third Hospital, Beijing, China2AGTC Gene Technology
Company Ltd., Beijing, China
Background: The serotypes of adeno- sociated virus (AAV) have
the potential to become important resources for clinical gene therapy.
Recent studies have compared the serotype-specific virion shells
on vectors transduction in different tissues and suggested rAAV2
b ed vectors pseudotyped with serotype 1 capsid proteins (rAAV1
vectors) allow superior gene transfer into normal skeletal muscles.
Method and results: To evaluate the potential role of rAAV1 vector
gene transfer in the treatment of skeletal muscle ischemia, 3 × 109
vector genomes (vg), 3 × 1010 vg and 3 × 1011 vg rAAV1-VEGF165
vectors for each mouse were injected in the mouse ishcemic skeletal
muscles. rAAV1-LacZ injected mice were controls. We demonstrated
that VEGF _expression in different groups were dosage- dependent me
ured by ELISA at 1 month post vector injection. Both 3 × 1010 vg and 3
× 1011 vg rAAV1-VEGF165 vectors for each mouse were sufficient for
angiogenesis and arteriogenesis in ischmic skeletal muscles. Furthermore,
the newly formed vessels in muscles injected with 3 × 1010 vg of the
rAAV1-VEGF165 vectors were significantly less leaky compared to those
in muscles injected with 3 × 1011 vg of the rAAV1-VEGF165 vectors.
Conclusion: Our results suggest that rAAV1-VEGF165 vector may be
a useful tool in the treatment of muscle ischemia and a lower rAAV1VEGF165 vector dosage is sufficient for new vessel genesis
TCT-18
Prospective Evaluation of the Effect of Paraoxonase Gln-Arg 192
Polymorphism on the Long Term Risk of Major Adverse Cardiac
Events After Coronary Stenting
Karam Souibri1, Adolphe Shayne1, Emmanuelle Filippi-Codaccioni1,
Sabine Fradin2, Rémi Morello3, Gilles Grollier1, Martial Hamon1
1
Service de Cardiologie, Caen, France2Service de Biochimie, Caen,
France3Service de Biostatistiques, Caen, France
Background: Oxidative modification of low density lipoproteins (ox-LDL)
in the artery wall is currently believed to be central in the pathogenesis of
atherosclerosis. Paraoxonase (PON1) is a high density lipoprotein (HDL)
associated enzyme that protects both HDL and LDL against oxidation.
Objective: We sought to evaluate the association between
Gln (Q)-Arg (R) 192 polymorphism of PON1 gene and the
risk of major adverse cardiac events (MACE) in patients with
established coronary artery disease (CAD) treated by PCI.
Methods: From January 1997, to January 1999, 1456 consecutive
patients have had stents in at least one of their coronary arteries. We
used blood samples for genotypic study after the procedure and the
patients’ written consent. 203 DNA samples couldn’t be used, and 11
patients were lost during the 5.7 mean years follow-up period, which
brought the final cohort to 1222 patients. Long term clinical outcome
was obtained and the rates of MACE (death, acute myocardial infarction,
percutaneous or surgical myocardial revascularization ) were compared
according to the insertion/deletion (Q/R) polymorphism of PON1.
Results: Of the 1222 patients, 46.3% had the QQ genotype, 43.6 had the QR
genotype and 9.9% had the RR genotype. All baseline clinical, angiographic
and procedural characteristics were identical in the three groups. Eventfree survival during the follow-up period was identical in patients with QQ
genotype compared to those carrying one or two R alleles. The predictors of
cardiovascular death in patients with CAD were age >= 65 years (RR=2, CI
0.95-4.19, p=0.068), creatinine clearance <80ml/min (RR=3.72, CI 1.3610.23, p=0.011), and LVEF<40% (RR=2.68, CI 1.45-4.97, p=0.002). There
is no difference for the other MACE according to PON1 polymorphism.
Conclusion: In this large prospective study PON1 Gln-Arg 192
polymorphism does not influence the long term prognosis of stented
patients. Our results do not discard definitely the pathogenic role of PON1
polymorphism in CAD but indicates that screening these patients for this
gene is not useful for secondary prevention strategies. PON1 activity and
concentration rather than its polymorphism may identify patients at risk
for MACE.
TCT-19
Nitric Oxide Synthase-3 Polymorphism and Outcomes after
Percutaneous Coronary Intervention
A.J. Conrad Smith, Oscar C. Marroquin, Suresh R. Mulukutla, Pratik B.
Patel, William D. Anderson, Joon Sup Lee, Debra Rosenfelder, Karen
Janosko, Dennis M. McNamara
University of Pittsburgh Medical Center, Pittsburgh, PA
Introduction: Nitric oxide influences platelet function and smooth
muscle cell proliferation after percutaneous coronary intervention
(PCI). A polymorphism is present in endothelial nitric oxide synthase
(NOS3), Asp298Glu. The Asp variant is a risk factor for CAD, however
the impact on outcomes post PCI is uncertain. We evaluated the NOS3
polymorphism and revascularization events the first year after PCI
Method: 674 patients referred for PCI were enrolled in a registry from January
2000 until 2003. Most PCI were with bare metal stents. Subjects were genotyped
and followed for one year or until a repeat revascularization event (PCI or
CABG). Kaplan-Meier event-free survival was compared by genotype subset.
Results: The cohort (mean age 64+ 11) was 96% white and 67%
male. In terms of NOS3, 40% of subjects were Glu298Glu, 49% were
Glu298Asp heterozygotes, and 11% were Asp298Asp homozygotes.
During the course of follow-up, 138 events occurred: 89 repeat PCI
(13%), 37 CABG (6%), and 12 deaths(2%). The overall event-free
survival at 30, 90,180 and 365 days was 98, 92, 87 and 80%. Asp298
was associated with poorer event free survival (Figure, p=0.008). Eventfree survival was poorest in Asp298Asp (96,88,81,69%) intermediate
in heterozygotes and best in Glu298Glu subjects (99,95,88, 84%).
Conclusion: Subjects with NOS3 variantAsp298 have poorer event free
survival after PCI. Analysis of genetic background has the potential to
delineate populations at greater risk for repeat intervention.
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Cellular and Humeral Characteristics of Injected Bone Marrow cells
Fail to Predict Clinical Response in Patients with Advanced Coronary
Artery Disease
Shmuel Fuchs1, Richard Baffour2, Giora Weisz3, Petros Okubagzi4,
Alexander Battler1, Martin B Leon3, Stephen E Epstein2, Ran Kornowski1
1
Rabin Medical Center, Petach Tikva, Israel2Cardiovascular Research
Institute, Washington, DC;3Cardiovascular Research Foundation, New
York, NY;4Cardiovascualr Research Institute, Washington, DC
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Background: Intra-myocardial injection of autologous bone marrow (BM)
may improve clinical response in “no option” patients with refractory angina
and myocardial ischemia. The improvement, however, is not uniform and
variability in clinical response was noted. We sought to assess whether cellular
and humeral characteristics of the injected BM cells predict clinical response.
Methods: BM cells obtained from 27 patients were isolated by Ficoll-Hypaque
gradient centrifugation and cultured in long-term culture medium (LTCM).
Weekly, half of the medium was removed and replaced with fresh LTCM. The
concentration of VEGF and MCP-1 in conditioned medium was measured
using ELISA. The BM cell population was analyzed by FACS analyzer using
laser light side scattering and monoclonal antibodies against CD34 and CD45.
Results: At 3 months, exercise duration time improved in 16 patients (2.5±2.0
min) and failed to improve in 11 (-1.0±1.1 min). The number of total injected
nucleated cells (CD45+), progenitor cells (CD34+) or the magnitude of exvivo secretion VEGF and MCP-1 by cultured BM cells failed to predict
change in exercise response (Table). Similar results were obtained when
CCS class was used as the response criteria (21 responders, data not shown).
Conclusions: Cellular and humeral characteristics of ABM cells do not
predict clinical response following transendocardial injection of these cells
in patients with refractory angina, underscoring the advisability for further
mechanistic exploration.
Total injected cells
(x106)
CD34+ cell number
(x106)
VEGF (at week 4,
ng/ml)
ΔVEGF (between
week 4 and 1, ng/
ml)
MCP-1 (at week 4,
ng/ml
ΔMCP-1 (between
week 4 and 1, ng/
ml)
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Responders
25±27
Non-Responders
28±30
P
0.85
0.72±1.85
0.38±0.28
0.33
4,975±3704
3,093±1467
0.70
4,496±3185
2,921±1393
0.75
2,178±295
2,317±379
0.10
1,002±516
943±627
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Interventional Heart Failure: Recent Developments
and New Directions
Room 147AB
(Abstract Nos. 21-24)
TCT-21
Use of the Impella Percutaneous Ventricular Unloading Catheter in
High-Risk PCI
Paolo Danna, Emanuela Piccaluga, Alessandro Colombo, Francesco
Lavarra, Romano Seregni, Maurizio Viecca
Ospedale Luigi Sacco, Milano, Italy
Background: The Impella ventricular assistance device (VAD) is
a micro-axial catheter-based pump which continuously aspirates
blood from the left ventricle and delivers it to the aorta. A surgically
implantable device has been tested in postcardiotomy heart failure. A 12french, 2.5 l/m percutaneous device is available for use in the cathlab.
Methods: The safety/effectiveness of the percutaneous catheter were
assessed in 12 patients undergoing high risk PCI (EF<30% and : CHF/
hypotension; unprotected LM; multivessel revascularization; degenerated
SVG; last remaining vessel). Mean age was 82(76-87) yrs; 10 pts were
male. Mean EF was 28±7%. Clinical presentation was chronic stable
angina (2), unstable angina (5), NSTEMI (4), STEMI with impending
shock (1). 7 pts had CHF. Procedures performed were: unprotected LM
PCI (4), old SVG PCI (2), 3 vessel PCI (5), last remainig vessel PCI (1).
Results: The device was placed successfully in 10/12 patients (83%).
Mean increase in MAP was 11±4 mmHg; mean increase in CO was
1.2±0.4 l/min; mean decrease in wedge pressure was 4.2±2.2 mmHg. All
procedures were performed as planned. Mean duration of support was 75
minutes. Device-related complications consisted in 1 groin hematoma.
TCT-22
Mechanical Circulatory Support Improves Recovery Outcomes in
Profound Cardiogenic Shock Post Acute Myocardial Infarction: A US
Multicenter Study
Mark Anderson1, Michael Acker2, Viqeshwar Kasirajan3, Michael
Madani4, Yoshifumi Naka5, Daniel Raess6, Louis Samuels7, Benjamin Sun8,
on behalf of all participating centers.
1
Robert Wood Johnson Medical School, New Brunswick, NJ;2University of
Pennsylvania, Philadelphia, PA;3Medical College of Virginia, Richmond,
VA;4University of California San Diego, San Diego, CA;5Columbia
University Medical Center, New York, NY;6Saint Francis Hospital,
Indianapolis, IN;7Lankenau Medical Science Hospital, Philadelphia,
PA;8Ohio State University Medical Center, Columbus, OH
Background: Acute Myocardial Infarction (AMI) complicated by
Cardiogenic Shock (CS) has a high in-hospital mortality despite prompt
coronary revascularization, inotropic drugs and intra-aortic balloon pump
therapy. More potent hemodynamic support via Ventricular Assist Devices
(VAD) could help these patients recover or bridge them to other alternatives
such as heart transplantation when conventional therapies have failed.
Methods: We report a multicenter US experience for treating patients with
profound circulatory failure post AMI and unresponsive to conventional
measures. Since November 2003, 45 such patients were supported in
21 US centers using AB5000 external VAD technology (ABIOMED,
Inc). Preimplant conditions included IABP 87%, mechanical ventilation
88%, cardiopulmonary resuscitation 71%, 2 or more vasopressors 75%,
2 or more inotropes 70%, hyperbilirubinemia 86%, hypercreatinemia
62%. Bi-VAD support was required in 53% of the patients. The average
time from onset of CS to VAD implant was 45.6 hrs (range 1-180 hrs).
Results: VAD implantation instantly stabilized hemodynamics with
significant improvements in cardiac index (1.57± 0.5 to 2.5± 0.5 l/min/m2,
p<0.0001), systolic aortic pressure (94± 14 to 115± 7mmHg, p<0.0001),
central venous pressure (17± 5 to 14± 5mmHg, p=0.05) and pulmonary
arterial pressure (41± 11 to 31± 7mmHg, p=0.01). Of the 41 patients with
known outcomes, 46% survived the hospitalization. Of these survivors,
58% recovered unassisted cardiac function and were discharged, while
21% were transplanted and 21% were bridged to other devices. The average
length of support for patients who recovered was 31 days (range 2-96
days) versus 44 days for those who were transplanted (range 4-95 days).
Conclusion: This study shows that a longer than anticipated support on an
external VAD (average of 31 days) can improve the chance of recovery for
AMI patients with profound Cardiogenic Shock.
TCT-23
Conclusions: The Impella percutaneous VAD was safe and effective
in providing circulatory assistance during high-risk PCI. Its use in other
indications (short-time support in patients with cardiogenic shock; AMI wiht
incomplete ST resolution or mechanical complications) awaits evaluation.
Transcatheter Closure of Ruptured Sinus of Valsalva Aneurysms: A
Single Center Experience
Saibal Mukhopadhyay, Vijay Trehan, Jamal Yusuf, Mohit D Gupta,
Ravinder Batra, Manish ` Sharma, Ramesh Arora, Sanjay Tyagi
G B Pant Hospital and Maulana Azad Medical College, New Delhi, India
Background: With advent of various occlusion devices for
closure of congenital defect, we attempted transcatheter closure of
congenital ruptured sinus of valsalva (RSOV) in 14 patients till date.
Method: Between Jan 1995 and April 2005, transcatheter closure of RSOV
was attempted in 14 patients (11 males, 3 females), age range (14-35 years).
All were symptomatic (NYHA Class II-IV) with features of congestive
cardiac failure. Echocardiography revealed origin of aneurysm (i) Noncoronary sinus - 5 with drainage into right atrium (ii) from the right coronary
sinus (RCS)- 9 (drainage into right ventricular inflow in three, into right
ventricular outflow (RVOT) in six). None had associated ventricular septal
defects (VSD) or significant aortic regurgitation (AR). Size of defect assessed
echocardiographically varied from 6-12 mm.All patients had normal origin
of coronary artery and significant left to right shunt(> 2:1). Arteriovenous
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loop was established by crossing defect from aortic end and snaring it
out of femoral vein.. Defect sizing was done with SwanGanz catheter or
Amplatzer sizing balloon and stretched diameter varied from 8 mm to
14mm. Occluder devices were deployed by antegrade venous approach in
all patients (Rashkind umbrella device, n=2 (before1998), Amplatzer duct
occluder, n=10 and Amplatzer atrial septal occluder, n=2) under fluoroscopic
and echocardiographic guidance taking care that there was no impingement
on the coronaries or on aortic/tricuspid valve before releasing device.
Result: There was complete abolition of shunt in 12 patients. One had
significant residual shunt causing intermittent hemolysis necessitating
urgent surgical repair while another with mild residual shunt had infective
endocarditis after 3 months. All but one patient (NYHA IV preprocedure
who died of progressive heart failure) became asymptomatic within
2 weeks. On mean follow-up of 42 months (range 2-122 months) all
patients are asymptomatic with device in situ and no residual shunt.
Conclusion: Transcatheter closure of RSOV is safe and feasible with
available Amplatzer devices and should be considered the preferred
treatment modality in patients without associated VSD or significant AR.
TCT-24
Combined Intramyocardial and Intracoronary Administration of
Autologous Stem Cells in Patients with Ischemic Cardiomyopathy
Silvia Charwat, Mariann Gyongyosi, Gilbert Beran, Irene Lang, Noemi
Nyolczas, Heinz Sochor, Sholeh Zamini, Aliasghar Khorsand, Dietmar
Glogar
Dept. Cardiology, Medical University of Vienna, Vienna, Austria
Background: The aim of our study was to investigate the changes
in myocardial perfusion and left ventricular function after combined
percutaneous intramyocardial and intracoronary administration
of autologous stem cells in no-option patients with chronic
myocardial ischemia and severely reduced ventricular function.
Methods: Sixteen patients (58+/-10y, 100% male) with ischemic
cardiomyopathy, not amenable for surgical or coronary revascularization,
have been treated with 27.3+/-15.1 ml autologous bone marrow (BM)
containing 2540 million mononuclear cells (MNCs, 3.3+/-2.4% CD34+
cells) with combined NOGA-guided intramyocardial (4.0+/-0.6 ml) and
intracoronary (25.9+/-13.2 ml) injections. The extent of rest and stress-induced
perfusion defects (expressed as % of the entire myocardium), and global
ejection fractions, and the myocardial voltage and local linear shortening
(LLS) values of the treated area were measured before and 6-month after
the stem cell therapy, by using 99m-Tc-Sestamibi perfusion scintigraphy,
contrast ventriculography and NOGA endocardial mapping, respectively.
Results:The combined application form of the stem cell therapy induced
significant increase in end-systolic volume (from 144+/-37 to 114+/39 ml, p=0.045) and global ejection fraction (from 36.8+/-10 to 43.8+/9.9 %) at the 6-month follow-up (FUP). A trend to smaller rest (from
33.3+/-11.4 to 28.9+/-12.1%, p=0.083) and stress-induced perfusion
defects (from 35.8+/-11 to 33+/-11.1%) were documented at the
FUP. The myocardial viability expressed as myocardial voltage value
improved nonsignificantly from 7.4+/-2.9 to 8.5+/-2.5 mV. A significant
increase in segmental wall motion was measured by LLS with NOGA
(from 5.0+/-2.4 to 7.2+/-2%, p=0.009) in response to stem cell therapy.
Conclusion: Combined percutaneous intramyocardial and intracoronary
autologous bone marrow-derived stem cell therapy induces significant
improvement in left ventricular function in no-option patients with ischemic
cardiomyopathy.
12H
TUESDAY 10/18/05 10:03 AM-11:03 AM (Room 146A)
Molecular Cardiology I:
New Frontiers in Cardiovascular Angiogenesis
Room 146A
Tuesday, October 18, 2005, 10:03 am - 11:03 am
TCT-25
A Meta-Analysis of the Placebo Effect in the Treatment of Refractory
Angina
Craig E Strauss1, Sue Duval2, Duana M Walton1, Timothy D Henry1
1
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital,
Minneapolis, MN;2University of Minnesota, Minneapolis, MN
Background: Chronic refractory angina is a growing problem in the
United States. Novel therapies including angiogenesis and enhanced
external counterpulsation have been studied in placebo-controlled trials.
While it is clear that a placebo effect is present, the magnitude and
duration of that effect has been variable presenting a challenge for the
trial design of future placebo controlled studies. We performed a metaanalysis to quantify the magnitude and time-course of the placebo effect in
randomized, placebo-controlled trials for the treatment of refractory angina.
Methods: MEDLINE was searched for clinical trials of novel treatments
for refractory angina not amenable to conventional therapies published
between 1985 and 2005. Included studies were blinded, randomized,
placebo-controlled trials with measures of exercise treadmill time.
Angina and quality of life indicators were evaluated when available.
Changes in exercise time were pooled using random effects models.
Results: Eight trials met the inclusion criteria. The pooled mean change
in exercise time for placebo subjects at 1, 2-3, and 4-6 month intervals is
shown in the table. In the 5 studies where angina class data were available,
improvements were noted for 17-57% of placebo subjects.
Studies (n)
Placebo subjects (n)
Pooled mean change
in exercise time (sec)
(95% CI)
1 Month
4
214
2-3 Months
5
304
4-6 Months
4
382
34 (20-48)
51 (36-66)
54 (19-88)
Conclusion: A prominent placebo effect is present in randomized, placebocontrolled trials of novel treatments for refractory angina. This placebo
effect persists at 6 months and has important implications for future trial
designs.
TCT-26
Xenogeneic and Allogeneic Adult Bone Marrow-Derived Stem Cell
Transplantation in a Porcine Model of Myocardial Infarction Using
3-Dimensional NOGA Guidance
Nabil Dib1, Shaun R Opie1, Ann Campbell1, Amir Gahremanpour1, Brigitte
Miedzybrocki1, Sahrena London2, Vanessa Ragaglia3, Joseph Wagner3,
Jing Yang2, Michael Lark2, Alice Alonso2, Natalie Macon2, Edward B.
Diethrich1
1
Arizona Heart Institute, Phoenix, AZ;2Cordis, Warren, NJ;3Neuronyx,
Malvern, PA
Background: Transendocardial, targeted NOGA-based human and
porcine adult bone marrow derived stem cell (ABM-SC) injections
in a porcine model of myocardial infarction may be safe and feasible,
improve left ventricular systolic function (primary endpoint),
and improve myocardial viability and promote angiomyogenesis.
Methods: 24 pigs underwent MI by percutaneous coil deployment in
the left anterior descending coronary artery at day 0. Cyclosporine was
administered at day 21 and continued daily until harvest, day 90. On day
30, 60 X 106 human or porcine adult bone marrow-derived stem cells
(hABM-SC or pABM-SC, respectively) were percutaneously injected with
the MyoStarTM catheter in and around the infarct (n=8/treatment group).
Cell delivery vehicle was injected as a control (control hABM-SC, n=4
and control pABM-SC, n=4). The NogaStarTM mapping catheter was used
to reconstruct the 3-dimensional electromechanical potential of the left
ventricle at days 30 and 90. LV unipolar voltage (UPV), used as an indicator
of viability, was recorded through NOGA mapping. Left ventricular
ejection fraction (LVEF) was assessed by quantitative left ventriculography
and was measured at days 0, 30, and 90. Histopathology was performed to
assess presence of proliferating cells, muscle specific cells, and capillaries.
Results: No significant differences in LVEF were seen between animals
immediately prior to transplant (n=24). NOGA procedures had 0% mortality
(24 mapping and 24 injection at day 30; 24 mapping at day 90). All treated
animals (n=24) survived to 90 days. There were no significant changes in
LVEF or histopathology between groups as a result of cell injection. Cell
treatment resulted in improvement in Overall LV UPV for hABM-SC
(Δ=0.86; p=0.031) and pABM-SC (Δ=1.79; p=0.043) groups. Apical LV UPV
improved within the hABM-SC group (Δ=1.09; p=0.016). No significant
improvements in LV or apical UPV were noted within control groups.
Conclusions: This study demonstrates the procedural safety and feasibility
of NOGA-based stem cell injections and the utility and low mortality of the
coil-infarcted porcine model. These data suggest potential improvement in
myocardial viability after ABM-SC transplantation.
TCT-27
Spontaneous Cardiomyogenic Differentiation of Human
Adipose Tissue Derived Stem Cells: Identification, Isolation and
Characterization Using Lentiviral Cardiac Promoter/Marker
Expression
Xiaowen Bai1, Kai Pinkernell1, Chistoph Nabzdyk1, Michael Schwarzer1,
Gregory Dick2, Jacob Reiser2, Robert Kutner2, Edward R Newsome1,
Eckhard Alt1
1
Tulane University, New Orleans, LA;2Luisiana State University, New
Orleans, LA
Background: Myocardial infarction (MI) results in a loss of cardiac
tissue. Stem cell therapy is a novel approach for myocardial
repair. Adipose tissue is a readily available source of stem cells.
In this study we investigated the potential of human adiposederived stem cells (ADSC) to differentiate into cardiomyocytes.
Methods: ADSCs (passage1-5) were cultured under standard conditions
in alpha-MEM including 20% FBS, 1% glutamine, 1% penicillin/
streptomycin and transduced with two different lentiviral vectors
simultaneously: 1) one expressing eGFP controlled by the Nkx2.5
promoter, and 2) the other expressing DsRed2 controlled by the myosin
light chain-2v promoter (MLC-2v). Nkx2.5-eGFP and MLC-2v-DsRed2
dual positive cells were isolated using FACS. Gene expression levels
using RT-PCR and electrophysiological properties of dual positive
cells using Fura-2-calcium imaging and patch clamp were investigated.
Results: Ten to 22% of ADSCs cultured in the regular medium expressed
eGFP, 0.8-2.5% expressed DsRed2 and 0.3-2% expressed both GFP
and DsRed2. Dual positive cells expressed cardiomyocyte-specific
mRNAs including: Nkx2.5, MLC-2v, GATA-4, ANP, Connexin-45,
Connexin-43, Troponin I, L-type calcium channel alpha-1c subunit
(Cav1.2). The function of voltage dependent Cav1.2 was further
verified through Fura-2-calcium imaging after depolarization with
80mM KCl. Dual positive cells expressed a variety of ionic currents,
including an inactivating K+ current resembling that of cardiac myocytes.
Conclusions: Cardiomyocyte like cells can be isolated from ADSCs in vitro
using lentiviral fluorescent indicators under the control of a Nkx2.5 and
MLC-2v promoter. These cells show gene expression, protein
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TCT-28
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Stem Cell Mobilization into Peripheral Blood is Impaired in Patients
with Restenosis after PCI
Giuseppe Richichi, Francesco Pelliccia, Guido Meoni, David Mocini,
Christian Pristipino, Vincenzo Pasceri, Antonino Granatelli, Giacomo
Menichella
San Filippo Neri Hospital, Rome, Italy
Background: Rapid repair of the injured arterial wall after PCI
can prevent restenosis. To this end, circulating stem cells seem to
play a crucial role in the repair process. Accordingly, the aim of this
study was to assess the hypothesis that restenosis after PCI occur in
patients who have an impaired stem cells activity after vascular injury.
Methods: We studied 25 patients who had restenosis 6 months after PCI
(Gr. A) and 25 age- and sex-matched patients (Gr. B) who had no restenosis
at follow-up angiography. All patients had PCI with >1 bare metal stents.
Peripheral blood samples were drawn at time of PCI. FACSCalibur flowcytometer was used for SCs assay and absolute number of mononuclear
cells, CD34+, CD45+, CD105+, and CD133+ were evaluated.
Results: The two groups had similar absolute numbers of mononuclear
cells (6,82+1,14 vs 6,76+1,30 n/μL, NS). Compared with Gr.B, conversely,
Gr. A patients showed significantly lower absolute numbers of CD45+,
a leukocyte marker, (72,28+12,32 vs 83,08+7,24 n/μL, p=0.002), and
CD105+, a marker of neo-angiogenesis, (179,61+71,24 vs 216,57+63,96 n/
μL, p=0.04). On the opposite, Gr. A patients had significantly higher absolute
numbers of the endothelial markers CD34+ (0,140+0,074 vs 0,101+0,054
n/μL, p=0.04), and CD133+ (0,063+0,022 vs 0,034+0,026 n/μL, p=0.0001).
Conclusion: Stem cell mobilization into peripheral blood after PCI and
stenting is abnormal in patients who experience restenosis at 6-month.
Impaired stem cells response to vascular injury seems to contribute to
delayed angiogenesis and excessive endothelialization, thus being a novel
mechanism underlying the phenomenon of restenosis.
14H
TUESDAY 10/18/05 10:30 AM-11:30 AM (Room 145AB)
Platelet Inhibition I: New Insights into Aspirin and Thienopyridine
Utilization
Room 145AB
Tuesday, October 18, 2005, 10:30 am - 11:30 am
TCT-29
Profile and Prevalence of Aspirin Resistance in Patients with
Coronary Artery Disease
Burak Pamukcu, Huseyin Oflaz, Imran Onur, Sabahattin Umman, Mehmet
Meric, Yilmaz Nisanci
Istanbul University Istanbul Faculty of Medicine, ISTANBUL, Turkey
Aim: To determine the profile and the prevalence of
aspirin resistance in patients with coronary artery disease.
Material and Methods : We detected the prevelance of aspirin resistance
in a cohort of 413 (24.2% female) patients with coronary artery disease.
All patients were on 80-300 mg/day regular aspirin therapy. Platelet
functions were analyzed in Platelet Function Analyzer (PFA)-100 (Dade
Behring,Germany) device with collagen and/or epinephrine (Col/Epi) and
collagen and/or ADP (Col/ADP) cartridges. Closure time (CT) ≤ 186 seconds
with Col/Epi cartridges was defined as aspirin resistance by PFA-100.
Results: In 88 (21.3%) patients aspirin resistance was present. Aspirin
resistant subjects were more likely to be older than aspirin sensitive
subjects (p=0.04). Between the aspirin resistant and aspirin sensitive
patients, there were not statistically significant differences in major
risk factors of coronary artery disease, number and localization of the
involved coronary vessels, serum lipid levels, and blood counts (Table).
Conclusion: In conclusion, the prevalence of aspirin resistance in our cohort
was 21.3% and aspirin resistance was more frequent in elder subjects.
According to the high prevalence of coronary artery disease, today, globally
a lot of people are affected by aspirin resistance. Aspirin resistance may
play a role in cardiovascular events. We need further studies to optimize
antiplatelet therapy and to prevent major cardiovascular events in aspirin
resistant patients.
Table
Age
Sex (women)
Hypertension
Diabetes mellitus
Cigarette smokers
LDL cholesterol
Hemoglobin
Platelet count
Aspirin resistant
61.14 ± 9.13
28.4%
61.3 %
22.7 %
47.7 %
110 ± 30
13.9 ± 1.1
235 000
Aspirin sensitive
58.06 ± 9.87
23.1%
60.9 %
19.3 %
54.7 %
105 ± 30
13.7 ± 1.2
231 000
p
.040
.300
.940
.488
.292
.282
.967
.543
TCT-30
The Effectiveness of Triple Antiplatelet Therapy with Aspirin,
Clopidogrel, and Cilostazol after Successful Drug-Eluting Stent
Implantation in Real World Practice: The Incidence of Subacute Stent
Thrombosis at One Month
Seung-Whan Lee1, Seong-Wook Park2, Myeong-Ki Hong2, Young-Hak
Kim2, Nae-Hee Lee1, Youn-Haeng Jo1, Cheol-Whan Lee2, Jae-Joong Kim2,
Seung-Jung Park2
1
Soonchunhyang University, Bucheon, Seoul, Republic of Korea2Asan
Medical Center, Seoul, Republic of Korea
Background: The cilostazol and clopidogrel have different action
mechanism of inhibition of platelet. Thus, triple antiplatelet therapy
with aspirin, clopidogrel and cilostazol may have synergistic effect
to prevent thrombotic complications in patients undergoing drugeluting stent (DES) implantation. We evaluated the safety and efficacy
of triple antiplatelet therapy after successful DES implantation.
Methods: From April, 2003 to February, 2005, we prospectively enrolled
582 patients (894 lesions) who received triple antiplatelet therapy after
successful DES implantation (1380 stents; 1274 sirolimus-eluting stents, 106
paclitaxel-eluting stents). All patients were followed up prospectively after
the procedure during one month. The primary end point was the incidence of
subacute stent thrombosis (SAT). The secondary end point was major adverse
cardiac events including death, nonfatal myocardial infarction, target lesion
revascularization and side effects of study drugs including major bleeding,
vascular complication, hepatic dysfunction, and hematological complications.
Results: Multi-vessel stenting, left main stenting, and primary stenting
was performed in 45.2%, 21.1%, and 4.0%, respectively. Overlapping
of stents was required in 353 lesions (39.5%). During study period,
1 patient (0.2%) developed SAT at 4 days after primary stenting for ST
elevation myocardial infarction. No patients experienced death during
study period. Nonfatal myocardial infarction occurred in 2 patients
(0.3%). Target lesion revascularization was required in 2 patients
(0.3%). The rate of major adverse cardiac events was 0.3% at one
month. The overall adverse drug effects, including major bleeding,
neutropenia, hepatic dysfunction, and thrombocytopenia, were 1.7%.
Conclusions: Our study using triple antiplatelet therapy showed that the
incidence of SAT after DES implantation was 0.2%, which is lower than
those of previous studies using conventional antiplatelet therapy after
DES implantation. The triple antiplatelet therapy may be safely applied in
patients or lesions with a high-risk of stent thrombosis.
TCT-31
Is One-Month Clopidogrel Treatment Only before Major Surgery
is Safe and Feasible in Patients Undergoing Percutaneous Coronary
Intervention with Drug-Eluting Stents?
Seung-Woon Rha, Soon Yong Suh, Uk Yeol Chwe, Jin Won Kim, Chang
Gyu Park, Hong Seog Seo, Dong Joo Oh
Cardiovascular Center, Seoul, Republic of Korea
Background: Clopidogrel (Plavix®) is known to reduce early stent
thrombosis. However, possible deleterious effects of 1-month clopidogrel
treatment on hemostasis and stent thrombosis before major surgery
in the setting of contemporary percutaneous coronary intervention
(PCI) with drug-eluting stents (DES) have not been fully investigated.
Methods: Patients (pts) were randomly assigned with Sirolimus-eluting
stent (SES, Cypher™), Paclitaxel-eluting stent (PES, Taxus™) or both
before major surgery. After one-month administration of aspirin 100 mg
and clopidogrel 75 mg after PCI, all pts were encouraged to discontinue 5 to
7 days before surgery and resume at postop 3 days unless there is significant
risk of postop bleeding complications. In-hospital bleeding complications,
stent thrombosis and adverse clinical outcomes were assessed.
Results: A total 15 pts (Male; 10, Age; 62.8 ± 11 years) who underwent
standard PCI with DES before major surgery were enrolled. A total 28 DESs
(8-Cypher, 20-Taxus) were utilized to treat 28 lesions. All treated lesions
are type B & C and 26.7% (4/15) of pts received more than 3 DESs. Mean
DES diameter was 2.98 mm and mean DES length was 27.5 mm. Mean
duration of discontinuation of aspirin and clopidogrel before surgery was
5.8 ± 1.1 days, after surgery was 4.4 ± 2.7 days and total duration was 8.3
± 4.8 days. Forty seven percent (7/15) of pts underwent cancer surgery and
mean duration from PCI to surgery was 44.6 ± 11.0 days. One pt suffered
from post op wound oozing and received 2 units of transfusion (1/15,
6.7%). One pt showed CK-MB>2 X normal (1/15, 6.7%) and 2 pts mildly
elevated B-type natriuretic peptide (BNP, 2/15, 13.3%) without manifested
heart failure. There were no significant postop bleeding complications,
acute and subacute stent thrombosis and adverse clinical outcomes.
Conclusion: Only one-month administration of aspirin and clopidogrel after
PCI with DES before major surgery, discontinuation 5 days before surgery
and resume 3 days after surgery appears to be safe and feasible without
significant bleeding complications, acute and subacute stent thrombosis or
adverse clinical outcomes.
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TCT-32
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Clopidogrel Nonresponders: A Comparison With Prasugrel (CS-747,
LY640315), a Novel Thienopyridine P2Y12 Receptor Antagonist
Govinda J Weerakkody1, John T Brandt1, Christopher D Payne1, Joseph A
Jakubowski1, Nagy A Farid1, Hideo Naganuma2, Kenneth J Winters1
1
Eli Lilly and Company, Indianapolis, IN;2Sankyo Co., Ltd., Tokyo, Japan
Background: Lower levels of inhibition of platelet aggregation (IPA) with
clopidogrel (C) have been associated with a higher risk of adverse events after
percutaneous coronary intervention (PCI). Thresholds of IPA, objectively
defined with Bayesian classification theory, were used to identify nonresponders
to C and prasugrel (P), a thienopyridine P2Y12 receptor antagonist.
Methods: An integrated database of ADP (5 µM and 20 µM)-induced
platelet aggregation as measured by turbidometric aggregometry was
analyzed from 3 single-center cross-over clinical pharmacology studies.
Subjects (N=112, aged 18-65 years) were healthy volunteers with a baseline
maximum platelet aggregation (MPA) of >70% to 20 µM ADP and were
randomized to either a C 300 mg loading dose (LD) or a P 60 mg LD. The
change in MPA (ΔMPA) from baseline and IPA were evaluated at both 45 and 24 hours after the LD. Nonresponders were individuals achieving
either a ΔMPA< 15% or an IPA < 20% in response to 20 µM ADP. For 5
µM ADP, a nonresponder was defined by a ΔMPA < 20% or an IPA < 25%.
Results: For 5 µM ADP, 22% of subjects were nonresponders to C and none
were nonresponders to P (p<.001) based on IPA. For 20 µM ADP, 43% were
nonresponders to C and none were nonresponders to P (p<.001) based on IPA.
Conclusions: The proportion of nonresponders depends in part on
the concentration of ADP. The nonresponse rate to a P 60 mg LD was
significantly lower than that observed with a C 300 mg LD, as measured
with thresholds objectively defined with Bayesian classification theory.
Table
5 μM ADP
ΔMPA < 20%
IPA < 25%
20 μM ADP
ΔMPA < 15%
IPA < 20%
16H
Clopidogrel
% of
Nonresponders
Prasugrel
P-value
27%
22%
0%
0%
<0.001
<0.001
39%
43%
0%
0%
<0.001
<0.001
TUESDAY 10/18/05 2:00 PM-4:45 PM (Room 146AB)
Endovascular
Room 146BC
Tuesday, October 18, 2005, 2:00 pm - 4:45 pm
TCT-33
Carotid Artery Stenting (CAS) in 2172 Patients: 5-Year Results in
High-Volume Centers (ELOCAS Registry)
Jennifer C Sugita1, M Bosiers2, P Peeters3, K Deloose2, J Verbist3, F
Castriota4, A Cremonesi4, Horst Sievert1
1
CardioVascular Center Frankfurt, Frankfurt, Germany2Department of
Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium3Department
of Cardiovascular & Thoracic Surgery, Imelda Hospital, Bonheiden,
Belgium4Department Cardiology, Villa Maria Cecelia Hospital, Ravenna,
Italy
Background: Compared to the traditional surgical standard of care, only
limited information is available regarding the long-term outcome of carotid
stentimplantation.We report data of CAS up to 5 years, both acute and late stroke/
death and restenosis rates as observed in 4 high-volume European centers.
Methods: Between 1993 and December 31st, 2004, 2172 patients were selected
over the four participating centres, with intention to treat endovascularly.
Conscientious follow-up was done according to the in-hospital stipulations
of each centre and was entered into a database both retrospectively and
prospectively. Long-term restenosis and stroke-death rates were investigated,
statistically analysed and stratified using the Kaplan-Meier method.
Results: Of the 2172 patients, 2165 (99.7%) were technically successful. Of
these 306 (14.1%) were performed without and 1859 (85.9%) with embolic
protection device (EPD). Stenting was performed in 2069 (95.6%) cases.
96 (4.4%) patients received balloon dilation only. Kaplan-Meier analysis
of major stroke/all death for the total population showed stroke/death
rates of 4.1% (nar1 = 1356), 10.1% (nar = 476) and 15.5% (nar = 138)
after 1, 3 and 5 years respectively. Kaplan-Meier analysis of significant
restenosis (>50%) showed restenosis rates of 1.0% (nar = 1363), 2.0%
(nar = 480) and 3.4% (nar = 139), after 1, 3 and 5 years respectively.
Conclusion: The ELOCAS registry represents the largest patient
cohort followed over the longest period of time comparing stroke/
death and restenosis rates. The peri-procedural stroke/death rate
in the treated patient population is very low in comparison with
earlier published series. Neurological events, cerebrovascular
mortality and restenosis throughout long-term follow-up are rare.
1
nar = number at risk : describing the number of patients at risk for the
endpoint at the mentioned time
TCT-34
Carotid Angioplasty in Diabetic Patients
Oscar A Mendiz, Carlos M Fava, León R Valdivieso, Gustavo A Lev,
Ricardo A Costantini
Fundación Favaloro, Buenos Aires, Argentina
Background: Cardiovascular interventions have worse outcomes
in Diabetic patients (Ptes) comparing with Non-Diabetics.
Aim: to compare in-hospital and follow-up (F-U) evolution
of Diabetic (DBT) Ptes vs. Non-Diabetics (N-DBT) who
received
carotid
artery
angioplasty
and
stenting
(CAS).
Methods: between October 1995 and May 2005, 387 CAS procedures
were done. Ninety (23.3%) were DBT and 297 (76.7%) N-DBT Ptes.
Angiographic success (AS) was considered when residual stenosis
<30%, Procedural success (PS) when AS without in-hospital major
complications (major stroke, related-death, AMI, urgent surgery).
Population: mean age (years) 67.2±7.9 vs. 68±9.6, male 77% vs.
70.3%, Hypertension 88.0 vs. 84.8%. Previous symptoms; nonspecific 14.3% vs. 12.2%, stroke 22 vs. 13.8% (p 0.09), TIA 8.8
vs. 14.8%.Other vascular antecedents; MI 12.1% vs. 15.8%,
CABG 13.2 vs. 18.8%. Another major cardiovascular surgery
(CVS) was done at the same day of CAS in 6.6% of both groups.
Results: Treated vessel were similar, bilateral CAS was done in 4.5
vs. 3%; distal protection devices were used in 77.8 vs. 72.6%. AS was
achieved in 100% vs. 99.3%; PS in 97.8% vs. 97.3%. Non-related death
occurred in (MNR) 1.1% vs. 0.7%, all were related to CVS, major
Stroke 1.1% vs. 1.3%, minor stroke 5.5% vs. 1% (p 0.01), TIA 5.5% vs.
2%. Any neurological event (any stroke or TIA) 12.1% vs. 4.4 (p 0.01).
Follow-up was achieved in 95.5% at 16.7 ±16.8(1-79) months of
DBT and 92.4% at 20.1±17.8 (1-110) months of N-DBT. EcoDoppler evaluation was available in 70.5% vs. 74.5%. Events
at F-U were Stroke ACV 4.7% vs. 3.5%, related-deaths 0% vs.
2.2%, non-related deaths 3.3% vs. 4.7%, restenosis 2.2% vs. 2.5%.
Conclusion: In this unselected cohort of Ptes; Diabetics, had a higher
incidence of in-hospital neurological events but similar evolution at followup.
TCT-35
Carotid Stenting for the Prevention of Stroke: 3-Year Follow-Up
of the SAPPHIRE Trial and US Carotid Feasibility Demonstrates
Durability of the Procedure
Jay S. Yadav1, David Snead2, Kenneth Ouriel1, Pierre Fayad3, Barry
Katzen4, Mark Wholey5, Sidney A. Cohen2, for the SAPPHIRE
Investigators
1
The Cleveland Clinic Foundation, Cleveland, OH;2Cordis Corporation,
Warren, NJ;3University of Nebraska College of Medicine, Omaha,
NE;4Miami Cardiac and Vascular Institute, Miami, FL;5Shadyside
Hospital, Pittsburg, PA
Background: The present report evaluates the durability of carotid
artery stenting (CAS) for prevention of stroke with follow-up to
3 years in the US Feasibility Study (USFS) & SAPPHIRE study.
Methods: Asymptomatic patients with > 80% stenosis & symptomatic
patients with > 50%/60% (SAPPHIRE/USFS) stenosis by ultrasound
or angiography & a high risk criteria were enrolled at 29/33 centers
(SAPPHIRE/USFS) The primary endpoint for USFS was 30-day postprocedure Major Adverse Events (MAE - death, any stroke &/or
MI). For SAPPHIRE, the primary endpoint was a composite of 30day MAE plus death &/or ipsilateral stroke between 31 days & 360
days. Annual follow-up to 3 years included independent neurologic
assessment of ipsilateral stroke. In SAPPHIRE, patients were either
randomized to carotid endarterectomy (CEA) or CAS or were deemed
too high risk for CEA and were included in a non-randomized stent arm.
Results: 261 patients received CAS in USFS; 334 patients were randomized
in SAPPHIRE to either CAS or CEA; an additional 406 patients were
enrolled in the non-randomized stent arm. Kaplan-Meier (K-M) analyses
of stroke rates in both registries and the randomized SAPPHIRE arms
demonstrate that: 1) Most strokes were peri-procedural, 2) Event rates
plateau from ~30 days to 3 years and 3) Stroke curves overlapped for patients
randomized to either CEA or CAS. Similar overall observations hold for
both asymptomatic (~70% of enrollment) & symptomatic patients (~30%
of enrollment). K-M analysis of target lesion revascularization (TLR) with
follow-up to 2 years in the randomized arms of SAPPHIRE demonstrate
reintervention rates favoring CAS (1.4%) vs. CEA (6.1%), P = 0.031.
Conclusions: Most strokes are equally peri-procedural for CAS or CEA.
Stroke incidence after the first 30 days is minimal for the duration of the
3-year follow-up in USFS & SAPPHIRE. Rates of TLR favor CAS over
CEA at 2 years.
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TCT-36
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Durability of Endoluminal Stenting for Obstructive Lesions of the
Subclavian Artery: Multicenter Registry in Japan
Sunao Nakamura1, Kimihiko Kanno1, Shinko Soma1, Hiroyuki Sato1,
Naoyuki Kurita1, Mizuki Hirose1, Osamu Hirashima1, Akihiko Kanazawa1,
Koji Hozawa2, Hitoshi Nakamura2, Kazutoshi Yamamoto2, Nobuyuki
Makishima3, Shotaro Nakamura4, Jun Koyama4
1
New Tokyo Hospital, Matsudo, Japan2Chiba Central Medical Center,
Chiba, Japan3Kobari General Hospital, Noda, Japan4Secomedic Hospital,
Funabashi, Japan
Background: Obstructive lesions of the subclavian artery can
result in arm claudication, symptoms of subclavian steal. Aim:
To evaluate the safety, efficacy and durability of endovascular
stenting for treating 325 obstructive lesions of subclavian artery.
Methods: We performed 325 cases of endoluminal stenting for 305 patients
(207 males, 64±12 years). All procedures were performed with Palmaz
stents (210 cases) and Wall stents (115 cases), 220 cases (72.3%) were
used transradial approach. Indications for stenting were arm claudication in
175 cases, subclavian steal syndrome in 72 cases and myocardial ischemia
secondary to compromised flow through internal mammary grafts in 58
cases. Results: Procedural success (defined as abolition of pressure gradient
across the aorta and subclavian artery and a residual diameter stenosis
<20% without major complications was achieved in 324 patients (99.7%).
Only one patient had a major complication (mediastinum hemorrhage
due to subclavian artery rupture). Baseline diameter stenosis was reduced
from 89.6% to 14.2±9.0%, mean systolic pressure difference was reduced
46.4±14.8 mmHg to 4.4±2.4 mmHg (p<0.01). There was no cerebral or
distal embolization. In 308 of 325 patients (94.8%) we performed, followup angiography ranged from 6 months to 8 years (mean, 41 months).
Primary angiographic patency at 5 years was 99% (only 2 restenosis: 1.0%).
Conclusions: Endoluminal stenting of the subclavian artery is safe and
effective with high technical success and these clinical benefits are durable
at least 5 years.
TCT-37
Acute and Long-Term Outcomes for Treatment of Lower Extremity
PAD with SilverHawk Plaque Excision System
Roger Gammon1, Joseph Cardenas2, Venkatesh Ramaiah2, John Runyon3,
Peter Fail4, Craig Walker5, David Allie5, Jack Chamberlin6, Maurice
Solis7, Lawrence Garcia8, Prakash Makam9, Jose Vale10, Stefan Kiesz11
1
Austin Heart Hospital, Austin, TX;2Arizona Heart Institute, Phoenix,
AZ;3Christ Hospital, Cincinnati, OH;4Terrebonne General Medical Center,
Houma, LA;5Cardiovascular Institute of the South, Lafayette, LA;6Alexian
Brothers Hospital, Elk Grove Village, IL;7Macon Cardiovascular
Institute, Macon, GA;8Beth Israel Deaconess Medical Center, Boston,
MA;9Community Hospital, Munster, IN;10Marion General Hospital,
Marion, OH;11Northeast Methodist, San Antonio, TX
Purpose: Peripheral arterial disease (PAD) presents substantial treatment
challenges as long term data continue to reveal high restenosis rates and the
need for secondary interventions. Plaque excision has emerged as a treatment
with effective mid term results. This analysis evaluated the long term outcomes
following treatment with the SilverHawk Plaque Excision System (SH).
Methods: Data were collected through TALON, a prospective,
non-randomized registry enrolling consecutive patients undergoing
plaque excision for the treatment of lower extremity PAD
with SH. Immediate procedural results as well as target lesion
revascularization (TLR) rates at 12 months were evaluated.
Results: 505 patients (1047 lesions, 617 limbs) underwent 664 SH
revascularization procedures. Baseline clinical and demographic
characteristics included: male gender 60%, mean age 69.5 years, current
smoker 67%, diabetes 51%, coronary artery disease 53.3%. 14% of the
18H
limbs were treated for critical limb ischemia (defined as Rutherford Becker
score 5-6). 56.2% of patients had multiple lesions treated. Moderate-severe
calcification was present in 67% of lesions. 27.9% were occlusions. 25% of
lesions were located below the knee. Mean SFA lesion length was 77.1 mm.
Stand-alone SH was used in 74% of the cases resulting in a reduction in
the mean diameter stenosis from 85% to 10%. Adjunctive stent placement
was required in 5.3% of the lesions. Minor post SH complications
include: 1.2% perforations, 2.2% minor dissections and 0.4% occlusions/
thrombosis. Twelve month follow-up data was available for 65 patients
with 166 lesions. Kaplan-Meier analysis demonstrated freedom from TLR
in 80% of all lesions and 90% of below the knee lesions at 12 months.
Conclusion: High procedural success rates, low complication rates and
favorable intermediate results with SH for treatment of PAD have been
previously described. That the 1- year TLR rate of 20% is similar to
previously reported mid-term results indicates preservation of treatment
benefit with SH over long-term follow-up. These favorable acute and
long term outcomes identify SH plaque excision as a primary therapy in
revascularization of lower extremity PAD.
TCT-38
Early Results of Plaque Excision in the Treatment of Lower Extremity
In-Stent Restenosis
Maurice Solis1, Stefan Kiesz2, Roger Gammon3, Venkatesh Ramaiah4,
Craig Walker5, David Allie5, John Runyon6, Joseph Cardenas4
1
Macon Cardiovascular Institute, Macon, GA;2Northeast Methodist, San
Antonio, TX;3Austin Heart Hospital, Austin, TX;4Arizona Heart Institute,
Phoenix, AZ;5Cardiovascular Institute of the South, Lafayette, LA;6Christ
Hospital, Cincinnati, OH
Introduction: In-stent restenosis (ISR) following successful treatment
of atherosclerotic lesions is a serious problem in the treatment of lower
extremity peripheral arterial disease (PAD). Although several treatment
options, including bypass grafting, percutaneous transluminal angioplasty
and/or stenting are available, long term results typically reveal high
restenosis rates and the need for additional intervention. The SilverHawk
Plaque Excision System (SH), which enables the removal of large amounts
of atherosclerotic plaque, offers a new approach for treatment of ISR
lesions. The objective of this analysis was to report the safety, efficacy,
and short-term patency rates for treatment of ISR lesions with SH.
Methods: A retrospective review of TALON, a multicenter, nonrandomized
observations outcomes registry for treatment of lower-extremity PAD with SH
was performed. Sixty-one patients, 66 limbs and 73 lesions were treated for
ISR. Mean follow-up was 6.8 months. Average age was 67.9 years and 67.2%
were male. Patients’ atherosclerotic risk factors included diabetes mellitus
- 45.9%, history of smoking - 80.4% and history of hypertension - 85.7%.
Baseline Rutherford-Becker scores for the treated limbs were 1-3 in 75.9%
,4 in 16.1% , and 5-6 in 4.8% of patients. Treated lesions were located in the
iliac (17.8%), SFA (74%), popliteal (6.8%), and tibioperoneal trunk (1.4%).
Results: The percent of plaque burden was decreased an average of 70.4%
(82.6% ± 11.6% pre-procedure to 12.2% ± 8.6 post-SH). The ankle-brachial
index increased from a mean pre-procedural 0.67 to a mean post-procedural
0.77, an increase of 13%. A Kaplan-Meier analysis revealed the three month
patency rate to be 93.5% (SEM 0.04) and the six month patency rate to be
90.1% (SEM 0.05). There was one major procedure related complication,
a retroperitoneal bleed, and five grade A/B dissections. Over the length
of the study period there was one death and one deep vein thrombosis.
Conclusions: Short-term follow-up results indicate plaque excision
with SH is a safe and effective method for treatment of ISR in the lower
extremities.
TCT-39
Plaque Excision in “Real World” Superficial Femoral Artery Disease:
12-Month Clinical and Angiographic Follow-Up
Samuel J Stagg, III2, Adam A Allie1, Michael W McElderry1, Esmond A
1
Background: Percutaneous superficial femoral artery (SFA) treatments are
characterized by sparse angiographic follow-up data and high restenosis
therefore reintervention rates. The SilverHawkTM plaque excision (PE)
catheter (FoxHollow Technologies, Inc., Redwood City, CA) is a device
that allows PE and retrieval without barotrauma. 16-channel multidetector
CT angiography (CTA) is a noninvasive angiographic technique
that has been validated with standard angiography for SFA imaging.
Methods: Between September 1, 2003 and May 1, 2005 251 limbs
with 324 lesions were treated with the SilverHawkTM PE system
(Rutherford Class 3 = 10/251 (3.9%), 4 = 24/251 (9.5%), 5 = 201/251
(80.0%), 6 = 16/251 (6.3%). 89 limbs with SFA disease and 102 lesions
were available for 12-month clinical and CTA follow-up. Lesion
location: SFA 89/89 (100%), popliteal 7/89 (6.8%), and infrapopliteal
6/89 (6.7%). SFA treatment: PE/sole therapy 74/89 (83.1%), PE/PTA
5/89 (5.6%), PE/laser 4/89 (4.5%), and PE/PTA/stent 6/89 (6.7%).
Results: Mean SFA lesion length = 15.3 cm (range 2-36 cm); ABI pre (0.60
± 0.14) and post (0.74 ± 0.13); SFA primary patency rate = 71/89 (79.7%);
SFA primary-assisted patency = 83/89 (93.2%); limb salvage = 92.1%,
target lesion revascularization (TLR) = (14.6%) 13 of 17 were reintervened.
Lesion analysis (Table).
12-Month CTA Infrainguinal Lesion Subset Analysis N = 89 Limbs and 102 Lesions
PrimaryInfrainguinal
N=
> 70%
100%
Primary
Assisted
Lesions
Incidence
Restenosis
Occlusion
Patency (%)
Patency
(N=102)
(N=102)
(%)
(%)
(%)
1. SFA
89 (87.5%)
71 (79.7)
14 (15.7)
4 (4.4)
83 (93.2)
(overall)
TASC B
3 (3.3%)
3 (100)
3 (100)
3 (100)
3 (100)
52 (58.4%)
44 (84.6)
5 (9.6)
2 (3.8)
49 (94.2)
TASC C
9 (10.1%)
7 (77.7)
2 (22.2)
1 (11.1)
7 (77.7)
TASC D
24 (26.9%)
20 (83.3)
4 (7.6)
1 (4.1)
21 (87.5)
SFA ISR
2. Popliteal
7 (6.8%)
6 (85.7)
1 (14.2)
0 (0)
7 (100)
3. TPT4 (3.9%)
3 (75.0)
1 (25.0)
0 (0)
4 (100)
Peroneal
4. ATA-PTA
2 (1.9%)
1 (50.0)
0 (0)
1 (50.0)
1 (50.0)
TASC = TransAtlantic Inter-Societal Consensus
ISR = In-stent restenosis
TPT = Tibioperoneal trunk
ATA = Anterior tibial artery
PTA = Posterior tibial artery
Conclusion: The SilverHawkTM PE system intermediate CTA follow-up
results appear encouraging resulting in acceptable 12-month primary
patency, primary-assisted patency and limb salvage rates.
TCT-40
Initial Clinical Experience with the “Orbital Atherectomy System”
Thomas Zeller1, Horst Sievert2, Ulrich Frank1, Karlheinz Buergelin1, Uwe
Schwarzwaelder1, Thomas Schwarz1, Martin Kliem1, Uwe Rothenpieler1,
Franz-Josef Neumann1
1
Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany2Klinikum
Bethanien, Frankfurt, Germany
Purpose:
Multicentre
safety
and
feasibility
study
with
a
new
orbital
rotational
atherectomy
device.
Methods: We tested a new wire guided (0.009’’) rotational atherectomy
device in vessel diameters of 2.0 to 5.0 mm in diameter. The device is
available with a 1.2mm, 1.7mm and 1.9mm diameter abrasive “Crown”
and can be introduced through a 5F sheath or a 6F guiding catheter. Its
unique orbital rotation potentially allows treating vessels with larger
diameters compared to the diameter of the burr from atherosclerotic tissue.
Results: Twenty-four lesions in 17 patients were treated including the SFA
(n=8), popliteal artery (n=1), tibioperoneal trunk (n=2), posterior tibial
artery (n=4), peroneal artery (n=5), anterior tibial artery (n=3). Technical
success rate (including postdilatation) was achieved in 94% of the pts.
(16/17) and in 92% of the lesions (22/24). In the successful cases, the
average percent stenosis was reduced from 86% (60-100%) to 44% (0-80%)
after orbital atherectomy and to 6% (0-30%) after additional therapy. One
minor complication (distal embolization of a fresh thrombus) and one major
complication (target vessel perforation and occlusion) occurred. The device
was most effective in infragenicular arteries. However, in vessels with a
diameter >3.5mm, the atherectomy capacity was not sufficient to achieve
a stand alone atherectomy result and required postdilatation in all cases.
Conclusion: The new rotational atherectomy device is suitable in
infragenicular arteries to achieve a stand alone angioplasty result in most
cases. Caution is demanded in small vessels with curves because the
potential risk of perforation if too large a Crown is used at high rotational
speeds. In vessels with a diameter >3.5mm, even the 1.9mm Crown is not
able to achieve a stand alone atherectomy result without additional balloon
angioplasty. Larger Crown size development will permit use of the device
in larger vessels like the SFA.
TCT-41
Long Term Lesion Patency and Freedom from Limb Amputation: A
Unique Treatment Option for Critically Ischemic Lower Limbs
Roger S. Gammon M.D., Jennifer R Nelson
Austin Heart, Austin, TX
Background: Critical Limb Ischemia (CLI, Rutherford-Becker, RB ≥ 4)
results in high rates of limb amputation causing profound morbidity and
a 2-year mortality rate nearly 50%. The treatment options using plaque
displacement pose formidable complications along with high rates of
restenosis. The SilverHawk (SH, Foxhollow Tech.) device excises plaque.
We sought to determine the efficacy of the SH device in providing CLI
patients clinical improvement and freedom from lower limb amputation.
Methods: Consecutive CLI patients undergoing plaque excision
(PE) in the lower limbs were included. Study endpoints included
immediate procedural and angiographic outcomes, plus freedom
from lower limb amputation or lesser than planned amputation.
Results: 144 lesions in 59 CLI patients were included. Lesions were
located in the femoral/popliteal arteries (92, 64%), iliac arteries (4, 3%),
infra-popliteal arteries (47, 33%) and one (<1%) in a saphenous vein
graft. Prior to PE, 19 (13%) lesions were restenotic and 125 (87%) were
DeNovo. Lesions requiring post-PE adjunctive therapy (AT) totalled
29 (20%). The primary modality for AT was angioplasty in 16% of the
study population versus stent placement in 3%. The mean lesion length
was 71 mm. The mean absolute reduction in lesion percent stenosis was
73%. Complications included vessel dissection in 13 (9%) lesions with 4
(3%) dissections secondary to the SH device. Procedural complications
were seen in less then 4% of the patient population and included
thrombus (2%), embolus (1%), and aneurysm (<1%) requiring covered
stent placement. Prior to PE, 46 (55%) CLI patients had minor or major
ischemic tissue loss and amputation was either planned or imminent. Only
6 (13%) of the tissue loss patients had amputation and 2 reported lesser
amputation than planned before PE. Twelve reported visible healing of
the previously ischemic tissue after at least 3 months post-PE. Available
six month follow up showed a mean decrease in RB scores of 4.5 to 1.9.
Conclusions: PE provided by the SH device demonstrates favorable
early procedural and angiographic outcomes in CLI patients along with
significant freedom from limb amputation. Additional long term follow up
will be presented.
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Angiographic Analysis of Stent Fracture in Superficial Femoral
Artery (SFA) or Proximal Popliteal Artery Lesions Treated with the
SmartTM Nitinol Self-Expanding Stent and Relationship to Adverse
Clinical Events
Ricardo A Costa1, Alexandra J Lansky1, Ecaterina Cristea1, Marc
Bosiers2, Johannes Lammer1, Dierk Scheinert3, Thomas Zeller4, Alexander
Tielbeek5, John Anderson6, Benjamin Wiesinger7, Hans Tielemans8, Jean P
Beregi9, S Duda10
1
Cardiovascular Research Foundation and Columbia University
Medical Center, New York, NY;2St Blasius Ziekenhuis, Dendermonde,
Germany3Herz Zentum Leipzig, Leipzig, Germany4Herzzentrum Bad
Krozingen, Bad Krozingen, Germany5Catherina Ziekenhuis, Eindhoven,
Germany6Ashford Specialist Center, Ashford, Australia7Gunnar
Tepe, University of Tubingen, Eberhard-Karls-University, Tubingen,
Germany8Cordis, Waterloo, The Netherlands9Centre Hospitalier Regional
Universitaire de Lille, Lille, France10University of Medicine Berlin,
Berlin, Germany
disease. The purpose of this abstract is to provide long-term clinical followup of patients treated in a prospective, multicenter, FDA-approved trial.
Methods: Patients with femoropopliteal arterial stenoses or occlusions
measuring <10cm in length were enrolled in a prospective, non-randomized
multicenter registry. All patients were treated with cryoplasty (PolarCath,
CryoVascular Systems, Inc., Los Gatos, CA) with a primary endpoint
of target lesion revascularization (TLR) at 9 months. Long-term clinical
follow-up of TLR rates and ankle-brachial indices (ABI) have now
been collected for 2 to 4 years following initial cryoplasty treatment.
Results: A total of 102 patients were enrolled at 16 centers and 9month TLR was found to be 17.8% yielding clinical patency of 82.2%.
Kaplan-Meier estimate of freedom from TLR at 16 months was found
to be 77.8%. Long-term TLR data and ABI for this patient cohort
will be available for presentation at the time of the annual meeting.
Conclusion: Long-term clinical follow-up is of critical importance to
document the durability of cryoplasty for the treatment of infrainguinal
arterial lesions.
Background: Stent fracture after treatment of the SFA/prox. popliteal
artery has been reported in several studies however its impact on
restenosis and clinical outcomes is unknown. We therefore assessed
this in the multicenter SIROCCO trial, a prospective, randomized,
double blind study using the nitinol, self-expanding SMARTTM stent.
Methods: 93 pts were enrolled (phase I, n=36; phase II, n=57). Stents
were available in 6 & 7mm diameters and 80mm length, and multiple
stents were allowed. Independent core lab analysis at 6-month FU included
angiograms of the limb + flat plate X-rays of the stented segment. Stent
fracture (defined as: type 1=single strut fracture; type 2=multiple single
strut fractures; type 3=complete transverse linear separation without
stent displacement; and type 4=complete transverse linear fracture with
stent displacement) was classified according to strut separation (0-2mm,
2-4mm, and >4mm) and distance from the overlap (<20mm or >20mm).
Results: Pre-procedure total occlusion was present in 63.9%, mod./severe
calcium in 50%, reference diameter was 4.79mm and lesion length was
83.2mm. At FU, stent fracture was found in 18% of pts (16/88), and was
associated with long lesions (130.3 vs 73.7mm, p<0.0001; for stent fracture
vs no fracture) and multiple stent implantation (>2 stents) (50 vs 12.7%,
p=0.007; for stent fracture vs no fracture). The majority of fractures were
type 1 (n=8); type 2 (n=4), types 3 (n=2) and 4 (n=2). The prox.-mid SFA
was the most common site of stent fracture (12/16), 75% had 0-2mm strut
separation, and 69% were located <20mm from the overlap. Angiographic
complications at the fracture site were found in only 2 patients: 1 restenosis
(type 1 fracture) - no TLR performed and 1 ulcer (type 4 fracture) - PTFE
covered stent implanted. Furthermore, all patients were asymptomatic,
and no additional target lesion revascularization was performed.
Conclusions: In the SIROCCO trial, stent fracture was found in 18%
of patients treated with the SMARTTM stent at 6 months FU, and was
associated with long lesions and multiple stent implantation. Importantly,
stent fractures were not associated with angiographic restenosis or adverse
clinical outcomes.
TCT-43
Long-Term Clinical Follow-Up of Cryoplasty for Femoropopliteal
Arterial Disease: Results of the Big CHILL Multicenter Trial
John R Laird1, Giancarlo Biamino2, Michael R Jaff3, Thomas McNamara4
1
Washington Hospital Center, Washington, DC;2Universitat Leipzig
Herzzentrum, Leipzig, Germany3Massachusetts General Hospital, Boston,
MA;4UCLA Medical Center, Los Angeles, CA
Background: Cryoplasty was recently introduced as an effective new method
for the treatement of infrainguinal arterial lesions. We have previously
reported on the mid-term outcomes of cryoplasty for femoropopliteal
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The 3rd SCA&I Imaging Symposium
Room 147AB
TCT-44
Coronary Rotational Angiography (RA): A New Acquisition Modality
Allowing 3D Modelling
Jerome Clerc1, Philippe Guyon2, Niels Bakker3, Mark Wassenaar3, Bernard
Chevalier2, Bernard Glatt2, Thierry Royer2
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Centre Hospitalier de Creil, Creil, France2Centre Cardiologique du Nord,
Saint Denis, France3Philips Medical Systems Nederland B.V., Best, The
Netherlands
Background: The acquisition protocols during coronary angiography
are well established and standardized. However, advances in
computer processing allow new developments in 3D image
synthesis, and reduction in radiation (Re) and contrast volume (Cv).
Method: to evaluate a new methodology including a RA with 3D modelling,
25 consecutive pts were prospectively analyzed. In 27 arteries (14 left and
13 right coronaries), conventional projections were compared to a single
RA. Image quality and diagnosis value were rated independently by 4
seniors. Procedure time, pt Re (equivalent dose) and Cv use were calculated.
Results:
Coronary Angiogram
Quality
Procedure Time
Radiation Exposure
Contrast Volume
Classic
91% fair
7.0±2.0 mn
1.02±0.4 mSv
22.1±9.72 ml
Rotation
86% fair
4.5±1.7 mn
0.25±0.04 mSv
9.9±1.73 ml
p
NS
0.001
< 0.0001
< 0.0001
Conclusions: Procedure time, Re and Cv are significantly reduced
by RA. Digital processing with 3D coronary modelling provides
new opportunities to analyse the coronary tree.
Diagnostic Accuracy of Coronary Angiography Using 64-Slice
Computed Tomography for Detection of Coronary Artery Disease in
an Unselected Population: Reliability in the “Real World”
Mariko Ehara, Masato Kawai, Osamu Kato, Tetsuo Matsubara, Mitsuyasu
Terashima, Etsuo Tsuchikane, Yoshihisa Kinoshita, Tomomichi Suzuki,
Tatsuya Ito, Yoshihiro Takeda, Jean F Surmery, Kenya Nasu, Nobuyoshi
Tanaka, Akira Murata, Takahiko Suzuki
Toyohashi Heart Center, Toyohashi, Japan
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Background: The purpose of present study was to investigate the accuracy
of 64-slice computed tomography (CT) to detect coronary artery disease
(CAD) in the daily clinical practice, without any patient selection.
Methods: Using 64-slice CT (SOMATOM Sensation Cardiac 64,
Siemens), coronary angiography was performed in 127 consecutive cases
with suspected CAD. Nine patients (7%) had a history of bypass surgery,
and 71 (56%) had undergone stent implantation. Beta-blocker was not
administered prior to scan. Thereafter, invasive coronary angiography
(ICA) was performed. Significant stenosis was defined as a diameter
reduction of > 50%, and segmental analysis was performed in 14
segments. Sensitivity, specificity, positive and negative predictive values
(PPV and NPV) of CT angiography were obtained compared with ICA.
Results: Mean heart rate during scan was 74 beats per minutes, scan time was
13.7 seconds and total amount of contrast material was 74 ml. Among all 1778
segments, 182 (10%) were unable to evaluate because of accidental arrhythmia
or tachycardia, calcification, low opacification, or inadequate breathholding. Correlation between CT angiography and ICA showed a sensitivity
of 90%, a specificity of 94%, a PPV of 89% and a NPV of 95%, respectively.
Conclusion: In an unselected patient population, 64-slice CT is highly
accurate for the detection of significant stenosis. CT images evaluation is
possible in a large majority of patients, which support its use in the daily
practice.
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Left
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Diagnostic accuracy of the main coronary arteries
Overall
Sensitivity Specificity
PPV (%) NPV (%) accuracy
(%)
(%)
(%)
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TCT-46
64-Slice Multidetector Computed Tomography Accurately Detects
a High Prevalence of Coronary Artery Disease Among High-Risk
Symptomatic and Asymptomatic Patients
Sze-Piaw Chin, Tiong-Kiam Ong, Wei-Ling Chan, Chee-Khoon Liew,
Houng-Bang Liew, Annuar Rapaee, Kui-Hian Sim
Department of Cardiology, Kuching, Sarawak., Malaysia
Background: We have previously confirmed the feasibility and
accuracy of the latest 64-slice MDCT with improved spatial and
temporal resolution for the detection of clinically significant coronary
stenoses in patients with known or suspected coronary artery disease
(CAD). Whether 64-slice MDCT is useful in patients with acute
coronary syndrome, atypical pain or asymptomatic is not known.
Methods: 208 patients (males 140, mean age 56 years,) underwent
computed tomography angiography (CTA). The clinical presentations
were ACS (group 1; n=41), documented chronic stable CAD (group 2,
n=37), exertional angina or positive exercise tolerance test (group 3,
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n=51), atypical chest pain or equivocal exercise test (group4, n=34) and
asymptomatic patients of of intermediate-high cardiovascular risk (group
5, n=45). Lesions ≥50% were regarded as significant and correlated to
conventional coronary angiography (CCA) as ‘gold standard’ comparison.
Results: Significant CAD on CCA was present in 84.4% of group 1, group 2
=87.5%, group 3=56.7%, group 4=18.2% and group 5 =27.3%. Correlation
between CTA and CCA for detection of coronary stenoses exceeded
85% in all patient groups. Median calcium score was lowest in groups 4
(0HU) and 5 (12.5HU) patients and highest in group 2 (155HU). Group
1 (87HU) had similar score as group 3 (77 HU). Calcium score correlated
with age (r=0.30, p<0.001) and number of CAD (r=0.63, p<0.001)
Conclusions: 64-slice CTA can performed with high accuracy in patients
with ACS and other presentations and may be useful as a screening tool for
CAD in asymptomatic or ‘atypical chest pain’ patients.
TCT-47
Assessment of Recovery of Myocardial Function and Early Left
Ventricular Remodeling by Magnetic Resonance Imaging in the Early
Phases of Acute Myocardial Infarction
Suresh R Mulukutla, Orly Goitein, William D. Anderson, Oscar C.
Marroquin, Joan Lacomis
University of Pittsburgh, Pittsburgh, PA
Background: While primary angioplasty for acute MI reduces infarct
size, there is significant risk for microvascular obstruction which
may attenuate the benefits. Cardiac delayed enhancement (DE) MRI
assesses resting ischemia, microvascular obstruction, and viability.
Cardiac MRI also assesses myocardial function (EF) and measures of
early left-ventricular (LV) remodeling, including end-systolic volume
(ESV), end-diastolic volume (EDV) and LV mass. Few studies have
assessed changes in these parameters in the post-stent period. We
assessed the hypothesis that DE MRI could assess measures of LV
remodeling in primary angioplasty patients in the peri-infarct period.
Methods: 12 patients who presented with acute ST-elevation MI and
who underwent primary angioplasty with drug-eluting stents underwent
DE MRI at 1 day and 4 weeks after revascularization. A standard 17segment reference was used with a total of 408 segments evaluated.
These LV segments were evaluated in each patient for function, perfusion
and viability and to quantify EF, ESV, EDV and LV mass. Comparisons
were made for each patient between the early and late MRI studies.
Results: The average age was 53 years and 67% were male. The left anterior
descending, right coronary, and circumflex were involved in 50%, 33% and
17%, respectively. On the follow-up study, 45% of abnormal segments
improved in function, 55% improved in perfusion and 41% improved in
viability assessment. Comparisons of the baseline and follow-up studies
revealed the following: (1) Significant increase in EF (48% vs 56%, p<0.05);
(2) Significant decrease in ESV (69 vs 53 ml, p<0.01); (3) Significant
decrease in LV mass (113 vs 100 g, p=0.01). EDV trended downward.
Conclusions: Significant recovery in LV function was noted in acute
MI patients treated with drug-eluting stents. Cardiac DE MRI revealed
improvement in EF and suggested improvement in markers of LV
remodeling including decreased ESV and LV mass at follow-up. The study
also showed improvement in perfusion and viability at the follow-up study,
suggesting that the improvement in perfusion may correlate with improved
function. Further analysis is required to assess the mechanisms behind these
favorable changes.
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Interventional Pathobiology: Insights and Clinical Implications
Room 151AB
support the central role of the inflammatory pathway in the pathophysiology
of stent restenosis. PL may be an excellent candidate for a human drug
eluting stent trial.
Table
Intimal Thickness (mm)
TCT-48
Statin Use is Associated with Enhanced Tissue Factor Pathway
Inhibitor Expression and Reduced Tissue Factor Activity in Human
Carotid Plaques
Ariel Finkelstein1, Raj Makkar2
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Tel-Aviv Medical Center, Tel-Aviv, Israel2Cedars Sinai Medical Center,
Los Angeles, CA
Background: Statin-induced reduction in clinical events are attributed to
plaque stabilization with reduced vulnerability to plaque disruption. The effects
of statins on human plaque thrombogenicity, however, remain unknown.
Methods and results: Since tissue factor (TF) and TF pathway inhibitor
(TFPI) determine plaque-thrombogenicity , we investigated the effects of
no statin therapy (controls;n=19) or 3 months or more of Pravastatin (PR)
(n=10) or Atorvastatin (AT) (n=10) treatment on TF and TFPI expression
and TF activity in human carotid plaques removed during endarterectomy.
Carotid plaques were assessed for TF and TFPI immunoreactivity, TFPI
expression by ELISA and Western Blot and TF activity by activity assay.
Plaque TF immunoreactivity did not differ between controls and PR or
AT patients.TFPI immunoreactivity was higher than controls in both PR
(5.1±2.2% versus 1.0±0.7%, p=0.001) and AT treated patients (5.1±2.7 versus
1.5±0.9%, p=0.002).Plaque TFPI by ELISA and Western blot confirmed
higher TFPI levels in AT treated patients compared to controls (16.3±6.4 nM
versus 7.5±5.6 nM, p=0.02 and 581367 versus 177652 densitometric units
respectively ).The TF activity was reduced in plaques of AT treated patients
compared to controls (0.07±0.03 nM versus 0.17±0.09 nM, p=0.01). C
Conclusion: This study provides the first human data to suggest that
statin use is associated with reduced plaque TF activity most likely due to
increased TFPI expression.
TCT-49
Pimecrolimus Eluting Cobalt Stent Decreases Inflammation and
Restenosis in a Porcine Model
Joseph Aragon1, Ryan Berg1, Saibal Kar1, Vladimir Royter1, Gregory
Cogert1, Renu Vermani2, Frank Litvack1, Neal Eigler1
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Cedars Sinai Medical Center, Los Angeles, CA;2CV Path, Gaithersburg,
PA
Background: Pimecrolimus [PL] ( Novartis Inc.), a novel ascomycin
macrolactam derivative, is a T cell selective inhibitor of production and
release of pro-inflammatory cytokines acting directly at the gene level.
Unlike other ‘Limus’ compounds, it does not inhibit the mTOR regulatory
protein and as such acts primarily as an anti-inflammatory without direct
anti-proliferative properties. We describe the histologic effects of PL
in the porcine coronary model delivered by the Conor COSTAR stent.
Methods: PL COSTAR (Conor Medsystems) stents with 300 µgm
of either intermediate [PL-Int],(n=13) or slow (n=13) release kinetics
from a PLGA erodable polymer, and bare controls (n=10) were
implanted in farm pigs and histology was performed at 28 days.
Results: At 28 days, histologic analysis was highly significant for
lower intimal thickness, diameter stenosis, and inflammation (table)
in favor of the both PL stents in comparison to bare. Injury score,
intimal fibrin and endothelialization were equivalent among all stents.
Conclusion: PL is highly effective in inhibiting restenosis at 28 days in
a porcine model when compared to bare cobalt controls. As the primary
mechanism of action of PL is the suppression of inflammation, these data
Area Senosis (%)
Injury Score
Inflammation Score
Intimal Fibrin
Endothelialization (%)
Bare
PL-Slow
PL-Int
0.40±0.17 0.26 ± 0.14 0.22 ± 0.13
P Value
P<0.0002 DES
vs. Bare
P<0.05 DES vs.
42 ±17
31 ±15
26 ±13
Bare
0.77±0.63 0.62 ± 0.29 0.47 ± 0.46
P=NS
P<0.0004 DES
1.46±1.53 0.33 ±0.73 0.27 ±0.52
vs. Bare
0.57±0.74 0.70 ±0.67 0.70 ±0.99
P=NS
89 ±15
85 ±17
84 ±22
P=NS
TCT-50
Biodegradable Polymer Coated, Paclitaxel Eluting Stents in the
Porcine Coronary Arteries
Krzysztof Milewski1, Pawel Buszman2, Aleksander Zurakowski3, Jacek
Pajak4, Jerzy Stojko5, Motaz Abu Samra3
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Animal Cath Lab, AHP, Katowice, Poland2American Heart of Poland,
Ustron, Poland3Acute Coronary Care Unit, Upper-Silesian Center of
Cardiology, Katowice, Poland4Department of Histopathology, Upper
Silesian Medical School, Katowice, Poland5Upper Silesian Medical
School, Katowice, Poland
The aim of our study was to evaluate inhibition of intimal hyperplasia by
biodegradable polymer coated, paclitaxel eluting stent (BP-DES).Additionally
we tested the influence of biodegradable polymer PLA on in stent restenosis.
Methods: Six domestic pigs (weight from 35 to 40 kg) were included in the
study. Three days prior to the procedure 500mg of ticlopidine and 150mg of
Aspirin p.o. was administered and the therapy was continued for 28 days.
During the procedure each animal received 100mg/kg of heparin i.v. Under
general anesthesia we punctured a femoral artery and inserted a standard 6F
introducer sheath. Then JR4 and Amplatz R-L guiding catheters were used
to intubate both coronary arteries. Six stainless steel stents (SS), 6 polymer
coated stents (PLA) and 6 BP-DES (3 x 15mm), were deployed into three
different coronary segments under QCA control. Each stent was implanted
with stent to artery ratio of 1.15:1.0. On the 28th day after the procedure a
control coronarography and IVUS examination was performed.
Then, all animals were sacrificed, the arteries with stents were
isolated and flushed with heparin solution and with 10% Znbuffered formalin under the pressure of 100mmHg to perform
further IVUS ex vivo and complet histopathological analysis.
Results: All vessels were patent after the implantation and after 4 weeks.
No acute or late thrombosis was observed. On basis of QCA analysis
we found statistical lower LL in BP-DES subgroup (0.08±0.09 for BPDES vs 0.48±0.13 for SS and 0.87±0.39 for PLA; ANOVA; p=0.02)
and also lower %DS in BP-DES supgroup (8.43 ±3.01 for BP-DES
vs 18.57 ±2.81 for SS and 26.32 ±7.51 for PLA; ANOVA; p<0.05). In
vivo IVUS examination demonstrated significantly smaller NI area, LL
and %DS in BP-DES (p<0.05) in comparison to SS and PLA subgroup.
Conclusion: BP-DES effectively reduced development of in stent
neointimal hyperplasia assessed by QCA and IVUS in vivo. This second
generation DES may reduce the rate of late thrombosis/restenosis caused by
inflammatory reaction to polymer. Complete histopathological results will
be available at the time of abstract presentation.
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TCT-51
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The Effect of Granulocyte-Colony Stimulating Factor on In-Stent
Restenosis Model in Porcine Coronary Artery
Sang Yup Lim, Youngkeun Ahn, Myung Ho Jeong, Yong Sook Kim, Soo
Yeon Joo, Moon Hwa Hong, Jeong Ha Kim, Sang Rok Lee, Kye Hun Kim,
Il Seok Sohn, Young Joon Hong, Hyung Wook Park, Ju Han Kim, Weon
Kim, Jeong Gwan Cho, Jong Chun Park, Jung Chaee Kang
Background: Stem cell mobilization using granulocyte colonystimulating factor (G-CSF) to the infracted heart showed improved
cardiac function in many studies. But, with use of G-CSF, aggravation
of in-stent restenosis (ISR) may occur and could be a serious problem.
The purpose of this study was to characterize the effects of G-CSF
on in-stent restenosis (ISR) model in porcine coronary arteries.
Methods: Twenty bare stents (3*18 mm) were implanted in 20 porcine
coronary arteries (Stents without G-CSF: Group I, Stents with G-CSF:
Group II, n=10 in each group). G-CSF (10 µg/kg/day, once a day) was
injected subcutaneously for 7 days from 24h after stent implantation.
Complete blood count (CBC) with differentical count was checked
before and 3 days after G-CSF injection. Twenty eight days after
stenting, pigs were sacrificed after quantitative coronary angiography
(QCA) and intravascular ultrasound (IVUS) analysis of coronay arteries.
The coronaries were perfusion-fixed and stained, and pathologic
examination was performed by computer-aided histomorphometry.
Results: The findings of initial CBC were not different significantly
between the two groups, but 3 days after G-CSF injection, white blood cell
and monocyte count were significantly higher in Group II (7,950±1,523/
mm3 vs. 24,672±1,087/mm3, p<0.001 and 282±37/mm3 vs. 2,505±338/mm3,
p=0.001 in each). The minimal luminal diameter at 28 days was larger in
Group I than that in Group II according to IVUS anlysis (3.26±0.58 mm vs.
2.11±0.06 mm, p<0.001). The neointimal area at 28 days was significantly
smaller in Group I than that in Group II (3.14±0.99 mm2 vs. 12.97±3.75
mm2, p<0.001). The area stenosis was significantly lower in Group I than
that in Group II (27.94±9.55 % vs. 76.74±12.01 %, p <0.001). The ratio
of inflammatory cells out of the number of total cells in the neointima was
6.48±1.69 % in Group I and 10.12±6.33 % in Group II at 28 days (p<0.001).
Conclusion: Stem cell mobilization using G-CSF aggravates ISR by local
inflammatory cell infiltration.
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TUESDAY 10/18/05 4:22 PM-5:22 PM (Room 146A)
Molecular Cardiology II: Myocardial Regeneration and Repair
Room 146A
TCT-52
Results of the MYOHEART Study, a Phase 1 Skeletal Myoblast Study
for Congestive Heart Failure
Warren Sherman1, Nicholas Chronos2, Timothy Henry3, Stephen Ellis4,
David Holmes5, Patrick Whitlow6, Diana Crisan Crisan7, Lisa Mowatt2,
Betsy Wilson3, Kelly Brezina6, Damita Carryer5, Valentin Fuster7
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Columbia University Medical Center, New York, NY;2American
Cardiovascular Research Institute, Atlanta, GA;3Minneapolis Heart,
Minneapolis, MN;4Cleveland Clinic, Cleveland, NY;5Mayo Clinic,
Rochester, MN;6Cleveland Clinic, Cleveland, OH;7Mount Sinai Hospital,
New York, NY
Background: Preliminary studies of autologous skeletal myoblast (ASM)
implantation during CABG suggest improvement in clinical status and left
ventricular (LV) function, with minimal potential risk. These studies involve
dual interventions, thereby obscuring effects attributable to ASM alone. We
report the early results MYOHEART, a multicenter, Phase 1 study of ASM
as the sole intervention, in patients with congestive heart failure (CHF).
Methods: With an open label, dose escalation design, ASM were implanted
transendocardially with a percutaneous catheter delivery system in patients
with NYHA Class 2-3 CHF due to chronic post-MI systolic left ventricular
dysfunction (SLVD). EF 20-40% and without residual myocardial ischemia
were eligible. All subjects were required to have ICDs before entry.
Primary objectives assessed feasibility and safety of ASM procurement and
implantation, and included extensive arrhythmia surveillance. Secondary
objectives measured clinical and noninvasive parameters of LV function.
Results: As of 5/25/05, 26 subjects were enrolled and 6 implanted with ASM
in first two cohorts (25 or 75 x 106). Patient characteristics: age 55+/- 8 (M:
F - 7:0), CHF Class 2.3+/-.0, baseline EF = 22+/- 1.9. There were no acute
procedural-related adverse events. In follow-up (1-12 mo) three subjects
had brief runs of nonsustained VT (less than 10 bests). One had ICD shocks
related to rapid AF. Progressive advances in ASM processing (variable FBS
and growth factor concentration) were incorporated during the first 12 months.
Conclusion: Preliminary results from this Phase 1 study demonstrate
the feasibility and safety of ASM procurement and catheter-based
administration. The frequency of arrhythmias at these dosing levels is low.
1-3 month data from all 15 subjects will be presented.
TCT-53
Clinical Trial on Emergent Intracoronary Autologous Bone Marrow
Mononuclear Cells Transfer for Patients with Acute Anterior
Yanlin Lee1, Junbo Ge2, Juying Qian2, Jianhui Shi2, Qibing Wang2, Yuhong
Niu2, Bing Fan2, Xuebo Liu2, Aijun Sun2, Yunzeng Zou2
1
Huashan Hospital, Shanghai, China2Zhongshan Hospital, Shanghai,
China
Objective: To evaluate the effects of emergent intracoronary transfer of
bone marrow mononuclear cells (BMMCs) on left ventricular function and
myocardial perfusion in patients with first acute anterior myocardial infarction.
Method: After successful emergent percutaneous coronary intervention
(PCI) for acute ST-segment elevation anterior wall myocardial infarction,
Twenty-night patients were randomly assigned to either a control group
(n=15) that received optimum postinfarction medical treatment, or a
BMMCs transplantation (BMT) group (n=14). In BMT group, bone
marrow was instantly aspirated from ilium and the autologous BMMCs
were injected to the anterior descending branch through an infusion
catheter within 3 hours after stenting, and patients then received optimum
postinfarction medical treatment. Endpoint was the change in global and
regional left ventricular function, and the amelioration of myocardial
perfusion through 201-thallium scintigraphy in 6 months follow-up.
Results: Left ventricular ejection function (LVEF) at baseline (determined
1 week after PCI by echocardiography) was 55.0±6.7% in control group
and 55.3±8.3% in the BMC group, which are similar between the two
groups. After 6 months, mean LVEF had decreased by 0.1% in the control
group but increased by 5.0% in the BMC group (p=0.015). By quantitative
LV angiography at 6 months, global LVEF significantly increased in
BMT group (51.4±11.1% before transfer vs 58.7%±11.6%, p=0.046,
n=10), but decreased in the control group (52.5±10.4% vs 51.6%±14.0%
, p=0.61, n=10). In addition, there was a significant improvement of left
ventricular myocardial perfusion at 6 months in BMT group valuated
by the semiquantitative score of myocardial perfusion defects, which
were decreased from 22.6±9.2 at one week after PCI to 13.3±11.2
(p=0.002). No severe ventricular arrhythmia exists in both groups.
Conclusions: In patients with acute anterior myocardial infarction,
emergency intracoronary transfer of autologous BMMCs seems to be safe
and effective in improving the left ventricular systolic function as well as
the myocardial perfusion in 6 months follow-up.
TCT-54
Improvement of Myocardial Perfusion and Left Ventricular
Function in Patients with Ischemic Heart Disease after Combined
(Intramyocardial and Intracoronary) Bone Marrow-Derived Stem
Cell Therapy
Mariann Gyongyosi, Gilbert Beran, Irene Lang, Silvia Charwat, Noemi
Nyolczas, Heinz Sochor, Sholeh Zamini, Aliasghar Khorsand, Gerald
Maurer, Dietmar Glogar
Dept. Cardiology, Medical University of Vienna, Vienna, Austria
Background: Intracoronary or intramyocardial injections of bone marrow
(BM)-derived autologous stem cells improves myocardial perfusion and
function. The aim of the present study was to determine the effect of the
combined (intramyocardial plus intracoronary) injections of non-selected BM
mononuclear cell (MNC) treatment on stress-induced and rest perfusion defects
and global and segmental wall motion in patients with ischemic heart disease.
Methods: Eighteen patients (51+/-12 y, 89% male) with previous
myocardial infarction received combined (3.9+/-0.5 ml NOGA-guided
intramyocardial plus 26.2+/-13.5 ml intracoronary) injections of
autologous BM MNCs (total cell number: 4100+/-3732 million, CD34+:
4,9+/-4.2 million). Baseline and 6-month follow-up (FUP) gated 99mTc-MIBI-Persantin myocardial scintigraphy (measured parameters:
global ejection fraction /EF/, rest and stress-induced perfusion defects
expressed as % of the entire myocardium) and NOGA endocardial
mapping (measured parameters: mean unipolar voltage /UV/ and local
linear shortening /LLS/ values of the injected area) were perfomed.
Results: The resting (from 34.2+/-9 to 28.6+/-10.6%, p<0.05) and
stress-induced (from 37.8+/-8.7 to 32+/-9.8%, p<0.05) perfusion
defect decreased after 6 month. The mean UV value of the injected
area increased nonsignificantly. The number of the total injected BM
cells exhibited positive linear correlation with the FUP EF (p=0.01,
r=0.709) and LLS (p<0.05, r=0.628), and negative linear correlation
with the stress-induced (p=0.01, r=0.708) and resting (p<0.01, r=0.722)
perfusion defects. Interestingly, the absolute number of CD34+
positive cells showed only a week non-significant correlation with the
FUP myocardial perfusion and function parameters (max. r=0.562).
Conclusions: Intramyocardial plus intracoronary injections of large amount
of unselected BM MNCs induces significant improvement in myocardial
perfusion and function in patients with ischemic heart disease. It seems that
the functional benefit of BM MNCs is at least partly related to the paracrine
effects of the transplanted cells.
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TCT-55
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A Novel Population of Adult Derived Cardiac Progenitor Cells is
Capable of Functional Myocardial Repair
Harald C Ott, Thomas S Matthiesen, Johannes Brechtken, Xiangrong Xin,
Samuel A Barnes, III, Wendy D Nelson, Saik-Kia Goh, Doris A Taylor
University of Minnesota, Minneapolis, MN
Background: Embryonic cardiac progenitor cells can be identified
by expression of flk1 and the absence of CD31. We have isolated and
expanded a similar cardiac progenitor population from the ADULT
rat heart. We hypothesize that these adult cardioblasts (ACB) are
capable of functional repair if injected into infarcted myocardium.
Methods: ACBs were isolated and expanded from ventricles of five
F344 rats (10 wks of age). Cell characteristics were confirmed by FACS
analysis and immunofluorescence (60% flk1+, 75% SSEA-1+, 5% CD31+,
35% ckit+, 11% isl1+, 6% sca-1+, 4% ABCG2+). Myocardial infarction
was induced by LAD ligation in 20 F344 Fischer rats. Two weeks after
infarction, either 200 µl of saline containing 1*106 cells (ACB group, n=11)
or 200µl of saline (control group, n=13) were injected into six sites in and
around the infarction scar. Echocardiography was performed 1 week before
and 1, 3 and 5 weeks after injection. Pressure volume loops were recorded
6 weeks after injection and hearts were processed for histological analysis.
Results: EF improved in ACB treated animals from baseline to week 5
(34.8±4.2 to 56.5±6.5%, p=0.001) but decreased in controls (36.5±3.7 to
28.2±3.8%, p<0.001). At follow up but not at baseline, EF was higher in
ACB treated animals than in controls (baseline: 34.8±4.2 vs. 36.5±3.7%,
p=0.218; week 1: 53.8±10.6% vs. 32.8±6.8%, p<0.001; week 3:
57.7±11.6% vs. 28.2±3.3%, p<0.001; week 5: 56.5±6.5% vs. 28.2±3.8%,
p<0.001). Left ventricular remodeling was attenuated in ACB treated
animals compared to controls (week 5: LVEDD 7.7±0.4 mm vs. 9.1±0.8
mm, p=0.001). At 6 weeks, maximal +dp/dt was higher in ACB treated
animals than in controls (5965±943 vs. 3274±962 mmHg/s, p<0.001).
Relaxation time (tau) was shorter in ACB treated animals (15.8±3.4
vs. 22.7±3.7 ms, p=0.008). Infarct size assessed by morphometry was
reduced in ACB treated hearts (19.6 ± 5.6 vs 25.3±0.16 % of LV volume,
p=0.043). By histology, PKH labeled ACBs engraft in the infarction scar.
Conclusion: Isogeneic ACBs isolated from adult ventricular biopsies
engraft within injured myocardium after direct injection and improve both
systolic and diastolic left LV function after myocardial infarction.
26H
The 6th Annual Microvascular Reperfusion
and Primary Angioplasty Symposium:
Advancing the Frontiers of Acute Myocardial Infarction Therapy
Room 145AB
TCT-56
Does Vessel Size Have an Impact on The Efficacy of Distal Protection
in Patients Undergoing Primary Angioplasty? An EMERALD Trial
Analysis
Issam Moussa1, Roxana Mehran1, Alexandra Lansky1, Mitchell Krucoff2,
Raymond Gibbons3, Mansoor Qureshi4, Anna Kalynych5, Mark Turco6,
Heinz P. Schultheiss7, Gregg W. Stone1
1
Columbia University Medical Center, New York, NY;2Duke University
Medical Center, Durham, NC;3Mayo Clinic Foundation, Rochester,
MN;4St. Joseph Mercy Hospital, Ann Harbor, MO;5Crawford Long
Hospital, Atlanta, GA;6Washington Adventist Hospital, Takoma Park,
MD;7University Hospital Benjamin Franklin, Berlin, Germany
Background: Prior single-center, observational studies suggested
that slow reflow may be more common in larger vessels during
primary PCI for acute MI. This finding has not been reproduced in a
controlled multicenter trial. We sought to determine whether larger
vessels increase the liklihood of distal embolic complications during
primary PCI and whether distal protection may ameliorate this effect.
Methods: In the EMERALD trial, 501 patients presenting within 6
hrs onset of ST elevation MI at 38 international centers were randomly
assigned to PCI either with or without distal protection using the
GuardWire. Outcome measures included final TIMI flow and myocardial
blush, ST-segment resolution at 30 minutes, infarct size by tc-99m
sestamibi imaging (median day 10) and clinical outcomes through 6
months. Results were stratified by vessel size (>3.5mm vs. <3.5mm).
Results: Pts with larger compared to smaller vessels were more often males
(92% vs 75%, p=0.0004) and the culprit vessel was more often the RCA
(67% vs 47%, p=0.0009) with no differences between the groups with regard
to age, diabetes mellitus, time to presentation or adjunct pharmacologic
therapy. Outcomes as a function of randomization arm appear in the table:
Unprotected
>3.5 mm
<3.5 mm
(N=39)
(N=198)
Final slow
flow
13.5%
4.1%
Distal
10.3%
2.0%
emboli
Final
Blush 0
18%
21%
or 1
Infarct size 9.0 (1,24) 9.5 (0, 22.5)
Complete
ST
resolution
69%
61%
at 30
minutes
6 month
0.0%
3.7%
death
P value
0.038
0.027
0.82
0.95
Protected (GuardWire)
>3.5 mm <3.5 mm
(N=46)
(N=192)
Impact of Early Abciximab Administration before Primary
Percutaneous Coronary Interventions in Anterior Myocardial
Infarction on Reperfusion and Left Ventricular Function
Tomasz Rakowski, Dariusz Dudek, Jaroslaw Zalewski, Jacek Legutko,
Stanislaw Bartus, Lukasz Rzeszutko, Danuta Sorysz, Krzysztof Zmudka,
Jacek S Dubiel
Jagiellonian University Institute of Cardiology, Krakow, Poland
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Background: Early abciximab administration before primary
percutaneous coronary intervention (PPCI) for STEMI is
recommended in guidelines. However, the proofs supporting
abciximab use before and during transfer for PPCI are limited.
Aim: To assess the effect of early abciximab administration on
early reperfusion, ST-segment resolution and left ventricular
function in patients (pts) with first anterior wall STEMI.
Methods: A total of 54 non-shock pts with STEMI <12h admitted to remote
hospitals with anticipated delay to PPCI < 90 min were randomly assigned
to two study groups - 23 pts received abciximab before transfer to cath lab
(early=group EA) and 31 pts in cath lab immediately before PPCI (late=group
LA). All pts received aspirin and heparin (70U/kg) before transfer to cath lab.
Results: Baseline characteristics were similar in both groups. Angiography
revealed more frequent infarct-related artery patency in EA group
(TIMI2+3: 47.6 vs 20.7% p=0.04). Better ST-segment resolution
>50%, 60 min after PPCI was found in EA group (85.7 vs 58.6%
p=0.04). There was a significant difference in 30-day left ventricular
end-systolic volume index (LVESVI) in echocardiography (figure).
Conclusions: Early abciximab administration before transfer
for PPCI in patients with first anterior wall STEMI is feasible
and results in more frequent infarct-related artery patency before
PPCI, better myocardial tissue perfusion after PPCI and lower
degree of left ventricular remodeling during 30-day follow up.
TCT-58
p-value
2.2%
2.2%
6.3%
2.1%
0.47
1.0
16%
15%
0.82
17 (4, 22) 12 (2, 27)
TCT-57
0.38
0.45
67%
62%
0.72
0.24
2.3%
2.1%
0.62
Conclusion: Slow reflow and distal thromboemboli are more frequent
during primary PCI of large compared to small vessels. These complications
can be prevented by distal protection, however, no benefits were apparent in
terms of final blush score, ST resolution, infarct size, or survival.
Association of Myocardial Blush Grade (MBG) and ST-Segment
Resolution (STR) Predicts Late Major Ischemic Events after
Mechanical Reperfusion in Acute Myocardial Infarction (AMI) Results from the EMERALD Trial
Alexandra J Lansky1, Ricardo A Costa1, Roxana Mehran1, Ken Mori1,
Ecaterina Cristea1, Yangbo Na1, Rachel Sanchez1, Laura Cassidy1, Bruce
R Brodie2, David A Cox3, Daniel Dulas4, Anna Kalynych5, Mansoor
Qureshi6, Barry Rutherford7, Heinz-Peter Schultheiss8, Mark Turco9, John
Webb10, Raymond Gibbons11, Mitch Krucoff12, Gregg W Stone1
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Cardiovascular Research Foundation and Columbia University
Medical Center, New York, NY;2Moses Cone Heart and Vascular Center,
Greensboro, NC;3Mid Carolina Hospital, Charlotte, NC;4Mercy Hospital,
n/a, IA;5Emory University, Atlanta, GA;6St Joseph’s Hospital, Atlanta,
GA;7Cardiovascular Consultants, n/a, MD;8Medical Clinic II, n/a,
NY;9Washington Adventist Hospital, Washington, DC;10n/a, n/a, NY;11Mayo
Clinic, Rochester, MN;12Duke Clinical Research Institute, Durham, NC
We
report
the
impact
of
MBG
on
clinical
stenting.
outcomes
in
pts
with
AMI
undergoing
1ary
Methods:
451
pts
with AMI<6
hours
underwent
1ary
stenting and had MBG, infarct size and STR analyzed.
MBG was graded as absent - 0/1, reduced - 2, or normal - 3.
Results: MBG 0/1 had more diabetes vs. 2 vs. 3 (24.4 vs. 7.8 vs. 11.9%,
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p<0.01), LAD infarct (72 vs. 37.9 vs. 28.1%, p<0.01), greater delay
to reperfusion (3.9 vs. 3.8 vs. 3.5 hrs, p=0.03). MBG was not predictor
of death nor MACE; though the association of MBG 3 + STR >70% +
TIMI 3 predicted ischemic MACE (HR 0.32, 95%CI 0.11, 0.93, p=0.04).
Conclusions: MBG after 1ary stenting strongly correlates with infarct size,
late mortality and reinfarction. A significant interaction is observed between
MBG and STR in predicting ischemic MACE in pts with optimal epicardial
reperfusion.
Variable
MBG 0/1
MBG 2
MBG 3
P value
Infarct size*
29.06±22.42
16.92±19.81
13.84±15.57
<0.0001
†
(Imputed )
LAD infarct
32.67±22.68
27.24±25.48
24.73±21.23
0.17
size* (Imputed†)
Non-LAD infarct
23.56±21.18
11.00±12.03
10.17±11.09
<0.0001
size* (Imputed†)
6 Months
Outcomes
Death
8.0
5.1
1.2
0.01
Reinfarction
9.5
0.9
2.5
0.003
7.0
5.7
6.4
0.93
Ischemic TVR
Disabling stroke
2.8
1.9
0.4
0.19
New onset severe
5.3
1.9
1.2†
0.09
heart failure
New onset
sustained
16.8
11.7
8.7
0.15
hypotension
Rehospitalization
1.5
1.9
0.8
0.68
for LVF
MACE related
to ischemic
17.1
11.6
8.0
0.04
complications
MACE related to
left ventricular
21.9
15.4
11.2‡
0.06
dysfunction
LVF=left ventricular failure; *measured by tc-99m-sestamibi on day 14-21
postprocedure; † 70% infarct size imputed for deaths prior to data acquisition;
†
p=0.03 vs. MBG 0/1; ‡p=0.02 vs. MBG 0/1.
ACS. Potential problems with the clinical use of HBOC are vasoconstrictor
effects ( NO scavenging side effect), oxidation of free hemoglobin,
immunogenicity, and volume overload due to its colloidal properties.
Methods: In this randomized, 3-arm (1:1:1) , double-blind, placebocontrolled, dose-finding pilot (Phase II) study we assessed the overall
safety and tolerability of two doses (15g, 30g) of iv HBOC-201 (Biopure
Corporation, Cambridge, MA, USA) vs control (colloidal volume
expander) in patients with one vessel disease scheduled to undergo
modern-day PCI for UA/NSTEMI. Safety assessment included systemic
and coronary hemodynamics, untoward drug interaction effects, (serious)
adverse events, as well as biochemical markers of inflammation,
myocardial necrosis (CK, CK MB, troponin.), renal and hepatic function.
Results: This trial was completed in April 2005 and remains blinded pending
final cleaning of the data set. A total of 46 patients (age 38-74, 34 males) were
randomized at 5 centers in Europe. One patient withdrew Informed Consent
before receiving trial-specific treatment. Forty-one (serious) adverse events
were reported by the investigators, 26 were added by the independent
DSMB. We recorded no SAE judged related to the study drug. Alterations
in systemic hemodynamics with a critical rise in blood pressure (SBP >
180mmHg) was observed primarily in 2 of 3 treatment groups. Critical
blood pressure elevations were reduced following a protocol amendment
instructing antihypertensive treatment when necessary (7/30 patients before
vs. 2/16 patients after amendment). Elevations of hepatic and/or pancreatic
enzyme measurements were more common in 2 of the 3 treatment groups.
Conclusions: This trial is an important step in the safety assessment of a
potential new therapeutic agent for the management of cardiac ischemic
events. Comparison of adverse events in the treatment vs. control groups
following unblinded assessment will be presented.
TCT-59
Hemoglobin-Based Oxygen Therapeutics in (Elective)Percutaneous
(Coronary) Revascularization. A Phase II Pilot Safety and Feasibity
Study
Ton Slagboom1, Robert J de Winter2, Evelyn Regar3, Gerhard C Schuler4,
Holgar Thiele4, Geert Jan Laarman1, Guy R Heyndrickx1, Guy R
Heyndrickx5, Patrick W Serruys3
1
Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands2AMC,
Amsterdam, The Netherlands3Erasmus Medical Centre, Rotterdam, The
Netherlands4Herzzentrum Leipzig GmbH, Leipzig, Germany5Onze Lieve
Vrouw Ziekenhuis, Aalst, Belgium
Background: Because of their ability to perfuse and deliver oxygen,
hemoglobin-based oxygen carriers (HBOC) have been proposed to treat
28H
WEDNESDAY 10/19/05 10:21 AM-11:06 AM (Room 146A)
Platelet Inhibition II:
New Insights into Glycoprotein IIb/IIIa Antagonist Utilization
Room 146A
Wednesday, October 19, 2005, 10:21 am - 11:06 am
TCT-60
Evaluation of Novel Dose of c7E3Fab (Abciximab) On Periprocedural
Troponin I Release in Radial Access Percutaneous Coronary Stenting
as Elective Day case Procedure. The ENFORCED Study
Rajaram Anantharaman1,2, Srinivasan Manivannan1, Somnath Kumar1,
Jean Ansell1, Paul Kelsey1, Munir Pirmohammed2, Anoop Chauhan1,
David H Roberts1
1
Blackpool Fylde & Wyre Healthcare NHS Trust, Blackpool, UK,
Blackpool, United Kingdom2University of Liverpool, Liverpool, United
Kingdom
Background: Radial approach provides the safety and feasibility to do day case
percutaneous coronary intervention (PCI). Optimum anti-platelet treatment
for elective PCI is not well known. Standard dosing regimen of abciximab
could not be used for day case PCI and shorter infusion times has not been
studied before. We studied the effect of either bolus or bolus plus 6h infusion
of c7E3Fab(abciximab, Reopro) on Troponin I (TnI) release in elective PCI.
Method: In this prospective, randomized, placebo controlled study 180
consecutive patients suitable for elective PCI were recruited. Group1
(n=60): no abciximab, Group2 (n=60): bolus abciximab (0.25mg/kg)
and Group3 (n=60): bolus (0.25mg/kg) plus 6 hour infusion (0.125µg/
kg/m) of abciximab. All patients were pre-treated with Aspirin 300mg
and Clopidogrel 300mg 12 to 24 h pre-procedure. Blood samples were
collected for TnI and for inhibition of platelet aggregation (IPA) using
the Ultegra RPFA assay at baseline,(15minutes), 4h and 24h after study
drug was given. Primary end point was the incidence of TnI elevation
(>0.1µg/L) at 24h post procedure. Major adverse cardiac events (MACE)
including myocardial infarction (MI), target lesion revascularization
(TLR) and death at 24h and 30d post procedure were recorded.
Results: There were no significant differences between the 3 groups in
baseline and angiographic characteristics. Procedural success (residual
stenosis < 25%, without abrupt closure or symptomatic MI) was 96%,
with 95% receiving stents and in >95% through successful radial access
in all 3 groups. The results showed, elevated TnI% (38, 37 p>0.99, 35
p=0.71)respectively. The IPA% (15 minutes, 4h mean±standard deviation)
were 90.9±9.8, 78.1±10.7 and 92.8±6.0, 84.1±5.3 in groups 2 and 3
respectively. There was one death on day 28 in group 1 due to MI in the
community (1.6% MACE at 30d) and no MACE at 24h.(h=hours, d=days)
Conclusion: Addition of either bolus or bolus plus 6 hour infusion of
abciximab in patients pre-treated with Aspirin 300mg and Clopidogrel
300mg 12 to 24 hours pre-procedure is not associated with significant
decrease in elevated TnI during uncomplicated moderately complex elective
PCI inspite of acheiving adequate IPA (>80%).
TCT-61
Impact of Baseline Platelet Count on Outcomes of Patients
Undergoing Primary Percutaneous Coronary Intervention for Acute
Myocardial Infarction: Analysis from the CADILLAC trial
Eugenia Nikolsky1, Roxana Mehran1, Cindy L Grines2, Mark Turco3, David
A Cox4, James E Tcheng5, Bruce R. Brodie6, Giulio Guagliumi7, John J
Griffin8, Alexandra J Lansky1, Manuela Negoita9, Dennis John Mercado9,
Tayo Addo1, Gregg W Stone1
1
Columbia University Medical Center, New York, NY;2William Beaumont
Hospital, Royal Oak, MI;3Washington Adventist Hospital, Tacoma
Park, MD;4Mid Carolina Cardiology, Charlotte, NC;5Duke Clinical
Research Institute, Durham, NC;6The Moses H. Cone Memorial Hospital,
Greensboro, NC;7Ospedali Riuniti di Bergamo, Bergamo, Italy8Columbia
University Medical Center, Virginia Beach, VA;9Cardiovascular Research
Foundation, New York, NY
Background: Despite the role of platelets in the pathogenesis of acute
myocardial infarction (AMI) is well recognized, the relationship
between absolute platelet count and prognosis of pts with AMI
is unknown. We examined the database from the multicenter
randomized CADILLAC trial to determine the effect of baseline
platelet count on outcomes of pts with AMI treated with primary PCI.
Methods: In CADILLAC, of 2,082 pts, platelet count on admission was available
in 2,021 pts (97.0%). The median platelet count was 231x109/L (range: 38x109/
L to 709x109/L). Pts were divided into quartiles of baseline platelet count.
Results: Pts in higher quartiles of platelet count were younger, more
frequently female and current smokers, and had lower prevalence of prior
MI. Higher baseline platelet counts were associated with higher rates of
30-day reinfarction and ischemic target vessel revascularization (TVR), and
higher rates of 1-year death or reinfarction (Figure). Rates of target vessel
occlusion/thrombosis at 1-year steadily increased as baseline platelet count
increased (0.2%, 0.8%, 1.0% and 2.0%; P=0.03). By multivariate analysis
higher platelet count was an independent predictor of 30-day reinfarction
(HR=8.0, P=0.018), 1-year reinfarction (HR=4.0, P=0.02), and of 1-year
death (HR=3.16, P=0.02) but not of target vessel occlusion/thrombosis.
Conclusion: Higher baseline platelet count in pts with AMI undergoing
primary PCI should be recognized as an important risk factor for reinfarction
and death.
TCT-62
Different Effects of Tirofiban and Aspirin plus Clopidogrel on
Myocardial No-reflow and NOS in a Mini-Swine Model of Acute
Myocardial Infarction and Reperfusion
Yang Yuejin, Zhao Jinglin, Chen Jilin, Gao Runlin
Fu-Wai Heart Hospital, Beijing, China
Myocardial no-reflow is the inability to reperfuse a myocardial region
after prolonged ischemia, despite reopening of the infarct related artery.
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It has been verified that glycoprotein IIb/IIIa inhibitor tirofiban can
reduce myocardial no-reflow after acute myocardial infarction, though
the mechanism is still uncertain. We hypothesized that tirofiban reduces
myocardial no-reflow probably by protecting endothelium from injury.
Methods: Coronary ligation area and area of no-reflow were determined
with both myocardial contrast echocardiography in vivo and pathological
means in thirty-two mini-swines randomized into 4 study groups: 8 in
control, 8 pretreated with aspirin-clopidogrel combination (A-CC) for 3
days, 8 given an intravenous infusion of tirofiban and 8 in sham-operated.
Acute myocardial infarction and reperfusion model were created with threehour occlusion of the left anterior descending coronary artery followed by
one-hour reperfusion. Results: Both A-CC and tirofiban significantly and
equivalently decreased the maximal platelet aggregation rate from 45.7±6.2%
and 46.8±7.2% to 14.3±5.6% and 12.9±3.6% respectively (both P<0.01),
suggesting both have the same strong antiplatelet effect. Compared with the
control group, tirofiban significantly decreased area of no-reflow on both
methods from 78.5±4.4% and 82.3±1.9% to 22.8±4.2% and 23.2±2.7% of
ligation area respectively (both P<0.01), increased blood nitric oxide level
from 34.2±8.3 to 49.1.5±14.4 μmol/L (P<0.05), increased constitutive NOS
activity from 0.51±0.11 to 0.81±0.18 U/mg prot and mRNA expression from
0.47±0.13% to 0.66±0.12%, but decreased inducible NOS activity from
0.76±0.12 to 0.41±0.11 U/mg prot and mRNA expression from 0.54±0.13%
to 0.39±0.11% in reflow myocardium (all P<0.05-0.01). In contrast, A-CC
failed to significantly modify parameters above (all P> 0.05) except for
decreasing inducible NOS activity from 0.76±0.12 to 0.39±0.15 U/mg prot
(P<0.01) and mRNA expression from 0.54±0.13% to 0.40±0.07% (P<0.05).
In conclusion, tirofiban reduce myocardial no-reflow mainly because of
endothelial protection instead of antiplatelet activity.
30H
WEDNESDAY 10/19/05 10:30 AM-11:30 AM (Room 145AB)
Diabetes and Cardiovascular Disease: Attacking the Epidemic
Room 145AB
TCT-63
Outcomes of Percutaneous Interventions in Diabetics Treated with
Drug Eluting Stents or Bare Metal Stents: SOLACI Registry Results
Amanda G M R Sousa, Andrea S Abizaid, Ernesto Ban Hayashi, Fausto
Buitron, Irving Peña, Expedito Ribeiro, Eugenio Marchant, Jorge Belardi,
Alberto Suarez, Hugo Londero, Marco Martinez Rios, Daniel Berrocal, J
Eduardo Sousa, on behalf of SOLACI Registry Participants
Latin American Society of Interventional Cardiology - SOLACI, Sao
Paulo, Brazil
Background: Diabetes mellitus has a deleterious influence on early
and late outcomes after BMS. DES become available for clinical use in
Latin America since May 2002. Therefore, we sought to investigate the
1-year results of diabetics (IDDM and NIDDM) treated with sirolimus
(SES) and paclitaxel (PES) eluting stents in the 2003 SOLACI database
compared to diabetics treated with BMS in the same period of time.
Methods:
Specific
questionnaires
were
sent
to
the
registered
sites
in
20
Latin
American
countries.
Results: 4,357 diabetics patients (P) treated with stents were included in the
database: BMS=3.724 (85.5%); SES=353 (8.1%); PES=280 (6.4%). The
clinical and angiographic characteristics as well as the 1-year MACE are
displayed in the table.
Patients (n)
Female Gender (%)
Mean age (y)
Clinical Presentation
Unstable Angina (%)
AMI (%)
Angiographic Data
MVD (%)
EF ≤ 40% (%)
Ref Diam (mm)
Target Lesion
B2/C type (%)
Lesion Length (mm)
1 year MACE
Death (%)
MI (%)
TVR (%)
MACE (%)
SES
353
34.6
60.2±6
PES
280
33.7
59.3±7.9
BMS
3,724
38.8
61.8±3.1
41.1
8.8
58.4
5.1
49.8
10.8
52.1
24.7
2.78±0.20
37.1
36.8
2.90±0.27
41.6
30.6
3.01±0.18
65.6
18.74±6.12
64.1
20.93±5.49
49.3
16.98±2.99
2.16
1.17
5.74
9.07
0.41
1.32
4.04
5.77
1.84
6.13
17.5
25.48
Conclusions: Routine utilization of SES and PES for diabetic patients
reduces importantly the rate of TVR and adverse cardiac events at 1-year
compared to bare metal stent implantation.
TCT-64
Outcomes in Diabetic Patients with Multivessel Disease and Long
Lesions: Results from the DECODE STUDY
Charles Chan1, Robaayah Zambahari2, Upendra Kaul3, Sidney A Cohen4,
Maurice Buchbinder5, on behalf of the DECODE Study Investigators
1
National Heart Centre, Singapore, Singapore2National Heart Institute,
Kuala Lumpur, Malaysia3Batra Hospital and Medical Research Centre,
New Delhi, India4Cordis Corporation, Warren, NJ;5Foundation for
Cardiovascular Medicine, La Jolla, CA
Background: Safety & efficacy of multi-vessel/multi-lesion
intervention with drug-eluting stents in diabetic patients is unknown.
The hypothesis of the DECODE study was that safety and efficacy
outcomes with SES (CYPHER®, Cordis Corp, Warren, NJ) would
be superior to outcomes with BMS (Bx VELOCITY™, Cordis Corp,
Warren, NJ) in diabetic patients with de novo native coronary lesions.
Methods: 200 patients with up to 2 lesions in up to 2 vessels were to be
randomized 2:1 (SES vs. BMS). Up to 3 stents per patient were allowed.
Life-long Aspirin and 12 weeks post-procedure Plavix were administered.
The primary endpoint was 6 month angiographic in-stent late loss. The
trial was terminated early following the recommendation of the DSMB
with a total of 83 diabetic patients (128 lesions) enrolled at 4 US and 7
Asia/Pacific sites. 54 patients were randomized to SES and 29 to BMS.
Results: Results are presented in the table below. Compliance to repeat
angiography at 6 months was 93%. There were 11 patients (7 SES, 4 BMS)
in whom all lesions treated were > 20 mm.
Age
Male
Insulin treatment required
Oral medication
HbA1C level
At baseline
At six months
Number of lesions treated
Number of vessels treated
RVD
Lesion length
MACE at 6 months
Death
Myocardial infarction
Target lesion
revascularization
Stent thrombosis
In-stent late loss
All patients
Long lesions (>20mm)
In-stent binary restenosis
All patients
Long lesions (>20mm)
SES
59±10 years
68.5% (37/54)
18.5% (10/54)
88.9% (48/54)
BMS
62±10 years
65.5% (19/29)
20.7% (6/29)
96.6% (28/29)
p-value
0.118
0.810
1.000
0.412
7.85%
7.67%
1.5
1.4
2.51 mm
15.06 mm
11.1% (6/54)
0
1.9% (1/54)
9.3% (5/54)
0
7.38%
6.87%
1.6
1.5
2.51 mm
15.03 mm
34.5% (10/29)
6.9% (2/29)
6.9% (2/29)
27.6% (8/29)
0
0.226
0.028
0.460
0.346
0.957
0.915
0.018
0.119
0.278
0.054
---
0.23 mm
0.11 mm
1.10 mm
0.90 mm
<0.001
0.001
9.0% (7/78)
0
52.4% (22/42)
50.0% (2/4)
<0.001
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Conclusion: In diabetic patients, SES was shown to be superior to BMS for
both the primary endpoint, in-stent late loss, as well as MACE at 6 months,
despite the inclusion of patients with > one vessel/lesion, or lesion length >
20 mm. The SES late loss of 0.23 mm is consistent with measurements of
late loss in non-diabetic patients from other CYPHER trials.
TCT-65
Late Clinical Outcomes of Diabetic Patients Receiving DrugEluting Stents in the U.S.: Results from the Strategic Transcatheter
Evaluation of New Therapies (STENT) Group
Barrett Cheek1, Steven Rohrbeck1, Darryl Kalil1, Bruce Brodie2,
Christopher Metzger3, James Hermiller4, Stanley Juk5, Fred Krainin6,
Henry S. Jennings, III7, Charles A. Simonton8, Angela D. Humphrey9
1
High Point Regional Health System, High Point, NC;2LeBauer
Cardiovascular Research Foundation, Greensboro, NC;3Wellmont Holston
Valley Medical Center, Kingsport, TN;4St. Vincent Indianapolis Hospital,
Indianapolis, IN;5Sisters of Charity Providence Hospitals, Columbia,
SC;6McLeod Regional Medical Center, Florence, SC;7Saint Thomas
Hospital, Nashville, TN;8Carolinas Heart Institute, Charlotte, NC;9R.
Stuart Dickson Institute for Health Studies, Charlotte, NC
Introduction: Recent small randomized trials and registries
have shown favorable improvement in restenosis in diabetics
receiving drug-eluting stents (DES) outside the U.S. This report
provides the late clinical outcomes of “real-world” diabetics
receiving DES from a multicenter, prospective registry in the U.S.
Methods: The STENT Registry represents the first U.S. multicenter
prospective registry for drug-eluting stents initiated in May 2003. All PCIs
are enrolled prospectively at 8 participating centers with clinical follow-up
at 3 and 9-months. Data is entered into a centralized web-based database
and major events are adjudicated by the physician principal investigators.
Results: Through February 2005, a total of 1988 DES-only procedures
have reached 9-month follow-up with a follow-up rate of 88% of all
procedures. Of these, there were 589 diabetics (29% of total) with 390
diet/oral diabetics (20%) and 181 insulin-treated diabetics (9%). Baseline
variables show mean age 63 yrs, male 63%, acute coronary syndrome
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74%, multivessel disease 59%, LVEF 52% and urgent/emergent procedure
indication in 79%. Average vessel diameter was 3.0 mm with lesion length
15.7 mm, and 1.4 DES per procedure. Late outcomes show target vessel
revascularization (TVR) of 2.1% overall, 1.9% for diet/oral diabetics and
2.8% for insulin-treated diabetics. In-stent thrombosis occurred in 1.0% of
diet/oral and 0.5% of insulin diabetics. Overall MACE (death, MI, TVR)
occurred in 8.4% overall, 6.2% in diet/oral and 12.7% in insulin-treated
diabetics. Insulin diabetics showed almost twice the rate of MI and death
compared to diet/oral diabetics (MI 3.3% vs. 1.0%)(death 7.7% vs. 3.6%).
Conclusions: Clinical restenosis is highly suppressed with DES in “realworld” diabetic coronary intervention. However, insulin-treated diabetics
continue to show higher MACE rates than non-insulin diabetics due to a
higher incidence of MI and mortality.
TCT-66
Drug-Eluting Stents: Clinical and Angiographic Outcomes in Diabetic
Patients
Dharam J Kumbhani1, Anthony A Bavry2, Thomas J Helton2, Deepak L
Bhatt2
1
University of Pennsylvania, Philadelphia, PA;2Cleveland Clinic
Foundation, Cleveland, OH
Objective: Diabetic patients have higher rates of poor outcomes after
percutaneous intervention, including greater rates of MACE (major adverse
cardiac outcomes), TLR (target lesion revascularization), TVR (target
vessel revascularization) and restenosis. Although drug-eluting stents
improve outcomes across a wide range of patients and are commonly
used in diabetic patients, their exact effect in diabetic patients has not
been quantified. Accordingly we sought to systematically estimate the
degree of benefit from the use of drug-eluting stents in diabetic patients.
Methods: We conducted a meta-analysis on 8 studies that compared
outcomes in diabetic patients who received drug-eluting or bare metal stents
(SIRIUS, E-SIRIUS, RAVEL, DIABETES-I, TAXUS-II, -IV, -V and -VI).
Results: A total of 1,497 diabetic patients were randomized to receive
either a drug-eluting stent (sirolimus or paclitaxel) (n=713) or a bare
metal stent (n=784). Clinical follow-up ranged from 9 to 12 months.
The number of insulin-dependent diabetics (IDDM) ranged from 23%
to 35%. Major adverse cardiac outcomes were reduced 61% by drugeluting stents [Risk Ratio (RR)=0.39, 95% confidence interval (CI)
0.29-0.53, p<0.0001]. This outcome was driven primarily by a 66%
reduction in TLR (RR=0.34, 95% CI 0.25-0.46, p<0.0001). This effect
was similar for sirolimus and paclitaxel-eluting stents, and for IDDM and
non insulin-dependent diabetic (NIDDM) patients. The number needed
to treat to prevent 1 TLR was 8 patients (95% CI 6-10). There was no
difference in the risk of myocardial infarction (RR=0.50, 95% CI 0.221.14, p=0.099) or stent thrombosis (RR=0.31, 95%CI 0.03-2.88, p=0.30).
Conclusions: Drug-eluting stents are effective in both IDDM and NIDDM
patients in significantly reducing major adverse cardiac outcomes. Only 8
diabetic patients need to be treated to prevent one TLR. Clinical events such
as myocardial infarction are non-significantly reduced from the use of drugeluting stents, while there is no difference in the risk of stent thrombosis.
32H
Coronary Stent Design and New Clinical Trial Insights
Room 151AB
TCT-67
Evaluation of the Effectiveness of a Stent Covered with Biosynthetic
Cellulose Compared to Bare Metal Stent in a Rabbit Model of
Angioplasty.
Ronaldo R L Bueno1, Enio E Guerios1, José C E Tarastchuk1, Paulo M P
Andrade1, Deborah C Nercolini1, Frederico T Ultramari1, Luiz F Farah2,
Pablo A. Sanchez2
1
Hospital Universitario Evangelico, Curitiba, Brazil2Bionext, Curitiba,
Brazil
Background: The biosynthetic cellulose (BC) is a perfectly biocompatible
tissue used in several fields of medicine, mainly with reconstructive
purposes. Its use has never been tested in endovascular system.
Objective: to compare the efficacy of angioplasty performed with
conventional bare metal stents (BMS) and with a newly developed
stent covered with BC (SCBC)in an experimental model in rabbits.
Methods: Seven BMS and 7 SCBC were implanted in the iliac arteries
of 7 rabbits. Four weeks after stent implantation, they were restudied
angiographically and with intravascular ultrasound (IVUS). The rabbits
were sacrificed and the specimenswere analysed hystologically.
Results: No intra-stent angiographic restenosis was observed, either with
BMS or with SCBC. The results of IVUS analysis are depicted in the table.
Conclusions: These results demonstrate that BC has no adversal effects in
endovascular system. Indeed, 4 weeks after implantation in iliac arteries of
rabbits, a higher intra-stent luminal cross-sectional area was obtained with
SCBC compared to BMS. Being totally biocompatible, BC has the potential
to accelerate reendothelization of the stented area, act as a barrier to smooth
muscle cell migration, deliver drugs and be a platform for endothelial cell
seeding, suggesting a novel approach in the treatment of restenosis.
CSA=cross sectional area (mm2)
Mean reference CSA (mm2)
Stent CSA (mm2)
Lumen intra-stent CSA (mm2)
Neointima area (mm2)
SCBC
6.3± 1.4
6.7± 0.9
5.7± 0.8
1.0± 0.3
BMS
6.4± 1.3
6.4± 1.3
5.3± 0.9
1.1± 0.5
p-value
0.87
0.15
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0.82
TCT-68
Safety and Feasibility of Novel Guidewire-Based Self-Expanding Stent
Delivery System
Masao Yamasaki1, Yasuhiro Honda1, Yoichiro Hongo1, Bill George2, Julian
Nikolchev2, Paul G Yock1, Peter J Fitzgerald1, Marc Gradman3
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Stanford University Medical center, Stanford, CA;2CardioMind, Inc.,
Sunnyvale, CA;3Palo Alto Medical Foundation, Stanford, CA
Background: Despite the significant advantage of neointimal suppression,
the clinical benefit of drug-eluting stents is occasionally hampered by
the limited deliverability and accessibility of the balloon-expandable
delivery system through complex coronary anatomy. This study evaluated
the safety and feasibility of a new guidewire-based self-expanding
stent delivery system designed to address these clinical problems.
Methods: The CardioMind stent system (CardioMind, Inc. Sunnyvale,
CA) consists of a bare-metal self-expanding nitinol stent incorporated into
an assembly miniaturized to a 0.014-inch profile, offering a guidewirelevel crossing profile and flexible performance for small or tortuous vessel
stenting. To date, a series of different prototypes (n=20) have been evaluated
in 7 swine normal coronary artery models (5LAD, 9 LCX, and 6 RCA).
To test the deliverability in challenging anatomy, distal small segments of
coronary vessels were selected as the target sites. Stents were 2.0 to 3.0
mm (median: 2.5 mm) in nominal diameter and 12 or 18 mm in length.
Results: All but 2 stents of 1 particular prototype were successfully
implanted in the coronary segments (5 LAD, 7 LCX and 6 RCA). Poststent 3D-IVUS analysis, performed in a subset of 11 cases, showed
uniform and complete stent expansion over the stented segment (reference
lumen diameter: 2.3±0.3 mm; stent diameter: 2.3±0.2 mm; symmetrical
index as minimum/maximum stent diameter: 0.88±0.05). No adverse
vessel response was observed including stent edge tears, thrombus
formation, and intra-stent tissue protrusions, except for one case of
vessel damage at the distal adjacent segment, associated with postdeployment imaging procedures. Incomplete apposition was observed
in 3 cases, due to intentional nominal stent-vessel size mismatch.
Conclusion: The novel guidewire-sized stent system demonstrated feasible
deliverability and accessibility with good stent expansion in swine coronary
models. This platform may further enhance the clinical utility of drugeluting stents to treat complex lesions with challenging anatomies.
TCT-69
Low Thrombogenicity Human Recombinant Elastin Protein - A New
Physiologic Coating for Vascular Stents
Kenton W Gregory1, Brian H Kim2, Carl Wamser2, Jeffrey Teach1, Robert
W Glanville1, Maria Anderson1, Zhen Ren1, Ann Bazar1, Rui-Qing Qian1,
Russell Jones3, Renu Virmani3, Elias Rivera3
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Providence Health System, Portland, OR;2Portland State University,
Portland, OR;3CV Path, Gaithersburg, MD
Drug eluting, coated metal stents reduce restenosis but may increase
thrombogenicity and reduce endothelialization compared to bare
metal stents(BMS). Elastin proteins have been shown to have low
thrombogenicity, down regulate smooth muscle cell migration and also bind
drugs. We investigated the biocompatibility of a covalently bound human
recombinant elastin (HRC) metal stent coating and its potential to reduce
thrombogenicity in porcine coronary arteries. Thombogenicity, inflammation
and endothelialization were assessed in 40 domestic swine 7 and 14 days
after HRC coated (5 µm thickness) and uncoated 3mm x 12mm MedtronicAVE S7 stents were randomly placed in LAD or LCX arteries. Swine were
pretreated with aspirin and clopidegrel, anesthetized and given IV Heparin
(ACT > 250 sec) during stent deployment. Clopidegrel and aspirin were
given orally until sacrifice where endothelialization, inflammation and
thrombosis were assessed with angiography, light and scanning microscopy.
The operator and observers were blinded as to treatment effect. There were
no acute, sub-acute or angiographic evidence of occlusive thrombus in either
group. Percent endothelialization was not significantly different at 7 days in
HRC coated or uncoated stents, 93.9% ± 3.0 vrs 96.8 % ± 2.8; p = 0.115.
Fibrin amount was reduced in HRC coated stents-score: 1.22 ± 0.54 vrs 2.0
± 0.00 in BMS; p = 0.017. Stent struts % with fibrin attached was reduced in
HRC coated stents 85.44% ± 8.28 vrs 97.75% ± 4.44 in BMS; p = 0.009 at 7
days and 23.43% ± 9.57 vrs 90.2% ± 7.70; p = 0.017 at 14 days. Inflammation
scores were not significantly different at 7 and 14 days in either group.
Conclusions: Human recombinant elastin protein coatings reduced
thrombus adherance to metal stents at 7 and 14 days. Inflammation and
endothelialiazation were not affected even though this was a human protein
placed in a swine artery. Human recombinant elastin proteins may be an
improved and more physiologic coating with inherent favorable vascular
effects as well as serve as an improved platform for intravascular drug
delivery over present stent and stent coating technologies.
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TCT-70
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Nitinol Stent Fractures: Benign? or Malignant? Angiographic and
Fluoroscopic Follow-Up in 110 Superficial Femoral Artery Stents
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Background: Superficial femoral artery (SFA) in-stent restenosis (ISR) rates
of > 30-50% have raised concerns regarding current SFA stent technology
prompting the development of new stent designs and local drug delivery
systems. 6/33 (18.1%) nitinol stent fractures (NSF) were reported “clinically
benign” at 6 months in the SFA birdlimes-eluting stent study (SIROCCO)
but a 40% ISR rate was reported at 24 months. Recent published data
from Europe regarding the FEmoral STenting in Obstructions (FESTO)
trial have suggested high NSF rates that are associated with significantly
decreased SFA patency rates versus stented SFAs without fracture.
Methods: Between January 2000-May 2004, 110/380 (28.9%) SFA stented
patients had repeat angiography and NSF analysis using fluoroscopy
magnification. A NSF classification was developed: I = single strut fracture,
II = multiple strut fractures, III = complete linear horizontal NSF without
displacement, IV= class III with displacement. 72/110 (65.5%) developed a NSF.
Results: See table analyzing NSF by classification, location and
angiographic stenosis.
Table.
I
II
III
IV
NSF Classification
N = 72
%
27
37.5
32
44.4
11
15.2
2
2.7
< 50%
10
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Angiographic
Stenosis
> 50%
15
2
23
5
7
4
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NSF Analysis by Location
Stent Use Stent Site NSF Site
SFA
N = 72
N = 110
Proximal
1
7 (6%)
2 (29%)
(P)
Mid (M)
1
13 (12%) 3 (23%)
Distal (D)
1
10 (9%)
5 (50%)
P-M
2
19 (17%) 13 (69%)
M-D
2
23 (21%) 15 (65%)
P-M-D
3-5
38 (35%) 34 (89%)
NSR 72/110 (65.4%)
Average Lesion Length: 98 +/- 70 mm
Time to Angiography: mean = 10-month (range 2-32)
Stents per case: mean = 2.3 (range 1-5)
Symptomatic
7 (26%)
15 (47%)
9 (82%)
2 (100%)
Classification
I II III IV
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86
2 22 8 2
Conclusion: Nitinol stent fractures occurred frequently, 72/110 (65.5%),
in this angiographic selected SFA patient population and are associated
with significant angiographic restenosis. Multiple stent use is particularly
associated with stent fracture, restenosis, and higher NSF classifications.
Nitinol stent fractures in the SFA require further investigation.
34H
WEDNESDAY 10/19/05 11:02 AM-12:02 PM (Room 147AB)
Plaque Modification and Debulking in the Drug-Eluting Stent Era:
Atherectomy, Atherotomy, and Laser
Room 147AB
Wednesday, October 19, 2005, 11:02 am - 12:02 pm
TCT-71
Rotational Atherectomy Prior to the Stenting with Sirolimus-Eluting
Stent for Long Coronary Lesions: Multicenter Registry in Asia
Sunao Nakamura1, Jang-Ho Bae2, Yeo H Cahyadi3, Wasan Udayachalerm4,
Damras Tresukosol5, Sudaratana Tansuphaswadikul6
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New Tokyo Hospital, Matsudo, Japan2Konyang University Hospital,
Daejeon, Republic of Korea3Husada Hospital, Jakarta, Indonesia4King
Chulalongkorn Memorial Hospital, Bangkok, Thailand5Siriraj Hospital,
Bangkok, Thailand6Chest Disease Institute, Bangkok, Thailand
Background: Sirolimus-eluting stent (SES) have been reported
to be effective in preventing neointimal formation and reducing
restenosis.
However,
the
optimal
percutaneous
coronary
intervention (PCI) for long lesions (≥30 mm) is still unknown.
Methods: We assessed baseline clinical and angiographic characteristics,
in-hospital and 12-month major adverse cardiac events (MACE) in
482 consecutive patients with long coronary lesions. Patients were
divided into 355 patients, 427 lesions treated with one or more SES
and 127 patients, 149 lesions treated with rotational atherectomy
(mean burr/artery ratio 0.70, mean burr size 1.98 mm) prior to SES.
Results:
The
baseline
clinical
characteristics
between
2 groups were similar. See table for the clinical results.
Conclusion: In long lesions, rotational atherectomy prior to Sirolimuseluting stenting provide an advantage in terms of long-term clinical and
angiographic outcomes.
SES
Rota+SES
Number of patients/lesions
355/427
127/149
In-hospital
Procedural success (%)
97.2
98.4
MACE (%)
0.8
0.8
Lesion length (mm)
35.8 ± 10.8 37.8 ± 12.5
MLD post (mm)
2.58 ± 0.66 2.70 ± 0.70
12-month
MACE (%)
1.1
1.6
Angiographic restenosis
10.7
4.7
(%)
Repeat PCI (%)
8.5
3.9
In-lesion late loss
0.35 ± 0.40 0.19 ± 0.25
p
NS
NS
NS
NS
NS
<0.05
<0.05
<0.05
TCT-72
Treatment of Left Main Lesions Using a Strategy of Atherectomy
and Placement of a Single Drug-Eluting Stent is Safe, Effective, and
Results in Excellent Clinical Outcomes
David C Metzger1, Gregory A. Braden2, Sudershan Gupta1
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Cardiovascular Associates, P.C., Kingsport, TN;2Forsyth Memorial
Hospital, Winston-Salem, NC
Background: Percutaneous interventions (PCI) of left main (LM) lesions
have been limited by a relatively high restenosis rate, sometimes manifesting
as sudden cardiac death. Drug-Eluting Stents (DES) have reduced restenosis in
other coronary lesions, but little data is available in LM lesions. Pretreatment
with atherectomy to debulk the LM and prevent plaque shift into the LAD
or Circumflex, followed by single DES placement and high pressure PTCA
to assure stent apposition may be an effective strategy for these LM lesions.
Methods: We treated 24 patients (ages 70 ± 9) at two high volume
centers with atherectomy (15-RA, 9-DCA), implantation of a 3.5
mm DES, and high pressure ( 4.1 ± 0.28mm) PTCA. Ten patients
were “protected” by 1 graft, 7 were “unprotected’. Procedural
success and in hospital complications were recorded. Patients with
unprotected LM lesions had routine cath at 3-4 months. The remaining
patients were seen at 2 months and 6 months, with events recorded.
Results: Procedural success (TIMI 3 flow, <30%residual stenosis, no
major complications) was 100%. There were no in-hospital myocardial
infarctions or deaths. . Six patients (“unprotected” LM) had cath at 34 months with widely patent LM DES; the seventh unprotected LM
patient is asymptomatic at 2 months. Two “protected” LM patients
underwent cath, with patent LM DES. There was one death at 4 months,
with the patient having an MI in the LAD after a SVG insertion (LM
DES patent at time of emergent cath). The remaining patients are
asymptomatic, with fourteen patients having completed 6 month follow up.
Conclusions: Treatment of left main stenosis with atherectomy, drugeluting stents, and high pressure PTCA is safe and effective with a low
incidence of clinical events at 6 months follow-up and excellent patency at
3-4 month follow up catheterization. Long term registries and randomized
trials should help to determine if this is the preferred treatment of patients
not sent for surgical revascularization.
TCT-73
Treatment of Bifurcation Lesions with Atherectomy and Drug-Eluting
Stenting of the Parent Vessel: An Effective Strategy with Excellent
Procedural and Clinical Outcomes in a Large Series
David C Metzger1, Eduardo Balcells1, Gregory Braden2
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Cardiovascular Associates, P.C., Kingsport, TN;2Forsyth Memorial
Hospital, Winston-Salem, NC
Background: Bifurcation Lesions (BIF) represents a significant challenge
for percutaneous interventions (PCI), with lower procedural success and
high restenosis rates. Drug-Eluting Stents (DES) have lowered restenosis in
non-bifurcated lesions, but BIF lesions treated with DES continue to have
high restenosis rates. Atherectomy of bifurcation lesions, with debulking
and avoidance of plaque shift into the Branch Vessel (BV), followed
by DES in the Parent Vessel (PV), may preserve the benefits of DES in
the PV, while maintaining patency of the BV without stent placement.
Methods: We treated 50 patients with BIF lesions with atherectomy and
DES of the PV. The BV was treated with PTCA and/or atherectomy, with
provisional stenting with a DES only if dissection or residual stenosis of
>50% was present. Procedural success and in-hospital complications
were recorded. Patients were seen at 2 months and 6 months clinical
follow-up, or if they had new angina, and events were recorded.
Results: Fifty (50) patients (age 58 ± 8) were treated with atherectomy
and DES. Thirty-two patients underwent Rotational Atherectomy (RA),
and 18 patients had Directional Coronary Atherectomy (DCA). The BV
was treated with PTCA (or cutting balloon) in 28 patients, RA ± PTCA
in 10 patients, RA + DES in 2 patients, PTCA + DES in 1 patient, DCA
± PTCA in 9 patients. Kissing balloon PTCA was performed in 19
patients. Procedural success (TIMI 3 flow, <30% residual stenosis, no
major complications) was 100%. There was one in-hospital NSTEMI,
and no deaths. At follow-up (29 completed 6 months, 15 completed 2
months follow-up), there have been two incidences of restenosis, both in
unstented branch vessels subsequently treated with a DES in each case.
No deaths or MI’s have occurred, and other patients are asymptomatic.
Conclusions: Treatment of bifurcation lesions with atherectomy and DES
of the parent vessel, with provisional stenting of the branch vessel, is safe
and effective, with a low clinical restenosis rates. Angiographic followup of these patients as well as a randomized trial against PTCA and DES
of the parent vessel will help determine if this is the preferred treatment
approach.
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TCT-74
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Plaque Excision with a Novel 8-French Compatible Device followed by
Paclitaxel-Eluting Stent Implantation for the Treatment of Complex
Coronary Lesions: Initial Experience
Alessandra Repetto1, Marco Ferlini2, Nedy Brambilla3, Maurizio
Ferrario1, Umberto Canosi1, Barbara Marinoni1, Davide Personeni1,
Luigi Angoli1, Ezio Bramucci1, Luigi Tavazzi1, Luigi Tavazzi1
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IRCCS Policlinico San Matteo, Pavia, Italy2Istituto Clinico Humanitas,
Rozzano, Italy3Istituto Clinico Sant’Ambrogio, Milano, Italy
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Background Since plaque shifting at the edges of a stent may play a role
in causing restenosis, coronary plaque excision before stent implantation
could be added to the local drug effect of drug-eluting stent in complex
lesions. The aim of the present study was to evaluate the results of
optimal plaque excision followed by paclitaxel-eluting stent (PES)
implantation for the treatment of de novo complex coronary lesions.
Methods and Results 53 patients/53 lesions (65±10 years, 72% males)
with myocardial ischemia and ostial/proximal LAD lesions (43%) or lesions
involving bifurcation (57%) underwent successful plaque excision (residual
stenosis <20%) before PES implantation. Plaque excision was performed
using a novel 8Fr compatible device (SilverHawk-Fox Hollow Technologies,
Redwood City, CA, USA). No procedural complications occurred. There
were 3 post-procedure non-Q-wave MI (CK-MB>2 times the upper normal
limit). During the median clinical follow-up of 9.2 months, neither death
nor MI occurred. Three patients experienced TLR (6%) due to recurrence of
angina symptoms. Acute and follow-up angiographic results are shown in
table. Binary restenosis rate at 8.6 months median time was 9%.
PRE
RD (mm)
Side branch
MLD (mm)
Side branch
DS (%)
Side branch
Acute gain
Late loss
2.92±0.31
2.23±0.41
0.59±0.29
0.97±0.62
81±9
56±24
POST-DCA
2.91±0.27
2.18±0.41
25±14
POST-PES
instent
3.04±0.26
2.29±0.30
2.93±0.36
1.53±0.50
5±12
33±19
2.35±0.37
FU at 8.6 months [n=31 (58%)]
prox edge
dist edge
3.11±0.36
2.75±0.41
instent
3.10±0.29
2.16±0.34
2.69±0.67
1.23±0.62
13±21
44±26
prox edge
dist edge
2.97±0.52
2.54±0.33
0.29±0.67
0.17±0.39
0.19±0.36
Conclusions The combined approach of plaque excision and PES
implantation appears feasible and safe in acute phase and in mid-term
follow-up in patients with coronary complex lesions. The preliminary
results show a favorable TLR rate at 9 months. For bifurcation lesions, the
results on side branch are promising too.
36H
Chronic Total Occlusions: Exploring the Final Frontier
Room 151AB
Wednesday, October 19, 2005, 2:39 pm - 3:39 pm
TCT-75
Percutaneous Coronary Intervention for Chronic Total Occlusions:
Improved Survival for Patients with a Successful Revascularization
Procedure Compared to a Failed Procedure
Shahid Aziz, Anthony D Grayson, Rodney H Stables, David R Ramsdale
The Cardiothoracic Centre, Liverpool, United Kingdom
Background: We performed a retrospective study comparing
the survival between patients with a successful and a failed CTO
revascularization by percutaneous coronary intervention (PCI).
Methods: Between 1/1/2000 and 30/6/2004, 543/5803 (9.4%) patients
underwent PCI for a CTO at our centre. A CTO was defined as an
occlusion of the artery present for at least 3 months with thrombolysis
in myocardial infarction (TIMI) flow grade 0 or 1. Patient records were
linked to a national database to monitor all deaths during follow up.
Propensity matching was used to balance out case mix differences.
Results: Technical success for CTO was 377/543 (69.4%). In-hospital
mortality was 0.3% and 1.2% for the CTO success and CTO failure patients
respectively. During a mean (SD) follow up of 2.4 (1.2) years, the mortality
rate was 2.5% in the CTO success patients and 7.3% in the CTO failure
patients. The crude hazard ratio for death with CTO failure was 3.92 (95%
confidence intervals 1.56-10.07; p=0.004). The rates of coronary artery
bypass and repeat PCI were 3.2% vs. 21.7% (p<0.001) and.10.8% vs.
5.1% (p=0.061) for the CTO success and CTO failure patients respectively.
We propensity matched 157 CTO success to 157 CTO failure patients;
mortality rates shown in the figure. The associated hazard ratio for death
with CTO failure was 4.63 (95% confidence interval 1.01-12.61; p=0.049).
Conclusion: Patients with a successful revascularization of a CTO by PCI
have an increased survival rate compared to patients with a failed CTO
procedure.
TCT-76
High Frequency Mechanical Recanalization of Chronic Total
Coronary Occlusions, Multi-Center European Study
Eberhard Grube1, Antonio Colombo2, Patrick Serruys3, Gabor Sutsch4
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Siegburg Heart Institute, Siegburg, Germany2Columbus Hospital
Center, Milan, Italy3Erasmus Medical Center, Rotterdam, The
Netherlands4University Hospital Zurich, Zurich, Switzerland
Background: Recanalization (RECA) of CTO (>30 days) remains
a challenge to PCI with varying success rates of 50% in routine and
80% in highly selected series. Procedure and fluoroscopy times (PT
and FT) with conventional techniques often exceed 90 and 40 min,
respectively. Failure is mostly caused by calcification and resistance to
conventional tools. The CROSSER™ High Frequency (HF) Mechanical
RECA System (FlowCardia, Inc., Sunnyvale, CA) facilitates crossing
of such CTO. The catheter (1mm, 6F guide compatible) is advanced
over any conventional 0.014” guidewire to the face of a CTO and
transmits the energy created by an ultrasound generator to its tip.
Methods: Ninety-seven CTO in 94 pts with documented unsuccessful
RECA attempts (>10 min of FT with traditional techniques) were enrolled
in a multi-center European prospective registry to study safety and
efficacy of CROSSER. Thirty pts were enrolled in a feasibility study to
test initial device safety. Following confirmation of safety and minor device
modifications a pivotal study was started. Primary endpoints (successful
RECA and MACE), time of device activation, PT and FT were recorded.
Results: CROSSER was well tolerated in all pts without any procedural
complications. No perforations occurred. Technical success was obtained
in 56 of 97 (58.8%) vessels (12 LAD, 19 Lcx, 64 RCA, 1 OM and 1
SVG) with an all over success (RECA followed by stenting and TIMI 2/3
flow) of 57.7%. The average length of the occlusions was 22mm (8-50).
Activation time of CROSSER averaged 2 min 49 sec. PT and FT were 1
h 39 min and 38 min respectively (an average of 14.7 min conventional
wire attempt and 24.0 min CROSSER/PCI procedure). Results show
that CROSSER is safe and effectively crosses CTO with a high clinical
success rate. Device improvements implemented following the feasibility
study achieved a higher success rate of 64.2% (64 pts, 67 CTO).
Conclusions: HF Mechanical RECA appears to be a safe and effective
technology to support RECA of CTO. This device is complementary to
conventional guidewire manipulation and has a high potential for CTO
treatment. However, additional trials (randomized or registries) are needed
to prove the efficacy of this novel device on a large scale.
TCT-77
Assessing the Safety and Effectiveness of Taxus in 183 Patients with
Chronic Total Occlusions: Insights from the TRUE Study
Eberhard Grube1, Giuseppe Biondi Zoccai2, Giuseppe Sangiorgi3, David
Antoniucci4, Bernhard Reimers5, Corrado Tamburino6, Carlo Di Mario7,
Antonio Colombo3, On behalf of the Taxus™ in Real-life Usage Evaluation
(TRUE) Study Investigators
1
Siegburg Heart Center, Siegburg, Germany2Interventional Cardiology
Unit, San Raffaele Hospital, Milan, Italy3EMO Centro Cuore Columbus,
Milan, Italy4Careggi Hospital, Florence, Italy5Mirano Hospital, Mirano,
Italy6Ferrarotto Hospital, Catania, Italy7Royal Brompton Hospital,
London, United Kingdom
Purpose: The Taxus stent has been proved effective in selected lesions/
patients undergoing percutaneous coronary intervention (PCI). There is
however uncertainty on its safety and effectiveness in chronic total occlusions
(CTO). We thus assessed early and mid-term results of patients undergoing
Taxus implantation after recanalization of CTO from the TRUE Study.
Methods: Consecutive subjects treated with Taxus stents in CTO (³3 months
from index event) were enrolled at 7 European centers. Clinical events were
adjudicated at 1 and 7 months, and angiographic follow-up performed between
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4 and 7 months. End-points of interest was freedom from major adverse
cardiovascular events (MACE), and rates of death, myocardial infarction
(MI), target vessel revascularization (TVR) and stent thrombosis (ST).
Results: A total of 183 patients underwent Taxus stenting in 253 lesions
(average number of Taxus 2.2±1.2, total Taxus length per patient 58±33
mm), and the target lesion was the right coronary artery in 40% cases,
the left anterior descending in 28%, and the left circumflex in 30%. Final
angiographic success after stent selection was 99%, with post-procedural
TIMI 3 flow in 98%. One-month adverse events were overall uncommon,
with 1.7% MACE, no death, 1.2% MI, no CABG and 1.1% TVR. At 7-month
clinical and angiographic follow-up there were 17.1% MACE, 2.8% death,
1.4% MI, 1.4% CABG, and 16.9% TVR (including 12.7% target lesion
revascularization). Stent thrombosis occurred only in one case (0.6% rate),
specifically less then 24 hours after the procedure in a patient with genetic
thrombotic diathesis. Preliminary angiographic follow-up data showed 17%
binary in-segment restenosis, with only 3.6% with Mehran type IV restenosis.
Conclusions: Percutaneous coronary paclitaxel-eluting stent implantation
provides favourable results in the challenging setting of patients with chronic
total occlusions. Despite the major reduction in restenosis in comparison
to historical controls with bare-metal stents, strategies to optimally deploy
currently available devices should be actively investigated in order to
further improve the present promising results.
TCT-78
Comparison of Efficacy and Safety between Sirolimus-Eluting Stent
(Cypher™) and Paclitaxel-Eluting Stent (TAXUS™) on the Outcome
of Patients with Chronic Total Occlusions: Multicenter Registry in
Asia
1
Background and Purpose: Both Sirolimus-eluting BX velocity
stent (Cypher™, Cordis) and Paclitaxel-eluting Express stent
(TAXUS™, Boston Scientific) have been reported to be effective
in preventing neointimal formation and in-stent restenosis. The aim
of this study is to compare the safety and efficacy of these 2 stents
on the outcome of patients with chronic total occlusions (CTO).
Methods: A prospective analysis of 808 patients with 922 CTOs (396
Cypher™ and 526 TAXUS™) in five high volume Asian centers after
successful recanalization of CTO (defined as TIMI flow trade 0 and the
age of occlusion was more than 3 months. Cypher™: LAD 53.5%,
LCX 26.8%, RCA 19.7%. TAXUS™: LAD 52.3%, LCX 22.1%,
RCA 25.6%) was performed. The study endpoints were major adverse
cardiac events (MACE) at 30 days and restenosis rate at 12 months.
Results:
The
baseline
clinical
characteristics
between
2 groups were similar. See table for clinical results.
Conclusion: The use of both stents in patients with CTO was equally safe
with low acute complication and very low incidence of restenosis.
Number of patients
Procedural success
(%)
MACE at 30 days
(%)
Reference diameter
(mm)
MLD post (mm)
MLD at 12 months
(mm)
Restenosis rate (%)
TVR (%)
MACE at 12 months
(%)
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100
TAXUS™
526
100
p
NS
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0.4
NS
2.86 ± 0.80
2.80 ± 0.80
2.74 ± 0.70
4.0
3.6
3.6
2.84 ± 0.90
2.70 ± 0.80
2.59 ± 0.75
6.7
6.7
6.7
NS
NS
NS
NS
NS
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WEDNESDAY 10/19/05 2:46 PM-3:46 PM (Room 146A)
Translational Research:
Migrating Therapeutic Discoveries from the Bench to Bedside
Room 146A
TCT-79
Final Results and Two Years Outcomes of a Trial Assessing a Nitric
Oxide Preserver Polymer-Coated Stent Implantation in De Novo
Coronary Lesions: Clinical, Angiographic, and Stent Volumetric
Analysis from NOBLESSE Trial
Costantino R Costantini1, Hugo F Londero2, Ivan De Scheeder3, Sergio G
Tarbine1, Costantino O Costantini1, Maria J Cabrera2, Marcelo F Santos1,
Rubens Z Darwich1, Mario C Maranhão1, Marcos Bubna1, Manoel S
Andrade1, Adroaldo Yared1
1
Hospital Cardiologico Costantini, Curitiba, Brazil2Sanatorio Allende,
Córdoba, Argentina3Leuven University, Leuven, Belgium
Background: The aim of this trial was to assess the safety and efficacy
of the Genic coronary stent, coated with a nitric oxide (NO) preserver
biodegradable polymer to avoid excessive intimal hyperplasia after
percutaneous treatment of de novo coronary artery lesions (DNL).
Methods: NOBLESSE was an international, multicenter, prospective
nonrandomized trial, including 45 patients, of any age or sex with a formal
indication for percutaneous coronary intervention of a type A or B1 DNL.
Patients were clinically assessed at 30 days and at 4, 12 and 24 months
after stent implantation. The primary end point was late loss of the treated
coronary segment as assessed by QCA at 4 months. The original protocol was
modified to include angiographic and IVUS analysis at 12-month follow-up.
Results: Mean age was 61,3; 64,4% were male. Lesions were located at
left anterior descending coronary artery in 42% of patients, and 41% were
type B1. Baseline RVD was 3,0 ± 0,2 mm, MLD was 1,07 ± 0,34 mm, and
the %DS was 64%. MLD after stent implantation was 2,76 ± 0,24 mm,
and acute gain was 1,69 ± 0,43 mm. There were no adverse events at 30
days. At 4 months, the TLR rate was 6% (3 pts.). At 12 months, there was
1 noncardiac death, resulting in a MACE free rate of 94%. Angiographic
follow-up was obtained in 98% of pts. At 4 months and 76% at 12 months.
There were no significant angiographic differences (p=NS) between 4 and
12 months QCA ( MLD=2,09 ± 0,53 vs 2,25 ± 0,38 mm, %DS= 30%vs 25%,
late loss 0,69 ± 0,52 vs 0,53 ± 0,08, binary restenosis = 9,5% vs 9,5%). 12
months Intimal hyperplasia volume at the stented segment was 25,9 ± 13,2
mm3, and the stent volume obstruction % was 21.8 ± 11,8. At 24 months
clinical follow-up was obtained in 97.3% of pts. and showed no MACE.
Conclusions: The absence of MACE at 30 days, 12 and 24 months suggests
that the genic stent coated with NO preserver polymer is safe. Late loss of
0.69 mm and a binary restenosis rate of 9.5% also suggest no detrimental
interaction between the polymer and neointimal hyperplasia at long term
follow up. The IVUS volumetric analysis supports this affirmation. The NO
preserver polymer may be an ideal carrier for drug elution from a stent
system.
TCT-80
Improvement of Left Ventricle Contractility, Perfusion and Ejection
Fraction in Patients with Acute Myocardial Infarction Treated with
Infusion of Bone Marrow Stem Cells
Stefan Grajek1, Malgorzata Popiel1, Piotr Breborowicz1, Maciej Lesiak1,
Rafal Czepczynski2, Anna Czyz3, Lidia Gil3, Andrzej Cieslinski1
1
First Department of Cardiology, Poznan, Poland2Department of
Endocrynology, Poznan, Poland3Department of Haematology, Poznan,
Poland
Aim of the study: an ongoing randomized clinical trial comparing left
ventricle contractility (LVC), perfusion (LVP) and ejection fraction (EFRNV) in pts with AMI after intracoronary infusion of autologous CD34+/
AC133+ bone marrow stem cells (BMSC) to control group of pts with AMI.
Methods: 30 pts with first anterior AMI after PCI of LAD randomized;
19 pts into BMSC group, 11 pts into control group. Fourteen pts in BMSC
group and 7 pts in control group have finished 6 month follow-up. BMSC
were administered at 5-7 day via infarct-related artery (IRA). Contractility
Index (CI) was calculated at 10 day (CI 10 day) and after 6 months (CI
6m). LVP was obtained with Tc-99m-MIBI SPECT and perfusion index
(PI) was calculated after 5-8 days at rest (PI 7day) and after 6 months at
rest (PI 6mR) and with dipyridamole (PI 6mD) for the whole ventricle
and for segments supplied with blood by IRA; CI-IRA and PI-IRA. Left
ventricle ejection fraction was obtained by radionuclide ventriculography
(RNV) after 5-10 days (RNV 7 day) and after 6 months (RNV 6m).
Results: CI 10day was 1,57+/-0,18 in BMSC group vs 1,59+/-0,25 in control
group [NS] and CI 6m was 1,47+/-0,16 vs 1,72+/- 0,29,resp. [p=0,02]; CIIRA 10day was 2,22+/-0,41 in BMSC group vs 2,21+/-0,4 in control group
[NS] and CI-IRA 6m was 2,07+/- 0,34 vs 2,58+/-0,37, resp. [p=0,005]. PI
7day was 2,47+/-0,64 in BMSC group vs 2,48+/-0,55 in control group [NS]
and PI 6mR was 2,29+/-0,4 vs 2,53+/-0,43 in control group [NS] and PI 6mD
was 2,11+/-0,39 vs 2,46+/-0,37, resp. [p=0,03]; PI-IRA 7day was 3,12 +/0,84 in BMSC group vs 3,06+/-0,56 in control group [NS] and PI-IRA 6mR
was 2,62+/- 0,7 vs 3,08+/-0,54, resp. [p=0,07] and PI-IRA 6mD was 2,46+/0,86 in BMSC group vs 3,2+/-0,58 in control group, resp [p=0,05]. RNV 7d
in BMSC group was 46,5+/-19 vs 41,5+/-6,9 in control group [NS] and RNV
6m was 50,3+/-7 vs 39,8+/-8 in BMSc vs control group,resp [p=0,009].
Conclusion: patients with AMI who received BMSC infusion via IRA
present with better left ventricle function - both contractility and perfusion
indeces (CI,PI) and ejection fraction (RNV) compared to control group after
6-months follow-up. Longer follow-up is warranted to observe whether
these effects maintain.
TCT-81
Efficiency of Intracoronary Stem Cell Transplantation in Patients with
Acute Myocardial Infarction and Chronic Ischemic Cardiomyopathy
Yelda Tayyareci, Yilmaz Nisanci, Murat Sezer, Ayhan Olcay, Berrin
Umman, Aytac Oncul, Mehmet Meric
Istanbul University,Istanbul Faculty of Medicine, Istanbul, Turkey
Objectives: Purpose of this study is to investigate the therapeutic
efficiency of intracoronary bone marrow derived progenitor
cell (BMC) transplantation in patients with acute myocardial
infarction (AMI) and chronic ischemic cardiomyopathy (ICMP).
Methods: 24 patients (n=12, post AMI; revascularized by primary PCI ;
n=12, severe ICMP) received intracoronary infusion of BMC, via over the
wire balloon catheter in left anterior descending artery (LAD). Technetium
99m-MIBI SPECT and echocardiography were used to assess left ventricle
(LV) functions and myocardial perfusion. Additionally, we measured
intracoronary pressures in LAD with fiberoptic temperature sensor
tipped guidewire. Index of microvascular resistance (IMR) defined as
simultaneously measured distal coronary pressure divided by the inverse of
the thermodilution derived hyperemic mean transit time. Pressure-derived
collateral flow index (CFIp) and coronary flow reserve (CFR) were determined.
Results: Evaluations were based on 20 patients who completed 6 months
follow-up period. We revealed a significant increase in ejection fractions (
35,2+8,9% to 39,1+8,9%, p=0,001 in AMI ; 31,5+8,4 to 35,8+9,8, p=0,001
in ICMP) and reduction in hypoperfused area (49,5+14% to 38,1+ 11,5%,
p=0,003 in AMI; 44,6+13,6% to 37,2+14,1%, p=0,001 in ICMP) by
sintigraphy. LV end-diastolic and end-systolic volumes showed no significant
alterations. However increase in CFR (1,28+0,4 to 2,02+0,6 ,p=0,04 in AMI
; 1,25+0,40 to 2,28+0,40, p= 0,04 in ICMP) and decrease in IMR ( 42+15 to
28+15,5; p=0,02, AMI; 47,6+12 to 33,3+16 ; p=0,04, ICMP) were significant.
Improvement in CFIp approached to statistical significance ( 0,14+0,03 to
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0,23+0,12 , p=0,06 in AMI ; 0,13+0,03 to 0,23+0,11, p=0,06 in ICMP).
Our results demonstrate that intracoronary BMC transplantation enhances
LV function primarily by improving neovascularization. This finding
evidenced by improvement seen in CFIp and CFR and reduction in IMR.
Additionally,efficiency of this method seems to be equivelant in both groups
of patients.
TCT-82
Double Balloon Occlusion System Superior to Single Balloon
Occlusion for Selective Interstitial Retrograde Venous Delivery
Todd J Brinton1, Erik T Price1, Fumiaki Ikeno1, Dongming Hou2, Jennifer
K. Lyons1, Mehrdad Rezaee1, Keith L. March2, Peter J Fitzgerald1, Alan C.
Yeung1, Paul G. Yock1
1
Stanford University, Stanford, CA;2Indiana University, Indianapolis, IN
Background: Cell-based therapies are emerging as treatment options
for myocardial infarction. We previously described a new method
that utilizes the coronary veins for pressurized interstitial retrograde
venous (IRV) cellular delivery. In this study, we compared the
efficiency and targeting of selective IRV delivery using a single balloon
occlusion catheter to an investigational double (proximal and distal)
balloon occlusion catheter system to isolate the treatment region.
Methods: An infarct model was created in 13 swine by percutaneous
balloon occlusion of the proximal LAD. Twenty-four million trace
metal-labeled micro spheres (10 µm) were delivered 6 (±1) days after
infarction using the anterior interventricular vein (AIV) and single
injection. 6 animals underwent IRV delivery using a single occlusion
balloon tipped catheter. 7 animals underwent IRV delivery using a double
balloon occlusion system. Animals were acutely sacrificed, and 1 cm
thick LV ring sections were stained with tetrazolium to quantify infarct
size and location. Each tissue ring was subdivided for quantitative and
distributive analysis of delivery efficiency using neutron activation of the
labeled micro spheres (BioPal Inc., Worcester MA). Three dimensional
topographic models were created to evaluate delivery distribution.
Results: Tetrazolium staining demonstrated that 12 ± 6% and 8 ± 6 % of
the LV had infarct in the single and double balloon group respectively.
The target delivery index (defined as counts within the targeted anterior
and septal LV regions divided by total delivered) was significantly higher
(p = 0.050) using the double balloon occlusion system (7.7 ± 3.9 %)
compared to single balloon occlusion (4.3 ± 2.6%). Three dimensional
modeling demonstrated both methods had anterior septal preference,
however, double balloon occlusion had greater apical targeting.
Conclusion: Delivery efficiency is improved using a double balloon
occlusion catheter system for IRV delivery. Both methods demonstrated a
LAD delivery distribution but efficiency and apical targeting were superior
using the double balloon occlusion system likely due to minimizing venovenous collateral flow during delivery.
40H
WEDNESDAY 10/19/05 3:35 PM-4:35 PM (Room 145AB)
EuroPCR Special Session: Interventional Insights from Europe
Room 145AB
TCT-83
Efficacy of Paclitaxel-Eluting Stent Implantation in Diabetic Patients
with De Novo Coronary Stenoses. Final Results of the DIABETES II
Trial
Cecilia Corros1, Manel Sabaté1, Pilar Jimenez-Quevedo1, Fernando
Alfonso1, Dominick Angiolillo2, Joan Antoni Gómez-Hospital3, José
Moreu4, Eduardo Pinar5, Rosana Hernández-Antolin1, Javier Escaned1,
Marco Costa2, Raul Moreno1, Camino Bañuelos1, Carlos Macaya1
1
Hospital Clinico San Carlos, Madrid, Spain2University of Florida,
Jacksonville, FL;3Hospital de Bellvitge, Barcelona, Spain4Hospital Virgen
de la Luz, Toledo, Spain5Hospital Virgen de la Arrixaca, Murcia, Spain
Background: The DIABETES (DIABETes and drug Eluting
Stent) II trial is a prospective multicenter registry aimed to
demonstrate the efficacy of paclitaxel-eluting stent implantation
on the inhibition of neointimal hyperplasia in diabetic patients.
Methods: From January to July 2004, 80 patients (118 lesions) were
included in the registry. Patients were eligible if they were insulindependent or non insulin-dependent diabetics, with significant de novo
coronary stenoses located in 1,2 or 3 vessels with signs or symptoms
of ischemia. The primary endpoint of the study was in-stent and insegment late loss lumen at 9-month follow-up. The use of abciximab was
recommended per protocol and dual antiplatelet therapy was routinely
prescribed (aspirin 100-300 mg per day indefinitely and clopidogrel 75
mg per day for at least 1 year). Clinical follow up was performed at 1,
9 and 12 months with angiographic follow-up scheduled at 9 months.
Results: The mean age was 65 ±15 years and 58% of patients were men.
Thirty-one patients (38,3%) were insulin-dependent. Multivessel disease
was evidenced in 59% of patients. Multivessel and multisegment treatment
were performed in 25% and 18% of patients, respectively. Seventy percent
of treated lesions were B2/C type and 8,7% were total chronic occlusions.
Mean stent length and diameter were 18.8±0.6mm and 3.0±0.3 mm,
respectively. As major adverse cardiac events, 1 peri-procedural non-Q
wave myocardial infarction occurred during hospitalization. Angiographic
follow-up was performed in the entire cohort of patients (100%). At
9-month follow-up, target vessel revascularization was required in 5
patients (6.25%). None of the patients experienced stent thrombosis.
Complete angiographic data will be presented during the Congress.
Conclusions: The implantation of paclitaxel-eluting stents in diabetic
patients with de novo coronary stenoses is safe with low rate of target vessel
revascularization at 9 months.
TCT-84
TAXUS VI Trial: 2-Year Outcomes in High-Risk Subgroups (Small
Lesions, Longer Lesions, Multiple Overlapping Stents)
Eberhard Grube1, Keith D Dawkins2, Guilio Guagliumi3, Adrian Banning4,
Krzysztof Zmudka5, Leif Thuesen6, Karl E Hauptman7, Jean Marco8,
William Wijns9, Joerg Koglin10, Mary E Russell10
1
Heart Center Siegburg, Sieburg, Germany2Southampton University
Hospital, Southampton, United Kingdom3Ospedali Riuniti Di Bergamo,
Bergamo, Italy4John Radcliffe Hospital, Oxford, United Kingdom5Jan
Pawel II Hospital, Krakow, Poland6Skejby Hospital, Aarhus University
Hospital, Aarhus, Denmark7Krankenhaus der Barmherzigen Bruder,
Trier, Germany8Clinique Pasteur, Toulouse, France9Onze-Lieve-Vrouw
Ziekenhuis, Aalst, Belgium10Boston Scientific, Natick, MA
Background: As a randomized, double-blind, multi-center trial, TAXUS
VI demonstrated improved clinical and angiographic outcomes of the
moderate release (MR) paclitaxel-eluting TAXUS stent (Boston Scientific)
compared to bare metal controls in long lesions treated with complex
procedures at 9 months. The TAXUS benefit was maintained in the overall
study population as well as in high-risk subgroups (small vessel size, long
lesion length, multiple overlapping stenting) at 12 months. Whether the
outcomes in these high-risk subgroups are sustained at 2 years is unknown.
Methods: A total of 446 patients (pts) were randomized to either
the TAXUS MR stent or the uncoated Express2 control stent in the
TAXUS VI trial. Two-year clinical follow-up was available in 428/434
(98.6%) patients. High-risk subgroups included pts with: 1) reference
vessel diameter (RVD) <2.5mm, n=123; 2) long lesions (lesion length
(LL) ≥26mm, n=82); 3) multiple overlapping stents (MS), n=124.
Results: At 2 years the TAXUS group had significantly
reduced
TLR
and
TVR
rates
compared
to
controls.
Results are depicted in the table.
RVD<2.5mm
(pts)
LL ≥26mm (pts)
MS (pts)
TVR (%)
TAXUS BMS
TLR (%)
TAXUS BMS
Cardiac Death
TAXUS BMS
ST (%)
TAXUS
BMS
n=60
n=61
n=60
n=61
n=60
n=61
n=60
n=59
15.0
n=45
8.9*
n=63
4.8*
31.1
n=36
27.8*
n=60
26.7*
8.3*
n=45
4.4*
n=63
4.8*
29.5*
n=36
27.8*
n=60
25.0*
1.7
n=45
0
n=63
0
3.3
n=36
0
n=60
1.7%
1.7
n=45
2.2
n=63
1.6
0
n=35
0
n=60
0
* = statistically significant between groups with p<0.05
Conclusion: At 2 years the TAXUS MR stent provides sustained efficacy
with significant reduction in TVR and TLR rate in overall population and
high-risk subsets. Sustained improvement of clinical outcomes coincided
with a favorable safety profile with low rates for death, MI, and stent
thrombosis in both groups out to 2 years.
TCT-85
Bifurcation Stenting with the Crush Technique: 9-Month Clinical and
Angiographic Outcomes
Angela Hoye1, Ioannis Iakovou2, Lei Ge2, Carlos A G van Mieghem3,
Andrew T L Ong3, John Cosgrave2, Giuseppe M Sangiorgi2, Flavio
Airoldi2, Matteo Montorfano2, Iassen Michev2, Alaide Chieffo2, Mauro
Carlino2, Nicola Corvaja2, Jiro Aoki3, Gaston A Rodriguez Granillo3,
Marco Valgimigli3, Georgios Sianos3, Willem J van der Giessen3, Pim J de
Feyter3, Patrick W Serruys3, Antonio Colombo2
1
Castle Hill Hospital, Kingston-upon-Hull, United Kingdom2EMO Centro
Cuore Columbus, Milan, Italy3Thoraxcenter, Rotterdam, The Netherlands
Introduction: The “crush” technique has been proposed as
a strategy utilizing drug-eluting stents for the treatment of
bifurcation lesions, however, the long-term outcome is unknown.
Methods and Results: We identified 231 consecutive patients who
underwent “crush” stenting for 241 de novo bifurcation lesions. Sirolimuseluting stents were used in 137(56.8%), and paclitaxel-eluting stents in
104(43.2%). Clinical follow-up was obtained in 99.6%. The rate of inhospital major adverse cardiac events (MACE) was 5.2%. At 9-months,
9(3.9%) patients had an event consistent with post-procedural stent
thrombosis. The rate of survival-free of target lesion revascularisation
(TLR) was 90.3%; the only independent predictor of TLR was left main
stem (LMS) therapy (OR 4.97; 95%CI 2.00 to 12.37, p=0.001). Survivalfree of MACE was 83.5%, independent predictors of MACE were LMS
therapy (OR 3.79; 95%CI 1.76 to 8.14, p=0.001), and treatment of patients
with multivessel disease (OR 4.21; 95%CI: 0.95 to 18.56, p=0.058).
Angiographic follow-up was obtained in 186(77.2%) lesions at a mean period
of 8.3±3.7 months. The mean late loss of the main vessel and side branch were
0.30±0.64mm and 0.41±0.67mm respectively, with binary restenosis rates of
9.1% and 25.3% respectively. Kissing balloon post-dilatation significantly
reduced the side branch late lumen loss (0.24±0.50mm versus 0.58±0.77mm,
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p<0.001), and binary restenosis rate (9.6% versus 41.3%, p<0.000001).
Conclusions: The crush technique of bifurcation stenting with drug-eluting
stents is associated with low rates of TLR and MACE for most lesions;
however, efficacy appears significantly reduced in LMS bifurcation lesions,
and further research is needed before the technique can be routinely
recommended in this group. Kissing balloon post-dilatation is mandatory to
reduce the rate of side branch restenosis.
TCT-86
N-Acetylcysteine for the Prevention of Contrast-Induced Nephropathy
in Patients Undergoing Primary Angioplasty
Gianfranco Lauri, Giancarlo Marenzi, Emilio Assanelli, Ivana Marana,
Jeness Campodonico, Marco Grazi, Monica De Metrio, Daniela
Trabattoni, Stefano Galli, Antonio L Bartorelli
Background. Patients with acute myocardial infarction (AMI)
undergoing primary angioplasty (pPCI) are at high risk for contrastinduced nephropathy (CIN) because of hemodynamic instability,
high dye volume, and unfeasibility of adequate prophylaxis.
Aim of study. We investigated the role of the antioxidant N-acetylcysteine
(NAC) in the prevention of CIN in patients undergoing pPCI. We
randomized 352 consecutive AMI patients undergoing pPCI to receive
NAC at standard dose (NAC group, 600 mg i.v. bolus before pPCI, followed
by 600 mg p.o. twice daily for the following 48 hours; n=115), NAC at
double dose (DD-NAC group; 1200 mg i.v. bolus before pPCI and 1200
mg p.o. twice daily for 48 hours; n=118), and placebo (controls; n=119).
Results Creatinine increase (>25% from baseline) after pPCI occurred
in 39 patients (37%) of the control group, 17 (15%) of the NAC group,
and 10 (8%) of the DD-NAC group (p<0.001). The overall in-hospital
mortality was 5.9% and was higher in patients with CIN than in those
without CIN (26% vs. 1.4%; p<0.0001). Thirteen patients (11%) died
in the control group, 5 (4%) in the NAC group, and 3 (2.5%) in the
DD-NAC group (p=0.016). The composite end-point of death, acute
renal failure requiring temporary renal replacement therapy or need of
mechanical ventilation was 18%, 7% and 5%, respectively (p=0.002).
Conclusion. Intravenous and oral NAC prevents CIN with a dose-dependent
effect in AMI patients treated with pPCI, significantly improving in-hospital
outcome
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THURSDAY 10/20/05 11:39 AM-12:39 PM (Room 152AB)
Vulnerable Plaque:
Pathophysiology, Detaction and Therapeutic Intervention
Room 152AB
Thursday, October 20, 2005, 11:39 am - 12:39 pm
TCT-87
“Hot” Plaque Results in Distal Embolization During Percutaneous
Coronary Stenting
So-Yeon Choi, Seung-Jea Tahk, Byoung-Joo Choi, Myeong-Ho Yoon,
Zhen-Guo Zheng, Sang-Yong Yoo, Gyo-Seung Hwang, Joon-Han Shin
Ajou University School of Medicine, Suwon, Republic of Korea
Background: The active Inflammation of plaque might be related
with spontaneous or procedure-related distal plaque embolization but
the relationship of plaque temperature and distal embolization after
percutaneous coronary intervention (PCI) has not been evaluated yet.
Methods: We measured the temperature difference of atherosclerotic
plaque and normal vessel wall in patients with coronary artery disease
using RADI wire. Temperature measurements were repeated twice and
the mean values were obtained. We also assessed the TIMI myocardial
perfusion (TMP) grade evaluated by filling and clearance of contrast in the
myocardium on angiogram before and after stenting. We divided patient
into two groups, group A is reduction of TMP grade, group B contains
no change and increased TMP grade after stenting compare to pre-PCI.
Patients with acute myocardial infarction were excluded in this study.
Results: 26 lesions (left anterior descending coronary artery 16, left
circumflex coronary artery 4, right coronary artery 6) in 25 patients (mean
age 62±8, male 16). Group A contains 6 lesions (23 %) when group B contains
the other 20 lesions. Clinical and angiographic characteristics were similar
between 2 groups except group A has more prevalence of UA(group A:
5(83.3%), group B: 5(25.0%), p=0.036). Difference of plaque temperature
was significantly higher in group A than group B( group A: 0.30±0.24°C,
group B 0.11± 0.04°C, p= 0.004 ) There was no difference of occurrence
of procedural complication such as coronary dissection and no reflow but
group A had high incidence of increase of CK-MB after stenting(group A:
4(66.7%), group B: 2(10.0%), p=0.019). Multivariate analysis showed that
the difference of temperature of plaque was the only independent predictor
of reduction of TMP (95% CI for Exp(B) 1.3217, 0.5627~5.5169, p=0.0188).
Conclusion: Preprocedural increased temperature difference of
atherosclerotic plaque and normal vessel wall was related with distal
embolization assessing by TMP grade after percutaneous coronary stenting.
Temperature measurement by RADI wire might has a useful diagnostic
value to predict the procedural related microvascular damage during PCI.
TCT-88
Accuracy of In Vivo Coronary Plaque Morphology Assessment:
A Validation Study of In Vivo Histology Compared with In Vitro
Histopathology
Kenya Nasu1, Etsuo Tsuchikane1, Osamu Katoh1, D Geoffrey Vince2,
Yoshihiro Takeda1, Jean-Francois Surmely1, Tatsuya Ito1, Mitsuyasu
Terashima1, Tetsuo Matsubara1, Takahiko Suzuki1
1
Toyohashi Heart Center, Toyohashi, Japan2The Cleveland Clinic
Foundation, Cleveland, OH
vitro histopathology of coronary atherosclerotic plaque obtained by
directional coronary atherectomy with corresponding in vivo tissue
characterization obtained by IVUS radiofrequency (RF) data analysis.
Methods: Coronary IVUS imaging of 21 patients with coronary
artery disease were obtained using a 30-MHz IVUS catheter with the
motorized pull-back system at 0.5 mm/s. Debulking region of in vivo
histology image was predicted from comparison between preand postprocedural 4 color coded maps reconstructed by ECG-gated RF data
analysis. Cross sectional histology slices were cut every 0.5 mm starting
from the most proximal part of the formalin-fixed debulking tissue.
Results: A total of 230 in vitro histology slices were obtained and
compared with the corresponding in vivo color coded map. Correlation
was favorable with high predictive accuracy (84.4% for fibrous,
90.7% for fibro-fatty, 85.9% for necrotic core, and 94.8% fore dense
calcium regions, respectively), as shown for one lesion in Figure.
Conculsion: In vivo IVUS RF data analysis is highly accurate for the
classification of the four component types of coronary artery plaque. These
results support the use of backscattered IVUS in clinical practice as a
reliable modality for plaque characterization.
TCT-89
Plaque Characterization by Intravascular Ultrasound Virtual
HistologyTM Analysis in Diabetic Patients
Kenya Nasu, Etsuo Tsuchikane, Osamu Katoh, Yoshihiro Takeda, JeanFrancois Surmely, Mitsuyasu Terashima, Tetsuo Matsubara, Tetsuo
Matsubara, Takahiko Suzuki
Background: Diabetes mellitus is one of the major risk
factors for coronary artery disease. However, there is little
data
evaluating
plaque
morphology
in
diabetic
patients.
Methods: Fifty-eight non-bifurcation significant native coronary lesions
(>75% stenosis by visual estimation) in 56 patients were imaged in vivo
with a 20 MHz phased-array intravascular ultrasound (IVUS) catheter
with motorized pull-back system at 0.5 mm/s. ECG gated backscattered
IVUS signals were acquired at the top of R wave. In vivo tissue
histology sections were reconstructed by radiofrequency data analysis
and evaluated from distal to proximal references of the target lesion.
Radiofrequency signals were classified into four component types: Dense
Calcium; Fibrous; Fibro-fatty; and Necrotic Core. For each image, the
percent of the different plaque components were analyzed. Then average
of the value from all the image slices for one lesion was calculated.
Patients were divided into two groups, a diabetic group (16 patients
with 16 lesions) and a non-diabetic group (40 patients with 42 lesions).
Results: Plaque composition was different between the two groups
with more Dense Calcium and Necrotic Core in DM groups (Table).
Conclusions: Compare to non-diabetic patients, coronary plaque
compositions in diabetic patients showed an increased amount of Dense
Calcium and Necrotic Core. This could possibly indicate an increased
frequency of vulnerable plaque in diabetic patients.
Virtual Histology analyses
Diabetics(n =16)
Plaque area, %
53.9±13.4
Fibrous area, %
56.9±10.2
Fibro-fatty area, %
14.8±10.5
Necrotic Core area, %
15.6±4.4
Dense Calcium area, %
12.7±5.0
Non-diabetics (n = 40)
52.6±12.8
62.0±13.4
18.2±9.7
11.6±5.5
8.4±5.7
p value
NS
NS
NS
0.009
0.01
Background: Characterization of atherosclerotic plaque components
is important to detect vulnerable plaque and the risk of its rupture.
Spectral analysis of backscattered intravascular ultrasound (IVUS)
signal enable to differentiate between four different tissue phenotypes
in vitro: fibrous; fibro-fatty; necrotic core; and dense calcium. The
aim of this study was to evaluate the correlative accuracy between in
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TCT-90
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Accuracy of Thin-Cap Fibroatheroma Detection by Optical
Coherence Tomography (OCT) Compared with Coronary Angioscopy
Yoshihiro Takeda, Osamu Katoh, Tatsuya Itoh, Kenya Nasu, Yoshihisa
Kinoshita, Etuso Tsuchikane, Mitsuyasu Terashima, Tetsuo Matsubara,
Takahiko Suzuki
Postmortem studies have associated thin-cap (<65 µm) fibroatheromas
(TCFAs) with vulnerable plaques. OCT provides high-resolution (10
µm) images of the vessel wall, as well as the accurate detection of lipid
core. We sought to evaluate the potential of OCT for detecting in TCFA.
Methods: We evaluated 17 patients with ischemic heart disease referred
for PCI. Both OCT and angioscopy of the entire target vessel were
performed before PCI. Culprit lesions as well as non-culprit lesions
were assessed and classified as lipid-rich plaques (LPs) for the 2 imaging
modalities. OCT criteria for a LP was defined, as previously validated, by
lipid occupying ≥2 quadrants of the cross-sectional image. The minimum
fibrous cap thickness was also measured within a LP. By angioscopy,
yellow or dark yellow surfaces on angioscopy were classified as LPs.
Results: Of the 17 culprit lesions, 15 were identified as LPs by OCT. Another
5 non-culprit LPs were also identified by OCT. Angioscopy detected 13
culprit and 4 non-culprit lesions as LPs, whereas 2 culprit and 1 non-culprit
lesions were shown as light yellow. All LPs identified by angioscopy were
seen as LPs in OCT images. However, LPs on angioscopy were associated
with a wide range of the minimum cap thickness as measured by OCT
(Figure). Furthermore, of the 17 LPs on angioscopy, the incidence of
plaques with the minimum cap thickness <65 µm was only 47% (8/17).
Conclusion: OCT detects lipid-rich and thin-cap (<65 µm)
plaques with a higher accuracy compared to angioscopy.
44H
THURSDAY 10/20/05 12:43 PM-1:43 PM (Ballroom C)
The Drug-Eluting Stent Summit IV (A)
Ballroom C
Thursday, October 20, 2005, 12:43 pm - 1:43 pm
TCT-91
Efficiency and Safety of the Sirolimus Stent in Complex Coronary
Artery Lesions. One Year Clinical Outcome of the Randomized
Scandstent Trial
Henning Kelbæk1, Leif Thuesen2, Steffen Helqvist1, Lene Kløvgaard1, Lars
Krusell2, Hans E Bøtker2, Kari Saunamäki1, Samir Aljabbari1, Gunnar V
Jensen1, Jens F Lassen2, Per Thayssen3, Anders Galløe4, Erik Jørgensen1
1
Rigshospitalet, Copenhagen, Denmark2Skejby Hospital, Århus,
Denmark3Odense Universitetshospital, Odense, Denmark4Gentofte
Amtssygehus, Gentofte, Denmark
Background: Sirolimus eluting stents improve the angiographic and clinical
outcome compared with bare metal stents in simple coronary artery lesions.
Methods: We randomly assigned patients with symptomatic complex
coronary artery disease to receive sirolimus eluting or bare metal stents. After
1 year major adverse cardiac events (MACE) including death, myocardial
infarction and target lesion revascularization (TLR) were recorded.
Results: Patients were included in the study, if they had lesions that
were occluded, bifurcational, ostial, or angulated in morphology. The
procedural success was 99% in both groups. They were well matched
in terms of demographic and angiographic baseline characteristics, 18
percent had diabetes mellitus, and 72 patients had a lesion with more
than one complexity. During 1 year follow up 8 patients (4.9%) who had
received sirolimus eluting stents had a MACE vs 57 (37.3%) in those who
received bare metal stents (P<0.001). Stent thrombosis was observed in
0.6 percent in the sirolimus stent group vs 3.1 percent in the bare metal
stent group (P = 0.15). TLR in the 4 subgroups are depicted in the table.
Conclusions: Compared with bare metal stents implantation of sirolimuseluting stents markedly reduced MACE in patients with complex coronary
artery lesions without increasing the risk of stent thrombosis. TLR was
virtually prevented in all patients except those with lesions located in
bifurcations.
Target Lesion Revascularization after 1 Year
Sirolimus Eluting
Bare Metal Stent
Stent
Occlusions n=126
38.1%
0%
Bifurcations n=125
26.3%
4.4%
Ostial lesions n=100
37.5%
0%
Angulated lesions
25.0%
0%
n=48
p
<0.01
<0.01
<0.01
<0.01
TCT-92
Appraising Paclitaxel-Eluting Stents in Over 1000 Very High-Risk
Patients. Insights from the Taxus in Real-Life Usage Evalutation
(TRUE) Study
Antonio Colombo1, Giuseppe Sangiorgi1, Giuseppe Biondi Zoccai2, David
Antoniucci3, Corrado Tamburino4, Carlo Di Mario5, Bernhard Reimers6,
Omer Goktekin5, Eberhard Grube7, on behalf of the Taxus in Real-life
Usage Evaluation (TRUE) Study Investigators
1
EMO Centro Cuore Columbus, Milan, Italy2Interventional Cardiology
Unit, San Raffaele Hospital, Milan, Italy3Careggi Hospital, Florence,
Italy4Ferrarotto Hospital, Catania, Italy5Royal Brompton Hospital,
London, United Kingdom6Mirano Hospital, Mirano, Italy7Siegburg Heart
Center, Siegburg, Germany
Purpose: The Taxus paclitaxel-eluting stent has been proved
safe and effective in selected patients. However, there is still
uncertainty on its risk-benefit profile in real-world patients at
higher risk for adverse events (MACE) or target revascularization.
Methods: 1050 consecutive high-risk patients undergoing Taxus stenting
were enrolled at 7 European high-volume centers, provided that the target
lesion was an unprotected left main (N=113, 11%), a bifurcation (N=219,
21%), a chronic total occlusion (N=183, 17%), a long lesion (> 28 mm,
N=283, 27%), in a small vessel (<2.75 mm, N=417, 40%), or the patient
had diabetes mellitus (N=315, 30%). Clinical events were adjudicated at 1,
7 and 12 months, with mandatory angiographic follow-up at 4-7 months.
Results: Across the 1050 included patients, 1865 lesions were treated with a
total of 2113 implanted Taxus (2.0±1.1 per patient, 1.2±0.6 per lesion, total
Taxus length per patient 46±30 mm). One-month MACE occurred in 4.3% of
patients, with 0.5% death, 3.5% myocardial infarction (MI), 0.1% coronary
artery bypass grafting (CABG), and 1.1% target vessel revascularization
(TVR). Seven-month events were as follows: MACE 18.9%, death 2.7%,
MI 5.2%, CABG 1.5%, TVR 16.4% and target lesion revascularization
(TLR) 11.5%. Angiographically adjudicated stent thrombosis (ST) was
uncommon, with a cumulative 0.8% at 7 months. Comprehensive rates
of ST (including sudden death) was instead 1.6%, with events predicted
independently by bifurcation lesion treatment (odds ratio 4.2, p=0.005).
Conclusions: In high-risk subjects and/or lesions, the performance of
the Taxus stent is very satisfactory, especially given the overall profile of
enrolled subjects and the limited number of stent thromboses. Angiographic
follow-up analyses are awaited, especially in the unprotected left main and
chronic total occlusion subgroups.
TCT-93
Preliminary Results of the Left Main TAXUS Pilot Study
Thierry Lefèvre1, Olivier Darremont2, Marie-Claude Morice1, Marc
Silvestri3, Yves Louvard1, Philippe Garot4, Jean-Louis Leymarie2,
Véronique Decalf1, Jordi Balcells1, Pierre Dumas1
1
Institut Cardiovasculaire Paris Sud, Massy, France2Clinique
Saint-Augustin, Bordeaux, France3UCV, Marseille, France4Institut
Cardiovasculaire Paris Sud, Quincy, France
Background: CABG is the gold standard treatment of unprotected
left main (LM) stenosis. Percutaneous coronary intervention (PCI)
using bare metal stents has been proposed as an alternative treatment in
some centers with excellent in-hospital results. However, these results
were partially impaired by the occurrence of restenosis leading to a
relatively high rate of re-intervention at follow-up compared to CABG.
Methods: A pilot study using the TAXUS stent was set up in 3 French
centers with wide previous experience in LM stenting. PCI was proposed
as an alternative to CABG in patients with de novo unprotected LM
stenosis. Technical recommendation was to cover the LM ostium with
the stent systematically and use a provisional T stenting approach in
cases of distal LM disease. Acute MI and cardiogenic shock were the
only criteria for exclusion. Prospective 1-, 7- and 12- month clinical
follow-up was set up with a recommended angiogram at 6 months.
Results : Between March 2003 and April 2005, 241 Pts with unprotected
LM were included (Euroscore 4.8+3.5, distal left main 75%). Angiographic
success was obtained in 99.6% and in-hospital MACCE rate was 3.1%
(death 0.9%, non-Q-wave MI 2.2%, Q-wave-MI 0%, emergency CABG
0%, stroke 0%). Seven month clinical follow-up is available in the first
166 patients included. They were 68+11 years old, 78% male, unstable
angina 33%, diabetes 28%. The ejection fraction was 61+12% and
Euroscore 4.5+3.0 (estimated in-hospital mortality rate in cases of CABG
5.3+6.8%). The number of other treated lesions was 1.2+0.9 and total
stent length 42+22 mm. Reference LM diameter was 3.71+0.49 mm. The
lesion was distal in 75% of cases. In patients with distal LM, a second stent
(T stenting) was used in 36% of cases and final kissing balloon inflation
was performed in 96% of cases. At 7-month follow-up total death rate
was 4.2% (cardiac 2.1%). Coronary angiogram was performed in 98
patients (59%). Left main restenosis was observed in 5/98 (5.2%): 1 in
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stent, 2 proximal to the stent, 1 distal and 1 in the ostial Circ. unstented.
Conclusion: Left main PCI using the TAXUS stent provided excellent
angiographic results and in-hospital outcomes. Preliminary follow-up is
very promising.
TCT-94
Effectiveness and Safety of Sirolimus-Eluting Stents in the Treatment
of Unprotected Left Main Coronary Bifurcation Stenoses
Seung-Jung Park, Young-Hak Kim, Bong-Ki Lee, Duk-Woo Park, KyoungHa Park, Kyoung-Min Park, Seung-Whan Lee, Bong-Ryong Choi, Cheol
Whan Lee, Myeong-Ki Hong, Jae-Joong Kim, Seong-Wook Park
Asan Medical Center, Seoul, Republic of Korea
Background Left main coronary artery (LMCA) bifurcation stenoses
remains a real challenge area for the interventional cardiologist.
We investigated the effectiveness and safety of using the sirolimuseluting stents (SES) for unprotected LMCA bifurcation stenosis.
Methods From March 2003 to June 2004, 104 consecutive patients
with unprotected LMCA bifurcation stenoses received SES implantation
at our institution. Stenting strategies were determined on the basis of
angiographic and intravascular ultrasound characteristics: stenting
across the normal left circumflex artery (LCX) (simple group, n=61),
kissing stenting in large sized LMCA with diseased LCX (kissing group,
n=22), and crushing stenting in diseased LCX (crushing group, n=21).
Results Procedure was successful in all patients. There was no death
or myocardial infarction during the follow-up (median, 15.0 months;
range, 8.7-22.9 months). Angiographic follow-up at 6 months was
performed in 87 (83.7%) patients. Target lesion revascularization
rate was 3.8% (2 in the kissing group and 2 in the crushing group).
Conclusions SES implantation is safe and effective for unprotected LMCA
bifurcation stenoses, and appears to be a promising strategy for this complex
lesion.
*p<0.05, MB=main branch, SB=side branch (LCX), MLD=minimal lumen diameter
Simple group Kissing group Crushing group
Reference (mm), MB *
3.63±0.73
4.15±0.68
3.36±0.64
Reference (mm), SB
2.80±0.67
2.78±0.55
2.52±0.35
Acute gain (mm), MB
2.14±0.53
2.23±0.74
2.44±0.48
Acute gain (mm), SB *
-0.02±0.68
1.22±0.75
1.32±0.51
Late loss (mm), MB
0.03±0.27
0.24±0.80
0.26±0.42
Late loss (mm), SB *
0.19±0.60
0.61±0.48
0.73±0.91
Restenosis, MB
0/52
2/18 (11.1%)
1/17 (5.9%)
Restenosis, SB
3/52 (5.8%)
1/18 (5.6%)
4/17 (23.5%)
Restenosis, overall *
3/52 (5.8%)
3/18 (16.7%)
5/17 (29.4%)
46H
THURSDAY 10/20/05 1:00 PM-2:00 PM (Room 147 AB)
Cutting Edge Strategies in Acute Coronary Syndrome and Acute
Room 147AB
TCT-95
Long-Term Follow-Up Patients with ST-Segment Elevation Acute
Myocardial Infarction Treated with Sirolimus-Eluting Stent and
Paclitaxel-Eluting Stent
1
Background: Previous clinical study utilizing Sirolimus-eluting stent
(SES) and Paclitaxel-eluting stent (PES) in simple coronary lesions
demonstrated an impressive reduction in intimal hyperplasia and restenosis.
However, clinical efficacy of SES and PES in treating patients with STsegment elevation myocardial infarction (STEMI) has not been validated.
Methods: We assessed baseline clinical and angiographic characteristics,
in-hospital and 12, 24-month major adverse cardiac events (MACE) in
1838 consecutive STEMI patients who received on SES, PES or bare
metal stents (BMS) without cardiogenic shock undergoing emergent PCI.
Results:
The
baseline
clinical
characteristics
between
Conclusion: Implantation of Sirolimus-eluting stent and Paclitaxel-eluting
stent in STEMI patients is not associated with any risk of adverse in-hospital
events, and reduced the need for repeat PCI at follow-up.
In-hospital
12-month
24-month
Clinical success (%)
Death (%)
Stent thrombosis (%)
Death (%)
Angiographic
restenosis (%)
Repeat PCI (%)
Death (%)
Angiographic
restenosis (%)
Repeat PCI (%)
BMS
(n=388)
98.5
1.0
0.5
1.3
16.0
10.8
1.3
17.5
11.9
SES
PES (n=607)
(n=843)
98.8
99.0
0.8
1.0
0
0
0.9
1.2
*3.8
*3.3
*3.0
*2.5
0.9
1.2
*3.8
*3.3
*3.0
*2.5
p
NS
NS
NS
NS
0.01
0.01
NS
0.01
0.01
TCT-96
Clinical Outcomes Associated with Use of Drug-Eluting Stents
Compared with Bare-Metal Stents for Primary Percutaneous
Intervention
Steven J Kernis1, David Cohen2, Kimberly Reid3, Richard G Bach4, John
M Messenger5, Harlan Krumholz6, John Rumsfeld5, Jeptha P Curtis6, Eric
Peterson7, John Spertus3
1
Mid America Heart Institute, Leawood, KS;2Beth Israel Deaconess
Hospital, Boston, MA;3Mid America Heart Institute, Kansas City,
MO;4Barnes Jewish Hospital, St Louis, MO;5University of Colorado,
Denver, CO;6Yale University, New Haven, CT;7Duke University, Durham,
NC
Background: Drug-eluting stents (DES) have transformed the
landscape of interventional cardiology by lowering in-stent
restenosis following elective PCI. Their impact on clinical outcomes
in the setting of primary PCI has not been adequately studied.
Objectives: We compared 6-mos clinical outcomes associated with DES
compared to bare-metal stents (BMS) in patients undergoing primary
PCI in a multi-center observational study between 1/1/03 and 6/28/04.
Methods: Among 769 patients enrolled in the PREMIER Study who
underwent primary PCI, 197 patients had at least 1 DES (sirolimus or
paclitaxel) stent implanted and 572 were treated with only BMS. Bivariate
and/or multivariable models of 6-mos all cause death and rehospitalization
were used to describe clinical outcomes and to adjust for baseline
differences. Results: Baseline characteristics were comparable between both
groups. 6-mos mortality was significantly higher in the DES group (3.6%
for DES vs. 1.2% for BMS, p=0.043). (Figure). In contrast, DES patients
had significantly lower 6-mos all-cause rehospitalization (17.5% vs. 30%,
p=0.0026). In multivariate analyses, DES use was independently associated
with lower all-cause rehospitalization (HR 0.56, 95% CI = 0.38 - 0.83).
Conclusions: DES implantation during primary PCI was associated with
higher all-cause mortality and lower all-cause rehospitalization at 6
months. Further studies are urgently needed to verify these observations
and define the optimal application of DES in primary PCI.
TCT-97
Is the Mechanism of Acute Myocardial Infarction in Octogenarians
Different from Other Patients? An Intravascular Ultrasound Study
Salah-Eddine Hassani1, Gary Mintz2, Helen Fong1, Sang-Wook Kim1,
Kenneth Kent1, Lowel Sattler1, Augusto Pichard1, Ron Waksman1, Neil
Weissman1
1
Washington hospital center, Washington, DC;2Cardiovascular Research
Foundation, New-York, NY
Background:
We
used
intravascular
ultrasound
(IVUS)
to compare culprit lesion morphology in acute myocardial
infarction (MI) in octogenarians vs patients <65 years of age.
Methods: Between January 2002 and April 2005, 42 octogenarians and
52 pts <65 years of age underwent pre- intervention IVUS within 2 days
from MI symptom onset. Target lesions were defined as soft, fibrous,
calcified, and mixed. Quantitative measurements were performed at the
lesion site and at the proximal and distal references. Remodeling index (RI)
was defined as the lesion divided by the mean reference external elastic
membrane area (EEM CSA). Positive remodeling was defined as a RI ≥1.
Results: Octogenarians had more comorbidities [known coronary artery
disease (38% vs 11%, p=0.004), peripheral artery disease (24% vs 4%, p=0.007)
and chronic renal failure (38% vs 13%, p=0.008)]. Octogenarians mostly
(71%) presented with non ST elevation myocardial infarction (NSTEMI)
while pts <65 years presented almost equally with ST elevation myocardial
infarction (STEMI) and NSTEMI (56% vs 44%). Important IVUS differences
are shown in the table. Pts <65 years had more positive remodeling, plaque
rupture, and thrombus formation while octogenarians had longer lesions,
rare plaque rupture, and more negative remodeling and calcified lesions.
Conclusion: Compared to pts <65 years of age, markedly different
lesion morphologies in octogenarians suggest that the pathophysiologic
mechanism of the MI is also likely to be different.
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Thrombus, n (%)
Rupture/dissection,
n (%)
Soft plaque, n (%)
Calcified plaque, n
(%)
Lesion length, mm
Positive remodeling,
n (%)
Calcium arc, º
Distal
reference
plaque burden, %
Octogenarians
(n=42)
1 (2)
4 (9)
8 (19)
24 (57)
20.9±7.8
8 (19)
199±91
38.9 ±12.1
Patients <65 years
of age
(n=52)
7 (14)
16 (32)
26 (50)
5 (10)
16.6±6.1
29(56)
115±71
31.8 ±10.4
p-value
0.04
0.009
0.001
<0.001
0.004
<0.001
<0.0001
0.004
TCT-98
Transfer for Direct Percutaneous Coronary Intervention for STElevation Myocardial Infarction in the Elderly
Marc C Newell1, Jason T Henry1, Christopher R Henry1, Joseph A
Browning1, Barbara Tate Unger1, David M Larson2, James D Madison1,
Ivan J Chavez1, Timothy D Henry1
1
Minneapolis, MN;2Ridgeview Medical Center, Waconia, MN
Background: Data regarding outcomes of percutaneous coronary
intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) in the
elderly is limited, but suggested PCI is superior to fibrinolysis in highly
selected pts >70 years old (yo). There is no data regarding transfer of
elderly pts with STEMI. Methods: 591 STEMI pts presented to or were
transferred (n=448) to Abbott Northwestern Hospital for direct PCI. These
pts were divided into age groups (<70 (n=384), 70-80 (n=107), and >80
yo (n=100)) and followed for major adverse cardiac events (MACE),
including death, reinfarction, and stroke. No pts were excluded, including
cardiogenic shock (13.7%) and out of hospital cardiac arrest (9.9%).
Results: No deaths occurred during transfer in any age group. In hospital
and 30 day mortality in the >80 yo age group was significantly increased
when compared to that of the <70 yo and 70-80 yo groups (see table). There
was no significant difference between the <70 and 70-80 yo age groups.
Discussion: Pts are safely transferred for direct PCI regardless of age. Pts in
their 70’s are not at increased risk with transfer or PCI than younger pts. Not
unexpectedly, pts >80 yo have increased mortality compared to younger pts.
Despite the increase in mortality in pts >80 yo, this data compares favorably
to previous studies of selected elderly with STEMI and are much lower
than published data in octogenarians with STEMI. Our data suggest that all
STEMI pts should be offered transfer for PCI, regardless of age.
<70 years old 70-80 years old >80 years old
%
p-value
(n=384)
(n=107)
(n=100)
Cardiac arrest 8.6
11.2
13
0.43
Death
(in
1.8
3.7
12
<0.0001
hospital)
Death (30 days) 2
4
17
<0.0001
Reinfarction (30
2
0
0
0.14
days)
Stroke (30 days) 0.6
0
3.2
0.10
MACE
(in
3.1
3.7
12
0.0007
hospital)
MACE
(30
4
4
17
<0.001
days)
48H
Structural Heart Disease: Diagnosis and Interventional Approaches
Room 151AB
TCT-99
Edge-to-Edge Mitral Valve Repair Using the Percutaneous Evalve
MitraClip: One Year Results of the EVEREST Phase I Clinical Trial
Ted Feldman1, Hal S Wasserman2, Howard C. Herrmann3, Patrick L.
Whitlow4, Peter C . Block5, William A. Gray6, Elyse Foster7, Frederick St.
Goar8
1
Evanston Hospital, Evanston, IL;2Columbia University, New York,
NY;3University of Pennsylvania, Philadelphia, PA;4Cleveland Clinic,
Cleveland, OH;5Emory University Hospital, Atlanta, GA;6Swedish
Medical Center, Seattle, WA;7University of California, San Francisco,
CA;8Cardiovascular Institute, Mountain View, CA
The Evalve Cardiovascular Valve Repair System Endovascular
Valve Edge-to-Edge REpair Study (EVEREST I) uses a
percutaneous transseptal approach to adapt an established
surgical technique for treatment of mitral regurgitation (MR).
Methods:Under trans-esophageal echo guidance and general anesthesia,
the mitral leaflets are grasped with a clip, creating a double orifice valve
to reduce MR. The primary endpoint is major adverse events (MAE)
defined as death, MI, tamponade, clip detachment, cardiac surgery,
stroke, and septicemia at 30 days. Surgical candidates with >moderatesevere MR (grade 3+ or 4+) with symptoms (or asymptomatic with EF
<60% or LVESD >45 mm) were included. Major exclusions were EF
<30%, LVESD >55 mm, endocarditis, prior sternotomy (initially) and
rheumatic disease. The efficacy endpoint was core lab MR severity
<2+. We report 1 year outcomes in the initial Phase I study cohort.
Results: A total of 39 patients have had the procedure for degenerative
(85%) or functional MR (15%). One clip was implanted in 28 patients
(87%), 6 patients received 2 clips and 5 patient received no clip. 30 day MAE
included partial clip detachment without embolization in 3 patients who all
had elective standard surgical repair, and a stroke in one, which resolved by
1 month. No other 30-day MAE were reported. Among the 1st 27 patients
discharged home with a clip, length of stay was a mean of 1.7 days after clip
placement. After 1 month, 14 of 22 (65%) patients discharged with a clip and
completed core lab MR severity assessment had <2+ MR. Of the 14 patients
with MR <2+ at 1 month, 13 (93%) had maintainance of <2+ MR at 6 months.
MR severity did not increase from 6 to12 months in any of the 9 patients
with completed 12 month core lab follow-up. From the group of treated
patients who reached 12-month follow-up, 75% were free from surgery.
Conclusion: Edge-to-Edge mitral valve repair with the MitraClip can be
accomplished successfully using this percutaneous approach, reducing MR
in patients with degenerative and functional MR with an acceptable rate of
complications. Core lab determined MR reduction can be maintained for at
least one year.
TCT-100
Non-Implant Closure of Patent Foramen Ovale: First in Human
Results
Marijke Skowasch, Madlen Reschke, Michaela Leetz, Franziska
Buescheck, Evelyn Fischer, Yves Bayard, Ralph Hein, Klaus Lang,
Albrecht Roemer, Horst Sievert
CardioVascular Center Frankfurt, Frankfurt, Germany
Introduction: Transcatheter closure of patent foramen ovale (PFO) has
been successfully performed for more than 10 years with implantable
PFO closure devices to prevent recurrent paradoxical embolism. To
achieve closure with all currently available techniques, an implant is
left in the body. The PFXTM Closure System (Cierra, Inc, Redwood City,
CA) is a new device employing monopolar radiofrequency energy to
close the PFO percutaneously without leaving any implant in place.
Patients and Methods: Monopolar radiofrequency energy is applied
from the right atrial side of the septum to pull the septum primum
and secundum together and fuse the tissues closed . A standard
dermal ground pad is used as return electrode. PFO closure has been
attempted in nine consecutive patients aged 45 ± 15 yrs (18-65)
and was conducted under fluoroscopy and TEE guidance with local
anaesthesia. Indications for treatment were previous cryptogenic stroke
(n=3), transient ischemic attack (n=5) or paradoxical embolism (n=1).
Results: In 8 of 9 patients procedural success was achieved. Adequate
device placement was not achieved in one case because of PFO size/
morphology. Therefore, this patient received a conventional PFO closure
device. Average energy application and time was 29 ± 5 Watts lasting 7 ±
3 minutes. Total procedure time (including protocol only required testing)
was 62 ± 17 minutes with a mean fluoroscopy time of 9 ± 4 minutes.
Immediate complete closure was achieved in 6 of 8 pts; two of the eight
patients showed a residual shunt under valsalva. There were neither peri- nor
post-interventional complications nor pain associated with the application
of radiofrequency energy. No arrhythmias were detected by ECG.
Conclusion: This initial experience suggests that the PFX closure system
is a technically feasible, safe and effective method, and provides several
benefits including elimination of risks associated with implantable devices.
The application of the present device design, however, may be limited in the
largest PFOs. Energy delivery takes only few minutes and is applied at low
levels compared to those in many cardiac ablation procedures.
TCT-101
Procedural and Late Outcomes of Percutaneous Patent Foramen
Ovale Closure in 1000 Patients: A Single-Center Experience
Sherman G Sorensen1, Peter J Casterella1, Steven C Horton1, Ali K
Choucair2, Laurie Raleigh3, Heather Aguilar3, K Wes McKnight3, Donald
L Lappé1, Heidi Thomas4, Joseph B Muhlestein4
1
Utah Heart Clinic and LDS Hospital Cardiology, Salt Lake City, UT;2LDS
Hospital Neurology and Cardiology, Salt Lake City, UT;3Utah Heart
Clinic, Salt Lake City, UT;4LDS Hospital Cardiology, Salt Lake City, UT
Background: Patent foramen ovale (PFO) closure has evolved in recent
years with significant changes in risk stratification, imaging methods,
anti-platelet regimens, and device design. This study evaluates immediate
and long-term outcomes of PFO closure with 3 different devices.
Methods: Review of PFO closures were made through outpatient records,
telephone (>1 year post procedure), catheterization laboratory and hospital
database. Risk stratification for recurrent stroke was defined from established
criteria: multiple MRI (MMRI), septal aneurysm (ASA), migraine
headache (MHA), and high shunt (HS). Serious adverse events (SAE) for
procedure and late outcomes: device related death (DRD), cerebrovascular
accident (CVA) with/without residual deficit, transient ischemic attack
(TIA), device related failure (DRF) (embolization, dislodgement, device
removal, second device placement, device thrombus (T), or device
infection (SBE)), pericardial effusion (PE) with/without tamponade, and
other cardiac sequelae (OCS). The annualized incidence of recurrent
CVA was compared to reported historical incidence of 3.8% per year.
Results: From 2001-2005, 1000 PFO closures were performed:
Cardioseal® (CS) 261 (26%), Amplatzer PFO ® (AMP) 689 (69%), and
Amplatzer SO® 50(5%). Most AMP patients (638) had program risk
stratification: MMRI 77%, ASA 43%, MHA 36%, HS 91%. Procedural
SAE were uncommon: access site bleeding (8), transfusion (7), CVA
without residual (1), device failure (1), and esophageal perforation
(1). Total SAE occurrence: DRD=1 (CVA + T), CVA=9 (0.9%; CS=5,
AMP=4 (residual deficit=0)), TIA=32 (3.2% CS=20 AMP=12), PE=3
(0.3% AMP=3 (0 tamponade)), T=3 (0.3% CS=3), SBE=2 (0.2%
49H
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CS=2), DRF with removal=5 (0.5%; CS=4, AMP=1), DRF with second
device=4 (0.4% CS=4), OCS=23 (2.3% (atrial arrhythmias)). Annualized
relative risk of CVA compared to historical controls=0.15 (p=0.01).
Conclusions: Catheter-based PFO closure performed in a structured, risk
stratified program setting is associated with a high immediate success rate
and a low incidence of late complications in patients followed for 2.5 (range
1-4) years. Complications may be related to procedural experience and
device design.
TCT-102
First Experience with a New Self Expanding Aortic Valve Prosthesis
for Percutaneous Treatment of Aortic Valve Disease in High Risk
Patients
Eberhard Grube1, Jean Laborde2, Ulrich Gerckens1, Lutz Buellesfeld1,
Stein Iversen1
1
Heart Center Siegburg, Siegburg, Germany2Clinique Pasteur, Toulouse,
France
Background: Percutaneous aortic valve replacement is a new promising
technology for patients with significant aortic valve stenosis (AS) and
high risk for surgery. The new CoreValve prosthesis is composed of three
bovine pericardial leaflets inserted within a self-expanding nitinol stent.
We report the results of the first 12 patients treated with this new device.
Methods and Results: A retrograde approach via the common iliac artery was
used for the valve deployment. The contralateral femoral vessels were used
for the temporary fem-fem-bypass for extracorporal circulation, unloading
the left ventricle during the actual stent expansion. Clinical, hemodynamic,
and echocardiographic outcomes were assessed serially during the procedure.
Echocardiographic follow-up to 30 days after prosthesis implantation
were performed to evaluate the short-term outcome. The procedure was
undertaken in general anesthesia. The prosthesis was successfully deployed
within the diseased native aortic valve in 10 of 12 patients, one patient
died due to ventricular rupture prior to device implantation, one patient
was converted to surgery due to unsuccessful device placement. 2D and
doppler echo immediately after device deployment showed a significant
reduction in transaortic mean pressure gradient from 45.7 +/- 25.2mmHg
to 10.5+/-5.1mmHg. In the in-hospital follow-up, 5 patients died, 4
procedure-related with myocardial perforation (1), crush-syndrome (1)
and multi-organe failure (2), and 1 patient non-procedure related due to
lung cancer. All patients developed temporary thrombocytopenia, that was
persistent if antiplatelet medication was not given. Patients with clopidogrel
and ASS showed restoration of normal platelet counts after 4-8 days.
The 5 patients with uneventful in-hospital follow-up were
discharged
with
significant
improvement
of
the
clinical
status. The 14 day follow-up was uneventful in all 5 patients.
Conclusion: This first experience with a self-expanding aortic valve
prosthesis using the retrograde approach confirms the concept with a
promising acute device success rate and immediate improvements of the
hemodynamic status. The safety profile is currently under evaluation.
50H
Innovative Devices and Futuristic Therapies
Room 150AB
TCT-103
Hemoglobin-Based Oxygen Therapeutics in (Elective) Percutaneous
(Coronary) Revascularization - The HEMOPURE Trial
Ton Slagboom1, Robbert de Winter2, Evelyn Regar3, Gerhard Schuler4,
Holger Thiele4, Gert-Jan Laarman1, Guy Heyndrickx5, Patrick Serruys3
1
Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands2Academisch
Medisch Centrum, Amsterdam, The Netherlands3Erasmus Medisch
Centrum, Rotterdam, The Netherlands4Herzzentrum Leipzig, Leipzig,
Germany5Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
Background: Because of their ability to perfuse and deliver O2, hemoglobinbased oxygen carriers (HBOC) have been proposed to treat ACS. Evaluation
of systemic and coronary hemodynamics is important because of the
potential vasoconstrictive effects and colloidal properties of these drugs.
Methods: In this randomized, 3-arm (1:1:1), double-blind, placebocontrolled, dose-finding pilot (Phase II) study we assessed the systemic,
pulmonary, and coronary hemodynamics of two doses (15g, 30g) of iv
HBOC-201 (Biopure Corporation, Cambridge, MA, USA) vs. control
(colloidal volume expander) in patients with one-vessel disease scheduled
to undergo PCI for UA/NSTEMI. Full systemic hemodynamic assessment
was performed including SBP, MAP, and CI. CFR during the 30 minutes
of study drug infusion was assessed in a non-target reference vessel (RV).
Results: This trial was completed in April 2005 and remains blinded
pending final cleaning of the data set. A total of 46 patients (age 38-74,
34 males) were randomized at 5 centers in Europe. Treatment groups
were equally matched for age, cardiovascular risk profile and anginal
status at screening. At interim analysis, no significant changes in coronary
artery (RV) diameter, or coronary flow velocity reserve were observed.
Significant changes in systemic hemodynamics were noticed in 2 of the
3 treatment groups. Preliminary data showed critical elevations of blood
pressure following CTM administration, in some cases above levels
(SBP > 180mmHg) that should not be exceeded in order to minimize the
risk of adverse events. A protocol amendment was instituted instructing
consistent blood pressure management using vasodilators when necessary.
Accordingly, critical blood pressure elevations were markedly reduced
(7/30 patients before, 2/16 patients after a protocol amendment).
Conclusions: This pilot study is the first step in assessing the safety of a
potential new therapeutic agent for treating and managing cardiac ischemic
events. The results of an analysis of the final 30-day unblinded systemic and
coronary hemodynamic data will be presented.
TCT-104
Percutaneous Septal Sinus Shortening (The PS3 SystemTM): A Novel
Procedure for the Treatment of Functional Mitral Regurgitation
Jason H. Rogers1, John Macoviak2, Patricia Takeda1, Reginald I. Low1
1
UC Davis Medical Center, Sacramento, CA;2Ample Medical, Inc., Foster
City, CA
Background: Functional mitral regurgitation (FMR) is prevalent and
current solutions include ineffective medical therapy or high-risk invasive
surgery. Prior research has demonstrated that the septal to lateral (SL) mitral annular diameter is increased in FMR, and that regurgitation
may be ameliorated by reducing this dimension. Specifically, direct SL shortening has been previously accomplished in an ovine open-chest
procedure with acute and chronic reduction of ischemic MR. We describe
a novel percutaneous technique (percutaneous septal sinus shortening or
PS3 System) which we have shown to ameliorate FMR in an ovine model.
Methods: Sheep underwent rapid right ventricular pacing to obtain
moderate to severe FMR with associated decreased LV ejection fraction,
LV and LA enlargement. Animals were anesthetized and intubated
for the procedure, which was performed primarily under fluoroscopic
guidance. Using a novel percutaneous approach (The PS3 SystemTM,
Ample Medical, Inc.) based on magnetic catheter techniques to be
described in complete detail, a bridge element is positioned between
interatrial septal wall and great cardiac vein anchors. By progressively
tensioning this bridge element, direct S-L shortening may be achieved.
Results: The PS3 System can effectively ameliorate FMR in acute and
chronic studies. To date, in 11 sheep, an average 26% reduction in the SL diameter was achieved (34 mm pre-, 26 mm post-PS3) and an average
2 grade improvement in MR was achieved (2.3+ pre-, trace post-PS3).
Complete echocardiographic and clinical characterization will be
presented. 30 day chronic studies to date demonstrate persistent MR
reduction, S-L shortening, with no migration, erosion or bridge thrombosis.
Conclusions: The PS3 System is a novel percutaneous procedure appears to
be effective in the amelioration of FMR in an ovine model. This technique
has several potential advantages over existing percutaneous methods. The
procedure utilizes standard catheter techniques and can be deployed largely
under fluoroscopic guidance. In addition, the bridge element allows direct
and precise S-L shortening to a diameter optimal for MR reduction.
TCT-105
Effects of Intracoronary Infusion of Peripheral Blood Stem Cells
Mobilized with G-CSF on Coronary Flow Reserve and Wall Motion
Index: An Intracoronary Doppler Flow Analysis: Interim Data from
the Magic Cell-DES Trial
Jung-Won Suh, Bon-Kwon Koo, Sung-A Chang, Sang-Hoon Na, Hyun-Jae
Kang, Hyo-Soo Kim, Dae-Won Sohn, Byung-Hee Oh, Young-Bae Park,
Yun-Shik Choi
Seoul National University Hospital, Seoul, Republic of Korea
Background In the MAGIC Cell trial data, we suggested that intracoronary
infusion of peripheral blood stem cells (PBSC) mobilized with G-CSF
improved left ventricular (LV) function. But the parameters which could
predict the myocardial recovery after PBSC infusion were not well known.
Therefore,
we
analyzed
Doppler
parameters
and
wall
motion
indices
by
cardiac
MRI.
Methods From our old myocardial infarction study (OMI) group
(cell infusion n=12, control n=13), the data of Doppler study group
(cell infusion n=10, control n=9) were analyzed. Recovery of global
and regional LV function and wall motion abnormalities were
measured using cardiac MRI before and six months after the coronary
intervention with/without cell infusion. Coronary Doppler study
was also performed after the procedure and at six month follow up.
Results Baseline clinical, angiographic and hemodynamic characteristics
were not different between two groups. Mean global wall motion index
(GWMI) and regional wall motion index (RWMI) changed over time
from1.75±0.43 to 1.67±0.43 (p=0.013) and from 2.30±0.69 to 2.23±0.71
(p=0.096) in the cell infusion group. In the control group, GWMI and RWMI
changed from 1.90±0.48 to 1.81±0.56 (p=0.028) and from 2.23±0.58 to
2.35±0.73 (p=0.30). CFR was improved significantly in cell infusion group
(1.91±0.68 at baseline & 2.54±0.97 at 6 months, p=0.025), but not in the
control group(1.85±0.68 & 2.41±0.51, p=0.13). Doppler flow pattern at the
time of initial procedure and RMWI change were analyzed together. In the cell
infusion group, baseline average peak velocity(APV,r2=0.22) and hyperemic
diastolic-to-systolic flow velocity ratio (DSVR, r2=0.26) showed correlation
with change in GWMI and baseline APV (r2=0.68) and hyperemic DSVR
(r2=0.25) revealed correlation with change in RWMI. In the control group,
there were no significant Doppler parameters correlated with the change in
WMI. CFR did not show correlation with change in WMI in both groups.
Conclusion Intracoronary infusion of PBSC showed significant
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improvement of WMI and CFR in patients with OMI. Also, the flow pattern
was more important parameter than CFR in predicting the myocardial
recovery in the PBSC infusion study.
TCT-106
LV Support Device Impella Increases Coronary Blood Flow in
Patients with Compromised LV Undergoing Angioplasty
Maurice Remmelink, Jan Baan, Jr., Jose P S Henriques, Robbert J de
Winter, Karel T Koch, Rene J van der Schaaf, Marije M Vis, Evert W
Scholten, Jan G P Tijssen, Jan J Piek
Academic Medical Center - University of Amsterdam, Amsterdam, The
Netherlands
Background: The left ventricular support device, Impella Recover® LP
2.5 has shown its safety and efficacy in hemodynamically compromised
patients. Theoretically, the enhanced flow over the aortic valve and
the unloading of the left ventricle could increase coronary perfusion
pressure. On the other hand, it could also lead to diminished coronary
blood flow (CBF) by a so called “Venturi” effect because of its position
close to the coronary ostia. Therefore, our objective was to determine
the effects on CBF during left ventricular support by the Impella.
Methods: In 5 patients, who underwent an angioplasty with circulatory
support by the Impella Recover® LP2.5, CBF was measured after the
percutaneous coronary intervention in a non-stenotic coronary artery. The
mean left ventricular ejection fraction was 29±6%. At five different support
levels (ranging from neutral 0.0 to 2.6 l/min) simultaneous pressure and flow
measurements were performed before and after injection of 3cc adenosine
for hyperemia using the Wavewire and Flowire. We calculated fractional
flow reserve (FFR) and coronary flow velocity reserve (CFVR) and
assessed the differences between the support levels using ANOVA analysis.
Results: The FFR during hyperemia remained the same at different
support levels. The baseline average peak flow velocity (APV) at different
support levels remained unchanged. The hyperemic APV increased
significantly with increasing support levels (p<0.05). The CFVR was
only significantly increased at the highest support level (2.6 l/min)
compared to the neutral support level (2.2± 0.7 vs.1.8± 0.6; p=0.01).
Conclusions: In conclusion, the left ventricular support device Impella
had no effect on FFR and baseline APV. The Impella increased hyperemic
APV resulting in an enhanced CFVR at the highest support level in
hemodynamically compromised patients, probably secondary to unloading
of the left ventricle.
52H
FRIDAY 10/21/05 8:54 AM-9:54 AM (Ballroom C)
The Drug-Eluting Stent Summit IV (B)
Ballroom C
Friday, October 21, 2005, 8:54 am - 9:54 am
TCT-107
Comparison of Paclitaxel versus Sirolimus-Eluting Stents
for Coronary Lesions in Diabetes: A Prospective Multicenter
Randomized, 6-Month Angiographic Follow-Up Study
Hyun-Sook Kim1, Seung-Whan Lee2, Jae-Hwan Lee3, Jae-Hyeong Park3,
Nae-Hee Lee2, In-Whan Seong3, Jae-Ki Ko1
1
Chonbuk National Univ. Hospital, Jeonju, Republic of
Korea2Soonchunhyang University Bucheon Hospital, Bucheon, Republic
of Korea3Chungnam National University Hospital, Daejeon, Republic of
Korea
Background: Clinical studies with drug eluting stents (DES) in
coronary lesions of diabetes have shown promising results. However, it
is uncertain that which of commercially available two DES, paclitaxeleluting stent (PES) and sirolimus-eluting stents (SES), is more
effective for diabetes. We performed a prospective randomized study
to compare the efficacy of PES with SES in patients with diabetes.
Methods: From October 2004 to May 2005, 200 consecutive diabetic patients
with 221 coronary lesions were randomly assigned to PES (Group I, n=98) or
SES (Group II, n=102) at three clinical centers . All patients received aspirin
indefinitely and clopidogrel for 6 months. The primary end point was insegment late loss at 6 months and the secondary end points were angiographic
in-segment restenosis at 6 months and major adverse cardiac events (nonfatal
myocardial infarction, death, or target lesion revascularization) at 9 months.
Results: The baseline clinical and angiographic characteristics were
similar between two groups. The reference vessel diameter, lesion
length and mean stent length were similar (Table 1). There were no
in-hospital events including death, acute myocardial infarction, target
lesion revascularization, or stent thrombosis. The 6-month angiographic
and 9-month clinical outcomes will be presented at the meeting.
Conclusions: This study showed excellent efficacy and safety profile of
these DES in diabetes. There was no statistically significant difference
between PES and SES.
Table 1. Procedural characteristics
Group I
Reference size (mm)
2.80±0.36
Lesion length (mm)
26.5±12.5
Total stent length (mm)
29.4±11.2
Pre MLD (mm)
0.65±0.39
Post MLD (mm)
2.68±0.37
Group II
2.70±0.42
24.8±10.8
29.4±10.9
0.74±0.38
2.62±0.39
P value
0.11
0.41
1.0
0.14
0.30
TCT-108
Prospective Randomized Multi-Center Head to Head Comparison of
the Sirolimus-Eluting Stent (CYPHERTM) and the Paclitaxel-Eluting
Stent (TAXUSTM): Twelve-Month Outcome of the REALITY Trial
Marie Claude Morice1, Patrick W Serruys2, Antonio Colombo3, Bernhard
Meier4, Corrado Tamburino5, Gulio Guagliumi6, Eduardo Sousa7, Oscar
Mendiz8, Eberhard Grube9
1
Institut Hospitalier Jacques Cartier, Paris-Massy, France2Erasmus
Medical Center, Rotterdam, The Netherlands3Centro Cuore Columbus,
Milan, Italy4Medizinische Universitätsklinik, Bern, Switzerland5Ferraroto
Hospital, Catania, Italy6Ospedale Riunuti, Bergamo, Italy7Instituto Dante
Pazzanese, Sao Paulo, Brazil8Institute of Cardiology & Cardiovascular,
Buenos Aires, Argentina9Herzzentrum, Siegburg, Germany
Background. The sirolimus- and the paclitaxel-eluting coronary stent systems
have been approved for use in almost all countries around the world. The
mechanisms of action of the two pharmaceutical agents are completely different
from one another, and at present there are no data available to demonstrate
the superiority of one system over the other in routine de novo lesions.
Methods. From August 2003 to February 2004, 1386 patients were
randomized in 90 centers in Europe, Latin America and Asia to receive
either the Cypher™ or the Taxus™ stent. Eligible patients had 1 or 2
de novo lesions in a native coronary artery between 2.25 mm and 3.00
mm in diameter. Direct stenting, bifurcation and ostial lesions were
allowed. The primary endpoint was in-lesion binary restenosis rate
by QCA at 8 months post-procedure. Secondary endpoints included
major adverse cardiac events (MACE) at 1, 8, 12, 18 and 24 months.
Results. A total of 1911 lesions were treated in 1353 patients of whom
28 % were diabetic. Demographic data and lesion complexity factors
were well balanced between the two groups. Lesions were BII or C in
86.4% of cases, 27.6% were > 20 mm in length and 5.2 % of patients
had true bifurcation lesions treated. Overall, 39.4% of pts received
only 1 stent with an average of 1.9 ± 1.1 stents per patient. Clinical
outcome at 8-months follow-up was similar in both groups including
mortality 1.8% vs 1.2% (n.s.), Q-wave myocardial infarction 0.1%
vs. 0.9% (n.s.), and clinically driven target lesion revascularization
5.0% vs. 5.4% (n.s.) in the Cypher™ and Taxus™ groups, respectively.
Conclusion. Both the Cypher™ and the Taxus™ stents are safe and
effective. The twelve-month clinical follow-up data will be presented at
the meeting.
TCT-109
Efficacy and Safety at 3 Years of the Sirolimus-Eluting Stent for the
Treatment of Patients with Long Lesions in Small Vessels from the
Canadian Multicenter, Randomized, Double-Blind Trial C-SIRIUS
Erick Schampaert1, Eric A. Cohen2, Francois Reeves3, Donald A.
Palisaitis1, Mouhieddini Traboulsi4, Lawrence Title5, Blair J. O’Neill5,
Dominic Raco6, Richard R. Mildenberger7, Sylvain Plante8, Louis Roy9
1
Hopital du Sacre-Coeur de Montreal, Montreal, PQ, Canada2Sunnybrook
and Women College Health Sicenc Centre, Toronto, ON, Canada3CHUM,
Hopital Notre-Dame, Montreal, PQ, Canada4Foothills Hospital, Calgary,
AB, Canada5Queen Elizabeth II Hospital, Halifax, NS, Canada6Hamilton
Health Science Centre, Hamilton, ON, Canada7Victoria Hospital, Victoria,
BC, Canada8Hospital, Toronto, ON, Canada9Hopital Laval, Quebec, PQ,
Canada
The randomized controlled trial C-SIRIUS, examining the efficacy and safety
of sirolimus-eluting stents (SES) vs. bare metal stents (BMS), previously
demonstrated a dramatic reduction in angiographic (8 months) and clinical (9
months) restenosis in patients with long lesions (15-32 mm) in small vessels (2.53.0 mm in diameter). This study reports on the clinical benefit at 720 and 1080
days, with an emphasis on cumulative events of individual patients over time.
Methods: One-hundred patients were enrolled in 8 Canadian sites.
Eight month angiographic follow-up was 88%. Clinical followup was obtained for all patients at 360, 720 and 1080 days. Clinical
endpoints included major adverse cardiac events (MACE: a composite
of death, myocardial infarction (MI), target lesion revascularization
(TLR)), stent thrombosis and any other revascularization.
Results: Baseline characteristics were similar between the 2 groups. In-stent
restenosis occurred in 20/44 BMS pts (45.5%) and in 0/44 SES pt (p<0.001).
At 360 days follow-up, hierarchal MACE was 18% in BMS vs. 4 % in SES
(p=0.029). There was 1 stent thrombosis in each group requiring TLR, 8
clinically-driven TLR in the BMS and 1 in the SES for a proximal edge 58%
stenosis. From 360 to 720 days, there were no additional events in the BMS,
while in the SES there was 1 cancer-related death, 1 non-target vessel Q wave
myocardial infarction, and one additional patient with in-lesion restenosis
(presenting as an acute coronary syndrome at 369 days). Therefore, the
target vessel failure rate was 22% in the BMS and 6% in the SES (p<0.05).
Conclusion: C-SIRIUS previously demonstrated that sirolimus-eluting stent
provided excellent clinical outcomes, including no late stent thrombosis,
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for patients with long lesions in small vessel at 9months. This benefit was
sustained at 720 day follow-up. Three years follow-up was completed in
June 2005 and will be presented.
TCT-110
Early Results and Six-Month Angiographic Follow-Up of DrugEluting Stenting in the Treatment of Unprotected Left Main Disease
Maria Elena Di Salvo, Nadia Garro, Anna Petralia, Gianpaolo Ussia,
Elisa Lettica, Alfredo Ruggero Galassi, Alessio La Manna, Corrado
Tamburino
Ferrarotto Hospital, Catania, Italy
Background: Unprotected left main (ULM) bare metal stenting (BMS)
has become widely used, but restenosis rate remains high (20-to-40%).
Recently drug eluting stents (DES) have been introduced in clinical
practice, but only few data concerning safety and reduction of
restenosis in unprotected LM disease are available at the moment.
Methods: We report our series of 107 patients (pts) with ULM stenosis
who underwent PCI with Sirolimus (31.8%) or Paclitaxel (68.2%) eluting
stents from June 2002 to May 2005. Seven pts (6.5 %) were affected
by in-stent restenosis after a previous bare metal stenting. Mean pt
age was 65 + 9 y, the ejection fraction was 51 ± 12; 32 pts (30%) were
diabetic, and 54 (50%) had unstable angina. Bifurcation was treated in
43 % of pts. Stenosis in other vessels was in 86 % of pts. The followup was at 1, 3 (clinical and stress test) and at 6 months (angiography).
Results: Procedural success was obtained in 98,7%. In-hospital MACCE were
3 (2.8 %) deaths (1 acute thrombosis, 1 sub-acute thrombosis, 1 cardiac failure)
and one CABG for ostial recoil. Non-Q wave AMI occurred in 1 pt (0.9 %).
At 1-month clinical follow-up (95 pts) there was no recurrence of
symptoms, 1 patient (1.0 %)died for cardiac failure. At 6-month clinical
follow-up (86 pts) 1 patient (1.2 %) died for non-cardiac disease,
2 patients (2.3 %) had TLR (1 re-PTCA and 1 CABG). Six-month
angiography achieved in 75 pts showed restenosis in 5 pts (6.6 %).
No different outcome was observed between Sirolimus and Paclitaxel stents.
Conclusion: Our preliminary data are encouraging; immediate results and
mid-term outcome confirm the safety of DES implantation in ULM stenosis
with a low rate of untoward events.
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MONDAY 10/17/05 9:00 AM - 5:00 PM (Exhibit Halls A and B)
Acute Myocardial Infarction
Exhibit Halls A and B
TCT-112
TCT-111
Microvascular Function and Myocardial Perfusion after Acute MI
Angioplasty in Anterior Versus Non-Anterior Infarcts: Results from
the EMERALD Trial
Edwin Lee1, George D Dangas1, Roxana Mehran1, Eugenia Nikolsky1,
Alexandra J Lansky1, John Webb2, David A Cox3, Bruce R Brodie4,
Mansoor Qureshi5, Anna Kalynych6, Mark Turco7, Heinz P Schultheiss8,
Daniel Dulas9, Barry D Rutherford10, David Antoniucci11, Mitchell W
Krucoff12, Raymond J Gibbons13, Denise Jones14, Gregg W Stone1
1
Columbia University Medical Center, New York, NY;2St Paul’s Hospital,
Vancouver, BC, Canada3Mid Carolina Cardiology, Charlotte, NC;4Moses
Cone Hospital, Greensboro, NC;5St Joseph Mercy Hospital, Ypsilanti,
MI;6Crawford Long Hospital, Atlanta, GA;7Washington Adventist
Hospital, Tacoma Park, MD;8University Hospital Benjamin Franklin,
Berlin, Germany9Mercy Hospital, Coon Rapids, MN;10St Luke’s Hospital,
Kansas City, MO;11Policlinico Careggi, Florence, Italy12Duke University
Medical Center, Durham, NC;13Mayo Clinic Foundation, Rochester,
MN;14Medtronic Corporation, Santa Rosa, CA
Background: Percutaneous coronary intervention (PCI) in acute
myocardial infarction (AMI) should aim not only for epicardial patency,
but also myocardial perfusion and microvascular flow. We assessed
microvascular flow, ST-segment resolution (STR) and infarct size by 99mTcSestamibi (MIBI) in LAD vs. non-LAD infarcts in the EMERALD trial.
Methods: 501 pts with AMI with symptoms less than 6 hrs
and ≥ 2mm ST elevation or new LBBB were randomized to
PCI with vs. without distal protection, had STR measurements
since admission, and MIBI imaging within 1 month post-PCI.
Results: The LAD group more frequently had baseline ST elevation,
TIMI-2 flow and Killip class≥2. The non-LAD group had more prior
MI, multivessel disease, and higher baseline LV ejection fraction. Time
from symptom onset to ER and first balloon inflation were similar. Post
PCI, pts in the non-LAD group had more TIMI-3 flow, lower corrected
TIMI frame counts, better myocardial perfusion (final myocardial blush
grade (MBG) 3), greater STR and smaller infarct size. By contrast,
patients in the LAD group had slower post PCI TIMI flow (final
TIMI 0 to 2) and decreased myocardial perfusion (final MBG 0/1).
There were no significant differences in event free survival (Table).
Conclusions: Patients with LAD infarct related artery had more severe
clinical presentation, and post-PCI had lower grades of TIMI flow,
microvascular perfusion, and larger infarct size; nonetheless, the clinical
event rates at follow-up did not differ significantly with MI location.
LAD (n=186) Non LAD (n=289)
85.2%
94.4%
Final TIMI flow 3
24
18
Final corrected TIMI frame count
Final MBG 3
40.1%
67.6%
35.1%
79.6%
ST resolution >70%
25.8 ± 21.8
11.3 ± 13.7
Infarct size Tc-99m (%LV)
30 day mortality
2.8%
2.1%
30 day MACE
7.7%
6.0%
6 month mortality
5.5%
4.9%
6 month MACE
13.5%
8.9%
P value
0.001
<0.0001
<0.0001
<0.0001
<0.0001
0.67
0.49
0.09
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Characteristics and Distribution of Calcific Spots within the Culprit
Vessel as Assessed by Intravascular Ultrasound in Patients with Acute
Barend L van der Hoeven, Su-San Liem, Pranobe V Oemrawsingh, Douwe
E Atsma, Marianne Bootsma, Katja Zeppenfeld, J Wouter Jukema, Martin
J Schalij
Leiden University Medical Center, Leiden, The Netherlands
Introduction: The risk of an acute coronary event is correlated with the
calcium score as determined by Electron Beam Computed Tomography
(EBCT). However, intravascular ultrasound imaging (IVUS) demonstrated
that unstable lesions generally contain less calcification than stable
lesions. We hypothesized that these apparently paradoxical findings can
be explained by the distribution of calcific spots within the coronary tree.
Methods: 60 pts (82% male, 58 ± 13 ys) were included in the study.
Motorized pullback IVUS imaging of culprit vessels was performed in
patients presenting with ST-elevation AMI referred for primary PCI,
immediately after crossing the guide wire through the culprit lesion.
All spots within the culprit lesion and within the adjacent 15 mm
proximal and 15 mm distal segments were counted and categorized
according to their arc and length: 0-<45º, 45-<90º, 90-<180º, >=180º;
<1.5 mm, 1.5-<3.0 mm, 3.0-<6.0 mm, >=6 mm. For all type of spots
the number of spots per millimeter segment length was calculated.
Results: Pts: history of CAD 5%, diabetes mellitus 8%, hypertension 21%,
hyperlipidemia 15%, smokers 59%, family history 33%. Culprit vessel:
LAD 65%, RCA 33%, LCX 2%. The table shows the number of calcific
spots per category.
Arc
Length
avg nr of spots / mm segment
avg nr of spots / mm segment
45
90 1.5 - <3 3 - <6
≥6
<45º
≥180º <1.5 mm
- <90º <180º
mm
mm
mm
Proximal 0.051* 0.040 0.022* 0.004* 0.036**
0.021
0.032 0.019
Lesion
0.093 0.056
0.034 0.011
0.078
0.043
0.039 0.027
Distal
0.053* 0.032* 0.010* 0.001* 0.034**
0.035
0.019 0.006*
Compared with lesion: *p<0.05, **p<0.005
Conclusion: Culprit lesions in patients with AMI are characterized by more
calcific spots per millimeter compared with proximal and distal adjacent
segments. Especially short spots are more common within culprit lesions
and seem to be a risk factor of plaque instability.
TCT-113
The Impact of Percutaneous Revascularization on Survival in
Patients with Myocardial Infarction and Advanced Left Ventricular
Dysfunction in the Multicenter Automatic Defibrillator Implantation
Trial II (MADIT II)
Aman K Kakkar, Craig Narins, Fred Ling, Scott McNitt, Arthur Moss,
Wojciech Zareba
University of Rochester, Rochester, NY
Background: Implantable defibrillator (ICD) is an effective treatment
modality in improving survival in post myocardial infarction (MI) patients
with advanced left ventricular (LV) dysfunction. Ischemia might be a cause for
arrhythmias leading to sudden cardiac death. The influence of percutaneous
coronary revscularization (PCI) in this group of patients is unknown.
Methods and Results: The MADIT II trial examined the impact of ICD
therapy on survival in post MI patients with LV ejection fraction (EF) of
less than 30%. The database was examined with respect to percutaneous
revascularization. Among 524 patients who received an ICD, 243 (46%)
underwent PCI and 281 patients (54%) received no revascularization
(NR).Patients who underwent PCI had higher usage of B blockers (68.3
vs 59.8%, p=0.04) and statins (67.9 vs 51.2%, p<0.001) as compared
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
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to NR. Patients who underwent PCI had lower probability of death
(8.7% vs 16.2%, p= .011) at 20 months.Among patients who received
an ICD, PCI was associated with a trend toward lower need for ICD
therapy (22%vs 31% at 2-year) during follow up. These difference did
not persist after adjustment for clinical variables in the multivariate
Cox regression analysis.Kaplan Meir Survival curve shown in Figure 1.
Conclusion: PCI in post MI patients with ejection fraction less than 30%
treated with ICD therapy was associated with a trend towards better survival
and less arrhythmic events. These preliminary merit further examination in
larger prospective studies.
TCT-114
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Drug Eluting Stents in Patients with Acute Myocardial Infarction:
Initial Results and Six Months Clinical Follow-Up of the Randomized
MISSION! Intervention Study
Barend L van der Hoeven, Su-San Liem, J Wouter Jukema, Pranobe V
Oemrawsingh, Douwe E Atsma, Marianne Bootsma, Katja Zeppenfeld,
Martin J Schalij
Leiden University Medical Center, Leiden, The Netherlands
Introduction: The MISSION! Intervention Study is a randomized, single
center study in 300 patients with acute myocardial infarction (AMI) comparing
drug eluting stent therapy in with the results of thin strut cobalt chromium
stent implantation. The intial results of the first 200 patients are presented.
Methods: Patients with AMI (< 12 hours) due to a de novo coronary
artery lesion with a reference diameter of 2.25 to 3.75 mm and a maximum
lesion length of 24 mm were included. Either a Cypher Select drug eluting
stent or a cobalt chromium Vision stent was implanted. The primary
angiographic endpoint of the study is the lesion late loss at 9 months.
Secondary endpoints include: target lesion revascularization rate at 12
months, and minimum lumen area (Intracoronary echo) at 9 months. All
patients received aspirin and clopidogrel for 1 year after the procedure.
Results: Patient characteristics: Age 59±11 years, Male 77%, Diabetes
Mellitus 12%, Family history of CAD 41%, Hyperlipidemia 15%,
Hypertension 24%, Smoking 53%, Previous AMI 5%, Previous PCI 3%,
Previous CABG 1%. Target vessel: LAD 58%, RCA 28%, LCX 14%.
Procedural success rate (<50% diameter stenosis+TIMI 3 flow) was
95%. Clinical succes (procedural success + discharge from the hospital
without MACE) was achieved in 91% of patients. Cumulative MACE at
1 months was: Death: 1.9%; re-AMI:1.3%; Sub-acute stent thrombosis
1.8%; Non-target lesion revascularization 6.9%. Cumulative MACE at
6 months was: 2.7%; re-AMI:2.7%; Sub-acute stent thrombosis 1.8%;
Non-target lesions revascularization 15%; Target lesion revascularization
4.5%. MACE free survival at 6 months was 80%. LV ejection fraction
(myocardial perfusion scintigraphy) at 3 months was 52%(±12.4%).
Conclusion: The randomized MISSION! Intervention Study comparing
drug eluting stent therapy with thin strut cobalt chromium stent implantation
in patients with AMI demonstrates excellent acute and long-term clinical
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results. Of interest is the high number of non-target lesion revascularization
procedures in this group of patients.
TCT-115
Coordinated Aggressive Medical and Interventional Therapy
for Acute Myocardial Infarction: Pre-Hospital Administration
of Thrombolysis with Urgent Culprit Artery Revascularization
(PATCAR)
Gregory M Giesler1, Mary Vooletich1, Vinay Julapalli1, Rajeev Garg1, Joel
Rester1, H. Vernon Anderson1, Stefano Sdringola1, Ali Denktas1, Richard
Bradley1, David Persse2, Richard W. Smalling1
1
U. Texas Health Sciences Center, Houston, TX;2City of Houston Fire
Department, Houston, TX
Background: Percutaneous coronary intervention (PCI) has improved
outcomes in patients presenting with ST-elevation myocardial infarction
(STEMI). Primary PCI has been limited by facility availability and
prolonged time to reperfusion. Previous trials (DANAMI, PRAGUE2, CAPTIM) of transport to a PCI center demonstrated pain onset
to balloon times of 188 to 277 minutes, initial infarct related artery
(IRA) patency (TIMI III flow) of 17-20% and a 30-day mortality of 57%. The PATCAR Pilot trial will test the hypothesis that pre-hospital
½ dose thrombolysis followed by immediate PCI will significantly
reduce time from onset of pain to IRA patency and reduce re-infarction
resulting in improved outcomes compared to full dose thrombolysis.
Methods: Patients in a large metropolitan area who activate emergency
medical services (EMS/911) are evaluated by EMS personnel for STEMI.
Patients meeting inclusion criteria are given in-field thrombolytic therapy
(10 units Retevase®) and transported directly to the Level I Cardiovascular
Center, with the interventional team activated during transport. Patients are
then randomized to receive a second dose of thrombolytic or emergent PCI.
Results: To date, 92 patients have been enrolled in the Pilot trial. No patient
randomized has had an adverse event prior to hospital arrival. Eighty
percent of patients with facilitated PCI had TIMI III flow on arrival to the
cath lab suggesting IRA patency occurred earlier than indicated by door
to balloon time. PCI was successful in all patients with no neurological
complications. Average pain onset to balloon time was 190 minutes.
Conclusion: Pre-hospital thrombolysis with facilitated PCI has shifted the
time from onset of pain to IRA patency earlier than current primary PCI
strategies. This early IRA patency may further reduce the 30-day mortality
to less than 5-7%. The benefits of ½ dose pre-hospital lysis with urgent
culprit artery revascularization (pre-hospital facilitated PCI) compared to
primary PCI will be evaluated in the PATCAR pivotal trial.
TCT-116
The Impact of Time-to-Balloon on Outcomes in Patients Undergoing
Modern Primary Angioplasty for Acute Myocardial Infarction
Chao Yang Soon1, Wan Xian Chan1, Ying Juan Wu2, Huay Cheem Tan1
1
National University Hospital Singapore, Singapore, Singapore2Clnical
Trial Epidemiological Research Unit, Singapore, Singapore, Singapore
Objective: The importance of time-to-primary percutaneous coronary
intervention (PCI) in acute ST-segment elevated myocardial infarction
(STEMI) has been controversial. We examine the relationship between
time-to-treatment and short- to medium-term clinical outcomes.
Methods: In a prospective cohort study of data collected from our
institution’s angioplasty database between June 2001 and May 2003, 208
consecutive patients (mean age 56.0 12.2 years; 88.5% men; diabetes
mellitus 23.6%) with STEMI and underwent primary PCI without
antecedent fibrinolytic therapy, were analysed. The main outcome
measures include mortality and major adverse cardiac event (MACE).
Results : Symptom-to-balloon time (median time 3 hours 55 mins)
significantly increased the MACE rate at 1-month (OR 1.45, 95%
CI 1.09-1.92, p=0.010) and 6-months (OR 1.19, 95% CI 1.00-1.41,
p=0.046) but not mortality at 1- and 6-months (at 1 month: p=0.25; at
6 months: p=0.87) after adjusting for relevant covariates. However,
door-to-balloon time (median time 110 minutes) does not significantly
influence mortality and MACE at 1- and 6-months (mortality at 1month:
p=0.73; 6 month: p=0.64, MACE at 1 month: p=0.71; 6 month: p=0.08).
Conclusions: Symptom-to-balloon time is an important predictor of
MACE in the short- and medium-term in contrast to door-to-balloon
time. Improving public awareness and accessibility of health services to
patients with STEMI is essential in reducing poor outcomes
TCT-118
Continuous On-Site Interventional Cardiology Coverage Results in
Significant Reduction in Door-to Balloon Times
Matthew Mick, Anita Arnold, Tanvir Bajwa, Anjan Gupta, Dana Kappel
St. Luke’s Medical Center, Milwaukee, WI
TCT-117
Clinical Outcomes of Modern Primary Angioplasty for Acute
Myocardial Infarction during “Office” Hours versus “Off” Hours
Chao Yang Soon1, Wan Xian Chan1, Ying Juan Wu2, Huay Cheem Tan1
1
National University Hospital Singapore, Singapore, Singapore2Clinical
Trial Epidemiological Research Unit, Singapore, Singapore, Singapore
Background:
Delay
in
time-to-reperfusion
during
primary
angioplasty (PA) is associated with poorer outcomes. We
decide to compare the outcomes of PA for acute ST-elevation
myocardial infarction (STEMI) during “office” versus “off” hours.
Methods: In a prospective observational study of data collected between
June 2001 and May 2003, 135 consecutive patients (64.9%) with STEMI
underwent PA without antecedent fibrinolytic therapy during “office”
hours (0800-1730hr Monday to Friday, 0800-1230hr Saturday). They were
compared with 73 consecutive patients (35.1%) who had PA during “off”
hours (any other time). The primary endpoints of this study were mortality
and major adverse cardiovascular events (MACE) at 1 and 6 month.
Results: Baseline demographics were similar for both groups. Mortality
at 1 month (office 8.3%, off 8.3%, p = 1.000) and 6 month (9.4% vs
11.4%, p=0.647) did not show any significant difference. The MACE
at 1 month (office 9.1%, off 8.5%, p=0.878) and 6 month (14.1%
vs 13.0%, p=0.843) were also similar. The door-to-balloon time
(median value 96 minutes for office hours, 138 minutes for off hours,
p<0.001) was significantly prolonged during “off” hours but not the
symptom-to-balloon time (231 minutes vs 237 minutes, p=0.234).
Conclusion: Primary angioplasty for AMI can be performed with equal
safety and efficacy during off hours compared with during office hours
despite longer door-to-balloon time.
Background: Prompt treatment of ST-elevation myocardial infarction
(STEMI) results in improvement in myocardial salvage and significant
reduction in mortality. One of the major impediments to prompt treatment is
the need to call in staff and cardiologists from home during the off-hours. We
sought to minimize this delay by instituting continuous in-house coverage
of our catheterization laboratory by staff and qualified cardiologists.
Methods: We initiated continuous coverage of our catheterization laboratory
in April, 2004. In the year prior to continuous coverage, 129 patients underwent
percutaneous revascularization (PCI) for STEMI (Group 1). After the change
in coverage, 130 patients underwent PCI for STEMI (Group 2). Groups were
compared for differences in baseline characteristics and distribution curves
were derived for door-to-balloon times during each of the years studied.
Results: Baseline characteristics were similar for the two groups, including
hypertension, diabetes, age, gender, lipid status, smoking, presence of
congestive heart failure, prior revascularization and time from onset of
symptoms to presentation. Group 1 had a significantly longer average
door-to-ballon time than Group 2 (108.8 minutes versus 79.8 minutes,
p=<0.0001).
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Conclusion: Continuous in-house coverage by cardiologists and staff
results in significant reduction in average door-to-balloon times. While not
practical in all institutions, this strategy removes at least one impediment
to prompt care.
TCT-119
Mayo Clinic Fast Track Protocol for ST-Elevation Myocardial
Infarction: Process Improvements to Minimize Delays in Treatment
Henry H Ting, Malcolm R Bell, John F Bresnahan, Luis H Haro, Angela
M Wills, Meghan B Lamp, Stephen F Pieper, LaVon N Hammes, ChoonChern Lim, Eric H Yang, Charanjit S Rihal
Mayo Clinic, Rochester, MN
Background: Regional patients with ST elevation myocardial
infarction (STEMI) transferred for primary percutaneous coronary
intervention (PPCI) may experience significant delays in treatment.
Methods: Fast Track protocol for STEMI uses current evidence and Lean
principles to prioritize value-added processes and eliminate waste. 8 regional
hospitals are activated and 3 helicopters cover 100 nautical miles. 12 regional
hospitals will be activated soon. For STEMI with onset of symptoms <3hours,
thrombolysis and transfer is preferred if there are no contraindications.
For STEMI with onset of symptoms >3hours, transfer for PPCI is
preferred if rapid transport is available. Lean process innovations include:
1. Single phone call to activate protocol and transport
2.
Regional
hospital
activates
Catheterization
Lab
3. Standard guideline for selecting reperfusion strategy and medications
4. Helicopter engine left running to minimize ground time
5. Glycoprotein IIB-IIIa inhibitor administered en route by transport nurses
Prospective
web-based
data
collection
tool
Results: From December 2004 to May 2005, 23 patients have been enrolled
in the Fast Track with 7 (30%) treated with thrombolysis and transfer and
16 (70%) transferred for PPCI. Controls are patients who were transferred
using usual, routine processes.
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NRMI
Regional Door-to-Thrombolysis
(Median, minutes)
Regional Door-to-Balloon
(Median, minutes)
30
185
Control
Thrombolysis
(N=3)
PPCI (N=8)
45
---
217
Fast Track
Thrombolysis
(N=7)
PPCI (N=16)
25
---
110
Conclusions: Fast Track protocol for STEMI implements current evidencebased care and utilizes Lean principles to prioritize value-added processes.
The process changes have improved time to treatment.
TCT-120
Early In-Hospital Treatment with Clopidogrel is an Independent
Predictor of Spontaneous ST Resolution in Patients with Acute ST
Elevation Myocardial Infarction
Abdulrahman Arabi, Devang Desai, Carol Chen-Scarabelli, Gautam
Kareti, Nancy Mesiha, Tiziano Scarabelli, Howard Rosman, Julius Gardin,
Mohamed Jabaren
St. John Hospital&Medical Center, Detroit, MI
Background:
Spontaneous
ST
segment
resolution
(STR)
after
acute
ST
elevation
myocardial
infarction
(STEMI)
is
associated
with
favorable
outcomes.
Objectives: The aim of this study was to identify independent predictors of
STR in patients with acute STEMI prior to primary percutaneous coronary
intervention (PCI) in the current era of new anti-thrombotic agents.
Methods: We identified, from a prospective hospital data registry,
all patients admitted with STEMI between January 2002 and June
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2004. Clinical and angiographic data of patients with and without
STR prior to primary PCI were collected. Cardiac markers were
measured on admission, 6 hours, and 12 hours after admission.
Results: A total of 206 patients were studied, with 37 patients (18%)
having spontaneous STR. There were a total of 12 deaths, with all of the
deaths occurring in the group without spontaneous STR (12/169 = 7.1%).
Stepwise logistic regression analyses identified the following as
independent predictors of STR: single vessel disease [p=0.016, odds ratio
(OR) 2.85, 95% confidence interval (CI) 1.2 to 6.7], collaterals (p=0.002,
OR 4.28, 95% CI 1.7 to 10.8), circumflex culprit vessel (p=0.008, OR
4.74, 95% CI 1.49 to 14.97), arterial thrombus (p=0.007, OR 5.76, 95%
CI 1.6 to 20.4), and clopidogrel given in the ambulance/emergency room
(p=0.0488, OR 2.10, 95% CI 1.00 to 4.40). However, glycoprotein IIb/
IIIa inhibitors and aspirin were not found to be independent predictors
of spontaneous STR. Patients with spontaneous STR were also found to
have preserved left ventricular (LV) ejection fraction compared to those
who did not have spontaneous STR (54.6% versus 39.8%, p<0.0001).
Conclusion: Patients with single vessel disease, thrombus, collateral
flow, and circumflex as the culprit vessel are more likely to have STR. In
addition, patients who received clopidogrel in the ambulance/emergency
room were two times more likely to have spontaneous STR. This suggests
that antiplatelet activity of clopidogrel plays a crucial role in spontaneous
STR with subsequent preservation of LV function in STEMI patients.
TCT-121
No-Reflow during Coronary Angioplasty for Acute Myocardial
Infarction is Associated with Increased Mortality
David Brosh, Abid Assali, Igal Teplitsky, Shmuel Fuchs, Ran Kornowski
Rabin Medical Center, Petach Tiqva, Israel
Background: No-reflow is a frequent event during percutaneuos coronary
intervention (PCI) for acute myocardial infarction (AMI) and it may
affect cardiac prognosis. The objective of this analysis was to evaluate the
occurrence of no-reflow as an independent predictor of adverse events.
Methods: We prospectively collected data from 488 consecutive
patients undergoing PCI for ST-elevation AMI, identifying those
with no-reflow, and analyzing their baseline characteristics
and clinical outcomes. All patients were treated using stents.
Results: Patients with no-reflow, n=41(8.4%), were older (65 ± 13 vs. 60
± 13 yrs; p=0.02), and more likely to have renal failure (20% vs. 6.6%;
p=0.008). They tend to arrive late to hospital (7.2 ± 8.8 vs. 4.4 ± 6.9 hrs;
p=0.02), and to have more TIMI 0-1 flow at presentation (88% vs. 66%;
p=0.009). Mean time from hospital arrival to PCI tend to be longer in pts
with no-reflow (3.8 ± 8.2 vs. 2.1 ± 5.6 hrs; p=0.08). Most cases of noreflow (73%) occurred after stenting. Procedures with no-reflow had lower
success rate (76% vs. 97%; p<0.001), and often required IABP (34% vs.
3%; p<0.001). At follow-up, peak CK was higher in patients with no-reflow
as compared to controls (2700 ± 1900 vs. 2000 ± 1800; p=0.04), more often
resulted in moderate to severe LV dysfunction (66% vs. 43%; p=0.008),
increased mortality (10% vs. 3%; p=0.05) and 30 days MACE (16% vs.
7.2%; p=0.09). By multivariate analysis, adjusted for risk factors, no-reflow
was found independent predictor of short-term mortality (odds ratio=3.3;
p=0.05), whereas, obtaining TIMI 3 flow was independent predictor of
better outcome (p=0.008). Also, female gender (odds ratio=2.38; p=0.003),
renal failure (odds ratio=4.39; p=0.0025) and pre-procedure TIMI flow 0-1
(odds=2.1; p=0.003) were independent predictors of developing no-reflow.
Conclusion: No-reflow during PCI for AMI appears mostly after stenting.
Its association with late arrival and worse TIMI flow at the beginning of the
procedure may indicate the presence of high-organized thrombus burden
with higher potential for distal embolization following stent deployment.
Regardless its mechanism, this event is an independent predictor of
increased mortality and MACE.
TCT-122
Percutaneous Coronary Intervention for Acute Myocardial Infarction
in the Elderly: Comparison on Clinical Outcome between Younger
Patients, Septuagenarians and Octogenarians
1
Funabashi, Japan
prevalence of renal insufficiency and multivessel disease, and had lower prePCI hematocrit (all p<0.03). T was associated with longer procedure, higher
incidence of post-PCI TIMI flow 0/1, more frequent use of abciximab, and
lower procedure success (all p<0.04). Pts treated with T had strikingly higher
rates of death in hospital, at 30 days and at 1 year (Figure). After adjustment
for potential confounders including T propensity score, T was identified
as independent predictor of death in hospital (OR=12.3; p=0.0002),
at 30 days (HR=7.11; p=0.0002) and at 1 year (HR=5.7; p<0.0001).
Conclusions: In pts undergoing primary PCI for AMI, T is associated with
markedly increased early and late mortality. Prospective randomized trial
should further address the role of T in outcomes of pts with AMI
Background: Previous studies have suggested that the elderly
patients have worse outcomes of percutaneous coronary interventions
(PCI). However, contemporary outcomes of PCI in those
patients with acute myocardial infarction (AMI) are still unclear.
Methods: We studied clinical, angiographical results of 430
consecutive octogenarians (mean age 84.6 years, 56.7% male), 672
septuagenarians (mean age 75.4 years, 64.0% male) and 2,100 younger
patients (mean age 58.8 years, 74.0% male) undergoing emergent
PCI for AMI from Apr. 1999 to Mar. 2004. The octogenarians had a
higher incidence of cardiogenic shock and congestive heart failure.
Results: See table.
Younger
Septuagenarians Octogenarians
patients
(70-79 years)
(≥80 years)
(<70 years)
Number of patients
2,100
672
430
Clinical success (%)
98.5
96.7
94.2
Cardiogenic shock
In-hospital
8.0
9.8
**16.7
(%)
Death (%)
0.6
1.9
*4.9
12-month Re-infarction (%)
6.9
7.9
*12.8
Re-heart failure (%)
8.0
7.9
*14.0
Death (%)
0.2
0.7
*3.5
TLR: re-PCI (%)
18.1
18.9
18.8
Any events (%)
24.6
27.2
*40.0
p
NS
0.01
0.05
0.05
0.05
0.05
NS
0.05
Conclusions: In octogenarians, emergent PCI in patients with AMI can be
performed with high success rate, albeit with high incidence of in-hospital
and long-term mortality, and adverse clinical events.
TCT-123
Blood Transfusion in Patients Undergoing Primary Percutaneous
Coronary Intervention for Acute Myocardial Infarction: Analysis
from the CADILLAC trial
Eugenia Nikolsky1, Roxana Mehran1, Cindy L Grines2, Mark Turco3, David
A Cox4, Thomas Stuckey5, Giulio Guagliumi6, John J Griffin7, Alexandra
J Lansky1, Yingbo Na8, Gabriela Turcanu8, Ramez Sulaiman8, Susheel
Kodali1, Carmen Spatareanu8, Gregg W Stone1
1
Columbia University Medical Center, New York, NY;2William Beaumont
Hospital, Royal oak, MI;3Washington Adventist Hospital, Tacoma Park,
MD;4Mid Carolina Cardiology, Charlotte, NC;5Moses Cone Memorial
Hospital, Greensboro, NC;6Ospedali Riuniti di Bergamo, Bergamo,
Italy7Virginia Beach General Hospital, Virginia, VA;8Cardiovascular
Research Foundation, New York, NY
Background: Despite the widespread use of red blood cell transfusion (T), there
is very limited evidence to guide transfusion decisions in pts undergoing PCI.
We evaluated outcomes of pts treated with T in the contemporary randomized
trial of pts undergoing primary PCI for acute myocardial infarction (AMI).
Methods: In the CADILLAC trial, of 2,060 pts with AMI randomized
to balloon angioplasty vs. stenting, each +abciximab, 82 (3.9%) pts
received a T not related to coronary bypass grafting during the index
hospitalization. To control for baseline differences, a propensity score
for T was constructed and included in multivariate analysis of death.
Results: Pts treated with T were older, more frequently female, had higher
TCT-124
Gender Differences in Angiographic, Echocardiographic, and Clinical
Results after Primary Angioplasty
Gabriele Borelli, Marco De Carlo, Giulia Branchitta, Roberto Gistri,
Paolo Caravelli, Alberto Balbarini, Anna S Petronio
Cardiothoracic Department, University of Pisa, Pisa, Italy
Background: Few data exist on the influence of gender on mortality after
primary angioplasty, although several studies on ST-elevation myocardial
infarction treated with thrombolysis reported a worse outcome in women. Our
aim was to investigate sex-related differences in clinical and angiographic
features and in long-term outcome in patients undergoing primary angioplasty.
Methods: Baseline clinical, angiographic, and echocardiographic
data and 1-year follow-up clinical and echocardiographic data on
210 consecutive patients undergoing primary angioplasty from
January 2003 to December 2003 were prospectively collected.
Results: Women were 47 (22.4%). Female sex was associated with older
age (67±11 vs 60±10 ys, p<0.001), smaller body surface area (1.76±0.16
vs 1.90±0.12 m2, p<0.001), higher prevalence of diabetes (38 vs 24%,
p=0.06) and hypertension (60 vs 41%, p=0.03), higher Killip class and
prevalence of cardiogenic shock (13 vs 5%, p=0.008), longer symptom
onset-to-balloon time (235±84 vs 214±54 min, p=0.06), smaller vessel
diameter (2.7±0.4 vs 3.2±0.5 mm, p=0.005), and higher prevalence of
lateral wall infarction (21 vs 10% , p=0.048). No difference was observed
in terms of angiographic success, final epicardial flow, myocardial blush
grade, ST segment elevation resolution, and peak creatine kinase. Women
showed a significantly higher incidence of major bleedings (8.5 vs 2.5%,
p=0.07), and a higher in-hospital mortality (4.3 vs 0% p=0.05). At 1-year,
the differences in mortality (10.6 vs 5.5%), target vessel revascularization
(6.4 vs 7.4%), recurrent angina (6.4 vs 7.4%), and reinfarction (4.1 vs 8.0%)
were not significant, with a similar event-free survival (72.3 vs 79.1%).
Women showed a higher prevalence of echocardiographic left ventricular
contractile recovery (81.0% vs 62.9%, p=0.04), while no difference
was found in terms of left ventricular remodeling (18.6 vs 22.9%).
Conclusion: Women treated with primary angioplasty have a higher inhospital mortality compared with men, mainly because of a higher risk
profile and more complex angiographic features. However, female sex is
not associated with a higher mortality at 1 year.
59H
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TCT-125
Adheren Junctions Were Disrupted after Acute Myocardial Infarction
and Reperfusion
Yang Yuejin, Zhao Jinglin, Chen Jilin, Gao Runlin
No-reflow is a complex condition associated with inadequate myocardial
perfusion of the coronary artery in the absence of epicardial obstruction
and associated with edema and heart dysfunction. Adheren junctions can
regulate vascular permeability barrier integrity and cardiomyocyte function.
We assessed the hypothesis that no-reflow is related to the disintegrity of
adherens junction proteins. METHODS: Twenty Pigs were subjected to
occlusion of the left anterior descending coronary artery (LAD) for 3 hours,
followed by reperfusion for 60 minutes. The area at risk and no-reflow zones
were determined by thioflavin-S, Evan’s blue staining. No-reflow zone size
was expressed as a percentage of area at risk (%NR/AR). The normal,
ischemic reflow and no-reflow myocardium samples were harvested at the
end of reperfusion. Adherens junctions were analyzed by total lysate that
were immunoblotted for VE-cadherin, beta-catenin, and gamma-catenin.
Frozen tissue sections were labeled with the same antibodies, and adherens
junctions were visualized by confocal microscopy. RESULTS: %NR/ AR
after 3 hours ischemia and 60min reperfusion is 82.3 ± 1.9% in the pig model.
Immunoblotting revealed a decrease in VE-cadherin (from 212.3±12.2%
in normal myocardium to 102.7±7.3% in no-reflow myocardium, P<0.01),
beta-catenin (from 153.7±10.5% in normal myocardium to 95.1±21.8% in
no-reflow myocardium, P<0.05), and gamma -catenin (from 167.2±14.4%
in normal myocardium to 101.3±13.9% in no-reflow myocardium,
P<0.05), indicating partial protein degradation. Confocal microscopy of
hearts obtained in the normal myocardium samples showed a continuous,
homogeneous pattern of cell-cell labeling that contrasted with an irregular,
discontinuous pattern observed in the no-reflow myocardium samples. In
conclusion, no-reflow is associated with signs of degradation of adherens
junctions.
P
O
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R
A
B
S
T
R
A
C
T
S
TCT-126
Abnormal Myocardial Blush Predict LV Remodeling after First Acute
Anterior Myocardial Infarction Undergoing Successful [Final TIMI
Flow 3] Primary Angioplasty
Abid R Assali, Ashraf Hamdan, I Teplitsky, N Zafrir, A Alejandro, D
Hasdai, S Imbar, A Sagie, A Battler, R Kornowski
Rabin Medical Center, Petah Tikva, Israel
Background: Left ventricular (LV) remodeling after acute anterior myocardial
infarction (AAMI) is a major risk factor of overt heart failure and death. The
aim of this prospective blinded study was to evaluate the association between
myocardial blush (MB) and LV remodeling in patients undergoing successful
[TIMI flow 3] percutaneous coronary intervention (PCI) for AAMI.
Methods: Patients with first AAMI were included if TIMI flow in
the culprit vessel was 3 at the end of PCI. Myocardial blush was
blindly measured at the of PCI. LV end-diastolic volume (LVEDV)
was assessed by serial echocardiograms within 24 hours (T1) of the
AAMI, 1 month (T2) and 6 months (T3) later. Remodeling was defined
as an increase in LVEDV of >10% in T2 and T3 compared with T1.
The results were analyzed according to LV remodeling on follow-up.
Results: The study sample included 26 patients. At one-month, 9 of the 26
patients (34.5 %) had LV remodeling. Results are shown in table. Similar
results were found when the six months remodeling was analyzed. No
patient with LV remodeling assessed at 1- and 6-months had MB-3 at the
end of the procedure as compared with patients without remodeling (71%,
p = 0.003; 67%, p = 0.001 retrospectively).
60H
Myocardial Blush - 3
Age [year]
Male
Blood pressure %
DM
Peak CK [U/Ml]
Time from chest pain to hospital arrival
(min)
Time from chest pain to PCI (min)
Remodeling No remodeling
0%
71%
58 ± 8
59 ± 4
100%
88%
11%
18%
11%
23%
3100 ± 2800 1980 ± 1440
110 ± 91
113 ± 85
178 ± 106
191 ± 88
P-value
0.003
0.8
0.4
0.6
0.6
0.2
0.9
0.2
Conclusion: Our results indicate that LV dilatation (i.e., pathologic
remodeling) still occurs after successful PCI (restoration TIMI 3) in a high
proportion of patients with AAMI. A better myocardial blush, after primary
angioplasty, may attenuate this process.
TCT-127
A Randomized Multi-Center Trial of Direct versus Rescue
Percutaneous Coronary Intervention for Acute Myocardial Infarction
Runlin Gao, Reperfusion Therapy Collaborative Group
Fu Wai Hospital, Beijing, China
Background: Rescue PCI can improve the prognosis in acute
myocardial infarction (AMI) patients who failed thrombosis. But it
is not clear if rescue PCI can obtain similar efficacy with direct PCI.
Methods: The ST elevated AMI patients with age≤70 years old, who
presented within 12 hours of onset of chest pain, were enrolled into the
study. The patients were randomized into 3 groups: (1) recombinant
staphylokinase (r-Sak, Chengdu Di’ao Jiuhong Pharmaceutical, China)
group in 104 cases; (2) recombinant tissue-type plasminogen activator (rtPA, Boehringer Ingelheim, Germany) group in 106 cases; (3) direct PCI in
101 cases. All patients received aspirin. Heparin was given intravenously
before thrombolytic therapy or during PCI. For all patients allocated
to thrombolytic therapy 90 min coronary angiography was performed.
Rescue PCI was undergone if the TIMI 3 was not achieved. Clopidegrel
300 mg was taken before PCI, followed by 75 mg daily at least 8 weeks.
Results: 311 eligible patients from 12 hospitals were enrolled into the study.
Direct PCI was completed in 93 cases with TIMI 0-2 .The patency rate was
97.8% and TIMI 3 flow 84.9%. 90 min coronary angiography was completed
in 200 cases of thrombolysis group. Rescue PCI was performed in 117 cases,
including 79 with TIMI 0-2 and 38 with TIMI 3 but with severe stenosis. After
procedure TIMI 3 was achieved in 54(68.4%) of the 79 cases with TIMI 02, which was significantly lower than that of direct PCI (P=0.0096). Among
the 38 cases with TIMI 3, 12 cases (31.6%) developed slow flow or no-reflow
after stenting. The composite clinical end-point (death and non-fetal MI)
was significantly higher in rescue PCI group (8.5%) than that in direct PCI
group (0.9%, P=0.0044). The incidence of hemorrhage (29.9%) in rescue
PCI was not significant different with thrombolysis group (29%, P=0.7877),
but was significantly higher than direct PCI group (8.9%, P=0.0006).
Conclusion: The composite end point (death and non-feta MI) is higher
in rescue PCI than in direct PCI group, which may relate to less TIMI 3
flow and more no-reflow or slow flow after procedure in rescue PCI group.
Rescue PCI increases bleeding risk compared with direct PCI.
TCT-128
Epicardial Vessel Patency, Myocardial Perfusion and Infarct Size
after Percutaneous Revascularization in Acute Anterior Versus NonAnterior Infarcts: Pooled Analysis from 4 Randomized Trials
George D Dangas1, Roxana Mehran2, Jeffrey W Moses1, Michael B
Collins1, Eugenia Nikolsky1, Alexandria J Lansky1, Giora Weisz1, Anil
Puruhit1, Martin B Leon1, Bruce B Brodie3, Mitchell Krucoff4, Cindy
Grines5, Simon R Dixon5, Gregg W Stone1
1
Columbia University Medical Center, New York, NY;2Cardiovascular
Research Foundation and Columbia University Medical Center, New York,
NY;3Moses Cone Hospital, Greensboro, NC;4Duke University Medical
Center, Durham, NC;5William Beaumont Hospital, Royal Oak, MI
Background. Reperfusion therapy in pts with acute myocardial infarction
(AMI) is targeted on achieving of epicardial vessel patency, restoration
of myocardial perfusion and preservation of microvascular function. We
assessed whether these effects differ in anterior vs. non-anterior infarcts.
Methods. In pooled analysis from 4 contemporary randomized trials
of mechanical reperfusion in AMI (EMERALD [study group: distal
embolic protection], COOLMI [cooling], AMIHOT [hyperbaric
oxygen delivery] and ICE-IT [temperature lowering], vessel patency,
reperfusion and infarct size were assessed using angiography, STsegment resolution (STR) monitoring, and Tc99m sestamibi, respectively.
Results. Pts with anterior vs. non-anterior AMI less frequently had rescue
PCI (12% vs. 17%, p=0.02), and had longer pain-to-door time (154±174
vs. 131±127min, p<0.0001). Anterior MI was associated with lower LVEF
(48±13% vs. 61±12%, p<0.0001) and higher prevalence of single-vessel
disease (55% vs. 45%, p=0.02). Medication use and outcomes are shown
in the Table. By multivariate analysis, anterior MI was an independent
predictor of greater infarct size (coefficient 17, standard error 1.3.
p<0.0001) and of 30-day MACE (odds ratio 2.55 [1.19-5.43], p=0.01).
Conclusions. Pts undergoing primary PCI for anterior AMI compared to pts
with non-anterior AMI, have lower rates of restoration of epicardial flow,
less complete STR and larger infarct size resulting in higher rates of 30-day
MACE.
Final TIMI flow 3
Final corrected TIMI frame count
Final myocardial blush grade 3
ST resolution >70% at 1 hour
Infarct size Tc-99m (%LV)
Discharge beta-blockers
Discharge ACE-I/ARB
30-day mortality
30-day major adverse cardiac events
Anterior MI
n=548
87%
24
40%
47%
24 ± 20
90%
81%
2.7%
5.9%
Non-Anterior MI
n=728
95%
18
68%
87%
10 ± 11
91%
70%
1.4%
3.6%
P value
<0.0001
<0.0001
<0.0001
<0.0001
<0.0001
0.32
<0.0001
0.10
0.06
TCT-129
Clinical Outcome following Drug Eluting Stent Implantation in
Octogenarians with Acute Coronary Syndrome
Salah-Eddine Hassani, Roswitha Wolfram, Zhenyi Xue, Augusto Pichard,
Kenneth Kent, Neil Weissman, Ron Waksman
Washington Hospital Center, Washington, DC
Background: Drug eluting stents (DES) have recently proven to
reduce restenosis rate as compared to bare metal stents for variety
susbset of patients and lesions. We sought to investigate, clinical
outcomes of octogenarians (patients> 80 years of age ) with
acute coronary syndrme (ACS) undergoing DES implantation.
Methods and Results: We compared 179 octogenarians and 1430
patients <80 years of age who underwent DES implantation for ACS.
Baseline characteristics revealed more female gender, Caucasians
(p=0.05), chronic renal failure (p<.001), heart failure (p<.001) and
low ejection fraction (p=0.02) in the octogenarians group. Patients<
80 years of age had a higher prevalence of positive family history
(p<.001), hyperlipidemia (p=0.03), smoking history and obesity (p<.001,
respectively). In hospital outcomes were comparable but octogenarians
had more acute renal failure (p=0.008). Outcomes at 6 months showed
a comparable restenosis rate between groups and a significantly higher
mortality and Q-wave MI rate in octogenarians(Table). Multivariate
analysis revealed age>80 years (p=0.01), cardiogenic shock (p=0.008) and
creatinine clearance (p<0.001) to be independent predictors of mortality.
Conclusions: DES implantation in octogenarians with ACS is clinically
safe and associated with a low rate of in-hospital events and repeat
revascularizations at 6-months. The higher mortality rate at 6 months is
probably due to the clinical presentation and comorbidities.
Death at 6-months (%)
Q wave MI at 6- months (%)
TLR at 6- months (%)
TLR-MACE at 6-months (%)
Late thrombosis (%)
Patients< 80 years of
age (n=1430)
29 (4)
9 (1)
22 (3)
60 (7)
3 (0.2)
Octogenarians
(n=179)
19 (19)
6 (6)
2 (2)
22 (22)
0
P
<0.001
0.002
1.0
<0.001
1.0
TCT-130
The Influence of Exercise Training Under Instructions on the
Structure and Function of the Heart and Function Capacity in Acute
Myocardial Infarction Patients
Aofeng Chiang, Fuchun Zhang, Baohui Zhang, Xiaowen Li, Xiaohong
Wang, Wei Gao
Peking University Third Hospital, Beijing, China
Backgound Myocardial infarction has a strong impact on the life-quality and
forward prognosis in patients. The aim of this study was to investigate the
influence of early exercise training (Cardiac rehabilitation) on the structure
and function of the heart for acute myocardial infarction(AMI) patients.
Methods and Results Patients meeting the inclusion criteria with
uneventful clinical courses after a first AMI were randomly assigned to
a 3- month exercise training period(n=35) or control group (n=29) after
successful PCI. All patients underwent NT-proBNP test, 2-dimensional
echocardiograms, and submaximal exercise test. At baseline, there were
no signification differences in NT-proBNP, left ventiricular end-diastolic
diameter (LVDd) and left ventricular ejection fraction (LVEF) between the
exercise and control groups, except in peak oxygen consumption(Vo2 peak)(
4.80±1.05 vs 3.91±1.49MET, P<0.05 ). After 3 months of exercise training, a
significant decrease in NT-proBNP was observed only in the exercise group
(from 845±903 to 335±246 pg/ml, P<0.05), not in the control group (from
1091±1101 to 1099 ±1168 pg/ml, P=NS), whereas there was significant
difference in NT-proBNP in both groups at 3m (P<0.01). The LVDd had
increased in the control group (from 51 ±6 to 53 ±5 mm, P=0.046) but not
in the exercise group (from 51 ±4 to 50 ±4 mm, P=NS), whereas significant
difference in LVDd between the two groups after 3 months (P<0.05).
Converely, LVEF had improved in the exercise group (from 55±8 to 60±8%
, P<0.05) but not in the control group (from52±9 to 53±12%, P=NS), while
significant difference in LVEF between the two groups after 3 months (P=
0.024). Furthermore, increase in Vo2 peak was significant in patients either
with or without exercise training(6.5±1.2MET vs. 4.9±1.2MET, P<0.01).
Conclusions In postinfarction patients, exercise training under instructions
can lower the NT-proBNP level, attenuate LVDd, improve LVEF, and
increase functional capacity. Furthermore, it is safe and feasible for
postinfarction patients without serious complications to conduct cardiac
rehabilitation exercise training under instruction in the early stage and
recovery stage of AMI.
61H
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TCT-131
Rescue Angioplasty versus a Conservative Management for Failed
Thrombolysis in Acute Myocardial Infarction: A Meta-Analysis
Babu Kunadian, Kunadian Vijayalakshmi, Joel Dunning, Andrew G C
Sutton, Robert A Wright, James A Hall, Mark A deBelder
The James Cook University Hospital, Middlesborough, United Kingdom
Prompt and effective restoration of coronary flow improves survival in
patients with acute myocardial infarction (AMI). Thrombolytic therapy fails
to restore TIMI 3 flow in 30% to 50% of AMI patients and is associated with
adverse prognosis. We performed a meta-analysis of studies comparing rescue
angioplasty (RA) to conservative management (CM) for failed thrombolysis.
Methods and results: A full systematic review was performed. Relevant
studies were combined using the DerSimonian and Laird Random
Effects Model for dichotomous clinical outcomes including death, repeat
MI, repeat revascularisation (RPCI), MACE, strokes and heart failure.
Heterogeneity was also assessed. We identified 5 trials including 800
patients and mean follow-up of 30 days. RA was associated with significant
benefit for reduced rates of MACE (OR, 0.65 [95% CI 0.52 to 0.81, p =
<0.01]),death (OR, 0.64 [95% CI 0.41 to 1, p = 0.048]), reinfarction
(OR, 0.48 [95% CI 0.25 to 0.94, p = 0.03]) and RPCI (OR, 0.37 [95%
CI 0.22 to 0.63, p = < 0.01]) and non-significant trends toward reduction
in heart failure (OR, 0.72 [95% CI 0.51 to 1.01, p = 0.06]). RA was
associated with more strokes (OR, 3.81 [95% CI 1.09 to 13.25, p = 0.04]).
This meta-analysis suggests that RA compared to CM results in reduced
mortality at 30 days, MACE,reinfarction and a need for RPCI.A reduction
in heart failure has not been conclusively established.This advantage is at
the expense of an increased rate in strokes. RA should be offered to suitable
patients who are likely to benefit.
TCT-133
Two Year Results of a Transfer Program for ST-Elevation Myocardial
Infarction: The Minneapolis Heart Institute Level 1 Myocardial
Infarction Program
Timothy D Henry1, Scott W Sharkey1, Kevin J Graham1, Wesley
R Pedersen1, Daniel L Lips1, Yale L Wang1, Barbara Tate Unger1,
Christopher R Henry1, David M Larson2
1
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B
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T
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A
C
T
S
PA level was significantly higher among patients who died than among who
survived (22.9±12.9 vs. 12.4±9.0, p<0.001). Compared with the first, second
and third quartiles (≤14μg/mL), patients in the highest quartile(>14μg/
mL) had a relative risk of subsequent death of 7.363 (95%CI, 1.83-29.66,
p=0.004). The t-PA level was independently associated with mortality (OR
7.481, 95%CI, 1.18-47.61, p<0.05) in a multivariate logistic regression
model, which included clinical variables, troponin I, brain natriuretic
peptide and C-reactive protein. The t-PA level (AUC 0.773, 95%CI, 0.5920.955) predicted 30 day mortality with sensitivity 80% and specificity
71.1% using 14μg/mL as cut-off value. The t-PA level was also higher
in patients with severe heart failure (20.2±14.9 vs. 11.5±7.3, p<0.01) or
significant ventricular tachyarrhythmia (23.3±14.3 vs. 12.0±8.4, p<0.01).
CONCLUSIONS Elevated t-PA antigen on admission is related to shortterm mortality in patients with AMI undergoing primary angioplasty.
TCT-132
Tissue Plasminogen Activator on Admission is an Important Predictor
for 30-Day Mortality in Patients with Acute Myocardial Infarction
Undergoing Primary Angioplasty
Cheol Whan Lee, Jung-Min Ahn, Bong-Ki Lee, Kyoung-Ha Park, BongRyong Choi, Duk-Woo Park, Young-Hak Kim, Myeong-Ki Hong, JaeJoong Kim, Seong-Wook Park, Seung-Jung Park
BACKGROUND Tissue plasminogen activator is emerging as an important
risk factor for coronary heart disease in the general population, but its
prognostic value remains unknown in acute myocardial infarction (AMI).
METHODS We measured t-PA on admission in 197 consecutive
patients with AMI undergoing primary angioplasty. The outcome
measure was death at 30 days, which occurred in 10 patients (5 %)
RESULTS The median t-PA level was 10μg/mL (range, 2-70μg/mL). The t-
62H
Background: Direct PCI for STEMI is superior when performed
in a timely manner in high volume centers, but 75% of STEMI pts
present to non PCI hospitals. We implemented an integrated system
for transfer of STEMI pts for direct PCI in 31 hospitals up to 200
miles from Minneapolis with >40 STEMI pts/mo being treated.
Methods: Abbott Northwestern (ANW) Hospital is a tertiary cardiac center
in Minneapolis. The “Level 1” MI protocol includes immediate activation
of transport services, mobilization of the cath lab team and administration
of adjunctive treatment following an established protocol. Hospitals <60
miles away receive direct PCI (Zone 1). Hospitals 60-200 miles away
(Zone 2) use a facilitated approach with ½ dose TNK before transfer.
Results: From 3/03-5/05, 448 STEMI pts were transferred for direct PCI
by ambulance (n=149) or helicopter (n=299). During the same period, 145
STEMI pts presented directly to ANW. No deaths occurred during transfer.
No pts were excluded including cardiogenic shock (13.7%), cardiac
arrest (9.9%) and elderly (17% >80). Despite this high risk unselected pt
population, in hospital mortality was only 3.5% with median length of stay
of 3 days. Door to balloon times (mins) and 30 day outcomes (no significant
difference) are shown in the Table.
In door 1- Transport In door 2- Total door- Mortality at Stroke at Reinfarction
out door 1
time
balloon
balloon
30 days
30 days
at 30 days
NA
NA
67
67
6.2%
1.4%
2.8%
ANW (145)
Zone 1 (301)
47
22
22
97
4.3%
1.3%
1.0%
Zone 2 (147)
57
31
20
117
3.4%
0.0%
0.0%
Conclusion: Rapid transfer of STEMI pts from community hospitals up to
200 miles from PCI centers in the US is safe and effective with an integrated
system of acute cardiac care with outcomes equal to pts who present to a
PCI center directly.
TCT-134
Newly Detected Abnormal Glucose Tolerance - Important Factor
Affecting Early and Late Outcome of Primary Percutaneous
Intervention in Patients with Acute Myocardial Infarction
Marek F Roik, Grzegorz Horszczaruk, Arkadiusz Rak, Joanna Wilczynska,
Andrzej Zielinski, Janusz Kochman, Grzegorz Opolski
1 st Department of Cardiology, Warsaw, Poland
Recent clinical trials revealed that patients (pts) with myocardial
infarction (MI) have a high prevalence of previously unknown diabetes
mellitus (DM) and impaired glucose tolerance (IGT). Whether the
poor prognosis is due to lower rates of myocardial perfusion in pts
with newly detect abnormal glucose tolerance is still unknown.
The aim of this study was to investigate whether a newly detected abnormal
glucose tolerance affect the angiographically measured myocardial perfusion
in infarct related artery (IRA) and affect the short and long term follow-up.
Methods: Pts (n = 124) aged from 37 to 78 years with AMI, treated by
Primary PCI , with no previous DM, myocardial infarction, admission
blood glucose <11.0 mmol/l were enrolled to this study. Angiographic
succsess was defined as flow TIMI-3 and Myocardial Blush Grade 3
in infarct related artery (IRA). Glucose metabolism was assessed by
means of fasting capillary blood glucose measured daily during the
hospital stay and test (OGTT, 75 g) during stable condition (day 5 - 7).
Results: There were no differences between those with (n = 53) or without
abnormal glucose tolerance (n = 71) with regard to postprocedural TIMI
flow grade 3, distribution of IRA and the frequency of stent implanted (
p = NS). Pts with abnormal glucose tolerance were more likely to have
absent myocardial perfusion (MBG 0/1, 53% % vs. 32 %, p < 0.05).
Abnormal glucose tolerance was an independent predictor of absent
myocardial perfusion (MBG 0/1), [OR] 2.54 [95% (CI) 1.29 to 5.06],
p < 0.05) and was the strongest predictor of diminished flow in IRA,
in-hospital and 3-month folllow-up cardiovascular events (p < 0.05).
Conclusions: 1) Despite similar rates of TIMI flow grade 3 after
primary PCI patients with abnormal glucose tolerance are more likely
to have abnormal myocardial perfusion as assessed by reduced MBG;
2) Diminished myocardial perfusion in pts with abnormal glucose tolerance
after primary pci may explain the higher rate of CV mortality and heart
failure in this group
TCT-135
Paramedics Independently Triage Patients for Primary Percutaneous
Angioplasty
Michel R. Le May1, Richard Dionne2, Justin Maloney2, John Trickett2,
Irene Whatpool2, Michel Ruest2, Ian Stiell2, Marino Labinaz1, Pat
Doucette1, Sheila Ryan1, Richard F. Davies1
1
University of Ottawa Heart Institute, Ottawa, ON, Canada2University of
Ottawa, Ottawa, ON, Canada
Background: Trials reporting on pre-hospital management of STelevation myocardial infarction (STEMI) had a physician accompanying
the mobile unit or the electrocardiogram (ECG) was transmitted to
a physician at the hospital. We sought to show that advanced care
paramedics (ACPs) can effectively and independently diagnose STEMI
in the field, and that ACPs can decide independently on transferring
patients (pts) for primary percutaneous coronary intervention (PCI).
Methods: During a pilot phase, ACPs were given ECG training in the
diagnosis of STEMI. After training, we allowed ACPs to triage pts with
chest pain, and transport pts with STEMI directly to a designated centre
for primary PCI, bypassing the city’s four hospital emergency rooms.
Most of the ambulance units (70%) had at least one ACP on board.
Results: Between August 2004 and January 2005, paramedics assessed
1379 pts with chest pain. Amongst these, 74 were transported directly
to the designated centre with a presumptive diagnosis of STEMI. on the
pre-hospital ECG. This was confirmed in 58 pts, of whom 57 underwent
immediate catheterization. One pt did not undergo catheterization because
of drug intoxication. Twenty-two pts with STEMI on the pre-hospital ECG
were transported to a community hospital instead of the designated centre.
Primary PCI was attempted and performed successfully in 54 of the 57 pts
(94.7%). The median time delay from the paramedic’s pre-hospital ECG
to balloon inflation was 88 minutes (Interquartile range: 63-110) and the
median time from hospital door to first balloon inflation was 63 minutes
(Interquartile range: 35-83). During transport, no patient (pt) experienced
a serious adverse event. In-hospital, one pt died (1.8%), one pt had a nonhemorrhagic stroke (1.8%), and no pt experienced abrupt vessel closure
after PCI. The median length of stay was 5 days (Interquartile range: 3 - 9).
Conclusion: Paramedics can be trained to independently triage pts with
chest pain and safely transport those with STEMI to a tertiary centre
for primary PCI. In our study, this was associated with short delays to
reperfusion and consequently favorable clinical outcomes. This approach
represents a new paradigm in the treatment of STEMI.
TCT-136
R-wave Amplitude Distinguishes Early Repolarization from Subtle
Anterior ST-Elevation Myocardial Infarction
Ayesha Khalil1, Stephen W Smith2, Kim Heller2, Scott W Sharkey1, Timothy
D Henry1
1
Minneapolis, MN;2Hennepin County Medical Center, Minneapolis, MN
Background: Anterior STEMI (MI) due to LAD occlusion
may be difficult to differentiate from early repolarization (ER).
We hypothesized that the ratio of T-wave amplitude (TA) to Rwave amplitude (RA) in leads V2-V4 differentiates MI and ER .
Methods: We evaluated ECGs in 124 consecutive MI pts undergoing
PCI with LAD occlusion and a control group of 70 consecutive pts
with ER. We excluded BBB and obvious MI (STE >5 mm). STE
at the J point (STEJ), RA and TA were measured to the nearest
0.5 mm in V1-V6. Analysis was by 2-tailed t-test and Chi square.
Results: 64 pts with MI and 70 with ER remained after exclusions.
See Table 1 for mean measurements and Table 2 for cutoffs.
Conclusion: TA:RA ratio is higher (because RA is lower) in subtle MI than
in ER. RA ≤5 is a better discriminator than any STE cutoff to diagnose
subtle anterior STEMI.
Measurement V2-V4
Mean STEJ
Mean TA:RA ratio
Mean max TA:RA ratio
Mean TA
Mean RA
V2-V4
Mean RA
STEJ
STEJ
MI (±CI), n=64
2.19 (±0.40)mm
2.44 (±0.5)
5.46 (±1.0)
6.98 (±0.6) mm
4.96 (±1.0) mm
ER (±CI), n=70
1.27 (±0.12)
0.66 (±0.09)
1.87 (±0.4)
6.01 (±0.8) mm
10.9 (±1.2) mm
Cutoff value Sens for MI Sepc for MI Accuracy
≤5mm
64%
93%
79%
>2.5 (n=26)
38%
97%
69%
>1.5 (n=64)
70%
64%
67%
p-value
<0.001
<0.001
<0.001
0.054
<0.001
p-value (vs mean
RA) Chi square
0.052
0.027
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TCT-137
A Comparison of Bare Metal and Drug-Eluting Stents in Patients
with Acute ST-Segment Elevation Myocardial Infarction
Joseph A Browning1, Christopher R Henry1, Marc C Newell1, Michael R
Mooney1, Daniel L Lips1, Jay H Traverse1, David M Larson2, Timothy D
Henry1
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Background: Drug-eluting stents (DES) reduce in-stent restenosis in
patients undergoing elective percutaneous coronary intervention (PCI).
Limited data are available regarding DES for ST-segment elevation
myocardial infarction (STEMI) despite widespread clinical use. Therefore,
we evaluated the occurrence of major adverse cardiac events (MACE)
among 472 consecutive patients with STEMI who received paclitaxeleluting (PES), sirolimus-eluting (SES) or bare metal stents (BMS).
Methods: We measured the clinical characteristics, acute and long
term outcomes in 472 consecutive STEMI patients who received
direct PCI with either a BMS (n=124), PES (n=202) or SES (n=146).
Patients were then followed for death, subacute thrombosis, nonfatal
reinfarction, target vessel revascularization (TVR) and combined MACE.
Results: The in-hospital mortality and 30-day results are summarized
in Table 1. Additional MACE events have occurred with 19 BMS, 5
SES and 5 PES to date in patients with 6 month follow up. Patients with
BMS were older but otherwise not different from patients with DES.
Conclusion: DES are safe and effective when compared to BMS in the
setting of STEMI. Early 6 month data suggest a decrease in MACE with
DES that is similar to outcomes in other clinical settings. There appears
to be no significant difference in outcomes between patients treated with
either PES or SES. Six month follow up is in process and will be complete
for >400 patients by October 2005.
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Outcome
In-hospital mortality
Death (30d)
TVR (30d)
Subacute stent thrombosis (30d)
MACE (30d)
BMS
4.8%
7.5%
1.6%
1.7%
9.2%
SES
0.7%
1.5%
1.5%
1.5%
3.0%
PES
1.5%
2.1%
1.1%
1.6%
3.2%
p-value
0.0678
0.0218
0.8954
0.9962
0.0465
TCT-138
Comparison of Prehospital Thrombolysis and Primary Percutaneous
Coronary Intervention in ST-Elevation Acute Myocardial Infarction
Ilkka V A Tierala, HAAMU-GHOST Investigators
Helsinki University Central Hospital, Helsinki, Finland
Background: Primary-PCI has been shown to be superior to
hospital thrombolysis in the treatment of STEMI . However,
direct comparisons of prehospital thrombolysis and primary
PCI
with
modern
antithrombotic
therapy
are
lacking.
Aims: To compare two treatment strategies, prehospital thrombolysis
and primary PCI with good antithrombotic medication begun early.
Methods: The treatment was prespecified by the geographical area where
the patient was first seen. In the city of Helsinki prehospital thrombolysis
was used ( N = 77 ) and from the surrounding areas the patients were
taken to primary PCI ( N= 111 ). Patients receiving thrombolytic treatment
underwent protocol-driven angiography 90-180 min after lytic therapy.
In the thrombolysis group antithrombotic medication consisted of ASA
and enoxaparin. In PCI group the patients received ASA, enoxaparin and
abciximab-bolus continued with iv infusion. Of the 111 patients in pPCIgroup 82 received the abciximab-bolus prehospitally and 29 in the cath lab.
For revascularisation there must be a stenosis of more than 70% or
a stenosis of more than 50% with less than TIMI 3 flow in the IRA.
Results : The mean age was 62 y in the PCI group and 64 y in the
thrombolysis group. The mean time from symptom-onset to first
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medical contact was 122min in thrombolysis group and 115 min in PCI
group. The mean time from symptom-onset to initiation of thrombolysis
was 162 min and to initiation of abciximab 165 min in the PCI group.
Success rate for pPCI was 96% and success rate for thrombolysis was
69%. Of the patients in the thrombolysis group 93% were revascularised.
The 30d death rate was significantly higher, 11.7 % in the
thrombolysis group compared to the death rate of 3.6% ( p< 0.05
)in the whole primary-PCI -group and only 2.4% ( p< 0.025 )
in those patients receiving the abciximab-bolus prehospitally.
Conclusion: The treatment strategy of primary PCI with aggressive
antithrombotic therapy begun prehospitally resulted in significantly lower
mortality in comparison with prehospital thrombolysis
TCT-139
Results of Transfer for Direct Percutaneous Coronary Intervention in
ST-Elevation Myocardial Infarction Patients with Cardiogenic Shock
Timothy D Henry1, Jason T Henry1, Andrey G Zenovich1, Marc C Newell1,
David M Larson2, Daniel L Lips1, Yale L Wang1, Michael R Mooney1,
Joseph A Browning1, Christopher R Henry1
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Background: ACC/AHA guidelines recommend early revascularization
for patients with STEMI and cardiogenic shock who are <75 years
old (class I), including transfer to PCI centers despite that no
data are available on the outcomes of STEMI patients transferred
with cardiogenic shock. Selected patients >75 may also benefit.
Methods: We report the results of 448 consecutive patients with
STEMI transferred to Abbott Northwestern Hospital (Minneapolis,
MN) for direct PCI as part of the Level 1 MI integrated transfer
program. 13.7% of patients had cardiogenic shock as defined by the
SHOCK trial. No patients were excluded from analysis, including
patients with out of hospital cardiac arrest (10%) and elderly (>80
years, 17%). Chi-square test was used in statistical analysis (p<0.05).
Results: Patients with cardiogenic shock were more likely to be older,
female, hypertensive and to have had a cardiac arrest. As expected, patients
with cardiogenic shock had a higher 30 day mortality (24.1% v. 0.8%,
p<0.0001), but lower than reported in the SHOCK trial. Age >80 years
was the most important predictor of mortality in patients with cardiogenic
shock when adjusted for age, gender, hypertension and cardiac arrest, see
table 1.
In hospital mortality Cardiogenic shock, n=58
<70 years old, n=289
3/22 (13.6%)
70-80 years old, n=86
3/18 (16.7%)
>80 years old, n=70
7/18 (38.9%)
No cardiogenic shock,
p-value
n=387
0/267 (0%)
<0.0001
1/68 (1.5%)
<0.04
2/52 (3.8%)
0.005
Conclusions: Our results support the ACC/AHA recommendations for
transfer of STEMI patients with cardiogenic shock to PCI centers. Although
patients >80 years of age had the highest mortality, that was even lower
than expected from the published trials.
TCT-140
Meta-Analysis of Randomized Controlled Trials of Rescue
Angioplasty
Tony Bainbridge, Farzin Fath-Ordoubadi
Manchester Heart Centre, Manchester, United Kingdom
Background: Published randomized controlled studies of rescue
angioplasty have involved relatively small numbers of patients
and have been underpowered to detect a reduction in mortality.
We performed a meta-analysis of available randomized controlled
trial data to evaluate both total mortality and composite endpoints.
Methods: An on-line computer database literature search (Medline,
Embase, Pubmed) identified published randomized controlled trials of
rescue angioplasty. Additional unpublished data was identified from
presentations at recent international meetings. Data analysis was performed
with Review Manager 4.2.7 software (Cochrane Collaboration 2004).
Results: Studies were reviewed by two investigators according to a prespecified protocol and those with a non-randomized controlled trial
design or significant selection bias were excluded. This left data from four
randomized controlled trials. Mean age ranged from 59 to 63 years, the
proportion of males ranged from 71 to 82%, anterior infarction ranged
from 42.7 to 48.4% and angiographic rescue angioplasty success ranged
from 85 to 92%. Data was pooled for the time period 30 days to 6 months.
Total mortality data for this period was available for 913 patients. Death
occurred in 29 of the 391 (7.42%) who underwent rescue angioplasty and
in 64 of the 522 (12.26%) who received conservative treatment. The test
for heterogeneity was negative (Chi squared = 3.14; df = 3; p = 0.37). A
fixed effects model gave an odds ratio in favor of rescue angioplasty of
0.57 (95% confidence interval 0.35 - 0.90) for total mortality. Data on
composite endpoints was available for 891 patients. A composite endpoint
was reached in 81 of the 377 (21.49%) who underwent rescue angioplasty
and in 151 of the 514 (29.38%) who received conservative treatment. The
test for heterogeneity was negative (Chi squared = 2.29; df = 2; p = 0.32).
A fixed effects model gave an odds ratio in favor of rescue angioplasty of
0.50 (0.35 - 0.73) for a composite endpoint. Conclusion: Meta-analysis of
available randomized controlled trial data does support rescue angioplasty
for a significant reduction in both total mortality and composite endpoints.
TCT-141
Impact of Time to Treatment with Primary PCI on Infarct Size and
Myocardial Reperfusion: Results from the EMERALD Trial
Bruce R. Brodie1, John Webb2, David A. Cox3, Mansoor Qureshi4, Anna
Kalynych5, Mark Turco6, Heinz P. Schultheiss7, Daniel Dulas8, Barry
Rutherford9, David Antoniucci10, Thomas Stuckey1, Mitch Krucoff11,
Raymond Gibbons12, Alexandra Lansky13, Yingbo Na13, Roxana Mehran13,
Gregg W. Stone13
1
LeBauer Cardiovascular Research Foundation and Moses Cone Heart
and Vascular Center, Greensboro, NC;2St. Paul’s Hospital, Vancouver,
BC, Canada3Mid Carolina Cardiology, Charlotte, NC;4St. Joseph
Mercy Hospital, Ypsilanti, MI;5Crawford Long Hospital, Atlanta,
GA;6Washington Adventist Hospital, Tacoma Park, MD;7University
Hospital Benjamin Franklin, Berlin, Germany8Mercy Hospital, Coon
Rapids, MN;9St. Luke’s Hospital, Kansas City, MO;10Policlinico Careggi,
Florence, Italy11Duke University Medical Center, Durham, NC;12Mayo
Clinic Foundation, Rochester, MN;13Cardiovascular Research Foundation
and Lenox Hill Heart and Vascular Institute, New York, NY
Background: The importance of time to treatment with primary
PCI is controversial, and there are little data on the impact of
time to treatment on infarct size and myocardial reperfusion.
Methods: The EMERALD trial randomized 501 pts with STEMI (< 6 hrs,
>2mm STE) undergoing primary PCI to stenting with or without GuardWire
distal protection. Infarct size was measured by sestamibi imaging at 5-14 days.
Results: There were no differences in outcomes between distal protection
and control patients. Shorter time to reperfusion was associated with
trends for better myocardial blush and lower mortality and with
significantly lower median infarct size. Shorter time to reperfusion
impacted infarct size in patients with anterior infarction (0% vs. 17%
vs. 20.5% vs. 30.5%, p = 0.026) but had little effect in non-anterior
infarction (3% vs. 7% vs. 7.5% vs. 10%, p = 0.23). Door-to-balloon
time was not correlated with infarct size or myocardial reperfusion.
Conclusions: Early reperfusion with primary PCI is associated with smaller
infarct size, with a greater impact in anterior vs. non-anterior infarction.
Incremental delays in reperfusion after 2 hours have little effect on infarct
size. These data have implications regarding the triage of patients with
STEMI for primary PCI.
Time to Reperfusion (hrs)
<2
2-3
>3-4
(n=24) (n=111) (n=130)
95.5
91.7
89.8
Final TIMI-3 Flow %
Final Grade 3 Blush %
66.7
65.3
57.1
Compete STR (60 min) %
62.5
67.3
69.4
2
9
12
Imputed Infarct size (%LV)
6 Month Mortality %
0
0
2.4
>4
(n=185)
87.8
50.3
67.5
11
5.3
P value
0.58
0.08
0.92
0.026
0.06
TCT-142
Multi-Vessel Disease Does Not affect Infarct Size but affects Clinical
Outcomes following Primary Angioplasty for Acute Myocardial
Infarction
Tayo A Addo1, Susheel Kodali1, Judah Weinberger1, Roxana Mehran1,
Martin Fahy1, Ramona Pop1, Simon Dixon2, William O’Neill2, Cindy
Grines2, Raymond Gibbons3, Martin B Leon1, Gregg Stone1
1
Cardiovascular Research Foundation & Columbia University Medical
Center, New York, NY;2William Beaumont Hospital, Royal Oak, MI;3Mayo
Clinic Foundation, Rochester, MI
Background: Multi-vessel coronary artery disease (MVD) is
associated with adverse long-term outcomes in stable and unstable
coronary disease. However its impact on infarct size and shortterm clinical outcomes after primary PCI for AMI is unclear.
Methods and Results: We assessed the impact of MVD versus single
vessel disease (SVD) on infarct-size, and 30-day outcomes in a pooled
analysis of 4 contemporary primary angioplasty trials (EMERALD,
AMIHOT, ICE-IT and COOL-MI) in which infarct size was determined
by tc-99m sestamibi myocardial perfusion imaging within 30 days.
Compared with patients with SVD, those with MVD were older (60.4 vs
57.7 yrs, P=0.002), had more hypertension (46.5% vs 35.5%, P=0.002)
and prior MI (10.8% vs 4.9%, p=0.004). However presence of diabetes,
time to presentation, door to balloon time, the infarct vessel characteristics,
baseline TIMI flow, LAD involvement and LVEF were not different. As
shown below, pts with SVD and MVD achieved similar rates of final TIMI
3 flow and ST segment resolution. Infarct size was not affected by MVD.
Despite these findings, death and major adverse cardiac events (MACE) at
30 days were significantly increased in pts with MVD. After multivariate
analysis, MVD remained a strong predictor of MACE, OR 3.83 (1.58-9.27).
Conclusion: Reperfusion success and infarct size are similar among
patients with SVD and MVD undergoing primary angioplasty for AMI.
Nonetheless, MVD is an independent determinate of adverse outcomes as
early as 30 days after presentation.
Final TIMI 3 flow, %
% ST resolution at 60 min, mean (SD)
Infarct size, % of LV, tc-99m SPECT,
median, (25%, 75% quartile)
Death at 30 days, %
MI at 30 days, %
TVR at 30 days, %
MACE at 30 days, %
MVD (381) SVD (347)
89.2
91
77.9±25.3
74.7±26.3
10.0 (0.0,
10 (0.0, 23.0)
25.0)
5.0
1.7
2.9
0.9
5.9
1.4
11.1
4.3
P Value
0.45
0.17
0.51
0.02
0.05
0.002
0.0008
TCT-143
Transient Left Ventricular Apical Ballooning - Long Term Follow-Up
of Polish Series. This is Winter Season Disease ?
Tomasz Pawlowski, Robert Gil, Jaroslaw Rzezak, Hanna Rdzanek
CSK MSWiA, Warsaw, Poland
Background: A new syndrome called transient left ventricular apical
ballooning (TLVAB) was described in Japanese patients so far. We observed
the evidence of TLVAB in our population. The aim of the study is to
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evaluate the acute and long term follow-up of patients’ with this syndrome.
Methods: The total population of 1869 patients with the suspicion
of acute coronary syndrome which were treated in years 2001-2004,
was screened. We collected data regarding clinical course embracing
physical or emotional trauma, ECG abnormalities, presence of balloonlike left ventriculography abnormality and history of myocardial
infarction. During follow-up, the evidence of cardiac events (death,
recurrence of chest pain, re-hospitalisation) were collected. In a series of
patients, the follow-up angiography with ventriculography was repeated.
Results: We have identified 30 patients with TLVAB ( 1 %) (all women,
mean age 72±12 y). In 28 patients ( 93 %) the symptoms of TLVAB
occurred in period October - April. In all patients, there was an evidence
of trauma (40 % physical and 60 % emotional). ECG recordings analysis
showed negative T waves on anterior leads in 93 % and ST elevation in
7 %. The clinical course of index hospitalization was benign in 96 %
and in one patient (4 %) the pulmonary edema occurred. Maximal MB
creatine kinase and troponin I levels were 38±12 U/l and 1.12±0.75
ng/dl, respectively. During follow-up (range 6 - 24 months, mean 12
months), there were two cases of chest pain recurrence, but without
clinical features of TLVAB (checked by echo or angiography). In 12
patients follow-up ventriculography was performed (mean time-point
3±1 months) - in all patients left ventricule abnormalities disappeared.
Conclusions: The transient left ventricular apical ballooning is a benign
syndrome mimicking acute coronary syndrome with good long term
outcome. Occurrence of the majority of cases during autumn / winter season
can suggest influence of neurohormonal changes.
TCT-144
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Rescue Percutaneous Coronary Angioplasty is an Independent
Predictor of Infarct Size in Patients with Acute Myocardial Infarction
Paul Sorajja1, Gregg W Stone2, Todd D Miller1, George Dangas2, Simon
Dixon3, Bernard J Gersh1, William O’Neill3, Roxana Mehran2, Raymond J
Gibbons1
1
Mayo Clinic and Mayo Foundation, Rochester, MN;2College of
Physicians and Surgeons, Columbia University and the Cardiovascular
Research Foundation, New York, NY;3William Beaumont Hospital, Royal
Oak, MI
Background. There is a paucity of data on infarct size among patients
who undergo rescue percutaneous coronary intervention (PCI) vs. those
who have primary PCI. We compared infarct size for patients with acute
myocardial infarction (AMI) who underwent rescue PCI vs. primary PCI
in a pooled cohort of patients who presented <6 hrs after symptom onset.
Methods. We pooled data on infarct size from 4 trials of PCI and
adjunctive therapy in patients with AMI: AMIHOT (n=243), ICEIT (n=204), COOL-MI (n=325), and EMERALD (n=427). Patients
presenting ≥6 hrs after symptom onset were excluded. In all studies,
infarct size was determined by tc-99m sestamibi imaging at a central
core laboratory with a mean time from PCI to scanning of 23±15 days.
Patients were stratified according to the strategy of primary (n=1,065)
or rescue PCI (n=185) as defined in the enrollment criteria for each trial.
Results. Patients who underwent rescue PCI had longer symptom onsetto-balloon time (median, 4.7 vs. 3.6 hrs; p<0.0001), were less frequently
diabetic (8.1% vs. 15.1%; p=0.02), and less commonly had TIMI 0 flow of
the infarct-related artery (38.9% vs. 66.9%; p<0.0001) than patients who
had primary PCI. However, the two groups were comparable with respect to
age, infarct location, and other cardiac morbidity. Patients with rescue PCI
tended to have greater infarct size (median, 14%) than patients with primary
PCI (10%; p=0.059). After adjustment for baseline clinical variables,
rescue PCI was a significant predictor of infarct size (HR, 3.25; p=0.02).
Conclusions. In AMI patients who present early after symptom onset (<6
hrs), those who undergo rescue PCI for failed thrombolysis have greater
infarct size than patients who have primary PCI.
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TCT-145
Safety of Sirolimus-Eluting Stents in Patients with ST Segment
Elevation Myocardial Infarctions and Thrombus-Laden Lesions
Christopher L F Gade, Dmitriy N. Feldman, Alexander J. Slotwiner, Atul
Sharma, Srihari S. Naidu, Manish Parikh, Geoffrey Bergman, Mun K.
Hong, Srihari Wong, Robert M. Minutello
NY Presbyterian Hospital-Weill Cornell Medical Center, New York, NY
Background: Initial trials of drug-eluting stents demonstrated efficacy
in limiting restenosis without a significant increase in stent thrombosis.
However, the incidence of stent thrombosis in higher risk risk patients with
more complex lesion morphologies remains unclear. We report our experience
in patients presenting with ST segment elevation myocardial infarction
(STEMI) who were found to have thrombus on angiography and who were
treated with percutaneous coronary intervention (PCI) with sirolimuseluting stents. The purpose of this study was to determine the incidence of
early and late adverse outcomes, including early and late stent thrombosis.
Methods: We studied 43 consecutive patients who presented to
our institution with STEMI, who were treated with PCI, and who
were found to have thrombus in the culprit lesion on angiography.
Thrombotic lesions were defined as intraluminal filling defects
surrounded by contrast material, seen in multiple projections.
Results: 43 patients meeting criteria were followed for a mean of 1 year.
The mean age was 59 years. The average ejection fraction was 42%. The
mean number of stents per patient was 1.3. Glycoprotein IIb/IIIa inhibitors
were used in 70% of patients. Diabetics comprised 23.3%, 9.2% had prior
CABG, 4.7% of lesions occurred within a prior stent, 18.6% of patients
had failed thrombolytic therapy and 16.2% presented in cardiogenic shock.
Two patients who presented in cardiogenic shock died in-hospital. At a
mean follow up of 1 year, there was 1 additional death in a patient who
expired after an elective CABG, 2 months after the index event. There was
a 4.7% incidence of target vessel revascularization (TVR) and a 16.3%
incidence of major adverse cardiac events (MACE), defined as death, MI
or TVR. Most importantly, there was no incidence of angiographically
documented or clinically suspected early or late stent thrombosis.
Conclusions: The use of sirolimus-eluting stents in acute STEMI with
culprit lesion thrombus demonstrated no increased incidence of mortality,
MACE, or TVR compared to historic controls. Most importantly, there were
no cases of early or late stent thrombosis in thrombus-laden lesions treated
with sirolimus-eluting stents.
Patch placement improved LV SD in the IR, (Fig 1). The LV diastolic relaxation
slope and the LVdiameter of the MI + patch is comparable to the normal rats (Fig 2).
Summary: 3DFC/collagen patches placed on the IR improved LV SD,
prevented LV dilation and normalized LV diastolic function post MI.
Angiogenesis, Myogenesis, and Cell Therapies
TCT-146
Gender and Age Differences in Ischemia Resistance and Proliferation
Capacity of Isolated Rat Skeletal Myoblasts
Thomas S Matthiesen, Harald C Ott, Tristan L Tieso, Doris A Taylor
Background: Autologous skeletal myoblast (SKM) transplantation has
been shown to increase EF in patients with heart failure. We hypothesize that
gender and age have an influence on ischemia tolerance and proliferation
capacity of SKM and thus could impact cell survival and patient outcome.
Methods: Biopsies were taken from soleus muscle of 6 old (40 weeks,
2 female, 4 male) and 6 young (7 weeks, 2 female, 4 male) RNU rats.
SKMs were plated at a density of 8,333 viable cells/cm2, and incubated
under either control (21% O2, 1000 mg/L glucose) or simulated infarct
ischemic conditions (0.1% O2, no glucose) for 24, 48, and 72 hrs.
Viability was assessed at 24, 48, and 72 hrs and compared to baseline.
Results: The combined number of viable cells was decreased after 48 and
72 hours of simulated infarct conditions compared to controls (24h: 73K and
75K p=0.896; 48h: 126K and 262K p=0.001; 72h: 151K and 504K p<0.001).
Viable cell counts after ischemia were increased in old cells relative to young
cells and in female cells relative to male cells. Within both gender groups,
viable cell counts were higher after ischemia in old cells compared to young
cells (female: 157K vs. 124K p=0.12; male: 116K vs. 91K p=0.047). Within
both age groups, the number of viable female cells was higher compared to
male cells (young: 124K and 91K, p=0.011; old: 157K and 116K p=0.027).
BrdU assay confirmed complete proliferation arrest in all ischemic groups.
Conclusion: Ischemia tolerance is higher among SKM isolated from older
animals and in the female gender.
Ischemia
24 hours
48 hours
72 hours
Combined
P value
Young (n=47)
Viable Cells
(x1000)
64.92 ± 32.4
107.0 ± 30.3 *
136.6 ± 47.3
103.6 ± 47.1 **
* p<0.05 vs. old
** p=0.016 vs.
old
Old (n=46)
Viable Cells
(x1000)
81.78 ± 42.2
146.8 ± 56.0
164.8 ± 57.0
131.9 ± 62.5
Male (n=57)
Viable Cells
(x1000)
61.65 ± 32.5 #
111.4 ± 33.7 #
132.8 ± 43.4 #
103.2 ± 47.1
# p<0.05 vs.
female
## p=0.002 vs.
female
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Female
(n=36)
Viable Cells
(x1000)
90.89 ± 40.0
149.8 ± 59.3
180.6 ± 57.1
140.4 ± 63.7
TCT-148
TCT-147
Implantation of 3DFC Patch Improves Left Ventricular Systolic
Function and Prevents LV Remodeling after Myocardial Infarction
Hoang Thai1, Lisa Castellano1, Elizabeth Juneman1, Rob Kellar2, Stu
Williams2, Mohamed Gaballa1, Steven Goldman1
1
University of Arizona/SAVAHCS Medical Center, Tucson, AZ;2University
of Arizona, Tucson, AZ
The effects of 3DFC patch placement on the infarcted region (IR) of
the left ventricle (LV) on systolic/diastolic function in a coronary artery
ligation (CAL) model of myocardial infarction (MI) were evaluated.
CAL to induce MI is performed on Sprague Dawley rats. The
3DFC patch is placed on the IR, for comparison an inert collagen
patch was also used on other MI rats. Echos were done at 6 weeks.
Hemodynamics was measured. LV regional systolic displacement
(SD) and LV pressure/diameter relaxation curves were obtained.
Repeated Direct Endomyocardial Transplantation of Allogenic
Mesenchymal Stem Cells: Safety of a High Dose, “Off The Shelf,”
Cellular Cardiomyoplasty Strategy
Kian Keong Poh1, Erik Sperry2, Randell Young3, Toby Freyman2, Kurt
Barringhaus4, Craig A Thompson5,6
1
St Elizabeth’s Medical Center and Tufts University School of Medicine,
Boston, MA;2Boston Scientific, Natick, MA;3Osiris Therapeutics,
Baltimore, MD;4University of Massachusetts Medical School, Worcester,
MA;5Dartmouth Hitchcock Medical Center, Lebanon, NH;6Dartmouth
Medical School, Hanover, NH
Purpose: Efficacy of cellular cardiomyoplasty seems to occur in a dose related
manner. However, the safety of multiple transendomyocardial transplantation
procedures to administer high cell dosages has not been previously reported.
The aims of this study were to assess the short- and intermediate-term
results of a repeated cell administration strategy and evaluate the safety
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of an “off the shelf” allogeneic mesenchymal stem cell (MSC) source.
Method: Porcine bone marrow-derived MSCs were cultured-expanded
through three cycles in vitro before transplantation. Yorkshire swine
weighing 30-40 kg were allocated to receive: (1) 800 X 106 allogeneic MSC
in 2 equal doses 14 days apart (n=5), (2) 400 X 106 allogeneic MSC (n=5),
(3) cryopreservant vehicle containing 10% DMSO, 5% Porcine Serum and
85% PlasmaLyte A, 14 days apart (n=2), or (4) sterile saline 14 days apart
(n=2). During each procedure, twenty 0.5ml aliquots of the assigned injectate
were administered using the Stiletto™ Endocardial Direct Injection Catheter
System, targeting at the left ventricular anterior, septal and lateral walls
under fluoroscopy. Vital signs and electrocardiograms were recorded during
the procedures and for 24 hours after. The animals were examined weekly
and cardiac enzymes were measured immediately post-procedure, and on
day 1, 15 and 90. Necropsy and histopathology were performed at day 90.
Results: Mean transendocardial injection procedure time was 40 ± 10
minutes. All ventricular target areas were accessed by the Stiletto™
system. Ventricular ectopic beats and non-sustained ventricular tachycardia
associated with catheter contact / endomyocardial injections were observed
in all cases. However, no sustained ventricular arrhythmia requiring
defibrillation, anaphylaxis or cardiac enzyme release was seen. All pigs had
normal examination findings and were alive from the time of procedure until
planned sacrifice at day 90. The 3-month histopathology data will be presented.
Conclusion: Repeated endomyocardial transplantation of high dose, bone
marrow derived allogenic cells appeared safe in a large animal, human
surrogate model. Such cellular cardiomyoplasty strategy warrants further
investigation.
TCT-149
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Transfer of Intravascular Angiopoietin-1 Gene Plasmid and Bone
Marrow Mononeuclear Cell Accelerate Reendothelialization in a
Balloon-Denuded Rat Carotid Artery
Weon Kim1, Myung Ho Jeong1, Ju Han Kim1, Young Joon Hong1, Jeong
Gwan Cho1, Jong Chun Park1, Jung Chaee Kang1, Takahisa Kondo2,
Toyoaki Murohara2
1
Chonnam National University Hospital, Gwangju, Republic of
Korea2Nagoya University Graduate School of Medicine, Nagoya, Japan
BACKGROUND: Gene transfer to the vessel wall may provide
new possibilities for the treatment of vascular disorders. Bone
marrow derived mononeuclear cells (BMMNCs) have been shown
to contribute to endothelial replacement after vascular injury. In this
study, we analyzed the effects of human Angiopoietin-1 (pCAhAng-1)
plasmid transfer with/without BMMNCs on neointima formation and
reendothelialization after endothelial denudation in carotid artery of rats.
METHODS AND RESULTS: Carotid arteries of SD rats were balloondenuded, and control vector (Group I), pCAhAng-1 gene plasmid (30ug)
transfer (Group II) and pCAhAng-1 gene (30ug) and BMMNCs (6×105
cell) delivery (Group III) was performed by 30 minutes of local dwelling,
immediately. Animals were euthanized 2 weeks after the gene/cell transfer,
and intima/media ratio (I/M), reendothelialization index, histology, and
cell proliferation were analyzed. A pCAhAng-1 gene transfer confirmed by
Lac Z stain and RT-PCR on 3 days after transfer. Administered PKH-26
green labelled BMMNCs incorporate into vessel wall 8 day after balloon
carotid injury by immunofluorescence stain. Two weeks after the gene/
cell transfer, I/M in the group I was 0.81±0.16. pCAhAng-1 gene transfer
reduced I/M to 0.30±0.09 (p=0.000 versus control) and pCAhAng-1 and
BMMNCs transfer reduced I/M to 0.18±0.06 (p=0.000 versus control). The
reendothelialization area by Evans Blue stain was 41.6±6.9% in control vector
group, 75.9±5.9% in pCAhAng-1 (p=0.000 versus control), 82.3±4.3% in
combination group (p=0.000 versus control). CD31 and Factor VIII stain
showed was 41.±6.5% in control vector group, 72.5±11.1% in pCAhAng-1
(p=0.000 versus control), 86.4±5.7% in combination group (p=0.000 versus
control), but no significant difference between the group II and group III.
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CONCLUSIONS: These data demonstrated that transfer of pCAhAng-1
gene and BMMNCs delivery to balloon-injured arteries is associated with
accelerated reendothelialization and reduced neointima formation. These
finding may have implications for novel and practical combination therapies
for vasculoprotective approach.
TCT-150
Effect and Safety of Autologous Transplantation of Bone Marrow
Mononuclear Cells and Peripheral Endothelial Progenitor Cells by
Percutaneous Intracoronary Artery Injection on Myocardial Ischemia
Reperfusion Injury in Mini-Swine Model
Chongjian li, Runlin Gao, Yuejin Yang, Jilin Chen, Weixian Yang,
Fenfhuan Hu, Zaijia Chen, Shubin Qiao
Beijng Fuwai Hospital, CAMS & PUMC, Bejing, China
Background: With its advancing breakthroughs, stem cell therapy has
frequently given rise to more questions than answers. The safety, therapeutic
effectiveness and optimal type of stem cells are among the others.
Methods: 23 mini-swine myocardial ischemia reperfusion injury models
were randomized into three groups. (3.54±0.90)×108 autologous bone marrow
mononuclear cells (BM-MNC) per swine were transplanted by percutaneous
intracoronary artery injection in BM-MNC group (n=9), and (1.16±1.07)×107
peripheral endothelial progenitor cells (EPC) in EPC group (n=7), and in
the control group (n=7) phosphate buffer saline were used by the same
way. Ultrasonic cardiograhpy, hemodynamic parameters and myocardium
infarction size were evaluated before and 4 weeks after cell transplantation.
Results: 1 swine in the BM-MNC group died of acute myocardial infarction
(MI) 3 days after cell transplantation. 1 swine in the EPC group died of
cardiac tampnade due to the gauze misplayed in the pericardial cavum 5
days after cell transplantation. There were no inflammation, ossification,
calcification and abnormal hyperplasia except that there were clustered
cells in one swine in BM-MNC group. 4 weeks after transplantation, left
ventricular ejection fraction decreased 0.00±0.07 in EPC group, 0.02±0.090
in BM-MNC group and 0.10±0.03 in the control group, respectively. The
difference between the three groups was significant (P<0.05). Changes
of left ventricular end systolic pressure, cardiac output and +dp/dtmax
showed no significant difference between BM-MNC group and EPC
group (P>0.05), but there was significant difference compared with
control group. Left ventricular end diastolic pressure and -dp/dtmax changed
no-significantly before and after cell transplantation. Transplantation
of BM-MNC and EPC decreased MI size. Compared with BM-MNC
transplantation, EPC transplantation decreased MI size more significantly.
Conclusions: Autologous transplantation of BM-MNC and peripheral EPC
had significant beneficial effect on cardiac systolic function. The mechanism
lay probably in decreasing MI size. Transplantation of EPC was superior to
transplantation of BM-MNC as aspect to the efficiency.
TCT-151
Is There Additional Benefit of Intracoronary Transplantation of
Autologous Peripheral Blood Stem Cell in Patients with Acute
Myocardial Infarction ?
Jin-Ho Choi1, Il Rhee1, Jinoh Choi1, Wang-Soo Lee1, Sang-Chol Lee1,
Hyeon-Cheol Gwon1, Eun-Seok Jeon1, Duk Kyung Kim1, Sang Hoon Lee1,
Jeong-Euy Park1, YeonHyeon Choe2, DaeWon Kim3
1
Department of Medicine, Samsung Medical Center, Samsung Biomedical
Research Institute, Sungkyunkwan University School of Medicine,
Seoul, Republic of Korea2Department of Radiology, Samsung Medical
Center, Sungkyunkwan University School of Medicine, Seoul, Republic
of Korea3Department of Laboratory Medicine, Samsung Medical Center,
Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
Background: In this prospective nonrandomized open-labeled study, we
investigated whether the intracoronary infusion of autologous peripheral
blood stem cells (PBSC) in patients with successfully reperfused acute
myocardial infarction could safely improve myocardial function.
Methods: We enrolled only patients with left anterior descending artery
occlusion were enrolled to minimize bias related to the coronary artery
anatomy. Ten patients who underwent successful percutaneous coronary
intervention (PCI) 8.3±8.1 days after AMI and agreed to clinical trial
received granulocyte-colony stimulating factor for 4 days. Then PBSC
(2.0±0.7×109 mononuclear cells including 7.9±5.7×106 CD34+ cells)
were selectively infused into culprit coronary artery using transport
catheter. To maximize myocardial localization of PBSC, proximal
site of vessel was occluded by complaint balloon during cell infusion.
Results: After 6 month follow-up, left ventricular function evaluated
by echocardiography and magnetic resonance imaging (MRI), and
microvascular function evaluated by Doppler wire were improved
in PBSC treatment group (left ventricular ejection fraction (LVEF);
37.2±7.5 vs 47.4±13.5% , p=0.027; coronary flow reserve; 1.90±0.50 vs
2.84±0.79, p=0.004). There was no in-stent restenosis or major adverse
clinical event. However, comparable improvement in left ventricular
function was also shown in control groups who underwent elective PCI
8.4±7.0 days after AMI (N=31; LVEF; 41.9±8.0 vs 47.7±11.9%; p<0.001)
or primary PCI (N=32; LVEF; 42.6±6.3 vs 48.6±7.1%; p<0.001).
Conclusion: Our preliminary result shows that for patients with AMI and
undergone PCI, additional intracoronary infusion of PBSC after AMI is safe
and feasible, but may not lead to significant difference of improvement in
myocardial function compared to standard PCI strategy.
TCT-152
Pathological and Functional Evaluation of GCSF Therapy in a
Porcine Model of Myocardial Infarction
Nirat Beohar1, Charles J Davidson1, Jayesh Mehta1, Seema Singhal1, Joel
Robbins1, James D Flaherty1, Mladen Vidovich1, Jonathan Rapp1, Adam
Brodsky1, Chad Rammohan1, Robert O Bonow1, Renu Virmani2
1
Northwestern University Medical School, Chicago, IL;2CV Path,
Gaithersburg, MD
We
evaluated
immediate
or
delayed
IM
G-CSF
in
a
porcine
model
of
acute
MI
and
reperfusion.
Methods: Controls (C): n=11 Early treatment (ET): n=17, G-CSF 300 μg QOD
for 20 d starting immediately; Delayed treatment (DT): n=8, G-CSF 300 μg
QD for 10 d starting 5 d post MI. MR performed at 5 (MR1) and 56 d (MR2).
Results: At 5 d (MR1), EDV, ESV, LVEF and normalized infarct mass
(Infarct mass/LV mass) were similar. Collagen type I or III was similar (C
vs ET vs DT, p=NS).
Control Early
Δ EDVml (MR2-MR1)
Δ ESV ml (MR2-MR1)
LVEF% (MR2)
Expansion Index (MR2) %
Capillaries/ (mm2)
Arterioles/ (mm2)
Macrophages/
(mm2)
* P < 0.05
17± 9 8 ± 7
11 ± 7 10 ± 7
47 ± 7 44 ± 7
33 ± 2 38 ± 2
Control vs
Early
(P)
0.005
NS
NS
NS
Contralateral wall (nonGroup
infarcted myocardium)
Control
513 ± 174*
Early
187 ± 246
Delayed t
202 ± 122
Control
12 ± 9
Early
10 ± 4
Delayed
8±2
Control
10 ± 9
Early
16 ± 13
Delayed
8±3
Delayed
22 ± 10
17 ± 7
38 ± 6
66 ± 2
Control vs
Delayed
(P)
NS
NS
0.008
0.001
Midscar
Border
220 ± 131 432 ± 160¥
242 ± 128 172 ± 177
159 ± 85 221 ± 97
23 ± 17
10 ± 6
35 ± 19
9±3
†
15 ± 4
7±2
48 ± 26
15 ± 12
64 ± 35
19 ± 18
38 ± 15
8±3
Conclusions: While ET with GCSF does not improve LVEF, it decreases
post MI LV dilatation. DT may cause infarct expansion and decreased LVEF.
No augmentation in scar vascularity occurred. Both regimens decreased
vascularity in border zone and contralateral non-infarct wall. These effects
of GCSF and its timing should be considered in therapeutic trial design.
TCT-153
Clinical Trail on Delayed Intracoronary Autologous Bone Marrow
Mononuclear Cells Transfer for Patients with Anterior-Wall
Yanlin Lee1, Junbo Ge2, Juying Qian2, Jianhui Shi2, Qibing Wamg2, Yuhong
Niu2, Bing Fan2, Lei Ge2, Feng Zhang2, Aijun Sun2, Yunzeng Zou2
1
Huashan Hospital, Shanghai, China2Zhongshan Hospital, Shanghai,
China
Objective: To evaluate the safety and efficacy of delayed bone marrow
mononuclear cells(BMMCs) transplantation on the improvement of
cardiac function in patients with anterior-wall myocardial infarction.
Methods and Results: A group (onset to transplantation <6 weeks,
n=14) and B group (onset to transplantation >6 months, n=13) patients
with anterior wall myocardial infarction were transfer with autologous
BMMCs through an infusion catheter which was placed with the tip in
the left anterior descending coronary artery after coronary angiography
and interventional therapy if necessary. After 6 months follow-up, a
significant increase of LVEF determined by ultrasonic cardiograph
(46.2±5.2% before transfer to 54.4±5.8%, p<0.001) and left ventricular
angiography (41.3±8.3% to 50.1±11.5%, p=0.02, n=10) was found in A
group, however insignificantly increase of LVEF in B group (43.8±7.7%
to 47.0±9.0%). In addition, LV end diastolic volume evidently decreased
in A group (122±25ml before transfer to 115±20ml at 6-months follow
up, p=0.055), but was unchanged in B group (141±45ml to140±38ml).
Conclusions: These results indicate that selective intracoronary transfer of
autologous, BMMCs in convalescent period might improve the ventricular
systolic function in patients with anterior-wall myocardial infarction, but
efficacy of transplantation in advanced stage seems not significant.
TCT-154
Over-the-Wire Balloon Temporary Coronary Occlusion vs. Perfusion
Catheter Technique for Transcoronary Transplantation of Autologous
Bone Marrow-Derived Stem Cells after Recent Myocardial Infarction
Piotr Musialek, Wieslawa Tracz, Krzysztof Zmudka, Jaroslaw Zalewski,
Zbigniew Walter, Marek Krochin, Marta Szostek, Dorota Weglarska, Piotr
Pieniazek, Aleksander B Skotnicki
Jagiellonian University, Medical College, Krakow, Poland
Poor homing of bone marrow-derived stem cells (BMSC) to the infarct
zone with intracoronary delivery can limit the outcome of BMSC
therapy. Past and current studies have used over-the-wire balloon
catheters (OTW) with a transient infarct-related artery occlusion and
cell injection via the catheter central lumen. This delivers the cells to
the proximity of the catheter tip while the flow is ceased, and induces
reactive hyperemia which can enhance undesired cell wash-out.
Materials and methods: In an ongoing study, we have randomly assigned
12 pts with first anterior AMI treated with stent-assisted angioplasty
and LV EF below 45% to one of two modes of transcoronary BMSC
delivery at 5-9 days: OTW temporary LAD in-stent occlusion (3 times
up to 3 min; cell suspension 10mL) or slow (50min/50mL) intracoronary
infusion via perfusion catheter with side holes (SH-PC). SH-PC directs
BMSCs to external layers of maintained laminar flow which can facilitate
interactions between BMSC and endothelium that are essential for
downstream homing. TTE, stress and contrast echo, SPECT and MRI
are performed prior to cell delivery and at 1 and/or 3, 6 and 12 months.
Results: OTW and SH-PC pts had similar infarct size (peak CK [mean]
4302 vs. 4741 U/L), EF prior to cell delivery ([mean] 40 vs. 39%),
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infused mononuclear cell number (mean 2.98 x 108 range 0.61-7.48
x 108 vs. 3.28 x 108 range 1.64-4.39 x 108), CD 34+ number (mean
1.79 x 106 range 0.30-3.44 x 106 vs. 1.62 x 106 range 0.48-4.32 x 106),
cell viability (91.5 vs. 91.8%) and clonogenicity. With neither technique
there was a detectable post-procedural flow deterioration or troponin
rise. However, 67% OTW pts had transient chest pain with ST segment
elevation or nsVT that limited coronary occlusion tolerance to 50-110sec.
In conclusion, our data indicate feasibility, safety and optimal tolerability
of transcoronary SH-PC delivery of BMSC. While further animal work is
critically needed to determine the mode of coronary BMSC delivery that
yields maximal homing, emerging understanding of BMSC trafficking and
adhesion mechanisms taken together with the enhanced cell wash-out by
reactive hyperemia, indicate that SH-PC cell delivery might be superior to
the ‘conventional’ OTW technique.
TCT-155
Hyperhomocysteinemia Leads to Cardiac Remodeling by Decreasing
Number of Microvessels and Inducing Cardiac Fibrosis
Yanhong Guo1, Fengying Chen1, Xinheng Feng1, Li Chen2, Wei Gao1
1
Peking University Third Hospital, Beijing, China2Institute of
Cardiovascular Sciences, Peking University, Beijing, China
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Objective: Recent reports indicate that hyperhomocysteinemia (Hhe) is an
independent risk factor for cardiac dysfunction and clinical heart failure.
The present study was designed to observe the effects of Hhe on ventricular
remodeling and function in rats and to determine the underlying mechanisms.
Methods: The Wistar rats were randomly distributed into the following
3 groups: 1) control group with normal diet (n=12); 2) Hhe1 group
with 1g/kg·day L-methionine for 4 weeks (n=12); 3) Hhe2 group with
1g/kg·day L-methionine for 4 weeks and then with normal diet for
an additional 4weeks (n=12). Before and after dietary treatment, rats
were subjected to echocardiographic assessment of left ventricular
(LV) dimensions and systolic function. At the expected time point,
the rats were killed for histomorphometric assessment of cardiac
remodeling by hematoxylin-eosin staining, picrosirius red staining and
immunohistochemistry for endothelia and vascular smooth muscle cells.
Results: The plasma Hcy concentration increased markedly after Lmethionine-diet and decreased to normal level after the additional
4 weeks (106 ±19μmol/L, 6 ±1μmol/L and 5 ±0.1μmol/L for Hhe1
group, Hhe2 group and control group, respectively). In Hhe1 and Hhe2
groups, the left ventricular systolic function and the number of cardiac
microvessels decreased, while systolic blood pressure, left wall strain,
cardiac smaller arterial wall thickness increased. LV and RV remodeling
was characterized by a disproportionate increase in perivascular and
interstitial collagen, coronary arteriolar wall thickening in Hhe1 and Hhe2
groups. The number of microvessels in Hhe1 group was less than control
group, while after an additional 4 weeks with normal diet, the number
of cardiac microvessels increased and was similar to the control group.
Conclusion: These results demonstrate that Hhe has direct adverse effects
on cardiac structure and function, suggesting that hyperhomocysteinemia
may be one risk factor for heart failure and cardiac remodeling. Induction
of collagen deposition, damage of endothelial barrier and microvessel,
direct or indirect influence of cardiac myocytes might be the underlying
mechanisms.
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TCT-156
Assessment of Bone Marrow Mononuclear Cells Distribution
by Radioactive Labeling after Intracoronary Delivery in Acute
Andre L S Sousa1, Claudio T Mesquita2, Suzana A Silva2, Rodrigo
Moreira2, Joao Assad2, Carlos H E Falcao2, Rodrigo Verney2, Nelson
Mattos2, Radovan Borojevic2,3, Hans F R Dohamann2
1
Pro-Cardiaco Hospital, Niteroi, Brazil2Pro-Cardiaco Hospital, Rio de
Janeiro, Brazil3University Federal do Rio de Janeiro, Rio de Janeiro,
Brazil
Background: The engraftment of bone-marrow mononuclear
(BMM) cells into the infarcted myocardium is the key to cell
therapy. Few studies had quantified cell engraftment in humans.
Objective: We determined BMM cells biodistribution after intracoronary
application in patients with ST-segment elevation myocardial
infarction, who had undergone angioplasty of the infarct related artery.
Methods and Results: In 5th day after the infarction 3 patients received
in the infarct related artery 1.0x108 bone-marrow mononuclear cells
delivery via the baloon catheter. Approximately 1 % of these cells were
labeled with technetium 99m (74 mBq) by incubation with HMPAO.
Scintigraphic images of the whole-body and tomographic images of the
heart were obtained 8 and 18 hours after the delivery of the stem cells. We
observed intense accumulation of the BMM labeled cells in the infarcted
area in the early and delayed images. Labeled cells were also identified in
the liver, spleen, and bone marrow. In the tomographic images we could
observe a distinct pattern of accumulation of BMM cells in the border of
the infarct. At 8 and 18 hours after BMM cells delivery 16% ± 4% and
11% ± 4% of the radioactivity was localized in the heart, respectively.
Conclusions: These findings suggest the engraftment of the BMM cells in
the infarcted area, predominantly in the infarct border, a prerequisite for the
success of stem cell therapy. Cell radiolabeling might provide an useful tool
for monitoring the fate of transplanted cells.
TCT-157
Single Clonally Purified Non-Hematopoietic Mesenchymal Stem Cells
Serve as a Superior Transplantation Cell Source for Cardiac Repair in
Rats with Myocardial Infarction
Shaoheng Zhang, Sr., Junbo Ge, Aijun Sun, Danling Xu, Juying Qian,
Jinyi Lin, Keqiang Wang, Yunzeng Zou
Shanghai Cardiovascular Research Centre, Shanghai, China
Objective: A variety of adult stem cells have been transplanted into the
infarcted (MI) heart and all improved cardiac function, however, comparative
studies are lacking to show which cell would be the most suitable source for
transplantation. We compared the effects of PBS, single clonally purified
non-hematopoietic bone marrow mesenchymal stem cells (snMSCs),
unpurified MSC (uMSCs), mononuclear cells (BM-MNCs), or peripheral
blood mononuclear cells (PB-MNCs) on cardiac healing post MI in rats.
Methods and results: BM-MNCs, uMSCs, snMSCs, and PB-MNCs were
prepared from human bone marrow and peripheral blood, respectively.
snMSCs showed homogenous fibroblast-like appearance, expressed
mesenchymal cell surface markers (SH2, SH3, CD29, CD44, CD71,
CD90, and CD147), functional specific markers of self-replication and
pluripotency (Oct4, Bmi1 and ABCG2), and cardiomyocyte marker
proteins such as myosin heavy chain, troponin T and desmin after induction
with 5-azacycline. PBS or various cell sources (5×106) were transplanted
into the ischemic zone immediately after MI. Three months later, compared
to pre-transplantation, cardiac function assessed by ejection fraction and
fraction of shortening were further decreased (P<0.05), whereas these
indexes recovery degrees among all the cell transplantation groups were
consistent with the transplanted cell purity, which demonstrated maximal
improvement by transplantation of snMSCs. The vessel density increase
was in proportion to the purity of transplanted cells. The collagen density
in the BM-MNC, the uMSC, and the snMSC groups was in inverse
proportion to these transplanted cell purity, and there were no statistical
significant differences between the PBS and the PB-MNC groups.
Furthermore, cardiomyocyte specific proteins or vascular endothelial
cell marker proteins expressions were the highest in the snMSC group.
Conclusion: Single clonally purified non-hematopoietic bone marrow
mesenchymal stem cells could be a more suitable transplantation cell source
for cardiac repair in rats with experimenatl MI.
TCT-158
Uncultured, Autologous Adipose-Derived Stromal Cells - A Novel Cell
Source for Cardiac Repair
Eckhard Alt, Mandy Scharlau, Kai Pinkernell, Chikezie Amadi, Karthik
Reddy, Nadine Matthias, Kerstin Daemen, Parwis Fotuhi
Tulane University, New Orleans, LA
Adipose tissue is a readily available source of many cell types
including stem cells. This study investigated the safety and
efficacy of freshly harvested, adipose-derived stromal cells
(ADSC) in a pig model of acute myocardial infarction (AMI).
An AMI was induced in 17 pigs (33±5kg, ADSC n=9, control n=8) by 3-hour
balloon occlusion of the mid LAD. During the AMI induction, subcutaneous
adipose tissue was harvested, processed and stromal cells isolated. At
reperfusion, 1.5 x106 cells/kg body weight (containing 10±5% stromal cells)
or vehicle alone was injected into the LAD distal to the occlusion. Gated
SPECT (99mTc-SestaMIBI) was performed immediately and after 4 and 8
weeks to assess the area at risk, infarct size and ejection fraction (EF). Vessel
patency was assessed by TIMI flow and coronary angiography measurements.
Results: Intracoronary injection of a cell suspension containing ADSC
significantly reduced the perfusion defect after 8 weeks compared to the
control group (*p≤0.05). A corresponding trend was seen in the EF, but did
not reach significance. Directly after the cell injection 2 ADSC had vessel
occlusion and 1 ADSC had TIMI-1 flow in the LAD. At 8 weeks 3 ADSC
animals showed a focal LAD stenosis characterized by intima hyperplasia.
ADSC
Control
Perfusion Defect in %
AMI
8 weeks*
41±8
35±9
39±6
44±5
AMI
32±13
35±10
EF in %
8 weeks
42±11
31±10
Autologous adipose tissue is a novel and promising source of stem cells
for tissue repair. Freshly isolated ADSC significantly reduce the perfusion
defect post-AMI. Further studies will help to identify the mechanism
affecting vessel patency and cardiac regeneration.
TCT-159
Ischemic Preconditioning Induces Mobilization of Bone MarrowDerived Haematopoietic but Not Mesenchymal Stem Cell
Mobilization in Porcine Ischemia-Reperfusion Model
Mariann Gyongyosi1, Sabine Steiner1, Christoph Kopp1, Serdar Farhan2,
Heda Kvakan1, Noemi Pavo1, Ferenc Manczur3, Rita GaramvÃ¶lgyi4, Zsolt
Petrasi4, Akos Hevesi4, Dietmar Glogar1, Kurt Huber2, Johann Wojta1
1
Dept. Cardiology, Medical University of Vienna, Vienna, Austria23rd
Department of Medicine Wilhelminenhospital, Vienna, Austria3Department
of Internal Medicine Szent-Istvan University, Budapest,
Hungary4University of Kaposvar, Kaposvar, Hungary
Background: Myocardial ischemia induces mobilization of bone
marrow (BM)-derived stem cells (SC) leading to homing of BM SCs
in infarcted myocardium resulting in angiogenesis and myogenesis.
The aim of the present study was to investigate the effect of
ischemic preconditioning on the mobilisation of BM hematopoietic
and mesenchymal SCs in porcine coronary occlusion/reperfusion.
Methods: Catheter-based 90 min coronary occlusion followed by 60 min
reperfusion was performed in 11 pigs (Group AMI). Preconditioning was
obtained in 14 pigs (Group P) by 2 cycles of 5 min of balloon occlusion
of LAD with 2 cycles of 5 min interval of reperfusion before the 90min
occlusion and 60 min reperfusion. The global left ventricular EF was
measured from the end-diastolic and end-systolic volumes calculated
from the area-length method of echocardiography. The size of myocardial
infarction in relation to area at risk (expressed as %) was determined
by blue dye injection and triphenyl tetrazolium chloride staining. BM
hematopoietic and mesenchymal SCs were characterized by coexpression
of CD31+, CD90+, CD44+ cells, measured by whole blood flow cytometry
from venous blood taken at baseline and at the end of the final reperfusion.
Results: Myocardial infarct size, expressed as % of area at risk, was
larger in Group AMI (26.6+/-4.1% vs 17.4+/-4.7%, p<0.05) as compared
with Group P. The global left ventricular EF was decreased in Group
AMI comparing Group P (32+/-7% vs 41+/-7%, p<0.05). Similar
relativ increase (ratio of post-final reperfusion and baseline values) in
haematopoietic SC concentration was observed in both groups (165+/117% vs 173+/-231% in Groups AMI and P). The mesenchymal SC
relativ increase was significantly higher in Group AMI as compared with
Group P (147+/-163% vs 82+/-20%, p<0.05). The relative increase of
mesenchymal SCs correlated with the size of infarction (r=0.66, p<0.05).
Conclusions: Ischemic preconditioning induces mobilization of BMderived haematopoietic but not mesenchymal Scs during ischemiareperfusion, while profound myocardial ischemia without warm-up
protective mechanism triggers parallel mobilization of mesenchymal SCs.
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TCT-160
Mobilization of Endothelial Progenitor Cells with Percutaneous
Coronary Angioplasty in Patients with and without Acute Coronary
Syndromes
Kreton Mavromatis1,2, Emir Veledar1, Tanuj Kamineni1, Muhammad
R Ishaque1, Johnson Pererira1, John S Douglas1, Ziyad Ghazzal1,
Henry Liberman1, Tanveer Rab1, Steven V Manoukian1, Christopher U
Cates1, Grant Anderson1, Dorothy House1,2, Diane Sutcliffe1, William S
Weintraub1, Peter C Block1, W Robert Taylor1, Arshed A Quyyumi1
1
Emory University, Atlanta, GA;2Atlanta VA Medical Center, Decatur, GA
Background: Animal studies show that circulating endothelial progenitor
cells (CEPCs) mobilize after vascular injury and ischemia, and contribute
importantly to vascular repair. We hypothesized that vascular injury caused
by coronary stenting (PCI) would mobilize CEPCs, and this would manifest
differently in patients with and without acute coronary syndromes (ACS).
Methods: Patients with stable CAD (troponin -, n=128) or ACS (troponin
+, n=24) who were undergoing PCI had blood drawn before (baseline),
and 1 day, 1 week, and 4 weeks after PCI. Patients with larger myocardial
infarctions (CK-MB>2x ULN) or without stable statin therapy were
excluded. CEPCs were cultured from blood mononuclear cells (MNCs),
and endothelial colony forming units (CFU) were counted after 7 days.
Results: In the entire patient cohort, CEPC levels were increased 1 day
(41%) and 1 week (24%) after PCI (Table). This CEPC mobilization
with PCI was only observed in the stable CAD patients. However,
ACS patients had higher baseline CEPC levels than those with stable
CAD (p=0.05), despite similar cardiovascular risk factors profiles.
Conclusions: PCI mobilizes CEPCs, particularly in patients with
stable CAD. Furthermore, ACS is associated with higher CEPC levels
at presentation than stable CAD. Thus, vascular and myocardial injury
in patients results in the activation of a fundamental vascular reparative
response, which can be observed as the mobilization of CEPCs.
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CEPC Mobilization with PCI (CFU/106MNC, mean +/-SEM)
Patients
Baseline
Day 1
Week 1
Week 4
All (n=152)
129+/-6
182+/-7**
160+/-7**
142+/-8
Stable CAD (n=128)
122+/-7
178+/-8**
155+/-8**
141+/-9*
ACS (n=24)
168+/-16
202+/-17
186+/-20
145+/-17
** =p<0.0001 compared to baseline; *=p<0.05 compared to baseline
TCT-161
Magnetic Resonance Fluorscopy for Precise Targeting and Monitoring
of Mesenchymal Stem Cell Engraftment Combined with Serial MRI
to Assess Efficacy
Wesley D Gilson1, Jeff W M Bulte1, Lawrence V Hofmann1, Parag
Karmarkar1, Asif Mahmood1, Ana V Soto1, Dorota Kedziorek1, Michele
Marcelino2, Randell G Young2, Mark F Pittenger2, Izlem Izbudak1,
Raymond C Boston3, Dara L Kraitchman1
1
Johns Hopkins University, School of Medicine, Baltimore, MD;2Osiris
Therapeutics, Inc., Baltimore, MD;3University of Pennsylvania, Kennett
Square, PA
Background: Despite the explosion of stem cell therapies to regenerate cardiac
tissue, noninvasive methods to determine the cell engraftment in clinical trials
are lacking. The recent development of magnetic labeling techniques, using
approved contrast agents, offers a noninvasive method to precisely target and
monitor stem cell persistence and serially follow improvements in function.
MRI studies in a dog model of myocardial infarction (MI) were undertaken
to develop a clinical protocol for mesenchymal stem cell (MSC) therapy.
Methods: A closed-chest MI was created under X-ray fluoroscopy using
a balloon LAD occlusion followed by reperfusion in 13 dogs. MRI (1.5 T,
GE) was performed at 72h post-MI to assess MI size and heart function.
72H
Using a custom MR-compatible injection catheter, autologous MSCs,
labeled with ferumoxides (30-150 x106), were injected transendocardially
in 6 dogs with targeting to normal (N), peri-infarction (P), and MI. MSC
persistence, MI size, and regional cardiac function were performed using
serial MRI (1, 2, 4, & 8 weeks post-MI). Systolic strain rate (SSR) was
determined from tagged MRI in N, P, and MI. SSR changes over 8 weeks
were compared to control MI dogs. Values are expressed as mean ± SEM.
Results: No difference in infarct size progression was seen between MSCtreated and untreated dogs at 72 h (19.3±9% vs. 20.0±5%) or 8 weeks postMI (8.1±2% vs. 8.9±2%). However, MSC-treated dogs retained myocardial
mass over 8 weeks (2.5±4% change) whereas control dog mass declined by
19.6±2.3% (P<0.01). MSCs persisted only in P and I, but disappeared from
N regions at 4-8 weeks. SSR initially improved at 1 week as myocardial
stunning resolved. However, at 8 weeks post-MI, only the peri-infarcted tissue
of MSC-treated dogs showed ongoing improvement (-0.41±0.04 MSC vs. 0.36±0.03 control SSR at 8 weeks, P<0.03) consistent with MSC persistence.
Conclusions: The therapeutic efficacy of MR-labeled MSCs after precise
targeting using MR fluoroscopic delivery was demonstrated. Since approved
agents were used for labeling, the translation of these techniques to clinical
trials should be straight-forward to give a better ability to monitor outcomes
and custom-tailor therapy.
TCT-162
The Effects of Radiocontrast on Myoblast Survival and Function
Warren Sherman1, Guilayne Senechal2, Jack Harvey2, Stuart K Williams3
1
Columbia University Medical Center, New York, NY;2Bioheart,
Incorporporated, Weston, FL;3University of Arizona, Tucson, AZ
Background: Catheter-based delivery of progenitor cells into the
myocardium is hampered by the lack parameters of acute success.
Potentially useful methods of measuring acute retention and tracking of
cells, such as echocardiographic tissue characterization and iron labeling
of cells, have not reached clinical application. Fluoroscopy is the standard
tool for guiding catheter-based procedures. Injecting radiopaque cell
products would simplify the online assessment of retention. We added
two different radiocontrast media (RCM) to autologous skeletal myoblast
(ASM) formulations to test in-vitro effects on cell survival and function.
Methods: ASM from healthy volunteers were processed, placed in
transport media and stored at 5º C for up to 96 hrs, to simulate methods
used in clinical studies. Isosmolar (iodixanol:”ISO”) or low osmolar,
nonionic (ioversol: “LON”) RCM were each added to samples of ASM
to achieve RCM concentrations of 10% or 20%. At various times up to
60 min, ASM viability (% Trypan Blue exclusion) and functionality
were measured in ASM-RCM mixtures as well as pure ASM (control,
“CONT”). Functionality was calculated as the % cells (by quintile)
forming myotubes (MT) after 10d in differentiation culture media.
Results: After 60 min. of exposure, the viability of ASM remained at > 80%
(CONT 82 + 3.6%), and did not change in the presence of either ISO (8790 + 2.9%) or LON (88-90 + 3.3%) contrast agents. The ability of ASM to
form myotubes (40-60% of cells in CONT, ISO and LON groups) was also
unchanged by exposure to RCM. P = ns for differences in viability or MT
Conslusion: Mixtures of ASM with RCM doe not compromise cell survival
or in vitro functionality. In the absence of demonstrated in-vivo toxic effects,
the combination RCM-cell formulations may enhance the determination of
acute procedural success of intramyocardial injections.
TCT-163
Impaired Mobilization of CXCR4+ /CD34+ Stem Cells Early in
Acute Myocardial Infarction is Associated with Low Left Ventricular
Ejection Fraction and High NT-ProBNP Levels after 1 Year of FollowUp
Wojciech Wojakowski1, Rafal Wyderka1, Anna Zebzda2, Joanna Ciosek1,
Anna Michalowska2, Katarzyna Maslankiewicz1, Marcin Majka2, Andrzej
Ochala1, Marek Krol1, Mariusz Z. Ratajczak3, Michal Tendera1
1
3rd Division of Cardiology, Katowice, Poland2Dept. of Transplantology,
Polish-American Children’s Hospital, Krakow, Poland3Stem Cell Biology
Program, James Graham Brown Cancer Center, Louisville, KY
Stem cells are mobilized into peripheral blood early in acute myocardial
infarction (AMI). In patients with low left ventricular ejection fraction (LVEF)
and high levels of NT-proBNP in acute phase of AMI the mobilization of
CD34/CXCR4+ cells is significantly impaired. It remains unknown whether
the stem cells mobilization can influence the LVEF in long-term follow-up.
Aim of the study was to correlate the early mobilization of stem cells
in patients with STEMI with LVEF, NT-proBNP levels, hematopoietic
cytokines, spiroergometric exercise test results in 1-year follow-up.
Methods and Results: 40 patients with STEMI were enrolled.
Blood samples were obtained on admission, after 24 hours and 7
days as well as after 1 year (12-16 months). Stem cells number was
measured using FACS and concentrations of NT-proBNP, SDF1, G-CSF, VEGF, IL-6 and HGF were measured using ELISA kits.
Results: In patients with baseline LVEF ≤ 40% as well as with NT-proBNP
levels in the highest tertile the number of mobilized CXCR4+/CD34+ stem
cells on admission was significantly lower in comparison to patients with
LVEF >40% (p<0.03) and NT-proBNP levels in the lowest tertile (p<0,001).
Moreover, patients with LVEF ≤40 after 1 year had lower baseline CXCR4+
cell counts than patients with LVEF>40% on follow-up visit (p<0.03).
Baseline number of CXCR4+ cells was positively correlated with LVEF
after 1 year (r=0.55; p<0.03) and in multivariate regression was independent
predictor of LVEF <40% after 1 year. The peak number of mobilized CXCR4+
stem cells early in STEMI was positively correlated with the number of
stem cells after 1 year (CD34+: r=0.35, p<0.05; CXCR4+: r=0.38; p<0.03;
CD117+: r=0.4, p<0.02) and patients with low baseline CXCR4 counts
had lower number of CD34+, CD117+ and CXC4+ cells as well as higher
levels of NT-proBNP after 1 year (all p<0.03). No significant correlation
between baseline stem cells number and exercise test results were found.
Conclusion: In STEMI patients with low LVEF and high NT-proBNP
levels the mobilization of stem cells into peripheral blood is significantly
compromised and is associated with lower LVEF, higher levels of NTproBNP and lower circulating stem cells number after 1 year.
TCT-164
Different Effects of Bone Marrow and Adipose Tissue Derived Stem
Cells on Coagulation and Platelet Activation
Michael Schwarzer, Roman Schlager, Kerstin Daemen, Kai Pinkernell,
Parwis Fotuhi, Eckhard Alt
Tulane University, New Orleans, LA
Background: Intracoronary application of a high number of cells for
myocardial repair bears the potential risk of prothrombotic effects on
the coronary circulation. The aim of this study was to analyze and
compare the effect of human stem cells from bone marrow (BMC)
and subcutaneous adipose tissue (ADSC) on platelet activation.
Methods: Stem cells were isolated by their adherence to cell culture
dishes. Human subcutaneous adipose tissue was digested using
collagenase (50 mg, 90 min) resulting in a single cell suspension. Cells
harvested after centrifugation were plated on cell culture dishes. Both
cell types were cultured under standard conditions for 15 days using
20% FBS in alpha-MEM. Increasing cell concentrations were incubated
with human blood for 2 minutes. After centrifugation the content of
tissue factor (TF) in the supernatant was determined by ELISA. In
addition, platelet-factor-4 (PF4) release induced by cells was investigated
with freshly isolated cells and cells after one passage. Furthermore
cells cultured on coverslips were immunostained for tissue factor.
Results: Cultured ADSC induced release of PF-4 in human blood
containing thrombocytes in a dose dependant manner, whereas cultured
BMC do not induce a measurable PF-4 release in thrombocytes.
Content of TF in 106 cultured ADSC cells was 7.5±4pg and could not
be detected in BMC. Antibody against TF inhibited the PF4 release
while both Heparin and Integrilin had no effect. Immunohistochemistry
confirmed tissue factor expression in cultured ADSC but not in BMC.
Conclusion: Tissue factor, a main inductor of coagulation could be detected
with ADSC but not with BMC. Cultured adipose tissue derived stem cells
effect a release of PF-4 in vitro while no release can be seen in BMC. This
indicates important differences in coagulation potential between cells
currently under investigation for intracoronary application and myocardial
repair.
TCT-165
Spectrophotometric Microscopy Reveals GFP-Labeled Autologous
Bone Marrow Side Population Cells Generating New Endothelium
and Cardiomyocytes in Infarcted Pig Myocardium
Jaap N Hamburger1, Thomas J Podor1, Gordon Pate1, Ryon Bateman1,
Jacqueline Saw1, Nana Rezai1, Karim Quayumi1, Bruce McManus1, Peter
Lansdorp2
1
University of British Columbia, Vancouver, BC, Canada2BC Cancer
Agency, Vancouver, BC, Canada
Background: Recent studies suggest bone marrow-derived stem
cells (BMSCs) have the potential to regenerate new blood vessels and
myocardium. However, difficulties with optically tracking the fate
of BMSCs labeled with green fluorescent protein (GFP) in areas of
myocardial ischemia and regeneration have lead to controversies whether
BMSC subpopulations can directly lead to the generation of endothelium
and cardiomyocytes through trans-differentiation or fusion mechanisms.
Methods: We used confocal spectrophotometric microscopy to track
the tissue distribution of BMSC-derived “side population” (SP) cells
transduced with GFP expressing lentiviral vectors and injected into the
infarct border area of hearts of domestic swine subjected to acute ischemia/
reperfusion injury and followed for 28 days. Cryosections were scanned
using laser excitation at 488-, through 900-nm to spectrally distinguish GFP
emission from the hallmark autofluorescence in ischemic myocardium.
Results: GFP+ cells were revealed using spectral unmixing software
and the emission signatures at different excitation wavelengths. SP cell
injected hearts demonstrated an increased number of small blood vessels
that stained for the endothelial cell markers, von Willebrand factor and
CD31. There were islands of GFP+ cells along the edges of surviving
myocardium with weak staining for troponin T and connexin 43. The
morphology ranged from individual immature type multi-nuclear cells
to groups of mature cardiomyocytes with normal 3D tissue organization.
Conclusions: Spectrophotometric microscopy vastly improves the
reliability to detect GFP-labeled cells in infarcted myocardium. Our results
indicate that injected SP cells are associated with the formation of new
blood vessels and lend further support to the notion that autologous SP cells
contribute to post MI cardiomyocyte repair.
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Atheroablation, Thrombectomy and Distal Protection
TCT-166
The Immediate and Long-Term Results of Successful Thrombectomy
During Primary Coronary Angioplasty in Acute Myocardial
Infarction
Jaroslaw Zalewski1, Wojciech Zajdel1, Nader El-Massri2, Piotr Klimeczek3,
Monika Durak1, Pawel Banys3, Mieczyslaw Pasowicz3, Krzysztof Zmudka1
1
John Paul II Hospital, Department of Hemodynamics and
Angiocardiography, Krakow, Poland2John Paul II Hospital, Department
of Coronary Disease, Krakow, Poland3John Paul II Hospital, Krakow,
Poland
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Background: We hypothesized that a successful thrombectomy
(STh) before primary coronary intervention (PCI) may improve
immediate and long-term results in patients with STEMI.
Methods: We evaluated 60 consecutive patients (pts, age 56.5±11.3 y) with
STEMI, treated with thrombectomy before PCI. Death and recurrent AMI
were recorded during a 1-year follow-up. TIMI flow grade was assessed after
the thrombectomy and after the whole procedure. STh result was defined as
TIMI-2 or -3 flow immediately after the thrombectomy. LV ejection fraction
(LVEF), wall motion score index (WMSI) and LV end-diastolic volume
(LVEDV) were evaluated by echocardiography 24 hours (1d) and 6 months
(6m) after PCI. Magnetic resonance imaging (MRI) used as a method of
evaluating of a risk area (RA), an infarct area (IA) and a microvascular
damage area (MA) was performed 2-4 days (d) and 6 months (6m) after
STEMI. The following indexes were calculated: IA/RA and MA/RA.
Results: STh result was achieved in 28 (46.7%) pts. After a 1-year
follow-up 2 pts died in STh group and 1 person in an unsuccessful
thrombectomy (uSTh) group (p=ns). During a 6-month follow-up an
infarct area decreased in both groups (p<0.05) and WMSI decreased only
in STh group (p=0.04). LVEF and LVEDV did not change significantly.
Conclusion: STh before PCI in STEMI reduces infarct size and
microvascular damage which is associated with the improvement of
segmental contractility in a 6-month follow-up. STh does not improve longterm clinical result and global LV function.
MA/LV-d
IA/RA-d
IA/RA-6m
LVEF-1d
LVEF-6m
WMSI-1d
WMSI-6m
EDV-1d
EDV-6m
LV Function Parameters
STh
uSTh
0,09±0,08
0,17±0,16
0.5±0.18
0.65±0.2
0.3±0.2
0.39±0.21
48±10
54±11
54±10
48±10
1.63±0.42
1.76±0.38
1.35±0.35
1.73±0.39
92±31
103±34
122±45
116±42
p
0.022
0.035
0.04
ns
ns
ns
0.019
ns
ns
TCT-167
Combined Embolic Protection and Thrombectomy in Percutaneous
Coronary Intervention of Acute Myocardial Infarction Using the
Proxis® Device
Karel T Koch1, Robbert J De Winter1, Jose P Henriques1, Allard C Van der
Wal1, Rene J Van der Schaaf1, Gerlind S Heyde1, Thomas Cherpanath1, Jan
J Piek1, Gabor Sutsch2
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Academic Medical Centre, Amsterdam, The Netherlands2University
Hospital of Zurich, Zurich, Switzerland
Background: Distal embolization may occur during primary PCI leading
to poor results. Proxis® (St. Jude Medical, St. Paul, MN), a novel embolic
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protection system that completely blocks antegrade flow during PCI by
means of a temporary occlusive balloon mounted at the tip of the device, may
prevent this complication and thus improve outcome in these patients (pts).
Methods: We evaluated the safety and feasibility of Proxis in a
series of consecutive primary PCI pts. The device was advanced
just proximal to the occlusion and the sealing balloon at the tip was
inflated. Then, the occlusion was crossed with a wire of choice and
standard PCI was performed. Each step of the intervention was carried
out under total proximal blockade. Aspiration of the stagnant column
was performed after each withdrawal of dilatation/stent balloons.
Results: Proxis was used in 131 pts (mean age 60.1 y; range 31-89;
102 males; LAD n=48; RCA n=74; RCX n=11). The intervention
was well tolerated in all pts. Recanalization was successful in
all pts and 96% of pts had TIMI-3 flow; 4 pts had TIMI-2 flow
and 1 pt TIMI-1 flow. MBG 2-3 was achieved in 96% of all pts.
STRES immediately after PCI was 65.3% ± 22.3 (mean) and STRES
>50% in 80% of pts and STRES > 70% in 50% of pts, respectively.
STRES at 1 hour was 80.7% ± 11.4 (mean); STRES >50% in 100% of
pts and STRES>70% in 81% of pts, respectively. Debris (confirmed by
pathology) was retrieved in 77% of pts. The 30-day MACCE-rate was 4%.
Conclusion: Combined embolic protection/thrombectomy with Proxis is
feasible and safe in the setting of primary PCI. The results suggest that this
device is highly effective for aspiration of embolic material during primary
PCI. Moreover, angiographic and myocardial recovery with Proxis are
excellent. Randomized trails are needed to prove whether these preliminary
observation can be reproduced on a larger scale.
TCT-168
Thrombus Aspiration Improves Coronary Flow and Myocardial
Reperfusion in Acute Myocardial Infarction: Final Results of
the DEAR MI (Dethrombosis to Enhance Acute Reperfusion in
Myocardial Infarction) Study
Paola Colombo1, Bedro Silva1, Riccardo Bigi2, Michela Caracciolo1,
Patrizia Pedrotti1, Paola Orrico1, Paolo Di Lorenzo1, Irene Bossi1,
Giacomo Piccalo1, Silvio Klugmann1
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Niguarda Hospital, Milan, Italy2University of Milan, Milan, Italy
Background: In patients with acute myocardial infarction
(AMI), percutaneous coronary intervention (PCI) may cause
thrombus dislodgment and impaired microcirculatory reperfusion.
This study is designed to test the hypothesis that a strategy of thrombus
aspiration before standard PCI may improve acute myocardial
reperfusion, measured by ST segment resolution (STR) and
Myocardial Blush grade (MBG), compared with standard PCI alone.
Methods: All consecutive patients with ST elevation AMI, admitted
within 12 hours of symptom onset scheduled for primary PCI and
without controindications to IIb/IIIa inhibitors, were randomly assigned
in two groups: A) standard PCI or B) Thrombus aspiration with the
Pronto™ extraction catheter (Vasc.solutions, Mineapolis) before standard
PCI (stent plus IIb/IIIa inhibitors). Electrocardiograms at arrival,
immediately after PCI and 90’ after the procedure as well as lateral
or right oblique views to evaluate final MBG were done in all patients.
Results: From January 2004 to May 2005 we have enrolled 155 pts, 6 drop
out, mean age 54 + 19 years, male 80%, anterior AMI (46%), diabetes 18%.
Baseline clinical and angiographic characteristics were similar between both
groups. Stenting and IIb/IIIa inhibitors were used in all cases. Complete
STR (> 70%) was 65 vs. 51% (p<0.05); MBG 3 was 90 vs. 43% (p<0.01);
coronary TIMI flow 3 was 89 vs 68% (p<0.01); cTFC 17+6 vs 21+9 (p<0.01);
angiographic embolization 5% vs. 19% (p<0.01); direct stenting 81% vs.
23% (p<0.01) between the aspirated and control groups respectively. We
had no hospital adverse cardiac events, except one pt with heart failure in
the control group and one acute revascularization in the aspiration group.
Conclusions: This results indicates that thrombus aspiration before standard
PCI is associated with better epicardial flow and improves myocardial
reperfusion measured with complete STR and MBG.
TCT-169
Effectiveness of a New Directional Coronary Atherectomy Device for
the Treatment of Ostial and Bifurcation Lesions: Findings from the
“Registro Italiano per Aterectomia Direzionale (Regata)”
Alessandra Repetto, Sr.1, Maria Luisa Laudisa2, Nedy Brambilla2, Mario
De Michele2, Ezio Bramucci1, Maurizio Ferrario1, Luigi Angoli1, Tullio
Usmiani3, Giorgio Lanteri4, Francesco Bedogni2
1
IRCCS Policlinico San Matteo, Pavia, Italy2Istituto Clinico
Sant’Ambrogio, Milano, Italy3Divisione Cardiologia Ospedaliera
Ospedale Molinette, Torino, Italy4Cardio Ricerche, Milano, Italy
Background: Plaque excision by mean of directional coronary
atherectomy (DCA) prior to stent implantation in native coronary
arteries is reported to reduce restenosis rate and improve outcome.
Aim: To evaluate the immediate and mid-term angiographic
and clinical results of a new coronary plaque excision device
(SilverHawk-Fox Hollow Technologies, Redwood City, CA,
USA) for the treatment of ostial and bifurcation lesions.
Methods: Between April 2003 and December 2004, 44 patients (79%
males, age 65±9 years, 61% with unstable angina) with de novo complex
lesions (50% B2; 60% ostial and 40% bifurcation) were enrolled in a
multicenter registry, and underwent DCA followed by stent implantation.
Patients were clinically evaluated during hospital stay, at 1- and 6 months.
Results: The primary success rate was 100%. The baseline vessel diameter
was 3.3±0.4 mm, with a mean lesion length of 12.5±4.3 mm. MLD was
significantly increased by DCA (from 0.63±0.36 mm to 2.06±0.40 mm),
and the obstruction was markedly reduced (from 83% to 36%). The acute
angiographic result further improved after stent implantation, with an MLD
of 3.42±0.40 mm and a mean residual stenosis of 2%. In one case, two stents
were implanted for a distal dissection. In two bifurcation cases, provisional
stent was implanted in the side branch. No coronary perforation occurred.
No significant cardiac enzyme increase were observed in any patient after the
procedure. At a median clinical follow-up of 6.7 months (interquartile range: 617), the total TLR rate was 14%; no death and myocardial infarction occurred.
Conclusion: In complex lesions, DCA using the SilverHawk device is safe
and is associated with a high rate of success and a favourable mid-term
outcome with a low incidence of clinical restenosis.
TCT-170
Significant and Sustained Vessel Patentcy Achieved with Foxhollow
SilverHawk Plaque Excision Catheter: Initial and Long Term
Procedural and Angiographic Outcomes
Roger S. Gammon M.D., Jennifer R. Nelson, Mary Wetherill CCRC,
Leticia Janak
Austin Heart, Austin, TX
Background: The successful treatment of infra-inguinal peripheral arterial
disease has primarily been limited by the high restenosis rates associated
with angioplasty and stent placement. Plaque excision (PE) by the
SilverHawk (SH, Foxhollow Tech.) device achieves luminal gain through
plaque removal rather than displacement. This difference induces less
barotrauma and may comparatively reduce complications and restenosis.
Methods: 190 consecutive patients undergoing 325 procedures treating 569
lesions in the lower limbs were included. Study endpoints include immediate
procedural and angiographic outcomes, lesion patency (duplex at 3, 6 and
12 months), and target lesion revascularization (TLR) at 6 and 12 months.
Results: Clinical indications included claudication (78%), rest pain (8%),
and minor or major ischemic tissue loss (14%). The minimum lesion length
was 2 mm and the maximum was 350 mm with a mean lesion length of
64.3 mm. Femoral/popliteal lesions totaled 409 (72%). 115 (20%) were
infra-popliteal lesions, 40 (7%) were iliac lesions and 5 (1%) were within
saphenous vein grafts. Moderate to severe calcification was present in 66%
of target lesions. Post-PE adjunctive therapy (AT) was required in 101 (18%)
lesions with angioplasty as the primary modality of post-PE AT in 15% of
the treated lesions. Adjunctive stent placement was required in 2.5%. The
mean pre-PE luminal diameter was 0.7 mm. Stand alone PE resulted in
a mean gain of 3.5 mm in luminal diameter. This represents an absolute
reduction of mean lesion stenosis of 69% from stand alone PE. No major
device related complications were reported. Dissection occurred in 2.5%
of stand alone PE lesions and increased to 8 % if adjunctive angioplasty
was used. Procedural complications included formation of thrombus (1%),
embolus (1%), perforation (0.4%) and aneurysm (0.5%). At 6 month
follow-up, 49 lesions (13%) in 26 patients had clinically driven (TLR).
Conclusions: Initial experience with SH PE appears favorable with high
procedural success and low complications. Early follow-up is encouraging
and additional long term data will be presented.
TCT-171
Rotational Atherectomy Prior to the Stenting with Sirolimus-Eluting
Stent for Diffuse In-Stent Restenosis: Multicenter Registry in Asia
1
Background: Diffuse in-stent restenosis (D-ISR) is still challenging
problem and optimal treatment has not been established.
Methods: To compare the efficacy and safety of stenting with Sirolimuseluting stent (SES) versus rotational atherectomy (mean burr/artery
ratio 0.70, mean burr size 1.97) prior to stenting with SES for the
treatment of D-ISR, we assessed baseline clinical and angiographic
characteristics, in-hospital and 12-month major adverse cardiac
event (MACE) in 488 consecutive patients. Patients were divided
into 297 patients, 347 lesions treated with one or more SES and 191
patients, 243 lesions treated with rotational atherectomy prior to SES.
Results:
The
baseline
clinical
characteristics
between
Conclusion: Rotational atherectomy prior to Sirolimus-eluting stent
provided an advantage in terms of long-term clinical and angiographic
outcomes.
In-hospital Procedural success (%)
MACE (%)
Lesion length (mm)
MLD post (mm)
12-month MACE (%)
Angiographic restenosis (%)
Repeat PCI (%)
In-lesion late loss
SES
297/347
100
0
30.5 ± 12.6
2.68 ± 0.58
0
12.8
9.4
0.30 ± 0.29
Rota+SES
191/243
100
0
29.8 ± 13.8
2.80 ± 0.70
0
5.2
3.7
0.10 ± 0.14
p
NS
NS
NS
<0.05
<0.05
<0.05
TCT-172
Thrombectomy Using The Thrombus Vacuum Catheter (Nipro®) In
Primary Angioplasty For Acute Myocardial Infarction.
Eric Oliver D Sison, Huay Cheem Tan, Ronald Lee, Jimmy Lim, Richard N
Torres, Yean Teng Lim
The Heart Institute, Singapore, Singapore
Background: Primary percutaneous coronary intervention (PCI) for
acute myocardial infarction is associated with high incidence of distal
thromboembolisation with resultant no-reflow and mortality. We evaluated
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the use of a novel TVAC Thrombus Vacuum Catheter (Nipro®, Osaka,
Japan) to reduce the thrombus load in the culprit coronary arteries.
Methods: A retrospective analysis of all patients who underwent primary
PCI in our institution and received thromboaspiration with Nipro® catheter
was performed. The clinical, angiographic and procedural data were
analyzed. The immediate post-procedural TIMI flow state and in-hospital
and 6 month major adverse cardiac events (MACE) of death, myocardial
infarction and repeat target vessel revascularization was studied endpoints.
Results: There were 72 patients in the analysis cohort in whom 82% were
males. The mean age was 56.5 + 11 years. Thrombus was observed in
68(94%) patients. Sixty-two (81%) patients had pre-procedural TIMI 0 flow.
Fifty-five (76%) patients achieved TIMI 2 to 3 flow immediately following
Nipro® catheter thrombosuction. Twenty five (35%) cases went on to
receive direct coronary stent implantation after initial thrombus aspiration.
Post-PCI, 67(93%) patients had TIMI 3 flow and 66(91%) patients
had TIMI myocardial perfusion (TMP) 2/3. There were no procedural
deaths in this cohort. Seven (9.7%) patients had no- or slow-reflow and
2(2.7%) patients had angiographic evidence of distal embolization.
At 6 months, there were 2 cardiac deaths and MACE rate was 11%.
Conclusions: Nipro® TVAC is effective and safe for use as adjunct
thrombectomy device in primary angioplasty for acute myocardial
infarction.
TCT-173
Comparison between Two manual Thrombectomy Devices: Head to
Head in Procedural Outcome
Massimo Mancone1, Leonardo De Luca1, Giovanni De Persio1, Angelo Di
Roma1, Alessandro Petrolini1, Bich Lien Nguyen1, Giulia Conti1, Gennaro
Sardella2
1
Policlinico Umberto I- University, Rome, Italy2Policlinico Umberto IUniversity la Sapienza, Rome, Italy
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Background: In patients (pts) with ST elevation myocardial infarction
(STEMI), percutaneous coronary intervention (PCI) may cause thrombus
dislodgment followed by reduced flow and impairment of microcirculatory
function, which is a negative independent predictor of myocardial
function recovery. Recent studies demonstrated that thrombectomy
devices significantly reduce distal embolization during primary PCI.
Aim: To assess the safety and efficacy in terms of intra- and periprocedural outcomes of two different thrombectomy devices
(Diver-Invatec®
and
Export-Medtronic®)
in
primary
PCI.
Methods: We randomized 63 pts (mean age 65±11, 48 male) referred to
our Hospital with a STEMI in order to undergo primary PCI (<9 hours from
symptoms onset), to Invatec (n=34) (I) and Export (n=29) (E) devices. No
differences on baseline ,clinical and angiographic preprocedural findings were
observed between the two groups. In all pts heparin (8000U/I i.c.), bolus of
Adenosine and additional Abciximab at standard dosages were administered.
Results: Presence of an intracoronary thrombus at basal angiography was
observed in all pts. A baseline TIMI 0 flow was found in 82.3% vs 79.3%, and
TIMI 1 in 17.7% vs 20.7%, in Invatec and Export groups respectively (p=NS).
After trombectomy, we observed a TIMI 0-1 flow in 47.0% vs 20.7% (p<0.04)
in patients treated with Invatec or Export, respectively. Final Myocardial
Blush Grade (MBG) 0 was achieved in 5.9% vs 6.9% (p=NS) and a MBG
3 in 41.2% vs 44.9% (p=NS), in Invatec and Export groups respectively.
An ST-segment resolution >50% was achieved in 79.4% vs 79,3% (p=NS)
and in 85.3% vs 86.2% (p=NS) 90 minutes after procedure in the 2 groups.
Conclusion: Our experience with two different manual thrombectomy
devices indicate that the clinical final result is identical but a pretreatment
with the Export Medtronic provides greater epicardial flow in STEMI
patients, suggesting that this thrombectomy device could remove more
thrombotic burden
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TCT-174
The Improved Outcome with AngioJetTM Thrombectomy Catheter
during Primary Stenting in Acute Myocardial Infarction Patients with
High-Grade Thrombus
Frank Tamburrino, Annapoorna S. Kini, Sachin Gupta, Prakash Krishnan,
Angelica M. Steinheimer, Paul Lee, Michael C. Kim, Samin K. Sharma
Mount Sinai Hospital, New York, NY
Background: Primary stenting during acute MI (AMI) with large
intracoronary thrombus is often complicated by slow-flow/no-reflow
due to distal embolization of intracoronary thrombus. The AngioJet
thrombectomy catheter has been utilized in this setting in order to limit
distal embolization and improve epicardial and microvascular flow. The
utility of AngioJet thrombectomy during primary stenting in AMI with
high-grade thrombus (≥ grade 3 in TIMI classification) is not known.
Methods: We analyzed 176 consecutive AMI patients with thrombus
grade ≥3 who underwent primary stenting with AngioJet (n = 94) and
without AngioJet (n = 82) and correlated with 30-day MACE and 1year survival. Baseline characteristics and in-hospital events were
obtained from interventional database. Two independent operators
analyzed pre- and post-procedure TIMI flow rates, corrected TIMI
frame count (cTFC) and tissue myocardial perfusion grade (TMPG).
Results:
Baseline
clinical
and
angiographic
characteristics
were comparable between the two groups (see Table).
Conclusion: Use of AngioJet thrombectomy prior to stenting of AMI
patients with high-grade thrombus improves epicardial and microvascular
flow, with a trend towards better short and long-term outcomes. Our
findings are in contrast with the negative results of AngioJet use in AiMI
trial, perhaps due to the different exclusion criteria (in AimI trial all pts were
included, irrespective of thrombus size, while this trial included only pts
with a large thrombus size).
Age (years)
Anterior MI (%)
Pain-to-door time (hrs)
Door-to-balloon time (min)
LVEF (%)
TIMI pre-PCI (%)
Thrombus grade (%)
TIMI post-PCI (%)
TMP grade (mean)
TMP grade 2/3 (%)
CTFC (mean)
30-day MACE (%)
1-year mortality (%)
Event-free survival at 1-year (%)
AngioJet
(n = 50)
62 ± 14
65
14 ± 3
183 ± 32
44 ± 10
0.66 ± 0.98
4.6
2.7
2.16 ± 10
66
22 ± 13
6
7.4
86
Non AngioJet
(n = 181)
66 ± 15
70
12 ± 4
169 ± 62
42 ± 10
0.93 ± 1.14
4.3
2.2
1.53 ± 1.1
43
28 ± 11
11
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0.007
0.006
0.01
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0.12
0.08
0.05
TCT-175
International Rinspiration Registry (100 Patients Treated with Fluidic
Thrombectomy in the AMI Setting)
Marco De Carlo1, John G. Webb2, Eberhard Grube3, Anna S. Petronio1,
Jaap N. Hamburger4, Mitchell W. Krucoff5
1
Dept. Cardio Toracico, University of Pisa, Pisa, Italy, Pisa, Italy2St.
Paul’s Hospital, Vancouver, BC, Canada3Heart Center Siegburg, Siegburg,
Germany4University of British Columbia, Vancouver, BC, Canada5Duke
University Medical Center, Durham, NC
Background: Successful reperfusion of the myocardium is the primary
objective of interventional treatment in patients with Acute Myocardial
Infarction (AMI). We investigated a new thrombectomy device (Rinspiration
System - Kerberos Proximal Solutions Inc, Cupertino, CA) with a different
mechanism of action. The catheter is a multi-lumen catheter, providing
simultaneous rinsing and aspiration. This design utilizes turbulent
infusion to improve the efficacy of aspiration over straight aspiration.
Methods: The Rinspiration Registry has completed enrollment in Canada
(n=33), Germany (n=22), and is presently completing up to 60 patients in Italy.
The primary inclusion criteria are: 2mm ST elevation in 2 contiguous
leads, and presentation less than 12 hours from pain onset. Use of a distal
protection filter (FilterWire EZ, Boston Scientific, Santa Clara, CA) is
allowed at physician discretion. The primary endpoint is analyzed by
independent 24-hour Holter Monitor Core Lab. Secondary end points
include final TIMI flow, Blush and 30-day major adverse cardiac events.
Results: At the time of submission, the Italian Registry, Rinspirate IT
(Italy), has enrolled 38 patients, of which 20 have been analyzed, both the
Canadian (n=33) and German (n=22) registries are complete. In these 75
patients, Rinspiration was successfully delivered at target site in 97% of
cases (90 out of 93), with a final TIMI 3 flow in 81% and Blush >2 in 63%
of patients. No device-related complications were observed. Three major
adverse cardiac events occurred at 30 days 4% (3 out of 72). ST resolution
≥50% and >70% at 60 minutes was achieved in 96% (65 out of 68) and
81% (54 out of 67) of patients, respectively. Complete Rinspirate IT (Italy)
and composite results from the international registry will be presented.
Conclusions: Use of the Rinspiration System is safe and feasible as an
adjunctive treatment for the AMI patient. Initial myocardial blush data
is consistent with previous AMI trials. The excellent ST resolution data
compare favorably with previous trial results using different mechanisms
and suggest a potential for measurable clinical benefit.
TCT-176
How Effective Are Distal Embolic Protection Filters in Carotid
Stenting? Clinical and Benchtop Testing Results
Michael H Wholey1, Ender Finol2, Mark Wholey3, Carl M. Scotti2, Ian
Verdinelli2
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Univ Texas San Antonio, San Antonio, TX;2Carnegie Mellon University,
Pittsburgh, PA;3Pittsburgh Vascular Institute, Pittsburgh, PA
OBJECTIVE: With a flow-loop system under simulated systolic
pressures, three of the major distal embolic filters were tested in
apex of angle with particles ranging 297-1000 microns (Mean 649
microns). Silicon tubing with 5, 5.5 and 6 mm diameters were used in
this bench-top testing model. Recapturing efficiency was also tested.
MATERIALS AND METHODS: The three embolic filters consisted of
Guidant Accunet (Santa Clara, CA), Cordis Angioguard (Miami Lakes, FL)
and Boston Scientific EPI EZ Filterwire (Natick, MA). These were placed
in a closed loop system with a peristaltic pump 180 mL/min of fluid at
80 mmHg consisting of a particle solution of dry blue-dyed microspheres
with density of 1.062 g/ml. The amount of injected material was verified
by counting particles with a BioScope with a surface index grid scale. The
average injection was 69.2 + 19.5 particles and the filter effectiveness was
determined based upon the actual number of particles injected. Particles
were injected and flow maintained for 5 minutes. At the end of the procedure,
the c-clamp on the test clamp was released and the in-line filter “A” which
weighed to measure the mean weight of particles that escaped capture.
This filter was then replaced with filter “B” which was used to measure
the mean weight of particles lost during recapture of the filter device.
A total of 15 observations were made in each group of brand and sizes.
RESULTS: The percentage of embolized particles that passed distal protection
filters for the 5.0, 5.5 and 6.0 mm tubing was 7.53%, 10.88% and 14.24% with
the Cordis Angioguard filter, respectively. This was statistically significant
compared to the other filters. The Guidant Accunet had 4.16%, 0.21% and
1.38% for the 5.0, 5.5 and 6.0 mm tubing, respectively. The Boston Scientific
EPI filter had 0.99%, and 0.21% for the 5.0 and 5.5 tubing, respectively.
CONCLUSION: There was significant differences in the capture
efficiencies of the Angioguard filter compared to the Boston EPI and the
Boston Accunet. We suspect structural differences such as the volume of
the basket contributed to the difference. Further testing with other devices
would be of scientific benefit.
TCT-177
Lesion Length is the Strongest Correlate of Adverse Events during
Saphenous Vein Graft Intervention with Distal Embolic Protection - A
PRIDE Substudy
Ajay J Kirtane1, Eugene R Heyman2, Christopher Metzger3, Jeffrey A
Breall4, Joseph P Carrozza, Jr.1
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Beth Israel Deaconess Medical Center, Boston, MA;2Statistical
Consultant, Montgomery Village, MD;3Wellmont Holston Valley Medical
Center, Kingsport, TN;4Indiana University, Indianapolis, IN
Background: Although distal embolic protection (DEP) during
saphenous vein graft (SVG) intervention reduces MACE, many
patients still experience MACE despite DEP, and the major
predictors of MACE among these patients are not well-characterized.
Objectives/Methods: We sought to identify correlates of 30day MACE among 631 patients undergoing SVG intervention
with DEP enrolled in PRIDE, a randomized comparison of the
TriActiv system with an active control (Guardwire or Filterwire).
Results: The only baseline covariates associated with MACE in
univariate analyses were lesion length, estimated plaque volume, and
SVG degeneration score. In multivariable analyses, lesion length was
the only independent correlate of MACE (OR 2.81 (1.82-4.34) per
log-increase in lesion length, p<0.001). Similarly, the most significant
independent correlate of CKMB-elevation was lesion length (OR 2.54
(1.59-4.04) per log-increase in lesion length, p<0.001). Lesion length
was also highly correlated with estimated plaque volume and the SVG
degeneration score. There were no significant interactions between the type
of DEP device used and the associations between lesion length and either
MACE or CKMB-elevation (all p-values for interaction not significant).
Conclusion: Angiographic lesion length was the strongest correlate of
short-term adverse events among patients undergoing SVG intervention
with DEP. The association between lesion length and adverse events was
consistent across all three DEP devices used.
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TCT-178
Persistent Complications in the Era of Distal Protection During
Intervention in Saphenous Vein Grafts: Interim Analysis from the
Evaluation of saphenous Vein grAfts in Coronary interventions Using
Adjunctive proTection and Evacuation (EVACUATE) Registry
Fadi Matar1, Richard Kerensky2, Michel Vandormael3, Tom Sullebarger1,
Peter Rossi4, Chantell Barrett5, Colleen Donoghue2, Rani Dadlani5,
Jennifer Warner5, Olivia Sires5, Greg Von Mering2, Reynaldo
Mulingtapang6
1
Florida Cardiovascular Institute, Tampa, FL;2Florida Hospital
Shands, Gainesville, FL;3Bay Pines Veterans Administration Hospital,
St. Petersburg, FL;4Medical Center at Bayonet Point, Hudson,
FL;5Cardioquest, Tampa, FL;6University of South Florida, Tampa, FL
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Background: Although distal protection devices (DP) were shown to
reduce events following percutaneous intervention (PCI) of saphenous vein
grafts (SVG), their applicability in clinical practice remains in question.
Methods: Subjects were identified from the ongoing multicenter
EVACUATE registry maintained by Cardioquest. Procedural
& clinical variables with angiographic core lab analysis were
collected for all consecutive patients undergoing PCI in SVG.
Results: Between 1/1/03-6/1/05, 95 patients (age 68+10 yrs, 78% males)
from 5 centers had PCI for 116 SVG lesions proximal to the distal
anastomosis.9 (7.8%) lesions were degenerated, & 86 (74.1%) were
thrombotic. Stents were used in 110 (94.8%) & DP was attempted in
72 (62%) lesions. In 6 lesions (8.3%) DP delivery failed &, in those, 2
(33%) had embolic events (EE) (compared with 3% EE if delivery was
successful, p=0.032). 4 lesions (9.7%) had angiographic complications
related to DP delivery. The table summarizes the angiographic &
clinical events. In a subset of 12 patients (14 lesions, all with thrombus)
Angiojet was used prior to DP advancement. Of those, 1 (7.1%) had an
EE compared with 8 (13.8%) occuring in those with DP alone (p=0.293).
Conclusions: 1-Clinical and angiographic complications remain significant,
2-DP was not attempted in a significant % of lesions, 3-DP delivery failure
results in significant complications, & 4-DP with adjunctive rheloytic
thrombectomy seems promising and will be further investigated in this
ongoing registry.
Post PCI MI
7 (7.4%)
Death
3 (3.1%)
MACE
9 (9.5%)
Embolization
12 (10.3%)
Angiographic
Complications
19 (16.4%)
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Bifurcation Lesions
TCT-179
Bifurcation Coronary Lesions Treated with a Novel Biolimus A9Eluting, Self-Expanding, Bifurcated Stent - Angiographic Results
from the Prospective, Non-Randomized, Multicenter AXXESS Plus
Trial
Ricardo A Costa1, Alexandre Abizaid2, Ralph Muller3, Alexandra J
Lansky1, Roxana Mehran1, Ken Mori1, Ecaterina Cristea1, Bindu Patel1,
Ramona Pop1, Maria Corral1, Brett Trauthen4, Stefan Verheye5, Franz J
Neumann6, Fausto Feres2, Dougal McLean7, Eberhard Grube3
1
Cardiovascular Research Foundation and Columbia University Medical
Center, New York, NY;2Institute Dante Pazzanese of Cardiology, Sao
Paulo, Brazil3Siegburg Heart Center, Siegburg, Germany4DEVAX Inc,
Irvine, CA;5AZ Middleheim Hospital, Antwerp, Belgium6Herzzentrum
Bad Krozingen, Bad Krozingen, Germany7Christchurch Hospital,
Christchurch, New Zealand
The AXXESSTM Plus Biolimus-A9-coated stent (DEVAX, Inc.) has a conical
shape that permits deployment in the main vessel (MV) and its side branch (SB)
ostium. It allows subsequent treatment (PTCA and/or DES) in the distal MV
and/or SB. We report the angiographic results of the AXXESS PLUS registry.
Methods: 136 pts were enrolled at 13 clinical sites. Angiographic inclusion
criteria included lesions >50% DS within 5mm of a bifurcation in vessels
2.5 to 4.0mm in diameter in the MV and ≥2.25mm in the SB. Treatment
included 4 modalities: type I - cone stent in the bifurcation carina only;
type II - cone stent in the carina + stent in the distal MV; type III - cone
stent in the carina + SB stent; type IV - cone stent in the carina + distal
MV and SB stents. The 1ary efficacy endpoint was in-stent late loss at FU.
Results: Stents were implanted as follows: 19.1% type I, 27.9% type II,
12.5% type III, and 40% type IV. Device success (defined as the ability to
place and deploy the study stent without failure or complications) was 96.3%.
QCA is shown in the Table. At 6 months angiographic FU (available in 53 pts
to date), restenosis at the SB stent occurred in only 2 lesions (1 at the ostium
and 1 at the distal stent location). Overall, in-stent restenosis rate was 9.4%.
Conclusions: The AXXESSTM stent for treatment of bifurcation lesions
appear to be effective compared to historical controls, warranting
randomized evaluation to standard bifurcation lesion therapy. Complete
angio FU will be presented.
Variable
MV
SB
Lesion length, mm
17.3±7.4
7.4±3.6
2.9±0.4
2.4±0.3
Reference diameter, mm
Preprocedure MLD, mm
0.7±0.3
0.9±0.4
Preprocedure %DS
74.9±8.4
62.8±14.6
Final MLD*, mm
2.8±0.5
2.4±0.4
Final %DS*
7.2±12.1
7.8±6.8
Acute Gain*, mm
2.0±0.5
1.7±0.3
FU MLD*, mm
2.7±0.6
2.1±0.5†
FU %DS*
7.4±20.7
14.5±18.8†
Late Loss*, mm
0.1±0.6
0.3±0.4†
Restenosis*, % (n)
5.7 (3/53)
8.3 (2/24) †
†
*In-stent measures; reflects only SB lesions that received stents.
P value
<0.0001
<0.0001
0.01
<0.0001
0.0005
0.76
0.0003
0.0001
0.16
0.09
0.64
TCT-180
Drug Eluted Stents in Bifurcation Lesions: Improved Long Term
Results
Abid R Assali, Igal Teplitsky, Shmuel Fuchs, Hana Vaknin-Assa, David
Brosh, Ran Kornowski
Rabin Medical Center, Petah-Tikva, Israel
drug eluted stents [DES] [CYPHER] for improving long-term results in
bifurcation lesions treated with percutaneous coronary intervention (PCI).
Background: PCI treatment of coronary bifurcation lesions remains
challenging with increased risk of in-stent restenosis especially
if both branches are diseased. Limited information is available
on long-term results if DES is used to treat both branches. .
Methods & Results: We prospectively followed all patients who underwent
PCI for symptomatic true bifurcation lesions at our center. In this study we
included only pts treated by stenting of both arms of the bifurcation lesion. 38
patients were treated using bare metal stents [BMS] and 13 patients using DES.
Conclusions: Our preliminary results clearly show that for the treatment
of true bifurcation lesions, stenting both branches using the DES Cypher
is associated with improved long term patency as compared to bare metal
stents.
BMS
38
61±12
71%
82%
13%
58%
71%
80%
2.6%
7.9%
39%
Number
Age (years)
Male
Acute coronary syndrome
Diabetes mellitus
LAD/DIAGONAL
Final Kissing Balloon
Anti GP 2b/3a
6 month death
Stent thrombosis
6 month ISR
DES
13
64±13
92%
77%
23%
69%
70%
100%
0%
0%
0%
P-value
0.7
0.1
0.7
0.4
0.7
0.6
0.005
0.4
0.3
0.005
TCT-181
Impact of Sirolimus-Eluting Stents on the One-Year Outcome of
Patients with Bifurcation Lesions: Multicenter Registry in Asia
1
Background: Previous clinical study utilizing Sirolimus-eluting stents
(SES) in simple coronary lesions demonstrated an impressive reduction in
intimal hyperplasia and restenosis. However, long-term efficacy of SES in
treating patients with true bifurcation lesions is still unknown. A prospective
Asian multicenter registry was set up in five high volumes Asian centers
to evaluate the efficacy of SES in the treatment of bifurcation lesions.
Methods: A total of 698 patients, 806 lesions (male 71.6%, mean age 69.2)
with bifurcation lesions (defined as a more than 50% stenosis in both parent
vessel and side branch, LMT/bifurcation 12.5%, LAD/diagonal 49.6%, LCX/
OM 21.1%, and RCA/PD 16.8%) were treated with 4 strategies: stenting
both vessels utilizing SES with Y-stenting (n=271), stenting the parent
vessel utilizing SES and balloon angioplasty of the side branch (n=280)
and stenting both vessels utilizing SES with crushing stenting with (n=185)
or without (n=70) post kissing ballooning (KB). We evaluated immediate
and long-term clinical results by 6 and 12 months coronary angiography.
Results:
See
table
for
clinical
results.
Conclusion: Our results suggest that stenting both vessels utilizing SES
with Y-stenting or crushing stenting with post kissing ballooning can
dramatically reduce the restenosis rate at follow-up.
Y-stenting
Single
stenting
280
0
Number of lesions
271
MACE at 30 days (%)
0
Angiographic restenosis rate (12
mo)
Both vessels (%)
3.7
4.3
Parent vessel (%)
3.7
4.3
Side branch (%)
9.6
*21.4
TLR: any vessels (%)
7.4
*20.7
p<0.05 vs Y-stenting, crushing stenting (KB+).
Crushing
stenting
(KB+)
185
0
Crushing
stenting
(KB-)
70
0
3.8
3.8
7.6
4.8
8.6
10.0
*20.0
*20.0
Objective: The purpose of this study was to evaluate the efficacy of
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S
T
R
A
C
T
S
TCT-182
Impact of Paclitaxel-Eluting Stents on the One-Year Outcome of
Patients with Bifurcation Lesions: Multicenter Registry in Asia
1
Background: Previous clinical study utilizing Paclitaxel-eluting
stents (TAXUS™) in simple coronary lesions demonstrated an
impressive reduction in intimal hyperplasia and restenosis. However,
long-term efficacy of TAXUS™ in treating patients with true
bifurcation lesions is still unknown. A prospective Asian multicenter
registry was set up in five high volumes Asian centers to evaluate
the efficacy of TAXUS™ in the treatment of bifurcation lesions.
Methods: A total of 708 patients, 821 lesions (male 70.6%, mean age 68.2)
with bifurcation lesions (defined as a more than 50% stenosis in both parent
vessel and side branch, LMT/bifurcation 13.2%, LAD/diagonal 50.2%, LCX/
OM 20.5%, and RCA/PD 16.1%) were treated with 4 strategies: stenting both
vessels utilizing TAXUS™ with Y-stenting (n=204), stenting the parent vessel
utilizing TAXUS™ and balloon angioplasty of the side branch (n=284) and
stenting both vessels utilizing TAXUS™ with crushing stenting with (n=278)
or without (n=55) post kissing ballooning (KB). We evaluated immediate
and long-term clinical results by 6 and 12 months coronary angiography.
Results:
See
table
for
clinical
results.
Conclusion: Our results suggest that stenting both vessels utilizing
TAXUS™ with Y-stenting or crushing stenting with post kissing ballooning
can dramatically reduce the restenosis rate at follow-up.
Y-stenting
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
Single
stenting
284
0
Number of patients
204
MACE at 30 days (%)
0
Angiographic restenosis rate
(12 mo)
Both vessels (%)
3.5
3.4
Parent vessel (%)
3.5
3.4
Side branch (%)
4.9
*18.6
TLR: any vessels (%)
4.9
*16.7
p<0.05 vs Y-stenting, crushing stenting (KB+).
Crushing
stenting
(KB+)
278
0
Crushing
stenting (KB-)
55
0
3.6
3.6
6.5
6.5
3.6
3.6
*18.2
*18.2
wave myocardial infarction (MI), defined as CK-MB>3 times the upper
limit of normal, occurred in 2 (6.4%) patients. One-month follow-up was
available in all patients and subacute thrombosis occurred in 1 (3.2%)
patient with protein S deficiency. Twenty-one patients were eligible for
6-month follow-up and control angiography was available in 16 (76%)
of them. Focal angiographic restenosis (diameter stenosis>50%) at the
ostium of the side branch was found in 2 (12.5%) cases. At follow-up there
were no deaths. The rates of target lesion revascularization, target vessel
revascularization (TVR), and major adverse cardiac events (defined as
death, Q-wav MI, and TVR) were 9.5%, 14.2%, and 19%, respectively.
Conclusions: The use of the “culottes” technique with DES appears safe and
has a high angiographic success rate and low rate of restenosis compared to
historical data with bare metal stents. These preliminary observations need
to be confirmed in larger studies.
TCT-184
The Effects of Drug Eluting Stent on the Fate of Side Branch of
Coronary Artery
Luyue Gai, Sr.
Chinese PLA General Hospital, Beijing, China
Background: Studies have demonstrated that instent restenosis compromises
side branch. Drug eluting stent (DES)reduces instent restenosis. The study was
performed to compare the fate of the side branch after BMS and DES. Methods:
Two hundred and thirty-six patients who had coronary stent implantation
and follow-up angiograms were included in the study. The angiograms
before, immediately after and at follow-up were analyzed retrospectively.
The changes of the side branches covered by the stents were evaluated.
Results: Although half the side branch covered by the stents was
compromised, the acute occlusion was only around 10% immediately
after the stenting. The differences were not significant among the three
stents. At the follow-up, most of the occluded side branches were
recanalized. There was no significant differences in the changes of stenosis
of the side branch among the three stents, although severer stenosis was
observed in the BMS. . However, when comparison was made between
the side branches from the instent restenosis and those from the non
restenotic segment, much better outcome was observed in the latter .
Table 1 Changes of side branches in DES and BMS
Table 2 Effects of instent restenosis on the late outcome of side branch
TCT-183
Is the “Culottes” Technique Safe and Effective for the Treatment of
Bifurcation Lesions with the Use of Drug-Eluting Stents?
Ioannis Iakovou, Flavio Airoldi, Iassen Michev, Matteo Montorfano,
Giuseppe M Sangiorgi, John Cosgrave, Antonio Colombo, Carlo Di Mario
EMO, Centro Cuore Columbus, Milano, Italy
Background: In studies with bare metal stents the use of the “culottes”
technique for the treatment of bifurcations has been associated with high rates
of restenosis and adverse events. Data regarding this technique with the use
of drug-eluting stents (DES) are limited. The aim of this study was to evaluate
the immediate and long-term outcome of the “culottes” technique with DES.
Methods: The “culottes” technique uses two stents and leads to full
coverage of the ostium at the expense of an excess of metal covering
the proximal end of the bifurcation. Final kissing balloon inflation is
performed at the end of the procedure to optimize the final angiographic
result. Between April 2002 to December 2004, 31 patients (31 bifurcations)
were treated with the “culottes” technique with the use of DES (9
with sirolimous-eluting stents and 22 with paclitaxel-eluting stents).
Thirty-six percent of the patients were diabetics and 27% had unstable
angina; 18% of the bifurcations involved in-stent restenotic lesions.
Results: Angiographic success was achieved in all patients. Non-Q
80H
Aggravated ostial stenosis
Improved ostial stenosis
Late occlusion
branch from instent
restenosis
n=95
26.32 (25/95)
10.53 (10/95)
5.88 (5/85)
branch from non
restenosis
n=563
4.82 (27/563)
19.54 (110/563)
0.78 (4/510)
P value
0.000
0.043
0.004
In conclusion, DES compromises side branch in the same way as the BMS.
By inhibiting neointimal growth, however, it improves the late outcome of
the side branches.
TCT-185
Bifurcation Lesions in the Coronary Arteries: Early Experiences with
a Novel 3-Dimensional Imaging and Quantitative Analysis before and
after Stenting
Danny Dvir1, Hadar Marom2, Ran Kornowski3
1
Sheeba Medical Center, Ramat Gan, Israel2Paieon Medical, Rosh Hayin,
Israel3Rabin Medical Center, Petach-Tikva, Israel
Background: Treating coronary bifurcation lesions is technically
challenging. Conventional 2-dimensional angiography lacks the
ability to image properly the true bifurcation geometry or its plaque
distribution. The objectives of this study were 1) to reconstruct in
3-dimensions (3D) coronary bifurcation lesions, and 2) to analyze
geometrical changes before and immediately following stenting.
Methods: The CardiOp (Paieon Medical) is a system for 3D reconstruction
of the coronary vessels. We conducted a retrospective evaluation of
27 patients (74% men, age 71±13 years) with bifurcation lesions in
the coronary arteries undergoing angioplasty procedures. Angulations
between bifurcation branches were measured, before and after stenting.
Results: Of the 27 bifurcations studied, 26 were successfully
reconstructed. Side branch involvement was found in 67% of the
cases. Pre and post-stenting comparison was evaluated in 18 cases
with excellent imaging. Angulation between the distal main branch
and the side branch before stenting was significantly higher than that
measured after stenting (71°±17 and 58°±18, respectively; p<0.01).
There were no other significant changes in the geometry after stenting.
Conclusion: 3D reconstructions may provide new insight into bifurcation
analysis in space. These algorithms may serve as an important tool
for planning of interventional procedures and accurate appreciation of
interventional results in complex bifurcation lesions scenario.
TCT-187
Incidence and Implications of Incomplete “Crush” Stent Apposition
after Sirolimus-Eluting Treatment of Coronary Bifurcation Lesions
- An Intravascular Ultrasound (IVUS) Analysis
Ricardo A Costa, Stephane G Carlier, Gary S Mintz, Kenichi Fujii,
Jose Ribamar Costa, Jr., Masashi Kimura, Koichi Sano, Kaoru Tanaka,
Ecaterina Cristea, Yangbo Na, Alexandra J Lansky, George D Dangas,
Roxana Mehran, Michael Collins, Edward M Kreps, Gregg W Stone,
Jeffrey W Moses, Martin B Leon
Cardiovascular Research Foundation and Columbia University Medical
Center, New York, NY
Objective: Bench studies report incomplete apposition of
stent struts at the carina after crush bifurcation stenting.
Methods: 25 pts had IVUS in both the main vessel (MV) and side
branch (SB) after successful crush stenting+final kissing inflations.
Incomplete crushing (IC) was defined as incomplete apposition of SB
or MV stent struts against the MV wall proximal to the carina (Figure).
Results: In 20 non-LM lesions, IC was found in 60%. IC was
associated with stent underexpansion at the SB ostium (Table).
Conclusions: IC of stent struts against the MV wall proximal to the carina
is a common finding after crush stenting in non-LM bifurcation lesions
and is associated with SM ostial stent underexpansion. IC may affect
drug delivery and, especially in the setting of ostial SB underexpansion,
contribute to restenosis.
Variable
TCT-186
No Touch is as Effective as Stenting and Ballooning in Managing
Compromised Side Branch
Luyue Gai, Sr.
Chinese PLA General Hospital, Beijing, China
Background Stenting across a side branch results in ostial compromise in
50% of patients. Various interventional techniques have been invented to
reduce the ostial stenosis without much benefit. We hypothesized that side
branches had extensive collateral communication with neighboring vessels;
therefore they might not need treatment even if they were compromised.
Methods Seventy-eight patients with compromised side branch (>2mm
) after stenting were included in the study. The No Touch management
was compared with stenting and ballooning. Pts were followed by
clinic visit and coronary angiography 6 months after the procedure.
Results The best immediate results were achieved with the stenting, followed
by PTCA and No Touch. At the follow-up, however, the side branch stenosis
in the stenting group increased from 10.0±21.2% to 53.3±41.1%. It remained
almost unchanged in the PTCA and No Touch groups. There were no
significant differences in the MACE among the three groups . Although DES
improved the long term angiographic results, MACE were almost the same .
The Effects of DES on the ostial stenosis in the side branches
Stenting group (N=17)
PTCA group (N=14)
No touch (N=47)
P value
Side branch ostial stenosis%
Baseline*
Immediately
Follow-up
64.05±20.59 10.00±21.21 53.37±41.11
82.14±17.18
57.5±28.87
46.43±32.49
76.21±20.59 76.21±20.59 68.39±26.27
0.077
0.000
0.057
p
Main Vessel (MV)
value
IC
CC
Side Branch (SB) p value
IC
CC
IVUS
Proximal Reference
EEM CSA, mm2
12.1±6.3 0.5
Lumen CSA, mm2
8.4±4.0 7.0±3.6 0.5
Distal Reference
2
EEM CSA, mm
9.4±4.6 10.4±5.5 0.7 7.0±3.5 6.9±3.7
Lumen CSA, mm2
7.2±3.4 6.9±3.3 0.9 5.3±2.6 4.9±2.6
Minimum Stent CSA, mm2 6.3±1.7 6.8±2.1 0.6 3.9±0.9 4.1±1.3
SB Ostium (5mm) Stent
4.2±0.8 4.3±1.6
CSA, mm2
Stent Expansion, %
0.3 77.1±7.6
IC=incomplete crush; CC=complete crush; EEM=external elastic membrane;
CSA=cross-sectional area
1.0
0.8
0.7
0.9
0.04
A
B
S
T
R
A
C
T
S
MACE%
52.94
28.57
38.98
0.412
* After main vessel stenting and before treatment of side branch.
Conclusion Stenting of the side branch with BMS is worse than the PTCA
and No Touch in terms of long-term angiographic results. Stenting with
DES improves the angiographic results, but has no significant clinical
benefit in comparison to PTCA and No Touch..
P
O
S
T
E
R
81H
TCT-188
Cardiac Troponin T and I and Creatine Kinase-MB as Markers of
Myocardial Injury Following Routine Stenting of both Main Vessel
and Side Branch versus Optional Side Branch Stenting in Bifurcation
Lesions
Kjell Nikus1, Saila Vikman1, Matti Niemelä2, Stefan James3, Jens Flensted
Lassen4, Andrejs Erglis5, Jan Skov Jensen6, Terje Steigen7, Pål Gunnes8,
Jens Aaroe9, Antti Ylitalo10, Steffen Helqvist11, Iwar Sjögren12, Oliver
Meyerdierks13, Leif Thuesen4, for the Nordic Bifurcation Study Group
1
Heart Center Tampere University Hospital, Tampere, Finland2Oulu
University Hospital, Oulu, Finland3Uppsala University Hospital, Uppsala,
Sweden4Aarhus University Hospital, Aarhus, Denmark5Latvian Centre of
Cardiology, Riga, Latvia6Gentofte Hospital, Hellerup, Denmark7Tromsö
University Hospital, Tromsö, Norway8Feiring Heart Clinic, Feiring,
Norway9Aalborg Hospital, Aalborg, Denmark10Central Hospital in Pori,
Pori, Finland11Rigshospitalet, Copenhagen, Denmark12Falun Hospital,
Falun, Sweden13Ullevål Hospital, Oslo, Norway
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
Background: Treatment strategies of bifurcation lesions may differ
in respect to rate of rise in biochemical markers of myocardial damage.
Methods: A randomized Nordic multicenter study of sirolimus-eluting
stents compared routine stenting of both main vessel and side branch
(MV+SB) with a strategy of routine main vessel stenting and optional
treatment of side branch (MV). ST-elevation myocardial infarction (MI)
patients (<24 h) were excluded. CK-MB and/or TnT/I were measured
before and 12-18 h post-procedure. Preliminary data from 200 patients
is reported. Complete data of 414 patients will be presented at the TCT.
Results: Twenty patients were excluded because marker values after the
procedure were missing. There was no statistically significant difference
between the two groups in the proportion of patients with any or more
than 3-fold post-procedural rise of CK-MB and/or TnT/I (Table). An inhospital major adverse cardiac event (cardiac death, stent thrombosis,
procedure related MI, target lesion revascularization) occurred in 12/91
(13%) in the MV+SB group and in 6/89 (7%) in the MV group, p=0.216.
Conclusion: After bifurcation stenting, any elevation of myocardial
biomarkers is frequent, while in-hospital major adverse cardiac events are
rare, independent of stent technique. Stenting of both main vessel and side
branch compared to stenting of main vessel with optional stenting of side
branch appears to be more often associated with minor myocardial damage
and early clinical events.
N
Biomarkers elevated preprocedure
Biomarkers with >3x increase
post-procedure
No elevation of biomarkers
Any elevation of biomarkers
Stent in main vessel
and side branch
91
22 (24%)
Stent in main
vessel only
89
20 (23%)
23 (25%)
50 (55%)
41 (45%)
17 (19%)
57 (64%)
32 (36%)
p-value
NS
NS
NS
NS
TCT-189
Procedural and Long-Term Results of Taxus Stent in Complex
Bifurcation Lesions. A Single Center Registry
Gabriele L F Gasparini, Guido Belli, Paolo Pagnotta, Dennis Zavalloni,
Marco L. Rossi, Marco Ferlini, Annachiara Aldrovandi, Melania
Scatturin, Patrizia Presbitero
Isituto Clinico Humanitas, Rozzano - Milano, Italy
Background: Treatment of bifurcation lesions with paclitaxel-eluting stents
(PES) is still associated with a high restenosis rates. In fact, several techniques
have been tested with variable results. In-stent restenotic bifurcation lesions
represent a very difficult subset to treat, with long term efficacy of PES
still unknown. A prospective single-center registry was established to
evaluate the efficacy of PES in the treatment of complex true bifurcation
82H
lesions and in the subgroup of patients with in-stent bifurcation restenosis.
Methods: A total of 123 patients with 126 bifurcation lesion treated with PESstents (defined as >50% stenosis in both vessels) were prospectively included
in our registry. Bifurcation lesion were treated with two strategies: stenting
of both vessels or stenting of the parent vessel and balloon angioplasty of the
side branch. Combined antiplatelet therapy was continued for 12 months.
Immediate and long-term clinical and angiographic outcome (mean followup: 9 months) was analyzed in the whole population and in the subgroup
of patients treatd in bifurcations at the site of previuos in-stent restenosis
Results: See Table for results.
Overall
Patients
Bifurcations
- treated with 1 stent
- treated with 2 stents
Diabetes
Mean lesion length (mm)
Mean main vessel diameter (mm)
Mean side branch diameter (mm)
Mean stent length (mm)
Mean stent diameter (mm)
Angiographic success
Procedural MACE
Restenosis rate:
- both vessels
- parent vessel alone
- side branch alone
TLR (any vessel)
123
126
88 (70%)
38 (30%)
42 (36.5%)
13.9
3.0
2.4
19.9
3.01
99.5%
0%
8%
5.5%
4.75%
0%
8%
Group 1
True
Bifurcation
90
93
76 (82%)
17 (18%)
29 (33%)
12.7
3.04
2.5
18.7
3.05
99%
0%
9.5%
4.75%
4.75%
0%
9.5%
Group 2
Restenotic
Bifurcation
33
33
12 (36%)
21 (64%)
13 (40%)
15.2
2.96
2.3
20.9
2.96
100%
0%
6.3%
6.3%
0%
0%
6.3%
MACE: major adverse cardiac events; TLR: target lesion revascularization.
Conclusion: Treatment of high risk bifurcation lesions with the Taxus stent
is feasible, with high success rates and adequate access to the side branch.
In-stent restenotic lesions at bifurcations can also be successfully treated
with comparable results.
TCT-190
Outcome of Drug-Eluting Stents for Coronary Bifurcations: Insight
Into the Crushed Stent Technique
Vinod Raxwal1, Kamal Gupta2, Robert Candipan1, James Vacek1, Peter
Tadros1
1
Kansas University Medical Center, Kansas City,, KS;2Kansas City VA
Medical Center/Kansas University, Kansas City,, KS
Background: Drug eluting stents (DES) have demonstrated marked
reduction in restenosis following percutaneous coronary intervention
(PCI) of non-bifurcation lesions. Utilization of DES in bifurcation
lesions employing “Crushed Stent Technique” has not been well studied.
Methods: We studied patients with bifurcation lesions who underwent PCI
using crush technique with DES in our laboratory from 2003 to 2005. A total
of 65 patients (49 male, 16 female) with mean age 64 ± 12 years were studied.
Results: Mean follow up was 7 ± 5 months. HTN was present in 74%,
diabetes in 28%, dyslipidemia in 94% and 20% were currently smoking.
Average length of stented segment was 58 ± 25 mm with total stents 3 ±
1. Stress testing was performed for evaluation of angina in 42% patients.
Coronary angiogram was performed in 25% patients. During the follow up
period 13(20%) patients had restenosis, the crushed stent arm had significant
restenosis in all patients and 44% of them had significant restenosis in both
limbs. Restenosis rate was 18% without a final kiss balloon dilatation
versus 21% with a final kiss balloon dilatation (p=NS). One patient had a
subacute stent thrombosis. One patient had an acute stent thrombosis who
also had thrombosis of a non-bifurcation stent. Fifteen percent patients
underwent target vessel revascularization of which 4(40%) had CABG.
Conclusion: The crush technique for bifurcating lesions
seems to be an effective treatment-utilizing DES. Final Kiss
Balloon dilatation did not appear to affect the restenosis rate.
Outcome of Drug-Eluting Stents for Coronary Bifurcations
N
Restenosis Final Kiss balloon dilatation
Restenosis No Final Kiss balloon dilatation
Target Vessel Revascularization
Sirolimus eluting stent
Final Kiss balloon dilatation
Restenosis
Paclitaxel eluting stent
Final Kiss balloon dilatation
Restenosis
65
10(21%)
3(18%)
10(15%)
33(51%)
26(79%)
6(18%)
32(49%)
22(69%)
7(22%)
TCT-191
Impact of Guidewire Positioning on Stent Expansion in Bifurcation
Lesions
Mamoru Nanasato1, Campbell Rogers2, Haruo Hirayama1
1
Nagoya Daini Red Cross Hospital, Nagoya, Japan2Brigham and Women’s
Hospital, Boston, MA
Background: Bifurcation stenting has traditionally produced relatively poor
results. Little information exists concerning how the site of guidewire entry
into a “jailed” side branch may effects stent configuration and lumen area.
Methods: An in vitro experiment was performed in a bifurcation model.
A balloon expandable stent was deployed in the main vessel across the
side branch opening. In 5 cases, a guidewire was advanced into the side
branch through a stent cell overlying the proximal aspect of the side
branch opening. In another 5 cases, a guidewire was advanced through s
stent cell overlying the distal aspect of the side branch opening. A second
balloon catheter was then inflated within stent struts at the ostium of the
side branch. Intravascular ultrasound (IVUS) was performed to measure
minimal stent or lumen cross-sectional area (CSA). Subsequently, the stent
was dilated with kissing balloon inflation, and IVUS again performed.
Results: After balloon inflation at the ostium of the side branch, IVUS
showed that stent struts protruded into the main vessel in all cases of the
proximal guidewire group. The distal guidewire group had significantly
larger minimal stent CSA after side branch balloon inflation (11.84 ±
0.80mm2 vs. 9.37 ± 0.85mm2, p = 0.0015). Kissing balloon inflation
reduced the protrusion of the stent struts into the main vessel in the proximal
guidewire group, resulting in equivalent minimal stent CSA on both groups
(12.55 ± 0.91mm2 vs. 11.42 ± 1.21 mm2, p = 0.13). Conversely, kissing
balloon inflation significantly reduced side branch minimal lumen CSA in
the proximal guidewire group from 6.39 ± 0.14 mm2 to 6.51 ± 0.54 mm2 (p
= 0.013), leaving significantly larger side branch minimal lumen CSA in the
distal guidewire group (6.35 ± 0.21 mm2 vs. 5.61 ± 0.54 mm2, p = 0.02).
Conclusions: The point of passage of a guidewire into a “jailed” side
branch influenced the stent deformity and minimal lumen CSA in the side
branch even after kissing balloon inflation.
TCT-192
bifurcation lesions were included : age 65±11 years, diabetes 28%,
multivessels diseases 63% and unstable angina 36%. The lesion involved
the LAD-Diagonal bifurcation in 62 % of cases, and was a Type 1 or 4 (true
bifurcation lesion) in 76% of cases. The MB was stented in 100% of cases
(stent length 20.5±5.5 mm), SB in 15% (stent length 11.3 ± 2.8 mm). Final
kissing balloon inflation was performed in 85% of cases. Angiographic
success was obtained in 99% for the MB, and 87% for both branches (Table1).
In hospital, 3 patients died (2 had hemoragic complications), 10
had non Q-wave MI (4.4%), 1 had Q-wave MI (0.4%). For the first
92 patients at 8 month follow-up, 2 died suddenly, there was no
additional MI. The target lesion revascularisation (TLR) rate was 3.2%.
Conclusion : Preliminary results suggest that treatment of bifurcation
lesions with PES using a SB PTS approach in the real world, is safe and
effective, with a very promising rate of TLR.
Table 1 : RVD : reference vessel diameter, MLD : minimal luminal diameter
Lesion Length
MLD pre
MLD post
MLD post
MLD post
12.8±5.3
0.76±0.46
2.72±0.49
2.72±0.49
2.72±0.49
5.7±5.3
1.12±0.71
1.98±0.91
1.98±0.91
1.98±0.91
TCT-193
Bifurcation Stenting with the Crush Technique is Associated with a
High Adverse Event Rate if Used to Treat the Distal Left Main Stem
Angela Hoye1, Ioannis Iakovou2, Lei Ge2, Carlos A G van Mieghem3,
Andrew T L Ong3, John Cosgrave2, Giuseppe M Sangiorgi2, Flavio
Airoldi2, Matteo Montorfano2, Iassen Michev2, Alaide Chieffo2, Mauro
Carlino2, Nicola Corvaja2, Jiro Aoki3, Gaston A Rodriguez Granillo3,
Marco Valgimigli3, Georgios Sianos3, Willem J van der Giessen3, Pim J de
Feyter3, Patrick W Serruys3, Antonio Colombo2
1
Castle Hill Hospital, Kingston-upon-Hull, United Kingdom2EMO Centro
Cuore Columbus, Milan, Italy3Thoraxcenter, Rotterdam, The Netherlands
Introduction: The “crush” technique has been proposed as a strategy
utilizing drug-eluting stents that ensures complete coverage of
bifurcation lesions, however, the long-term outcomes are unknown.
Methods and Results: We identified 231 consecutive patients who
underwent “crush” stenting for 241 de novo bifurcation lesions. Sirolimuseluting stents were used in 137(56.8%), and paclitaxel-eluting stents in
104(43.2%). Therapy was undertaken in the left main stem (LMS) in 47
(20.3%) patients. At 9 months, the overall rate of survival-free of target
lesion revascularization (TLR) was 90.3%; the only independent predictor
of TLR was LMS therapy (OR 4.97; 95%CI 2.00 to 12.37, p=0.001).
Conclusions: The crush technique of bifurcation stenting with drug-eluting
stents is associated with a low rate of TLR for most lesions; however, efficacy
appears significantly reduced in LMS bifurcation lesions, and further
research is needed before the technique can be routinely recommended in
this group.
Provisional T-Stenting Strategy Using Paclitaxel-Eluting Stent for
Coronary Bifurcation Lesion Treatment. The SURF Registry
O. Darremont1, P. Brunel2, T. Lefèvre3, J. Balcells3, Jl. Leymarie1, B.
Fischer1, E. Bressolette2, Y. Louvard3, MC. Morice3
1
Clinique St Augustin, Bordeaux, France2NCN, Nantes, France3ICPS,
Massy, France
Background: « Side branch (SB) provisional T stenting (PTS)»
is a simple and effective technique for coronary bifurcation lesion
treatment using bare metal stents. The safety and effectiveness of
this strategy using paclitaxel-eluting stent (PES) remains unknown.
Methods: Data were collected in all consecutive patients treated
with PES with a PTS strategy, excluding acute MI and distal left
main lesion. The acute clinical and angiographic results and the
8-month clinical status coupled with stress test were assessed.
Results: Between january and december 2004, 224 patients with 227
83H
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
Carotid Angiography and Intervention
(Abstract Nos. 194- 208)
TCT-194
Inpatient Resource Use and Costs of Carotid Artery Stenting
Procedures in Patients at High Risk for Surgery: Results from the
BEACH Trial
Natalia Olchanski1, Mary A Clark1, Rocco Ciocca1, William A Gray2
1
Boston Scientific Corporation, Natick, MA;2Swedish Cardiovascular
Research, Seattle, WA
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
Background: Interventional management has been proven effective for
patients at risk for stroke secondary to carotid disease. Recently, carotid artery
stenting (CAS) was approved for patients at high risk for surgery. There is
a lack of published data for costs of CAS, and whether Medicare payments
sufficiently cover costs of these high risk cases has not been investigated.
Methods: Total inpatient hospitalization costs were calculated using detailed
resource use collected during the BEACH trial multiplied by national
average unit costs in 2004. The BEACH trial is a prospective, multicenter
trial evaluating outcomes of patients with carotid artery stenosis at high risk
for surgery using the Carotid Wallstent and the FilterWire EX/EZ distal
protection system. Unit costs for medical devices, including balloons,
guidewires, retrieval devices, and others, were assigned using national
average prices for 2004. Additional cath lab costs were calculated using
average cath lab cost per minute (2003 MedPar data and Medicare cost
reports) multiplied by CAS procedure time. Remaining hospitalization costs
per day were calculated using MedPar data and length of stay from BEACH.
All costs were updated to 2004 when necessary using the Medicare hospital
market basket rate of increase (3.4%). Costs were calculated for all patients
and symptomatic subgroups with 50-69 (S1) and >70 % stenosis (S2).
Results: We analyzed initial hospitalization data for 747 patients in
BEACH. The mean age was 70 years, and 64% of the patients were male.
The mean duration of the cath lab procedure was 63.2 min for all patients,
65.9 min for group S1 (n=27), and 65.2 min for group S2 (n=176). The
median length of stay was 2 days overall and in each subgroup. The mean
costs for the cath lab procedure and overall hospitalization will be presented.
Conclusion: Most of the CAS cases are classified into extracranial
procedure DRG 533 (with complications and comorbidities), and 534
(without), with respective estimated national average payment rates $8,200,
and $5,227 in 2005. Additional information on the costs of CAS will be
helpful in determining appropriate payments by Medicare.
TCT-195
Effect of Gender on the Immediate and Late Clinical Outcomes of
Carotid Artery Stenting
Aravinda Nanjundappa, Mohammed Habeeb, Niten Singh, Robert Dieter,
Sangeeta Mandapaka, Donna Whitman, Regina Deeble, Susan Bowes,
Lowell Satler, John R. Laird
Washington Hospital Center, Washington, DC
Background: The outcomes of percutaneous coronary interventions (PCI)
have shown significant gender differences. Elderly females are known to have
poor outcomes following PCI. We compared the effect of gender on clinical
outcomes of carotid artery stenting (CAS) in patients age less than 70 years.
Methods: 205 patients who underwent CAS from 1999 to 2005 were
analyzed. All patients were pretreated with ASA and clopidogrel. The
early and late clinical outcomes comprised of cerebrovascular accident,
transient ischemic attack (TIA), myocardial infarction and death.
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A total of 134 males and 71 females were studied. The group was divided into
male and female patients below age 70 and above age 70 years. The outcomes
were measured at the time of hospital discharge, one month and at 6 months.
In patients more than age 70 years there was no difference in the clinical
outcomes.In patients less than age 70 years, 64 were men and 40 were
women. The baseline characteristics were comparable except for
hypercholesterolemia in females 77.5 % Vs men 95.3% (p value 0.010) and
TIA 42.5% Vs 20.3% (p value 0.015). The peri-procedural incidence of TIA
was statistically higher in females n =5 compared to men n=1 ( p value 0.030).
Conclusions: CAS is an safe and effective modality to treat severe carotid
artery stenosis. Females are more predisposed to adverse clinical outcomes
especially peri-procedural neurological events. This mandates a cautious
and meticulous technical approach in women undergoing Carotid artery
stenting.
Clinical outcomes
TIA prior to discharge
CVA prior to discharge
Death/MI prior to discharge
Intracranial bleed prior to discharge
TIA at 1 month
CVA at 1 month
Death at 1 month
TIA/CVA at 6 months
Death at 6 months
Females<70years Males<70years p value
12.5%
1.6%
0.030
2.5%
1.6%
1.00
2.5%
0%
0.385
0%
0%
0%
0%
0%
0%
0%
0%
8.6%
1.9%
0.297
2.9%
1.9%
1.00
TCT-196
The Continued Access Registry: Peri-Procedural Outcomes of Carotid
Stenting with Emboli Protection
Neil E. Strickman1, Jay S. Yadav2, Sidney A. Cohen3, on behalf of the
Continued Access Registry
1
St. Lukes Medical Towers, Houston, TX;2The Cleveland Clinic
Foundation, Cleveland, OH;3Cordis Corporation, Warren, NJ
Background: Endarterectomy and stenting with emboli protection was
evaluated in the pivotal SAPPHIRE Trial and successfully demonstrated
that stenting with emboli protection was non-inferior to CEA. Two periapproval studies were subsequently undertaken to collect additional
data on safety and efficacy of carotid stenting using the PRECISE™
Nitinol Stent System and the ANGIOGUARD™ XP Emboli Capture
Guidewire (Cordis Corporation, Miami Lakes, FL) in the treatment
of stenotic carotid artery disease in high risk patients. The present
report presents 30 day peri-procedural safety and efficacy outcomes of
carotid stenting in patients enrolled in the Continued Access Registry.
Methods: Asymptomatic patients with > 80% stenosis or symptomatic
patients with > 60% stenosis by ultrasound or angiography and a high
risk criteria were enrolled at 7 US centers. The primary endpoint was the
incidence at 30 days post-procedure of Major Adverse Events (MAE),
defined as any death, any stroke and/or MI. All patients were scheduled
to have follow-up at 30-days, 6-months and one year post procedure
which included an independent neurologic assessment of ipsilateral stroke.
Results: 434 patients were enrolled. Enrollment began on August, 2003
and ended February, 2005. 30 day follow-up was completed in April, 2005.
Conclusions: The 30-day primary endpoint data for the Continued Access
Registry will be presented and compared to the 30 day outcomes of the
SAPPHIRE Trial. In the SAPPHIRE trial, 30-days MAE was 4.4% (7/159)
for patients who received stenting with emboli protection compared to
9.9% (15/151) for patients who were treated by carotid endarterectomy (p
= 0.08).
TCT-197
Variability of Peripheral Quantitative Vascular Angiography:
Redefining the Guidelines for Clinical Trials
Anton W. M. van Weert1, Yvette Seppenwoolde2, Jeroen S. ter Horst1,
Marlies van den Ende1, Sergei G. Airiian1, Marcel Turenhout1, Ellen
Hekking1, Johan H. C. Reiber2
1
Bio-Imaging Technologies B.V., Leiden, The Netherlands2Leiden
University Medical Center, Leiden, The Netherlands
Background: For diagnosis and intervention in peripheral arteries,
X-ray angiography is the gold standard. Although angiographic data
from trials are used in regulatory submissions, in literature proper
data are lacking on its limitations and variability. The objective
of this study was to evaluate the quality and variability of QVA in
carotid arteries and to define new guidelines for using QVA in trials.
Method: Fifty-one pre-treatment angiograms of the internal carotid artery were
analyzed twice, with a 3-week interval, by 3 different observers using QVACMS® V5.2. Angiograms were randomized for each individual evaluation
and had a variety of characteristics (e.g. contrast, format) and potential
error sources (e.g. calibration, manual editing) to reflect real life trial data.
Results: The systematic and random errors in observer variability (Table) were
small and not significantly different. Poor image quality and manual editing
to (reference) contours had no significant influence on variability. By using
the interpolated reference diameter method, the 95% confidence interval for
individual diameter stenosis measurements was 5-11%, improving published
data for the NASCET (~30%), ECST (~19%) or CSI (~15%) methodology.
Conclusion: Inter- and intra-observer variability in carotid artery QVA
analysis is low when using an interpolated reference diameter method
and applying strict analysis procedures. The data presented provide new
guidelines for the use of QVA in clinical trials.
Inter- and intra-observer variability for QVA of the carotid artery.
Inter-observer variability Intra-observer variability
Systematic
Random
Systematic Random
error
error
error
error
Minimum Lumen Diameter
0.00
0.11
0.00
0.16
Reference Diameter
0.04
0.18
0.08
0.27
% Diameter Stenosis
0.06
2.67
-0.27
4.29
Segment Length
-0.18
1.46
-0.40
1.95
TCT-198
Capturing Debris and Reducing 30-Day Stroke Rates During Carotid
Stenting - The Effectiveness of Emboli Protection
Sidney A. Cohen1, David Snead1, Kenneth Ouriel2, Pierre Fayad3, Barry
Katzen4, Mark Wholey5, Jay S. Yadav2, for the SAPPHIRE Investigators
1
Cordis Corporation, Warren, NJ;2The Cleveland Clinic Foundation,
Cleveland, OH;3University of Nebraska College of Medicine, Omaha,
NE;4Miami Cardiac and Vascular Institute, Miami, FL;5Shadyside
Hospital, Pittsburg, PA
Background: We examined debris retained in AngioGuardTM filters (Cordis
Corporation, Miami Lakes, FL) used in the SAPPHIRE study and evaluated
correlated them to the 30 day stroke rates with and withoutAngioGuard™ use by
analyzing data from the US Feasibility study (USFS) and CASCADE studies.
Methods: Basket content analysis was performed on AngioGuardsTM
used in the pivotal SAPPHIRE trial. The benefit of emboli protection
was assessed using data from two non-randomized studies utilizing the
PRECISE® stent (Cordis Corporation, Miami Lakes FL) conducted in
Europe (CASCADE) and the United States (USFS). 25.6% (31/121)
in CASCADE and 32.6% (85/261) in USFS received stenting with
AngioGuardTM embolic protection while the remaining patients
received stenting alone; patients with emboli protection were enrolled
following those treated without emboli protection. Because the number
of patients in each trial is small, an exploratory analysis was performed
in which the data for 30-day stroke from these two trials was combined.
Results: The Armed Forces Institute of Pathology (core lab) analyzed the
contents of 294 AngioGuardTM XP filter baskets from the non-randomized
stent arm of the SAPPHIRE trial; 59.5% (175/294) of the baskets contained
material captured during carotid stenting. Analysis of retained material
identified smooth muscle cells, foam cells, collagen/elastin, platelets, media
and other materials consistent with atherosclerotic plaque components.
30-day stroke rates were 8.6% for the 266 patients treated with stenting alone and
2.6% for the 116 patients treated by stenting with distal embolic protection, an
absolute reduction of 6% and a relative reduction of 70% with a p value of 0.02.
Conclusions: The AngioGuardTM Emboli Protection Device apprears
extremely effective in capturing embolic atherosclerotic material released
during carotid stenting. 30 day stroke rates appear significantly reduced
when the AngioGuardTM filter was used during carotid stenting.
TCT-199
An Assessment of Interrater Reliability in the Treatment of Carotid
Artery Stenosis
Abhishek Nemani, Arshad Ali, Lawrence Sampson, James Wong, Kishore
Harjai, Richard Wells, Christopher Joy, Paul Buckthal
Guthrie Clinic, Sayre, PA
Carotid artery stenosis (CAS) is a major cause of stroke in US. Carotid
endarterectomy has been the recommended treatment for CAS. Recent
studies have established carotid stenting as an alternative for certain high
risk patients with CAS. This has created a turmoil among various specialties
participating in the care of these patients. The purpose of our study was
to determine through retrospective case review, if different subspecialty
physicians will make consistent therapeutic recommendations for CAS.
Case reviews of 20 patients with carotid artery stenosis, were presented to
seven physician-raters specializing in interventional cardiology (2), vascular
surgery (2), neurology (2), or interventional radiology (1). Each physician
reviewed cases independently and selected a therapeutic option. The
physicians were blinded to previous care provided. To test intrarater reliability,
two case-reviews were repeated. A total of 22 case reviews were rated.
A total of 154 responses were obtained. Physician-raters
recommendations are shown in table 1. Inter-rater agreement
was 77% (κ = 0.77). Intrarater reliability was 93 % (κ = 0.93).
A multi-speciality team providing care for CAS patients can reduce the
chances “turf battles” among various specialities, thus resulting in better
care for the patients. High Intrarater reliability of 93% points towards a
scientific approach based upon evidence based medicine adopted by various
specialities.
physician-raters recommended treatment
Medical Managewment
Endarterectomy
Stenting
Further Testing
36%
24%
32%
8%
TCT-200
Sirolimus Eluting Stents in the Carotid Artery. Increased
Inflammation but Persistent Prevention of Restenosis in Follow-Up
Gunnar Tepe, Jörg Schmehl, Jakub Wiskirchen, Stephan Heller, Norbert
Stauder, Claus Claussen
University of Tuebingen, Tuebingen, Germany
Background: Stent implantation in the carotid artery [CA] has been
shown to be feasible for treatment of CA stenosis. Even the restenosis
rate is reported to be much lower than in the coronary and peripheral
arteries problems may rise with increasing numbers of treated patients.
Methods: Eight pigs were randomly assigned to receive a sirolimus-eluting
nitinol self-expanding stent (7mm/80 mm) and the same stent without
sirolimus coating in the right or left CA. Starting 3 days before the intervention
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aspirin was given for four weeks and clopidogrel was administered for
10 days. Angiography and IVUS were done after 6 weeks and 6 months.
Results: After six weeks in both groups two subacute thrombotic occlusions
were observed. In the remaining vessels the neointima was significantly
reduced by sirolimus coated stents [SES] (5.9 ± 2.5 mm2 vs. 0.7 ± 1.0
mm2). Interestingly, the positive effect of SES sustained after 6 months
whereas there was a significant increase of neointimal formation in the bare
stents between 6 months and 6 weeks. Despite the sirolimus coating the
inflammation around the stent struts was significantly higher in the SES.
Conclusions: Sirolimus self expanding nitinol stents may be an effective
tool to reduce the restenosis rate in CA in selected cases. The high incidence
of subacute thrombosis may be attributed to an insufficient antiplatelet
therapy in a highly thrombotic setting with overstretch predilatation and
long-stent implantation. Despite an inflammatory reaction around the stent
struts of SES those stents had a persistent positive effect on the restenosis
rate. The increased inflammation the SES might have been due to the coating
of the drug eluting stents long after the complete release of sirolimus.
TCT-201
Carotid Stenting Using Emboli Protection: Reduction in Disabling
Stroke and Overview of the Feasibility, CASCADE, and SAPPHIRE
Trials
Jay S. Yadav1, Kenneth Ouriel1, Pierre Fayad2, Mark Wholey3, Sidney A.
Cohen4, for the SAPPHIRE Investigators
1
The Cleveland Clinic Foundation, Cleveland, OH;2University of
Nebraska College of Medicine, Omaha, NE;3Shadyside Hospital,
Pittsburg, PA;4Cordis Corporation, Warren, NJ
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Background: Stenting with and without emboli protection was evaluated
in patients presenting with severe carotid stenosis in the US Feasibility and
European CASCADE studies. Endarterectomy and stenting with emboli
protection were evaluated in patients presenting with severe carotid stenosis
in the SAPPHIRE Trial. Our data shows that emboli protection reduces major,
disabling strokes compared to either CEAor stenting without emboli protection
Methods: Asymptomatic patients with > 80-85% stenosis and symptomatic
patients with > 50-70% stenosis by ultrasound or angiography and a
high-risk criteria were enrolled in these studies. Patients were evaluated
for stroke by independent neurologic exam and strokes were stratified
in severity through a combination of outcome scales pre-procedure,
24 hours post-procedure, at discharge, and at 30 days. Major adverse
events were adjudicated by an independent Clinical Events Committee.
Results: Thirty-one (31) of the 121 patients in CASCADE and 85 of
261 patients in the U.S. Feasibility study were treated with stenting in
conjunction with the AngioGuard™ emboli protection device (Cordis
Corporation, Miami Lakes FL) while the remaining patients were treated
with stenting alone. No patients who received stenting with AngioGuard™
in either the CASCADE or US Feasibility study experienced a major
stroke. In the SAPPHIRE trial, no treated patient randomized to carotid
stenting experienced a major stroke; of 4 minor strokes, 3 resolved by
1 year (75%). In the extremely high risk non-randomized stent arm of
SAPPHIRE. 2.5% major strokes and 1.7% minor strokes were observed
at 30 days; five (5) of the 8 minor strokes resolved by 1 year (62.5%).
Conclusions: Emboli Protection is very effective at preventing major
strokes during carotid stenting and appears to be superior to either stenting
without protection or to CEA; the minor ipsilateral strokes that occur
frequently resolve with time.
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TCT-202
Patency of Carotid Stents is Preserved Over 12 Months as Determined
by Independent Duplex Ultrasound Oversight: The BEACH
Experience
Michael R Jaff1, Christopher J. White2, Rocco Ciocca3
1
Massachusetts General Hospital, Boston, MA;2Ochsner Clinic
Foundation, New Orleans, LA;3Boston Scientific Corporation, Natick, MA
Background: Carotid artery stenting (CAS) is a viable endovascular
alternative for patients (pts) with carotid stenosis and at high risk for
surgical carotid endarterectomy. BEACH was a prospective, singlearm, multicenter registry of such pts. All underwent carotid duplex
ultrasonography (CDUS) before, directly after, and at 6 and 12 months (m)
post CAS with the Carotid WALLSTENT® (CWS) and FilterWire EX®/
EZ™ (Boston Scientific, Natick, MA) distal emboli protection system.
Methods: All sites were certified in the method of CDUS by an
independent vascular ultrasound core laboratory (VasCore, Boston, MA).
Images were independently analyzed by registered vascular technologists
and over-read by a physician skilled in the interpretation of CDUS. The
primary composite endpoint included non-Q-wave myocardial infarction
(MI) through 24 hours; stroke, death and Q-wave MI through 30 days
(d); ipsilateral stroke and neurologic death through 1 year (y). Data
were compared to a calculated objective performance criterion (OPC).
Results: For the 480-pt pivotal group, the 30-d endpoint was 5.6%; the 1-y
composite endpoint of 9.1% was well below the OPC of 16.6%. Ultrasound
data are tabulated below.
ICA/CCA PSV
PSV MAX (cm/sec)
EDV MAX (cm/sec)
Ratio MAX
Pre347.0 ± 148
124.6 ± 74.4
5.3 ± 3.1
Post115.8 ± 40.7
35.0 ± 14.7
1.4 ± 0.5
1 Month
110.0 ± 37.6
34.6 ± 14.9
1.4 ±0.5
6 Months
147.0 ± 73.7*
47.6 ± 35.1*
1.9 ± 1.2*
^
†
12 Months
140.0 ± 68.8*
43.4 ± 21.7*
1.9 ± 1.1*‡
PSV=Peak Systolic Velocity; EDV=End-Diastolic Velocity; ICA/CCA PSV= Peak
Systolic Velocity Ratio of ICA vs distal CCA. All p values were calculated using the
Student’s T-Test method.
*p<0.0001 compared to post-procedure
^
p=0.74 compared to 6 months
†
‡
Conclusion: CAS with the CWS plus FilterWire EX/EZ is safe and
durable. Though post-CAS values for PSV, EDV, and ICA/CCA ratio were
statistically greater than at 6 and 12 m, the changes were not clinically
relevant. Additionally, there is no progression of PSV, EDV, or ICA/CCA
ratio over the latter 6 m of FU.
TCT-203
Carotid Angioplasty and Stenting under Cerebral Protection with
Occlusion Balloon - Technical Considerations
Michel HENRY1, Isabelle HENRY2, Antonios POLYDOROU3, Admanda
POLYDOROU3, Edmond LE BORGNE4, Michèle HUGEL1
1
Cabinet de Cardiologie, NANCY, France2POLYCLINIQUE, Bois-bernard,
France3Panteleimon General Hospital, ATHENS, Greece4Cabinet
Juridique, PARIS, France
Purpose: Carotid Angioplasty and Stenting (CAS) is emerging as a
new alternative treatment for carotid artery stenosis. 3 types of cerebral
protection devices are routinely used to reduce brain embolization
of debris. With a large series of patients, we would like to review the
techniques of occlusion of the ICA with the Percusurge™ device the
most common occlusion balloon used and describe advantages &
disadvantages of this method in comparison with other techniques.
Materials and Methods: 277 CAS were attempted in 251 patients (male:
201, mean age: 71.3±9.4 years). Mean % stenosis: 82.3±9.2 (70-99). Mean
lesion length: 14.4±6.3 mm. 64% of the patients were symptomatic. 45% of
the lesions were calcified, 72% ulcerated. Contralateral carotid artery was
stenosed in 50 patients, thrombosed in 14. We used the femoral approach in
275 cases & the brachial approach in 2 cases. In case of successful crossing of
the lesion, the occlusion balloon remained inflated during the whole procedure
in 228 cases. We deflated the balloon between predilatation & stenting in 47
cases. The dilated area was flushed during our first 40 procedures. We will
describe some tips & tricks to cross tight stenoses, tortuous vessels, to avoid
brain embolization due to the shadow zone below the balloon or to collateral
circulation and to avoid other complications, specific to this particular
technique. Other techniques like Rinsing + Aspiration, “ Rinspiration”
(Kerberos device) could be added to reduce embolic complications.
Results: Immediate technical success: 275/277 (99.3%). Intolerance
to occlusion balloon: 12/275 (4.4%). Mean occlusion time: 410±220
sec. (120-1480). Visible debris removed in all patients. 30 days
neurological complications: 5/277 (1.8%): 3 TIA, 1 retinal embolism,
1 brain hemorrhage. Other complications: spasm (n=10), impossibility
to deflate balloon (n=1). No dissection due to occlusion balloon.
Conclusion: Cerebral protection with the Percusurge™ Guardwire device
is safe and effective. Nevertheless some specific incidents or complications
may appear during the procedure and should be well known and well
managed to avoid neurological events. New techniques could be added to
reduce the embolic events.
TCT-204
Glomerular Filtration Rate and Carotid Artery Stenting: Long-Term
and Short-Term Outcomes
Luis Gruberg, Majdi Halabi, Shirush Petchersky, Arthur Kerner, Rafael
Beyar
Rambam Medical Center, Haifa, Israel
Background: Recent reports have stated that patients with
preoperative chronic kidney disease are at a significantly higher
risk for stroke and death after carotid endarterectomy or carotid
artery stenting (CAS) than patients with normal renal function.
Methods: We analyzed the impact of chronic kidney disease on the morbidity,
mortality and neurological outcomes in patients who underwent CAS at
our institution. Glomerular filtration rate (GFR) was estimated from serum
creatinine using the MDRD Study equation: GFR = 186 x (PCr)-1.154 x (age)-0.203
x (0.742 if female) x (1.210 if black). Patients were divided into three groups
according to the calculated GFR (≤59, 60 to 89 and ≥90 mL/min/1.73 m2).
Results: A total of 145 consecutive patients underwent 148 CAS procedures.
In-hospital and long-term outcomes are shown in the Table.
Age (years)
Female gender (%)
Diabetes (%)
Hypertension (%)
IHD (%)
Symptomatic (%)
S/P CEA (%)
GFR (mL/min/1.73m2)
In-hospital CVA (%)
In-hospital TIA (%)
In-hospital Death (%)
12-Months CVA (%)
12-Months Death (%)
Death/CVA
Death/CVA/Re-intervention (%)
GFR ≤59
(n=57)
72.5±8.3
24 (42)
24 (42)
44 (77)
34 (60)
27 (47)
30 (53)
48.2±8.9
3 (5.2)
2 (3.5)
1 (1.8)
3 (5.2)
2 (3.5)
5 (8.8)
8 (14)
GFR 60-89 GFR ≥ 90
p
(n=72)
(n=16)
70.0±8.4
66.6±8.7
0.03
23 (32)
6 (38)
0.49
23 (32)
9 (56)
0.15
60 (83)
12 (75)
0.60
38 (53)
8 (50)
0.67
28 (39)
6 (38)
0.61
44 (61)
11 (69)
0.47
73.1±8.2 110.3±23.6 < 0.0001
1 (1.4)
0
0.32
3 (4.1)
0
0.71
1 (1.4)
0
0.87
2 (2.8)
0
0.59
3 (4.2)
0
0.77
5 (6.9)
0
0.57
5 (6.9)
0
0.21
Conclusions: We have shown that in this high-risk group of patients who
underwent CAS, all patients regardless of the GFR, had excellent short- and
long-term outcomes. There was a trend to a numerically higher incidence of
the combined endpoint of death, stroke and re-intervention in patients with
reduced GFR, although it did not achieve statistical significance.
TCT-205
A Multicenter Registry of Carotid Artery Stenting with Cerebral
Protection in Octogenarians
Ioannis Iakovou1, Bernhard Reimers2, Giuseppe Sangiorgi1, Flavio
Airoldi1, Matteo Montorfano1, Iassen Michev1, Alaide Chieffo1, Antonio
Colombo1
1
EMO, Centro Cuore Columbus, Milano, Italy2Cardiology Department,
Ospedale Civile, Mirano, Italy
Background: Carotid artery stenting is being used as an alternative
treatment to surgical endarterectomy. Data from randomized studies
have shown increased rates of complications in octogenarians.
Objectives: To evaluate the short-term outcome of patients ≥80 years who
underwent carotid stenting with routine use of cerebral protection devices.
Methods: In 3 centers, 110 patients aged more than 80 years (73% men; mean
[+/- SD] age, 83 +/- 3 years) were treated with carotid stent implantation on 114
arteries. Cerebral protection was used in all patients and involved filter devices
(n=88), occlusive distal balloons (n=16), or proximal balloon protection (n=6).
Results: The protection device was positioned successfully in 98% of
the 110 attempted vessels. Neurologic complications occurred within
30 days after 5 procedures (4.5%), including 2 major strokes, 1 minor
stroke, and 2 transient ischemic attacks. There was 1 death (following a
major stroke). The post-hospital 30-day incidence of major stroke and
death was 1.8 %(2/110) vs. 1.5%(11/722) in patients <80 years (p=0.9).
Conclusion: Carotid stenting with routine cerebral protection in
cotogenarians appears feasible and safe, with a low occurrence of major
complications.
TCT-206
Applicability and Clinical Performance of Carotid Stenting with
Proximal Flow Blockage Cerebral Protection in a Real World
Population of 416 Patients: Results from the PRIAMUS Registry
Bernhard Reimers1, Gioacchino Coppi2, Roberto Moratto2, Roberto
Silingardi2, Giuseppe Sarropago3, Paolo Rubino3, Luigi Salemme3, Alberto
Cremonesi4, Fausto Castriota4, Raffaella Manetti4, Salvatore Sacca1
1
Cardiology Department, Mirano (VE), Italy2Vascular Surgery
Department, Modena, Italy3Cardiology Department, Mercogliano (AV),
Italy4Cardiology Department, Cotignola (RA), Italy
Purpose: The aim of this Italian prospective registry was to
evaluate the applicability and efficacy of the Mo.Ma Device
(Invatec, Italy) for the prevention of cerebral embolization
during carotid artery stenting (CAS) in a real world population.
Methods: In 4 Italian centers, 416 consecutive Pts (300 men; mean age
71.6±9 years) between Oct. 2001 and Mar. 2005 were treated with CAS
and with the Mo.Ma. Proximal Flow Blockage (PFB) Embolic Protection
System. The Mo.Ma achieved cerebral protection by endovascular clamping
of the Common Carotid Artery (CCA) and of the External Carotid Artery
(ECA). 264 symptomatic (63.46%) with >50% diameter stenosis and 152
(36.54%) asymptomatic pts with >70% diameter stenosis were included.
Results: Technical success, defined as the ability to establish protection
with the Mo.Ma and to deploy the stent, was achieved in 412 pts (99.03%).
The mean duration of flow blockage was 4.91±1.1 minutes. Transient
intolerances to flow blockage were observed in 24 pts (5.76%), but in all
cases the procedure was successfully completed. No peri-procedural strokes
(STK) and deaths were observed. Complications during hospitalization
included 16 minor STK (3.84%), 3 transient ischemic attacks (0.72%), 2
deaths (0.48%) and 1 major STK (0.24%). This resulted in a cumulative
rate at discharge of 4.56% all STK and deaths, and of 0.72% major STK
and deaths. All the pts underwent 30-day follow-up. At 30-day follow-up,
there were no deaths and no minor and major STK, confirming the overall
cumulative 4.56% incidence of all STK and deaths rate, and of 0.72%
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rate of major STK and deaths at follow up. In 245 pts (58.89%) there
was macroscopic evidence of debris after filtration of the aspirated blood.
Conclusions: This registry confirms and further supports the efficacy and
applicability of the endovascular clamping concept with PFB in a broad
patient series.
TCT-207
Outcome of Carotid Revascularization in High-Risk Female versus
Male Patients: An Analysis of The SAPPHIRE Trial
Heidar Arjomand1, Jay Yadav2, Bruce Bowers3, Firas Alani3, Jahan
Zeb3, Ismail Dairywala3, Carole Thomas3, Jennifer Yanoschak,3, Robert
Koenisberg3, Sheldon Goldberg3, Daniel McCormick3
1
Wentworth Douglass Hospital, Dover, NH;2Cleveland Clinic Foundation,
Cleveland, OH;3Hahnemann University Hospital, Philadelphia, PA
Background: Based on available data, low-risk female patients undergoing
carotid endarterectomy (CEA) do not derive equally good protection
against stroke as compared with male patients. There is limited data
on outcome of CEA and carotid artery stenting (CAS) with embolic
protection devices (EPD) in high-risk female versus male patients
Methods: We evaluated the outcome of carotid revascularization in 108
high-risk female patients, as compared with 219 male patients, in the
Stenting and Angioplasty with Protection in Patients at High Risk for
Endarterectomy (SAPPHIRE) trial. High risk features included age >
80 years, contralateral carotid occlusion, prior ipsilateral CEA, severe
LV dysfunction, prior neck radiation, and need for open heart surgery
in the following six weeks. The primary endpoint of this analysis
was the cumulative incidence of death, stroke, or MI at one year.
Results: Baseline characteristics will be available for presentation. Oneyear event rate is shown in the table. Composite one-year event rate in
female patients was 10.9% (CAS) and 15.1% (CEA) (p = 0.51). In male
patients, one-year event rate was 12.6% (CAS) and 22.2% (CEA) (p = 0.07).
Conclusions: In patients at high risk for carotid endarterectomy, CAS with
EPD has similarly good outcomes in female and male patients.
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One-Year Event Rate
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Death
7.3%
13.2%
Stroke
7.3%
7.5%
MI
3.6%
3.8%
Composite (death, stroke, MI)
10.9%
15.1%
1.8%
5.7%
Target lesion revascularization
Cranial nerve injury
0.0%
3.8%
using 99mTc-hexamethylpropylenamine oxime (HMPAO). Images were
blindly interpreted using the 10º color scale as well as by estimating the
lesion to normal ratio (LNR). RCP was considered normal with LNR =1, mild
hypoperfusion if LNR was <1-0.8, moderate if LNR was 0.6-0.79, and severe
if LNR was <0.6. Repeat BPS was done in 18 lesions, 4 weeks after stenting.
Results: ICA lesions were divided into 2 groups according to the severity
of luminal narrowing by DUS; GpI: 30 lesions (55.5%) with 60-80% ICA
stenosis, Gp II: 24 lesions (45.5%) with >80% ICA stenosis. Normal RCP
was found in 18 lesions (60%) in GpI vs 2 lesions (8%) in GpII, p<0.0001,
mild hypoperfusion in 9 lesions (30%) in GpI vs 5 lesions (21%) in GpII,
p=0.4, moderate hypoperfusion in 3 lesions (10%) in GpI vs 13 lesions (54%)
in GpII, p=0.001. None of the lesions in GpI vs 4 (17%) in GpII had severe
cerebral hypoperfusion (p<0.01). Repeat BPS was done in 18 lesions, 4
weeks after stenting. It showed marked improvement in the RCP, as reflected
by a significant decrease in the size and degree of hypoperfusion (mean LNR
0.56 ± 0.23 pre-stenting vs 0.92 ± 0.1 post-stenting, p<0.001). In GpII, an
excellent correlation was demonstrated between the degree of hypoperfusion
detected by BPS and the severity of ICA stenosis by DUS (r=0.78, p<0.005).
Conclusion: BPS is a simple, non-invasive functional imaging modality
that can detect the impact of various grades of asymptomatic carotid
stenoses on the RCP. It is also a reliable tool to assess the improvement of
RCP after carotid stenting.
Male
CAS(n = CEA(n =
111
108)
7.2%
13.0%
5.4%
7.4%
2.7%
9.3%
12.6%
22.2%
0.0%
2.8%
0.0%
5.6%
TCT-208
The Role of Brain Perfusion Single-Photon Emission CT in the
Evaluation of Patients with Asymptomatic Carotid Stenosis
Sameh A Salama1, Ahmed M Zaher2, Hussien Heshmat1, Azza Farrag1,
Hesham Yehia1, Essam Baligh1
1
Cardiology Department, Cairo University, Cairo, Egypt2Nuclear
Medicine Department, National Cancer Institute, Cairo, Egypt
Background: Management of asymptomatic carotid stenosis is currently
controversial. Brain perfusion SPECT (BPS) is a non-invasive imaging
modality that detects regional cerebral perfusion (RCP). Objectives:
To 1- detect the impact of >60% asymptomatic internal carotid artery
(ICA) stenosis on RCP, 2- monitor the improvement of RCP after carotid
stenting, and 3- identify the correlation between the severity of ICA
stenosis by Duplex ultrasound (DUS) and the extent of RCP by BPS.
Methods: 40 patients (54 ICA lesions), 29 males (72.5%), mean age 58±7
yrs, with >60% ICA stenosis by DUS were prospectively included. All
patients were asymptomatic. BPS was done, within 48hrs after the DUS,
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Structural Heart Disease
TCT-209
Acute Morphologic Differences between Alcohol Septal Ablation and
Surgical Septal Myectomy
Uma S Valeti1, Rick A Nishimura1, David R Holmes, Jr.1, Jerome F Breen1,
Philip A Araoz1, Charanjit S Rihal1, Bernard J Gersh1, Hartzell A Schaff1,
Barry J Maron2
1
Mayo Clinic, Rochester, MN;2Minneapolis Heart Institute Foundation,
Minneapolis, MN
Background: There is significant controversy regarding the different effects
of surgical septal myectomy (SM) and alcohol septal ablation (ASA).
Objective: To describe the acute morphologic differences
that
result
from
SM
and
ASA
using
cardiac
MRI
Methods and Results: Cine and contrast-enhanced MRI images were obtained
in HCM patients before and after SM (n=14) and ASA (n=17). The location
of the septal reduction, extent of myocardial necrosis and conduction system
abnormalities were compared. With SM, there was a discrete area of resected
tissue in the basal anterior ventricular septum and involved only the LV side
of the septum in a non-transmural fashion. (Fig A). There was no evidence
of post operative intramyocardial necrosis at the site of SM. In contrast, ASA
produced a large transmural infarction, located more inferiorly in the basal
septum and also extending into the inferior septum at the midventricular
level (Fig. B). The area of infarction due ASA was substantial, 17 ± 7
gm, 3-fold greater than the average amount of tissue resected by SM (6
± 5gm, p<0.0001). Left bundle branch block developed in 62% of SM
patients and right bundle branch block developed in 47% of ASA patients.
Conclusions: SM and ASA for severely symptomatic, drug refractory
patients with obstructive HCM have substantially different effects
on LV septal myocardium, in which only ASA produced a large
intramyocardial scar. These findings have important implications for
patient selection and management, as well as long term outcome.
TCT-210
Early Course of Hemodynamic and Morphologic Changes in Patients
Undergoing Alcohol Septal Ablation for Obstructive Hypertrophic
Cardiomyopathy is Influenced by Age of Patients
Josef Veselka1, Radka Duchonova1, Sarka Prochazkova1, Ingrid
Homolova1, David Zemanek1, Jana Palenickova1, David Tesar2
1
Dpt. of Cardiology, Prague 5, Czech Republic2Dpt. of Imaging Methods,
Prague 5, Czech Republic
Background: The hemodynamic and clinical benefit of alcohol septal
ablation (PTSMA) has been convincingly demonstrated in many studies
up to now. The aim of this study was to compare the time course of both
hemodynamic and morphological changes related to the age of treated patients.
Methods: Forty-four patients (54 ± 13 years, range 24-81 years) with a
symptomatic obstructive hypertrophic cardiomyopathy (HCM) receiving
a maximum medical therapy were enrolled consecutively. The study
population was divided into three groups according to their age; group
A [14 pts. (24-48 years)], group B [14 pts. (49-60 years)] and group
C [16 pts. (61-81 years)]. Clinical and echocardiographic data were
obtained at the baseline and periodically up to 12 months after PTSMA.
Results: At the baseline, there was a significant difference between septum
thickness (IVS) in age-related groups (24 ± 5 mm vs 21 ± 3 mm vs 19 ±
3 mm for groups A vs B vs C; p<0.01 for group A vs groups B and C). A
significant IVS reduction was identified in all age-related groups of patients
(p<0.01). There was a significant correlation between IVS and age at the
baseline and in the early postprocedural period. However, this correlation
was not significant after IVS remodeling at 3 and 12-month examination.
At the baseline, there were no significant differences between LV outflow
gradient in all age-related groups (70 mmHg [40 - 108] vs 54 mmHg
[40 - 89] vs 69 mmHg [37 - 97] for groups A vs B vs C). A significant
outflow gradient reduction was identified in all age-related groups of
patients (p<0.01). After multivariate adjustment, there was a significant
influence of age (p<0.01) on course of LV outflow gradient decrease.
Conclusion: PTSMA is an effective treatment option for patients with
obstructive HCM irrespective of their age. Our study suggests that the
younger patients are characterized by a thicker basal septum at the baseline
and slower hemodynamic and morphologic improvement within the early
postprocedural period.
TCT-211
Percutaneous Closure of the Left Atrial Appendage to Prevent Stroke
in Patients with Atrial Fibrillation - Current Results of the First USEuropean Multicenter Trial
Evelyn Fischer1, Mark Reisman2, William Gray3, Heyder Omran4, Paul
Kramer5, Antonio Bartorelli6, Paolo Della Bella6, Peter Block7, Carlo
DiMario8, Ray Matthews9, Jeffery Moses10, Allan Skanes11, Bernhard
Meier12, Athena Poppas13, David Williams14, Paul Teirstein15, Yves
Bayard16, Stefan Ostermayer1, Thomas Trepels1, Kai Billinger1, Michaela
Leetz1, Madlen Reschke1, Horst Sievert1
1
CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt,
Germany2Swedish Cardiovascular Research Institute, Seattle,
WA;3University of California, San Francisco, CA;4University of Bonn
Medicine and Cardiology, Bonn, Germany5Shawnee Mission Medical
Centre, Shawnee Mission, KS;6Centro Cardiologico S.p.A., Milan,
Italy7Emory University Hospital, Atlanta, GA;8Ospedale San Raffaelle,
Milan, Italy9Good Samaritan Hospital, Los Angeles, CA;10Lenox Hill
Hospital, New York, NJ;11London Health Sciences Centre, London, ON,
Canada12Swiss Cardiovascular Center Bern, Bern, Switzerland13Rhode
Island Hospital, Providence, RI;14Lenox Hill Hospital, Providence,
RI;15Scripps Clinic Medical Group, La Jolla, CA;16CardioVascular Center,
Farnkfurt, Sankt Katharinen, Frankfurt, Germany
Background: The left atrial appendage is the most important source of
cardiogenic thrombi in patients with atrial fibrillation, causing major
strokes. Closing the left atrial appendage (LAA) with the Percutaneous
Left Atrial Appendage Transcatheter Occlusion (PLAATO) device may
be an alternative for patients with contraindications for warfarin therapy.
Methods: The device is a self-expanding nitinol cage
covered with ePTFE. It is delivered through a 12 French
transseptal sheath especially designed to access the LAA.
111 patients with a mean age of 71±9 years were enrolled in the
PLAATO feasibility study and followed for a total of 168 patient years.
Results: In three patients a device could not be implanted due to complications
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when accessing the groin, a thrombus noted in the right atrium and cardiac
tamponade, respectively. In all other patients the device was successfully
implanted. During the procedure, cardiac tamponade occurred in 4 patients.
One had to undergo surgery and three pericardiocentesis. During follow
up, 9 patients died. Reasons for death were cerebral hemorrhage (1), multiorgan-failure (3), sudden cardiac death (1), renal failure (2), suicide (1) and
brain tumor (1). None of these deaths were procedure or device related.
In one patient, an echo-dense layer was found on the device surface at the 1 month
and 6 month follow up, but was resolved at the 9 month follow up without sequelae.
The expected annual risk of stroke of our patients based on the CHADS2 score
was 6.3%. Six patients sustained a stroke during follow up, so that the annual
stroke rate was 3.6%. That leads to a risk reduction by PLAATO of 43%.
Conclusions: Follow up tests show, that LAA occlusion with the PLAATO
device is a feasible and safe method to prevent stroke in high risk AF
patients with contraindication for warfarin therapy.
TCT-212
Cardiac Magnetic Resonance Imaging in Patients with Transcatheter
Closure of Patent Foramen Ovale
Thorsten Nusser1, Martin Höher2, Nico Merkle1, Olaf Grebe1, Jochen
Spiess1, Hans A. Kestler1, Matthias Kochs1, Vinzenz Hombach1, Jochen
Wöhrle1
1
University of Ulm, Ulm, Germany2Klinikum Bayreuth, Bayreuth,
Germany
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Background: Cardiac magnetic resonance imaging (CMRI) is a powerful
and non-invasive tool for detailed assessment of cardiac anatomy
and function. The value of CMRI compared with transesophageal
echocardiography (TEE) in patients undergoing transcatheter
closure of patent foramen ovale (PFO) has not been settled so far.
Methods: In patients with cryptogenic ischemic events and PFO CMRI
was performed pre and post PFO closure. The intervention was done
with fluoroscopy and TEE guidance using the Cardia Star™ device.
CMRI was compared to TEE regarding the detection of atrial septal
aneurysm (ASA) and contrast enhanced right-to-left shunting during
Valsalva maneuver. In CMRI the atrial septum was scanned using highresolution short axis cine images with a turbo-field-echo sequence
on a 1.5T whole body scanner. To determine provokable atrial rightto-left shunting in CMRI we performed contrast enhanced real-time
perfusion analysis in two cine sequences, a short axis and a long axis
4-chamber view, using a bolus of 0.1mmol/kg body weight Gd-DTPA.
Results: We analyzed 75 patients after cryptogenic ischemic events with
CMRI pre and after transcatheter PFO closure and at 12 months (n=65). In
high-resolution cine images ASA was seen in 28/75 (37%) compared with
63% (47/75) in TEE. We performed 211 CMRI studies with corresponding
TEE. With contrast enhanced perfusion analysis, CMRI detected right-toleft shunting in 48/72 (67%) of moderate or severe shunts but only 6/32
(18%) of mild shunts in TEE. No shunt was present in 107 patients with both
techniques. Volumetric and flow measurements revealed systemic shunts in
18/75 patients, which completely disappeared after closure. CMRI exlcuded
anomalous venous returns in all and detected coronary anomaly in two patients.
Conclusions: Present CMRI technique is inferior to TEE in detection of
contrast enhanced right-to-left shunting and identification of ASA, but
provides additional information regarding systemic shunts and cardiac
anomalies. In patients not tolerating the TEE probe, CMRI provides
valuable information on atrial septal morphology and cardiac shunting.
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TCT-213
Late Failure of Percutaneous PFO Closure: Mechanisms of Failure
and Treatment Options
Sherman G Sorensen1, James W Long2, Steven C Horton1, Peter J
Casterella1, Laurie Raleigh3, Heather Aguilar3, Donald L Lappé1, Joseph
B Muhlestein2
1
Utah Heart Clinic and LDS Hospital Cardiology, Salt Lake City, UT;2LDS
Hospital Cardiology, Salt Lake City, UT;3Utah Heart Clinic, Salt Lake
City, UT
BACKGROUND: Percutaneous catheter closure of patent foramen
ovale (PFO) is an increasingly accepted treatment option for stroke
prevention that has good procedural safety and early results. However,
late results due to device failure are unknown. Differences of device
design, device materials, implantation technique, healing effect,
or PFO morphologic features may influence long-term outcomes.
METHODS: From 2001-2005, 950 PFO closure procedures were
performed with 261 CardioSEAL® (CS) and 689 Amplatzer® PFO (AMP)
devices. Implant imaging used transesophageal echocardiography in 430
patients (pts) and intra-cardiac echocardiography in 520 pts. In our early
experience with the CS device, pts with long PFO tunnel (> 10 mm)
and large PFO with atrial septal aneurysm (ASA) were usually treated
by the transeptal technique. Eleven (1.0%) pts (3 AMP, 8 CS) required
evaluation and treatment for persistent or late failure of PFO closure
(range: 9-26 months post closure). Evaluation of these pts was prompted
by transient ischemic attack (TIA) in 4 pts, recurrent complex migraine
(migraine with TIA symptoms) in 3 pts, and persistent severe shunt in 4 pts.
RESULTS: There were 3 AMP pts that had severe persistent shunting.
All had ASA, long tunnel, and closure with a 35 mm AMP device.
Catheter treatment was not feasible and all were treated medically
without event. Of the 8 CS pts, 5 developed progressive shunt worsening
from implant to symptom presentation. All CS failure patients were
closed by the transeptal technique, had a tunnel of 15-27 mm, had
an ASA, and received a large device (40 mm= 4 pts, 33 mm= 4 pts).
Device retraction and arm splay was defined by echocardiography in
all and by surgical removal in 4 pts. There were 4 pts treated by second
device placement (second device: AMP PFO= 2 pts, AMP SO= 2 pts).
CONCLUSIONS: We conclude that 1) Late PFO closure failure is
uncommon and is multi-factorial; 2) Healing retraction is related to
transeptal placement and device type, but is treatable by second device
placement; 3) AMP failure due to non incorporation is difficult to treat
percutaneously; and 4) Complex PFO morphology may be better treated
with devices resulting in better defect filling and device apposition.
TCT-214
Incidence of Thrombus Formation on ASD and PFO Closure Devices
Ilona Hofmann, Madlen Reschke, Hildegard Lißmann-Jensen, Horst
Sievert
CardioVascularCenter, Frankfurt/Main, Germany
Purpose: A potential complication of transcatheter ASD and PFO
closure is a thrombus formation on the device. We analyzed the
incidence, morphology and clinical relevance of thrombus formation
on these devices detected by transesophageal echocardiography.
Methods: From August 1992 to April 2005, 1531 adult patients
underwent transcatheter closure of a patent foramen ovale (n= 969) or
an atrial septal defect (n=562). The transesophageal echocardiography
was performed after 4 weeks and 6 months and on clinical indikation.
Results: Thrombus formation was detected on the device in 19 (PFO:
n=12, ASD: n=7) of 1531 patients (1,2%). The size of thrombus
ranged from 3, 7 to 30 mm. Thrombus was attached on the left atrial
side in 11 patients, on the right atrial side in 4 patients and on the
both in 3. In 1 case thrombus was diagnosed on the Eustachean tube.
This was observed after 2-4 weeks in 14, after 6 months in 1,
after 1 year in 2, after 4 years in 1 and after 5 years in 1patient.
12 patients with thrombus had a Starflex-Occluder, 3 patients an ASDOSOccluder, in each case 1 patient an Amplatzer, a Cardioseal and in 2
cases were used the Helex. Post procedure device arm fractures were
found in 3 patients (16%) and atrial fibrillation in 2 patients (11%).
3
embolic
events
(3
minor
strokes)
occurred.
In 16/19 patients the thrombus resolved following anticoagulation
therapy (heparin, warfarin) or antiplatelet medication (aspirin,
clopidogrel). In 3/19 patients the thrombus had to be removed surgically.
Conclusion: The incidence of thrombus formation on closure
devices is low. In most of the patients the thrombus resolved
under anticoagulation therapy without clinical consequences.
Significant predictors of thrombus were device arm fracture, atrial
fibrillation, atrium septal aneurysm and specific occluder model.
TCT-215
Transcatheter Closure of Perimembranous Ventricular Septal Defect
by Amplatzer Devices: Immediate and Long-Term Follow-Up Results
Vijay Trehan, Saibal Mukhopadhyay, Jamal Yusuf, Mohit D Gupta, Manish
Sharma, Dinesh Raj, Ramesh Arora, Sanjay Tyagi
Background: Transcatheter closure of perimembranous ventricular septal
defect (PMVSD) is an evolving new therapeutic modality even for patients
with restrictive defects. We report our single center experience with Amplatzer
muscular ventricular septal occluder (AMSO) and Amplatzer asymmetric
perimembranous occluder (ASPO) with long-term follow up results.
Method: Between January1998 and December 2004, 82 patients (58 male,
24 female), aged 2-33 years (median 12 years) and weight 8-52 kg (median
24 kg) underwent closure of PMVSD (60 with AMSO and 22 with ASPO).
Included were patients of PMVSD with (i) small band or rim of ≥ 5 mm from
aortic valve (for ASPO defects with < 5 mm were also included). (ii) distance
from center to insertion of right coronary cusp >50% of required device size
(iii) aneurysm formation. Size of VSD assessed by echocardiography varied
from 2.5 to 12mm (mean 5.2 ± 2.1mm). 36 patients had aneurysm formation
and seven had left ventricle to right atrial communication. Pulmonary to
systemic flow ratio was > 2:1 in 32 patients (39%). Device was delivered
through transvenous route in all cases except one. Devices were deployed
under fluoroscopic and transthoracic echocardiographic guidance (TTE)/
angiography and size of device chosen(4-14 mm) was 2mm larger than that
determined by TTE but equal to stretched balloon diameter (34 patients).
Results: AMSO could be positioned successfully in all (n=60) while
ASPO had to be retrieved in 3 patients who developed acute AR with
hemodynamic compromise (superior margin of defect < 3 mm from aortic
valve in all) resulting in a procedural success rate of 96.4%. Incidence
of residual shunt 24 hours after procedure was 3(0.03%). All had trivial
shunts that disappeared within 1 month. New tricuspid stenosis was
observed in 1 patient with AMSO that resolved with balloon dilatation.
Patients were followed up by TTE and ECG at 24 hours,1,3 and 6
monthly thereafter. At 6-84 months (mean 38.2 ± 12.8) follow-up, there
was no incidence of migration/fracture of device, infective endocarditis,
aortic regurgitation, hemolysis or development of conduction defect.
Conclusion: Closure of PMVSD with Amplatzer devices is safe and
effective with low rate of complications.
TCT-216
Transcatheter Closure of Atrial Septal Defects and Patent Foramen
Ovale Using the Helex Septal Occluder
Stefan H U Ostermayer, Neil Wilson, Kai Billinger, Madlen Reschke, Yves
Bayard, Franziska Buescheck, Evelyn Fischer, Michaela Leetz, Margaret
Taaffe, Ralph Hein, Albrecht Roemer, Horst Sievert
CardioVascular Center Frankfurt, Frankfurt, Germany
Background: Transcatheter closure of atrial septal defects (ASD) and patent
foramen ovale (PFO) has become a routine procedure in many centers. The
Helex septal occluder (W.L. Gore and Associates, Flagstaff, AZ) is a twoumbrella device formed by one continuous nitinol wire which is covered by
ePTFE (expanded polytetrafluoroethylene). It has a unique spiral shape which
provides a very low profile and an atraumatic healing process after implantation.
Methods: Between December 1999 and May 2005 percutaneous interatrial defect closure using the Helex septal occluder was attempted
in 353 patients (51 ASD/ 302 PFO). Post procedure patients received
clopidogrel (PFO only), aspirin and a subacute endocarditis prophylaxis
for the first six months following the procedure. Transesophageal
echocardiography, fluoroscopy and chest-X-ray were performed at
one and six months. Thereafter, follow-up was performed clinically
and by questionnaire (14.6 ± 14.2 months, 430 patient years).
Results: Implantation of the Helex septal occluder was successful in
349 patients. In three patients the Helex occluder showed a suboptimal
position during implantation and was therefore removed and exchanged
for a different type of device. In three patients the occluder embolized
immediately following implantation or during the initial hospital stay.
In one of them a different device was implanted while two patients
received a Helex occluder during a second attempt. In two further patients
device embolization was noticed at the one and six months follow-up.
Both received a different type of device during a second procedure. The
stretched ASD diameter determined by balloon sizing was 13.0 ± 3.3 mm,
the stretched PFO diameter was 9.2 ± 3.6 mm. Twelve patients received a
second device: Two patients because of a second defect and ten patients
because of a residual shunt of the first occluder. One hundred thirty-eight
patients had an atrial septal aneurysm in additional to their ASD or PFO.
Conclusion: Transcatheter closure of inter-atrial defects using the Helex
septal occluder is a feasible and safe procedure even in defects with an
associated atrial septal aneurysm.
TCT-217
Migraine Induction by Brain Micro-Embolization During Contrast
Transcranial Doppler Evaluation of Right-to-Left Shunt
Sherman G Sorensen1, Deborah L Davis2, Laurie Raleigh2, Heather
Aguilar2, Peter J Casterella1, Brianna S Ronnow3, Ali K Choucair4,
Donald L Lappé1, Heidi Thomas3, Joseph B Muhlestein3
1
Utah Heart Clinic and LDS Hospital Cardiology, Salt Lake City,
UT;2Utah Heart Clinic, Salt Lake City, UT;3LDS Hospital Cardiology, Salt
Lake City, UT;4LDS Hospital Neurology and Cardiology, Salt Lake City,
UT
BACKGROUND: Brain micro-embolization (mEMB) due to right-toleft shunt (RLS) has been described with contrast echocardiography, brain
imaging (MRI) of divers with decompression illness, and while crossing a
patent foramen ovale (PFO) during closure procedures. RLS occurs in 50%
of migraine (MHA) patients (pts) with several reports describing migraine
improvement or even resolution with PFO closure. We have observed
severe MHA symptoms (MHA, A, visual loss, vertigo [MHA-SX])
induced by TCD suggesting that brain mEMB may be a trigger for MHA.
METHODS: Of 490 pts undergoing percutaneous PFO closure for recurrent
stroke, 176 (36%) reported active MHA before closure with 49 (28%) having
aura (A). Pre- and 90 day post-procedural power M-mode transcranial
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Doppler (TCD) with rest (R) and calibrated valsalva (V) agitated saline
contrast intra-venous injections were compared (N=148). Cerebral mEMB
events were quantified by automatic embolic detection program (scale of
1-5). A separate group of 225 consecutive pts referred for diagnostic TCD
were evaluated by questionnaire as to the onset of MHA-SX with TCD.
Indications for diagnostic TCD: cerebrovascular accident (CVA)=22%,
transient ischemic attack (TIA)=30%, MHA=49%, and abnormal MRI=69%.
RESULTS: Responses to PFO closure pre- vs. 90-day post procedure
included reduced incidence of active MHA: 176 vs. 23 pts (p=0.001), reduced
TCD-R: 2.74+1.02 vs. 0.52+1.02 (p=0.0001), and TCD-V: 4.73+0.73 vs.
1.86+1.71 (p=0.0001). Migraine symptoms during TCD testing occurred in
23% of the 225 pts, and MHA-SX was associated with severe shunt (p=0.003).
Of pts with severe shunting, 31% had MHA-SX. In the MHA pts, 49.6%
had a grade 5 TCD-V, and 50% had MHA-SX during testing. Although,
MHA-SX were induced in pts without prior history of MHA, MHA pts were
4 times as likely to have MHA-SX with TCD (p=0.01) than non-MHA pts.
CONCLUSIONS: We postulate that: 1) Brain micro-embolization during
contrast TCD may trigger migraine symptoms in pts with RLS, 2) Brain
sensitization in migraine sufferers results in heightened response to mEMB,
and 3) Spontaneous mEMB during daily life in pts with large RLS may
trigger MHA or other neurologic symptoms.
TCT-218
Is PFO Closure Effective in Reducing Migraine Symptoms? A
Controlled Study
Carey Kimmelstiel1, Christopher Gange1, Christopher Lyle2, David Thaler1
1
Tufts-New England Medical Center, Boston, MA;2Regulatory and Clinical
Research Institute, Minneapolis, MN
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Background: Several studies suggest a reduction in migraine
symptoms following percutaneous patent foramen ovale (PFO) closure.
These studies have been limited by their lack of a control group.
METHODS: We examined a database of all transesophageal
echocardiograms (TEE) performed over 1 year at a single center. Three
patient groups were identified: PFO undergoing endovascular closure
(Closed PFO; n=41), PFO treated medically (Open PFO; n=63), and age and
gender-matched subjects without PFO (controls; n=63). We interviewed all
subjects to determine the presence and severity of migraine with or without
aura. Headache frequency and severity were assessed retrospectively,
examining time points 3 months pre and post closure (Closed PFO)
or 3 months pre and post TEE performance (Open PFO and controls).
Migraine frequency and severity were assessed utilizing a standardized
questionnaire and the validated MIDAS migraine scoring system.
RESULTS: Migraines were significantly more common in PFO patients
than in controls - Closed PFO (24/41) 59%; Open PFO (26/63) 41%;
Controls (10/63) 16% (p < 0.05 for both PFO groups compared to
controls). In patients with migraine, endovascular closure had significant
beneficial effects on migraine frequency and severity (see table).
CONCLUSION: These controlled data suggest that migraine is
significantly more frequent in subjects with PFO and that PFO closure is
highly associated with a reduction in migraine symptoms. Randomized
trials are necessary to validate these data.
Change in migraine symptoms
Migraine Frequency
Migraine Severity
Reduced Same More
p*
Reduced Same More
20
2
2
13
9
1
Closed PFO
(n=24)
Open PFO
0
25
1
(n=26)
Controls
1
9
0
(n=10)
* compared to Closed PFO group
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0
23
0
<0.0001
<0.0001
1
9
0
0.027
TCT-219
Initial Experience with Alcohol Septal Ablation Using a Novel
Magnetic Navigation System
John Buergler1, Neal Kleiman1, Jennifer Franklin1, Kelly Elliott2, Sherif
Nagueh1
1
Baylor College of Medicine, Houston, TX;2Stereotaxis, St. Louis, MO
Background: Alcohol septal ablation (ASA) is now an established therapy
for the treatment of patients with hypertrophic obstructive cardiomyopathy
(HOCM). However, there are a number of cases in which it is difficult to
cannulate the target septal artery due to its small diameter and/or angulation
at its origin from the LAD. In these cases, the procedure may be aborted
altogether or carried out at the expense of a higher risk of arterial dissection.
Recently, a magnetic assistance system (MAI), in which magnetic fields are
used to guide and precisely position the wire to the desired site, was used to
help navigate the angulation from the LAD into the target artery. We herein
report on our initial experience with the use of the MAI system in ASA.
Methods: From October 2004 through April 2005, 14 patients (5 women)
with HOCM (septal thickness 1.9±0.3 cm), angina (mean angina class
2.6±0.9), and CHF (NYHA class 3.2±0.4) underwent ASA using the
MAI system (Niobe® Stereotaxis, Inc. St. Louis, MO). The system is
comprised of two magnets, one on each side of the patient, Windows®
based software that allows dynamic magnetic field directional control,
and a magnetically enabled 0.014 in. floppy tipped wire. Precise control
of wire tip direction is controlled in-vivo by operator/software interactive
control of the external magnetic field flux. A balloon is advanced over the
Stereotaxis wire. Once placed in the target artery, the wire was removed
and ethanol (2.2±1.1) ml was injected into 1.2±0.4 arteries with a peak
CK leak of 1050±582 u/l. The pressure gradient was obtained at baseline
and immediately after ASA via catheters in the aorta and left ventricle.
Results: The pressure gradient was reduced from 60±35 at baseline to
5±8 mm Hg (p<0.001) immediately after ASA. Overall, the procedure
success rate was 100% and there was no evidence of dissection or
other complications related to the use of MAI. Complications included
1 patient requiring permanent pacing due to complete heart block.
Conclusion: MAI has the potential to increase the success and safety of
ASA in patients with HOCM. Additional studies are warranted to prove
this hypothesis.
TCT-220
Patent Foramen Ovale: A Domestic Swine Model with Prevalence,
Structure, and Histopathology Comparable to Human Hearts
Hidehiko Hara1, Krzysztof Karnicki2, MaryLou Stewart2, Jamie M. Pelzel1,
Serge Rousselle3, Glen Smits3, Robert S. Schwartz1
1
Minneapolis Heart Institute Foundation, Minneapolis, MN;2Medical
Laboratory Surgical Services, Rochester, MN;3Charles River Laboratory,
Osceola, WI
Backgrounds: Patent foramen ovale (PFO) is becoming increasingly
important as multiple clinical syndromes are caused by this abnormality.
Novel technologies to close PFO percutaneously are under development
but lack an appropriate animal model for testing. We sought to evaluate the
domestic swine as a model for PFO in both gross and histopathologic features.
Methods: Experiments were performed using one hundred porcine hearts from
necropsy of domestic swine (age 4 to 6 months). They were examined for PFO
prevalence, appearance, size and occurrence of other atrial septal abnormalities.
Results: PFO was found in 32 of the 100 porcine hearts (PFO prevalence
32%, Confidence: 24-42%). One porcine heart had an atrial septal defect
(ASD) (ASD prevalence 1%, Confidence: 0-5%). Sixteen PFO were
measured, and showed tunnel length (12.0 +/- 5.6 mm) compared with long
axis from left to right atrium (4.7+/- 3.2 mm, 4.0 +/- 2.6 respectively, p=0.5).
Multiple regression analysis was performed on the length of PFO. The long
axis length from left atrium was the only predictor (r2=0.404, p=0.034).
Histopathologic comparison between human and porcine PFO demonstrated
marked similarity in cellular and matrix composition (Figure. a).
Conclusions: PFO prevalence in domestic swine is highly comparable
to that in humans. The porcine PFO exhibits size, gross and microscopic
structure virtually identical to that in humans. The domestic swine PFO
model may find use in testing new technologies for interventional PFO
closure.
TCT-221
MRI in Patients with Patent Foramen Ovale or with Residual Shunt
after Percutaneous Occlusion
Oliver K Mohrs1, Damir Erkapic1, Steffen E. Petersen2, Rainer Schraeder1,
Bernd Nowak1, Hans-Ulrich Kauczor3, Thomas Voigtlaender1
1
Cardiovascular Center Bethanien (CCB), Frankfurt / Main,
Germany2University of Oxford, Oxford, United Kingdom3German Cancer
Research Center (DKFZ), Heidelberg, Germany
Background: Patent foramen ovale (PFO) is a known cause of cerebral
strokes or transient ischemic attacks due to paradoxical embolism.
This study was designed to evaluate the feasibility of dynamic contrastenhanced MRI (ceMRI) to detect patent foramen ovale (PFO) or
residual shunt after percutaneous transcatheter closure of PFO.
Methods: We examined 25 patients (11 female, mean age 53 ±14), 19 patients
with first diagnosis of PFO and 6 with residual shunt after percutaneous
closure of PFO. Transesophageal echocardiography (TEE) served as the
clinical reference. A dynamic contrast-enhanced (10cc followed by 20cc
saline @ 6cc/sec Gd-DTPA) saturation-recovery-SSFP-sequence was
performed during Valsalva maneuver at 1.5 Tesla. Besides a qualitative,
visual analysis, the relative signal intensity (%) compared to baseline over
time was calculated for the left atrium (LA) and the pulmonary vein (PV).
Results: Visual analysis detected 23/25 cases by an early contrast
enhancement in LA due to contrast flow through PFO. The two false
negative results comprised one patient with first diagnosis of PFO
and one patient with a residual shunt. Patients with a huge PFO on
TEE presented with a bright enhancement in the entire LA and patients
with a small PFO only a slight enhancement near the atrial septum.
In 22/25 cases signal-to-time curves showed two signal-peaks in LA
compared to baseline signal. The first peak in LA (mean 190±73% of the
baseline signal) appeared 10±4 seconds earlier than the single signal-peak
in PV (mean 534±159%). A second signal-peak in LA (mean 585±148%)
followed immediately. The mean interval between the two signal peaks in
LA was 10±3 seconds during which the signal decreased (mean 129±32%).
Conclusion: This study demonstrates that dynamic ceMRI has the potential
to reliably detect PFO and residual shunts after percutaneous closure of
PFO. Especially patients who cannot tolerate the transesophageal probe
could benefit from a non-invasive MRI approach.
TCT-222
Transcatheter Closure of Large Atrial Septal Defects under
Transoesophageal Echocardiographic Guidance Without Balloon
Sizing Maneuver
Furong Zhang, Junzhu Chen, Qianmin Tao, Liangrong Zheng, Jianhua
Zhu, Zhelan Zheng, Lei Yao, Yun Mu
First Affiliated Hospital,Zhejiang University, Hangzhou,Zhejiang, China
Background: The stretched balloon diameter(SBD) is supposed to
the gold standard for selecting the size of device. However, the balloon
sizing maneuver could overestimate the actual defect size, is time
consuming, is difficult in some large ASD. The purpose of this study
was to evaluate the feasibility of closure of ASD≥ 25 mm(range 25 to
32 mm) using transesophageal echocardiography (TEE) selecting the
device size of Amplatzer Septal Occluder(ASO) without balloon sizing.
Methods: Between Jan. 2000 and May 2003, large ASD closure with the
ASO was performed in 36 adults (mean age 45± 14years,range 20~66years,
23 female). The patients were divided into two groups. In the study group,
a closure of ASD was attempted using TEE without balloon sizing in the
18 patients. In the control group, ASD closure was performed using the
SBD in the other 18 patients. In the control group, we implanted devices
2~4 mm larger than the SBD. In the study group, A device with a waist
diameter 4~8 mm bigger than maximal TEE defect diameter was chosen.
Results: In the study group, ASD median diameter is 26.8±1.9 mm under
TEE; Devices ranging from 30 to 38 mm in diameter (33.3±2.4mm) were
implanted. In the control group, ASD median diameter is 26.5±1.9mm under
TEE and Devices ranging from 30 to 38 mm (33.7±2.2 mm),the SBD was
30.6±1.6 mm. There was no significant difference between the 2 Groups
in age,sex ratio,weight,Qp/Qs, defect diameter and diameter of devices
(P>0.05). An ASO was successfully implanted in all patients. Fluoroscopy
times,TEE times and procedure times in the study group were significantly
shorter than thoses in the control group (12.1±7.3 min vs. 19.4±6.7 min;
P<0.01),(20.5±5.4 vs.29.2±6.8 min; P<0.01), (52.8±13.2 vs. 78.3±15.1 min;
P<0.01). All of patients was no residual shunt found during 3~12 months
follow-up. TTE and chest radiographs showed no displacementof the occluders.
Conclusions: Transcatheter closure of large secundum ASD atrial septal
defect using ASO without Balloon Sizing Maneuver is accepted treatment
modality.
TCT-223
PFO Closure Using Premiere: The CLOSE UP Trial
Horst Sievert1, Franz Kleber2, Stephan Windecker3, Frank Uhlemann4,
Christine Tiefenbacher5, Franziska Büscheck1, Dennis W. Wahr6
1
CardioVascular Center Frankfurt, Frankfurt, Germany2Unfallkrankenhau
s, Berlin, Germany3Inselspital, Bern, Switzerland4Olgahospital, Stuttgart,
Germany5Universitatsklinikum, Heidelberg, Germany6Velocimed, Inc.,
Maple Grove, MN
Background: CLOSE UP was a prospective trial conducted to determine
the safety and performance of the Premere PFO Closure System.
Methods/Results: Seventy-three patients with a PFO and a history of
stroke or TIA felt to be due to paradoxical emboli were enrolled at 5 sites;
67 patients were implanted with the device (54 study, 13 roll-in patients).
Six patients did not receive the Premere device due to PFO and atrial
anatomy (3 study, 3 roll-in). Atrial septal aneurysm was present in 18;
average PFO diameter was 8.9 ±3.78 (range 1.9-19); 28 patients received
the 15 mm and 39 the 20 mm device. Closure rates, defined as ≤5 bubbles
on TEE Valsalva exam, are shown in Table 1; only those patients with an
echo study at that time point are reported. For example, the single 20 mm
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device patient open at 6 months did not have a study done at 3 months.
At the start of the trial only the 15 mm device was available; closure rates
appear better with the 20 mm device. There have been no events of death,
hemo-pericardium, stroke or TIA. One patient (1.9%) was found to have
visible thrombus on the left atrial anchor (TEE) at 3 months and received
heparin/coumadin. Five patients had transient new arrhythmias: 4 were
minor with no treatment; 1 with intermittent atrial fibrillation. Only the
patient with AF was treated; all arrhythmias resolved prior to 6 month.
Conclusion: The Premere device effectively closes PFO, and has a very
low risk of adverse events.
Closure at 2 weeks
Closure at 3 months
Closure at 6 months
PFO Closure Rate with Premere
All Study Patients
15 mm Device
% (n)
% (n)
67.3 (35/52)
47.6 (10/21)
89.8 (44/49)
75.0 (15/20)
92.9 (39/42)
90.5 (19/21)
20 mm Device
% (n)
80.6 (25/31)
100.0 (29/29)
95.6 (22/23)
TCT-224
Patent Foramen Ovale Closures Improves Migraine Severity and
Intensity
Sabu J George, Malek Numeir, Nicholas Skiadas, John Grammes,
Firas Alani, Grewal Rasveg, Benjamin Silverman, Juzer Lokandwala,
Zeb Jahan, Nicole Bruno, Bruce Bowers, Ismail Dairywala, Jennifer
Yanoschak, Carole Thomas, Daniel McCormick, Sheldon Goldberg
Hahnemann University Hospital, Philadelphia, PA
P
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Background:
Patients
with
cryptogenic
stroke
and
PFO
have a higher incidence of migraine. Recent data suggest
that PFO closure results in improvement of symptoms.
Methods: We reviewed all patients undergoing PFO closure for neurologic
events from 2002 to 2004. Patients with migraines were identified using
the International Headache Society Criteria. Follow up was obtained via a
questionnaire using the MIDAS scale. Median follow up was 1.8 years. The
MIDAS grades were compared pre-and post closure using the Wilcoxon test.
Results: The files on 186 patients were reviewed. Follow up was obtained
in 158/186 (85%). Of these 36/158 (23%) had migraines (26 female,10
male). The indications for PFO closure were CVA in 20/36(56%) and TIA
in 16/36(44%). The pre-and post closure change in MIDAS grade is shown
in Figure 1. There was a significant decrease in MIDAS grade after closure
(p<0.001). Fifty six percent of patients (20/36) showed improvement of
at least one MIDAS grade, eight of whom had complete relief. Fourty
four percent of patients (16/36) had no change in MIDAS grade. A trend
towards more Conclusion: There was objective improvement in migraine
following PFO closure, especially in patients with more severe symptoms.
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94H
Treatment of In-Stent Restenosis
(Abstract Nos. 225- 235)
TCT-225
Intravascular Ultrasound Analysis of Sirolimus-Eluting Stents for the
Treatment of In-Stent Restenosis: Results from the TROPICAL Trial
Ryota Sakurai1, Junya Ako1, Hideaki Kaneda1, Ali H. M. Hassan1, Yasuhiro
Honda1, Eberhard Grube2, Andreas Mügge3, Wim Aengevaeren4, Paul G.
Yock1, Franz-Josef Neumann5, Walter Desmet6, Peter J. Fitzgerald1, The
TROPICAL Trial Investigators
1
Stanford University, Stanford, CA;2Krankenhaus Siegburg GmbH,
Siegburg, Germany3St. Josef Hospital/Ruhr-Universität Bochum,
Bochum, Germany4Academisch Ziekenhuis Nijmegen, Nijmegen,
The Netherlands5Herz-Zentrum Bad Krozingen, Bad Krozingen,
Germany6University Hospitals Leuven, Leuven, Belgium
Background: TROPICAL is a multicenter, prospective clinical
trial designed to evaluate the safety and effectiveness of sirolimuseluting stents (SES) for the treatment of in-stent restenosis. The
purpose of this study was to evaluate detailed vessel response to SES
implanted within the restenosed bare metal stents using serial IVUS.
Methods: In TROPICAL, 47 cases were enrolled in the IVUS substudy.
Serial IVUS imaging was performed at post-intervention and at 6-month
follow-up. Areas for vessel (VA), stent (SA), lumen (LA), and neointima
(NIA) were measured for the newly implanted SES. Both at the site
of minimum LA (MLA) and maximum NIA, 2-D IVUS analysis was
performed . To further characterize the vessel response along the entire
stented segment, a subset of 15 patients underwent 3-D IVUS analysis.
Results: At baseline, no apparent qualitative abnormality was
observed, except for mild incomplete stent apposition (ISA) in 1 case.
Minimum SA within SES was 4.4±1.1 mm2. At 6 months, no lateacquired ISA, edge dissection, aneurysm or thrombus was detected.
Table shows 2-D IVUS results. Neointimal volume index (neointimal
volume / stent length) was 0.1±0.2 mm3/mm, and %neointimal
volume (neointimal volume / stent volume x 100) was 2.1±3.3%.
Conclusion: Despite the relative stent underexpansion at baseline, minimum
neointimal proliferation within SES resulted in consistent preservation of
LA at 6 months. These favorable results were associated with no apparent
adverse vessel response as assessed by IVUS.
Average reference LA (mm )
VA at MLA site (mm2)
SA at MLA site (mm2)
MLA (mm2)
Maximum NIA (mm2)
%NIA (NIA / SA x 100) at maximum NIA site (%)
2
Baseline
(n=42)
6.6±2.2
12.5±3.7
4.4±1.1
4.4±1.1
_
_
Follow-Up
(n=38)
6.8±2.1
12.2±3.1
4.4±1.1
4.1±0.9
0.7±0.4
11.6±7.9
TCT-226
The Experimental Study on Mytrolimus-Eluting Stents to Prevent
Restenosis in Porcine Coronary Model
Hong Qiu, Runlin Gao, Sr.
Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of
Medical Sciences, Peking Union Medi, Beijing, China
Background: The safety and efficacy of sirolimus-eluting stenting
have been demonstrated. Whether Mytrolimus, a derivative of
sirolimus, has efficacy as same as sirolimus? The objective of
our study was to assess the efficacy of Mytrolimus (CCI-779)-
eluting stents in preventing restenosis in the porcine model.
Methods: Mytrolimus was synthesized by Pharmaron, LLC.(U.S.A.) The
stainless stents, 18mm in length and 3.0mm in diameter, were manufactured
by Microport Medical CO. Ltd.(Shanghai, China). The polymer used for
coating was polyolefin. The dosage of Mytrolimus was 160ug/stent. The
bare stents(n=10), stents coated with polyolefin(n=10) or stents coated with
Mytrolimus in polyolefin(n=8) were implanted in LAD or right coronary artery
of mini-swine. The cross sections of the stented coronary arteries were analyzed.
Results: The mean injury scores and luminal area were similar in three
groups. Between bare-stent group and sole polyolefin coated-stent
group, there were no significantly difference in neointimal thickness
above the struts (0.32±0.13mm vs 0.33±0.25mm, P=0.146) and between
the struts(0.29±0.13mm vs 0.28±0.23mm, P=0.217), neointimal
area[(2.34±0.95)mm2 vs (2.44±1.59)mm2, P=0.400] and percentage of
restenosis(36.17±13.14% vs 37.96±20.24%, P=0.295). To compared
Mytrolimus-eluting stent with bare-stent group, neointimal thickness
above the struts(0.18±0.08mm vs 0.33±0.25mm, P<0.05) and between
the struts(0.14±0.05mm vs 0.28±0.23mm, P<0.05) and neointimal
area[(1.09±0.24)mm2 vs (2.44±1.59)mm2, P<0.05] were significantly
decreased in the Mytrolimus group than in bare mental stent group. Compared
with bare-stent, the Mytrolimus stent was associated with a 55% reduction
in neointimal area. No restenosis developed in the Mytrolimus group.
Conclusion: The polyolefin coated-stent has good biocompatibility, similar
with bare-stent. The Mytrolimus-eluting stents can effectively inhibit the
neointimal hyperplasia in stented areas of coronary arteries 4 weeks after
stent implantation in porcine model.
TCT-227
Treatment of Recurrent and Diffuse In-Stent Restenosis with
Sirolimus-Eluting Stents in Diabetics Atients : Long-Term Outcome
Imad Sheiban, Amedeo Chiribiri, Claudio Moretti, Filippo Sciuto,
Pierluigi Omedè, Salvatore Colangeli, Premiano Lombardo, Walter
Grossomarra, Gaimpaolo Trevi
San Giovanni Battista Hospitali, Torino, Italy
Background: In-stents restenosis (ISR) remains the major
limitation of coronary angioplasty (PCI) in diabetic patients . In the
present study we evaluated the impact of re-PCI with drug eluting
stents in diabetics for the treatment of diffuse and recurrent ISR .
Methods: Among 136 consecutive patients (pts) with diffuse and recurrent
ISR in a native coronary vessel were treated with Cypher intrastent
implantation 42 were diabetics ( 21 insulin-dependent and the other 21
non insulin-dependent) . Mean age was65±10 years ; 80% male. A total
number of 72 Cypher (1,7 stent/patient) were implanted. Mean lesion lenght
was 23 ± 7 mm (from 15 to 42 mm). Double antiaggregation therapy was
continued for at least 3 months following the procedure. Followup visits
were planned at 1, 3, 6 and 9 months all pts. The following events were
evaluated: death, recurrence of angina,new myocardial infarction, SAT,
target vessel revascularization (TVR) or target lesion revascularization
(TLR). An elective 9-month angiographic follow up was planned in all pts
Results: Procedural success was 100%. No procedural MACE were
observed. Mean follow-up period was 654 ±215 days. 20 pts were followed
for at least 30 months 22 for at least 18 months. During follow-up there were
2 cardiac deaths, 1 q-AMI and no stroke or late stent thrombosis . 12 pts
underwent clinical-driven angiographic control 1 because of NSTEMI, 5 pts
for recurrent angina , 6 pts for positive ischemic test. Angiopraphic control
revealed in-Cypher restenosis in 9 pts . The remaining 3 pts had disease
progression on native vessels. Thus TVR/TLR occurred in 9 pts (21%) . 9month angiographic follow-up was completed in other 15 pts all were free
of symptoms . Only 1 patient had in Cypher restenosis. Thus total MACE
during follow-up period was 35.7 %. MACE occurred more frequently in
insulin dependent diabetic pts as compared to those non insulin dependent.
Conclusions: The treatment recurrent and diffuse ISR with Cypher stent in
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diabetic patients is safe. However, the recurrence of MACE on long-term
- mainly due to in-Cypher restenosis- especially in those insulin-dependent
is still representing the main limitation and might be due to longer lesions
treated and more stents used .
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TCT-228
after successful stent implantation (Cypher™: LMT 1.5%, LAD 44.2%,
LCX 27.8%, RCA 26.5%) (TAXUS™: LMT 1.5%, LAD 44.6%, LCX
22.9%, RCA 31.0%) was performed. The study endpoints were major
adverse cardiac event (MACE) at 30 days and restenosis rate at 12 months.
Results:
See
table
for
clinical
results.
Conclusion: The use of both stents in patients with D-ISR was equally safe
with low acute complications and low incidence of restenosis.
Stent-Based Nitric Oxide Elution Reduces Neointimal Proliferation in
a Porcine Carotid Overstretch Model
Charlotte Ng1, Dongni Feng1, Eyas Al-Shaykh Youssef1, Pam Rogers1,
Larry Solomon1, Kobi Iki2, Brian Johnstone1, Keith L. March1, Dongming
Hou1
1
ICVBM, KI of Cardiology, Indianapolis, IN;2Vscsular Architects, San
Jose, CA
Number of patients
MACE at 30 days (%)
Reference diameter (mm)
Lesion length (mm)
Stent length (mm)
MLD post (mm)
MLD at 12 months (mm)
Restenosis rate (%)
MACE at 12 months (%)
Background: Drug-eluting stents (DES) are currently the most effective
therapy for preventing in-stent restenosis. Currently marketed DES employ
cytostatic drugs which reduce neointimal growth. Nitric oxide (NO) is a
potent endogenous vasodilator that decreases inflammation and promotes
endothelialization. This study was aimed to evaluate the effect of sustained
local NO delivery by a novel stent, designed for treatment of peripheral artery
stenosis, on neointimal proliferation in a porcine carotid overstretch model.
Methods and Results: A spiral nitinol stent construct formed the
framework for the application of a multilayered drug-loaded matrix,
including a polymeric diffusion barrier designed to provide an initial burst
of NO followed by a prolonged low-level release. The system was enclosed
by an ePTFE (expanded polytetrafluoroethylene) membrane. Six pigs (n
= 3 per group) were used in this experiment. 3 pigs in the control group
were treated with non drug eluting stents in each carotid artery while 3 pigs
in the treatment group received NO-eluting stents in each carotid artery.
The stents (6 stents per group) were implanted into both carotid arteries
following balloon overstretch (balloon-to-artery ratio of 1.3:1). Angiogram
and intravascular ultrasound (IVUS) were done at baseline, immediately
post-stent placement, and at day 28 to evaluate vessel patency. The vessel
size at baseline and immediately post-stenting was identical. Quantitative
angiography revealed that the in-stent diameter stenosis was 16% ± 2% in
the NO-eluting stent group, in comparison with 36% ± 4 % in the control
group (mean ± SEM, p = 0.001), yielding a 56% reduction of diameter
stenosis. IVUS cross sectional analysis confirmed that the area stenosis
was 10% ± 1% in the NO eluting stent group vs 26% ± 3% in the control
group (p < 0.001), corresponding to a 62% reduction in the treatment group.
Conclusion: The NO-eluting ePTFE-covered stent significantly reduced
in-stent restenosis in a porcine carotid overstretch model. Stent-based NO
elution may be useful and clinically feasible for prevention of restenosis.
TCT-229
Cypher™
320
0
2.82 ± 0.70
31.5 ± 7.9
38.8 ± 10.5
2.63 ± 0.66
2.54 ± 0.77
7.5
7.5
TAXUS™
294
0
2.72 ± 0.69
29.5 ± 10.8
37.5 ± 10.1
2.52 ± 0.70
2.34 ± 0.69
10.2
10.2
p
NS
NS
NS
NS
NS
NS
NS
TCT-230
Efficacy of Treatment of Coronary In-Stent Restenosis Using
Paclitaxel-Eluting Stent in Patients with Diabetes Mellitus
Igor Pershukov1, Talantbek Batyraliev2, Yury Pya2, Igor Lazarev3, Zarema
Niyazova-Karben2, Larisa Petrakova3, Orhan Dogru2, Boris Sidorenko3
1
Regional Clinical Hospital, Voronezh, Russian Federation2Sani
Konukoglu Medical Center, Gaziantep, Turkey3Presidential Medical
Center, Moscow, Russian Federation
Background: In-stent restenosis (ISR) remains a major limitation of
percutaneous coronary intervention (PCI), especially in patients with
diabetes mellitus (DM). The efficacy of the paclitaxel-eluting stent
(PES) for treatment of in-stent restenosis in diabetics is still uncertain.
Methods: A total of 212 consecutive patients with DM and 276 ISR lesions in
coronary arteries were treated with 281 PES Taxus. Mean age was 63±10 years
and 37% of patients got insulin injections. PES had a mean length of 18.4±5.2
mm and was implanted at 15±3 bars directly in 71% of cases. Procedural
quantitative coronary angiography indicated a reference vessel diameter
of 3.04±0.53 mm, a pre-minimal lumen diameter of 0.77±0.39 mm, and a
stenosis rate of 75±12%. All patients received Clopidogrel (300 mg as loading
dose and 75 mg daily) for 6 months and Aspirin (100 mg daily) indefinitely.
Results: Major adverse cardiac events (MACE) within the first month
consisted of 1 deaths (0.47%). A complete 1-year follow-up was available for
159 patients (204 lesions). There were no additional deaths (0.63%), no Qwave myocardial infarctions, and target vessel revascularization was required
in 11 patients (6.9%) with 12 lesions (5.9%). The 1-year MACE rate was 7.5%.
Conclusion: PES implantation may be considered safe and effective, at 1
year, as a treatment of ISR in PCI practice for patients with DM.
TCT-231
of Patients with Diffuse In-Stent Restenosis
1
Impact of Sirolimus-Eluting Stents on the Outcome of Patients with
Diffuse In-Stent Restenosis: Multicenter Registry in Asia
1
Background and Purpose: Both Sirolimus-eluting stent (Cypher™, Cordis)
and Paclitaxel-eluting stent (TAXUS™, Boston Scientific) have been reported
to be effective in preventing neointimal formation and reducing restenosis.
The aim of this study is to compare the safety and efficacy of these two types
of stents on the outcome of patients with diffuse in-stent restenosis (D-ISR).
Methods: A prospective analysis of 614 patients with 706 D-ISR lesions
(320 Cypher™ and 294 TAXUS™) in the high volume Asian centers
Background and Purpose: Diffuse In-stent restenosis (D-ISR) remains
the major limitation of percutaneous coronary intervention. The efficacy
of Sirolimus-eluting stent (SES) for treatment of D-ISR is still under
evaluation. A prospective Asian multicenter registry was set up in five
high volume Asian centers to evaluate the SES in treatment of D-ISR.
Methods: A total of 960 patients with 1188 D-ISR lesions (male
72.9%, mean age 72.4, LMT 1.5%, LAD 44.2%, LCX 27.8%, RCA
96H
26.5%) in native coronary arteries were treated with SES (mean lesion
length 25.6±10.8 mm, mean stent length 35.8±12.8 mm). We evaluate
immediate and long-term clinical result by 6 and 12 months angiography.
Results:
See
table
for
clinical
results.
Conclusion: These results showed utilizing SES can dramatically suppress
the restenosis rate of D-ISR.
MACE at 30 days (%)
MLD post (mm)
Restenosis rate (%)
TVR (%)
960/1188
100
0
2.88 ± 0.74
2.64 ± 0.70
2.50 ± 0.60
2.53 ± 0.59
6.9
6.0
6.0
TCT-232
Nationwide Use of Intracoronary Brachytherapy Since the
Introduction of Drug Eluting Stents
Rajbir Sangha, Peter Y M Hui, Richard E Shaw, on Behalf of the ACCNCDR
Sutter Pacific Heart Centers - CPMC, San Francisco, CA
Background: In-stent restenosis is a problematic long term complication of
bare metal stenting. Brachytherapy is the only proven treatment modality
in the prevention of recurrent restenosis. Although effective, the cost,
inconvenience and unknown long term complications of brachytherapy
make it a less than ideal therapeutic option. Drug eluting stents (DES)
have been shown to be highly effective in the prevention of in-stent
restenosis, but the outcome of DES treatment of in-stent restenosis is
unclear. To evaluate if the introduction of DES has led to decreased
utilization of brachytherapy, the American College of Cardiology
National Cardiovascular Data Registry (ACC-NCDR) was examined.
Methods: Evaluation of 362,489 consecutive PCI procedures done
between 4/1/2003 and 9/30/2004 representing 403 institutions submitting
data to the ACC-NCDR. DES were introduced in April of 2003.
The use of brachytherapy and DES were calculated for each quarter.
Results: The table demonstrates the decrease in use of brachytherapy and
increase in use of DES across the 6 quarters.
Q2-03
52,636
Total # of PCIs
Brachytherapy
3.6%
Used
DES Used
19.4%
Total Sites
Submitting Data
128
on Brachytherapy
Brachytherapy
procedures
1-52
(range)
Q3-03
55,042
3.4%
39.8%
Q4-04 Q1-04 Q2-04
56,411 60,447 61,062
2.4% 2.0% 1.2%
45.7% 56.1% 67.7%
Q3-04 p-value
62,075
0.7% <0.0001
75.9% <0.0001
143
138
143
153
131
1-68
1-74
1-55
1-46
1-25
Conclusions: Analysis of the ACC-NCDR database demonstrates the
decrease in utilization of intracoronary brachytherapy since the introduction
of DES. The number of brachytherapy procedures performed per institution
has peaked and is in apparent terminal decline. This significant trend is
secondary to both the off-label use of DES for the treatment of in-stent
restenosis, and DES related reduction of in-stent restenosis.
Background: Recent data indicate the elevated serum high-sensitivity Creactive protein (hs-CRP) level predicts the risk of recurrent coronary events.
And statin therapy has been shown to decrease the risk of coronary events.
This study assessed the relation between pre-procedural hs-CRP and in-stent
neointimal hyperplasia (NIH) after stenting and examined the effects of
statins on the relationship between the restenosis development after stenting
and the serum hs-CRP levels of patients with coronary artery disease.
Methods: This study included 100 patients who underwent stent
implantation for angiographically significant stenosis. Patients
were divided into a normal CRP group (< 0.5mg/dL) and elevated
CRP group (≥ 0.5mg/dL) on the basis of serum CRP levels.
Results: All patients underwent angiographic and intravascular ultrasound
follow-up at six months. The baseline CRP level was 0.29±0.08 mg/
dL in the normal CRP group and 2.90±2.31 mg/dL in the elevated CRP
group. The NIH cross sectional area (CSA) in the minimal lumen
CSA at follow-up was significantly larger in the elevated CRP group
(1.9±1.3mm2 vs. 3.0±1.5mm2, p=0.001). A significant positive correlation
was found between pre-interventional CRP levels and NIH area (r=0.52,
p<0.001). In patients with normal CRP, association between the use
of statin and the restenosis development was not observed. However,
when the analysis was confined to patients with elevated CRP, statin
therapy significantly reduced the restenosis rate (24% vs. 36%, p=0.031).
Conclusions: Measuring pre-interventional hs-CRP levels may be helpful
to predict restenosis after stenting and statin therapy significantly reduced
restenosis rate in patients with elevated hs-CRP.
TCT-234
Sirolimus for In-Stent Restenosis: Long Term Results of SiroISR
Registry.
Philippe COMMEAU, Pierre-Olivier ROQUEBERT, Paul BARRAGAN
Polyclinique Les Fleurs, OLLIOULES, France
Background: In-stent restenosis (ISR) remains a major limitation of
percutaneous coronary intervention (PCI). The implantation of sirolimuseluting stent (SES) for ISR treatment is safe, feasible and effective at early
follow-up (FU) in several trials. These findings need to be confirmed at late FU.
Methods: Two hundred consecutive and unselected patients (pts) with
260 lesions were treated with 280 SES. Mean age was 65 +/- 12 years,
35.5% of pts were diabetic and 44.5% of pts presented an unstable
angina. The ISR patterns were I and II in 74.5 % , III and IV in 25.5 %
of lesions. SES were directly implanted in 78% of cases with postdilatation in only 7%. Procedural QCA indicated a reference vessel
diameter of 2.99 +/- 0.25 mm, a pre-minimal lumen diameter of 0.48 +/0.37 mm and a stenosis rate of 84 +/- 11 %. All pts received clopidogrel
(600 to 800 mg as loading dose and 150 mg daily) or ticlopidine (500 mg
daily) for 2 months.Clinical FU was obtained at 1, 6, 12 and 24 months.
Results: Angiographic and procedural success was achieved in all
pts. Major cardiac events (MACE) within the first month consisted in
2 non Q wave myocardial infarction (NQMI) (1%). At 1 year (96 %
compliance FU), MACE rate was 10% (death:0.5%,NQMI:1%,targe
t lesion revascularisation:8.5%). At 2 years (94.5% compliance FU),
MACE rate was 15.5% (death:2.65%,NQMI:1.1%,TLR:11.1%,coronary
bypass:0.5%). Event-free survival, at 2 years, was observed in 82.4% of pts.
Conclusion: SES implantation may be considered safe and effective, at 2
years, as a treatment of ISR in routine PCI pratice.
TCT-233
High Preprocedural High-Sensitivity C-Reactive Protein Levels
are Associated with Neointimal Hyperplasia after Coronary Artery
Stenting
Young Joon Hong, Myung Ho Jeong, Ju Han Kim, Weon Kim, Young Keun
Ahn, Jeong Gwan Cho, Jong Chun Park, Jung Chaee Kang
97H
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
TCT-235
Prospective Comparison of Sirolimus-Eluting Stents vs. Intracoronary
Brachytherapy for the Treatment of In-Stent Restenosis
Junya Ako, Yasuhiro Honda, Ali Hassan, Katsuhisa Waseda, Shinjo
Sonoda, Seung-Ho Hur, Peter J Fitzgerald
Stanford University, Stanford, CA
Background: The efficacy of sirolimus-eluting stents (SES) for the
treatment of in-stent restenosis (ISR) has not been systematically compared
to intracoronary brachytherapy (IBT). The aim of this IVUS study was to
compare SES and IBT with respect to the acute mechanical properties of
the target ISR segment and follow-up luminal dimensions at 6 months.
Methods: Patients with ISR were prospectively randomized (2:1) to either
SES or IBT. One hundred and five follow-up IVUS (71 SES: 34 IBT) were
available for this analysis. Vessel volume index (VVI), stent volume index
(SVI), and lumen volume index (LVI) were obtained by averaging the
vessel volume, stent volume, lumen volume with the longitudinal length,
respectively. Intimal volume index (IVI) was measured as SVI minus LVI.
Measurements of stented segments included uncovered old stents as well
as newly implanted stents. Δ intimal volume (Δ IH) was measured as IVI
at follow-up minus IVI at post-procedure. Lumen area loss is computed as
minimum lumen area (MLA) at post-procedure minus MLA at follow-up.
Results: At post-procedure, there was a significantly larger MLA in
SES compared to IBT. At follow-up, luminal dimensions were not
significantly different between the two groups in either stented or reference
segments. Although the Lumen area loss was 0.44±1.5 for SES and
0.14±1.3 for IBT, this difference did not reach statistical significance.
Conclusion: This IVUS study suggests that the two treatment modalities
are similarly effective for the treatment of ISR.
P
O
S
T
E
R
Post-PCI
MLA, mm2
LVI, mm3/m
Follow-up
MLA, mm2
Late lumen area loss, mm2
Δ IH, mm3/m
LVI, mm3/m
Distal reference LVI, mm3/m
Proximal reference LVI, mm3/m
SES
IBT
p-value
4.8±1.7
5.6±1.5
3.9±1.1
5.3±1.3
0.003
0.4
4.4±2.1
0.44±1.5
0.5±0.8
5.9±1.7
5.5±2.1
6.5±2.4
3.8±2.0
0.14±1.3
0.23±1.0
5.6±1.7
5.1±2.5
7.1±2.6
0.27
0.49
0.32
0.46
0.6
0.4
A
B
S
T
R
A
C
T
S
98H
Valvular Heart Disease
TCT-236
Predictive Value of EuroScore for In-Hospital and Follow-Up
Mortality after Balloon Aortic Valvuloplasty
Annapoorna S. Kini, Tirumalesh Venkatesh, Robert Pyo, Mary-Beth Duffy,
Pedro R. Moreno, Samin K. Sharma
Background: Balloon aortic valvuloplasty (BAV) is currently performed
in pts with severe aortic stenosis (AS) who either have prohibitive surgical
risk for aortic valve replacement or have limited life expectancy. EuroScore
is a simple risk stratification tool, derived from multiple baseline factors
and is predictive of in-hospital mortality after bypass surgery and has been
validated in the surgical literature. It is not known whether EuroScore
can be utilized to predict short- or long-term mortality after BAV.
Methods and Results: A total of 202 high-risk inoperable patients with
symptomatic severe AS underwent BAV at Mount Sinai Hospital from
January 2001 to December 2003. All pts were followed for in-hospital events
and follow-up mortality at median of 2.5 years (Table). Logistic EuroScore
on average over-estimated death risk by absolute 26% (predicted surgical
mortality of 34% vs. actual BAV in-hospital mortality of 8%) [95% CI 3% 20%; p <0.001]. Logistic EuroScore is useful in predicting BAV in-hospital
mortality (p = 0.029) but the predictive value is modest (ROC of 0.66
with c-statistic). Cutoff of significant mortality occurs at EuroScore of 10.
Conclusion: Present analysis suggests the use of Euroscore as a
simple risk stratification tool in predicting in-hospital mortality
after BAV. Also, AS pts with EuroScore >10 may be most
appropriate candidates for percutaneous aortic valve replacement.
Table.
Euroscore
≤5
6-10
10-15
>15
P
N
6
70
89
37
Predicted surgical
mortality (%)
4
12
36
58
In-hospital BAV
mortality (%)
0
4.3
10.1
16.2
0.029
Follow-up BAV
mortality (%)
16.7
27.5
37.2
40.1
0.05
TCT-237
Percutaneous Aortic Valve Implantation: A Large Annulus Prosthesis
John G. Webb1, Mann Chandavimol1, Samuel J. McClure1, Donald R.
Ricci2, Ronald G. Carere1, Christopher R. Thompson1
1
St. Paul’s Hospital, Vancouver, BC, Canada2Vancouver General Hospital,
Vancouver, BC, Canada
Objectives. We describe the initial clinical experience with a new large
(26mm) annulus Cribier-Edwards percutaneous aortic valve (PAV).
Background. The Cribier-Edwards PAV (Edwards LifeSciences Inc., Irvine,
CA) is a trileaflet equine pericardial valve mounted within a tubular slotted
stainless steel stent. Previous implants have employed a 23 mm outer diameter
PAV. Although initial results have been encouraging, valve embolization
at the time of implantation and paravalvular regurgitation have occurred.
The ideal relationship between annulus size and prosthesis size is unknown.
Methods. Implantation of 26 mm Cribier-Edwards PAVs was
undertaken in five patients with symptomatic severe aortic
valve stenosis. Patients were 82 + 5 years with median additive
EuroScore of 11 and 23.0% predicted operative mortality rate.
Results. The PAVs were successfully implanted in all 5 patients via the
retrograde trans-arterial femoral approach. Mean aortic gradient decreased
from 48 to 18 mm Hg with valve area increased from 0.7 to 1.6 cm2.
PHV embolization did not occur. There were no major procedural related
complications. At 40 + 16 days, all patients remain alive and out of
hospital.
Aortic annulus by echo (mm)
Valve area pre (cm²)
Valve area post (cm²)
Paravalvular regurgitation post (mean, range)
Valve embolization
23 mm (N=8)
22.0 ± 1.4
0.6 ± 0.1
1.3 ± 0.5
Mild: 2+ (0-3)
2
26 mm (N=5)
23.7± 1.5
0.7 ± 0.2
1.6 ± 0.2
Trivial: 1+ (1-2)
0
Conclusion. We have demonstrated the feasibility of PAV implantation via
the retrograde trans-arterial approach using a new large annulus prosthesis.
In selected patients a larger diameter device may be associated with a
lower risk of PAV embolization and post-implantation paravalvular aortic
regurgitation.
TCT-238
Clinical Outcome of PMV-Associated Moderate or Severe MR
Sung Hea Kim, Je Sang Kim, Seung Woo Park, Sang Hoon Lee, Kyung
Pyo Hong, Jung-Don Seo, Sang-Chol Lee
Department of Medicine, Sungkyunkwan University School of Medicine,
Cardiac and Vascular Center, Seoul, Republic of Korea
Background: Mitral regurgitation(MR) is a significant complication
after percutaneous mitral valvuloplasty(PMV). We sought to
investigate the natural history of moderate or severe MR after PMV.
Methods: PMV was performed in 183 consecutive patients with
severe mitral stenosis. Baseline and follow-up echocardiographic
and clinical data of 29 patients who developed moderate
or severe MR after PMV were reviewed retrospectively.
Results: Among the 29 patients, 19 developed moderate and 10 severe
regurgitation. Their mean age was 42±9 years. Mean follow-up period was
4.0±2.4 years. Excluding 2 patients who underwent emergency surgery
immediately after PMV and 1 patient who refused follow up, baseline
post-procedural echocardiography was performed in 26 patients 1 day
after PMV. MR grade improved in 35%(2/8 in severe, 6/18 in moderate
MR) after 1 year. Among these improved subjects, however, the grade
of MR re-progressed in 27% on 3-year and in an additional 36% on 5year follow-up. The overall progression rate for initial moderate MR
(n=18) was 15% and 53% in 3 and 5 years after PMV, respectively. Left
atrial size also showed a significant increase with time (p=0.02). A total
of 8 cases of major clinical events occurred during follow-up, with a 5year event rate of 32%. The events were; 2 cases of elective operation, 2
cases of new atrial fibrillation, 1 case of heart failure and 1 case of stroke.
Conclusion: PMV-associated moderate or severe MR shows relatively rapid
progression and frequent clinical events on follow-up. Special attention
is required in these patients including detailed history taking and annual
echocardiographic examination
TCT-239
Mitral Valvuloplasty in the Pediatric Age Group: Immediate and
Long Term Follow-Up Results
Vijay Trehan, Saibal Mukhopadhyay, Jamal Yusuf, Mohit D Gupta,
Praveen Singh, Ramesh Arora, Sanjay Tyagi
Background: Mitral balloon valvuloplasty (BV) is effective
therapeutic option but there is paucity of data on immediate/
long-term efficacy of BV in pediatric age group (≤ 15 years).
Methods: Hospital data between October 1987-December 2004 were
analyzed to determine immediate/longterm results of BV. 603/6870 (8.7%)
99H
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
≤ 15 years were studied. Age range was 6-15 (mean 11.3 ± 2.8 years)
mean height (142.2 ±11.8 cms); mean body surface area (BSA) (1.2 ±
0.2); male to female ratio 1.2:1. All had sinus rhythm. Preprocedure mitral
valve area (MVA) by echocardiography ranged from 0.4-1cm2; Wilkins
score ≤ 8 in majority (n=547, 90.8%). Mitral regurgitation (MR) was mild
in 112/603 (18.5%), moderate in 28 (4.6%), severe in 20 (3.3%). Inoue
balloon (Toray, Japan) was used for BV in 542 patients (89.8%) and
double balloon (Mansfield Scientific Inc) in rest (21-22 mm/m2 BSA).
Severe pulmonary arterial hypertension (mean PA pressure ≥ 50 mm Hg)
was present in 406 (67.3%) Successful procedure was defined as (MVA >
1cm2/m2 BSA or mean gradient < 5 mm Hg in absence of complication)
and restenosis (MVA ≤ 0.8cm2/m2 BSA or > 50% gain loss). Results:
592 (98.2%) patient had successful BV. MVA increased from 0.73 ± 0.16
cm2 to 1.88 ± 0.32 cm2 (p< 0.0001) and mean PA pressure fell from 68
± 15.4 to 27.6 ± 10.4 mm Hg (p< 0.001), transmitral gradient reduced
from 18.6 ± 6.12 to 3.6 ± 3.20 mm Hg; (p<0.001). 6 (0.9%) developed
severe MR (4 required mitral valve replacement). One had cardiac
tamponade (expired);4 had suboptimal result. All with preexisting severe
MR had successful BV, symptomatic improvement. 18 showed reduction
in severity of MR on followup (mild MR-4, moderate MR-14) only
2 required MVR. Over followup of 96.4 ± 38.2 months (range 5-195
months), 74 patients (12.2%) developed restenosis, of whom 58 (9.6%)
with class III/IV symptoms underwent successful redilatation and 6 (0.9%)
underwent successful third dilatation. No deaths occurred during followup.
Conclusion: MV provides excellent long-term palliation in pediatric
patients preserving native valve and avoiding complications of valve
replacement. Concomitant severe MR should not be considered an absolute
contraindication in this age group.
TCT-240
Percutaneous Aortic Valve Replacement Utilizing Novel Inflatable
Fabric Cuff Supported Tissue Valve in Ovine Model
Reginald Low1, Jason Rogers1, Gordon Bishop2, Randy Lashinski2
1
U.C. Davis, Sacramento, CA;2Direct Flow Medical Inc., Santa Rosa, CA
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
Background: Advances in percutaneous therapeutic vascular procedures
are being applied to nonsurgical percutaneous valve replacement and repair.
The feasibility of percutaneous transcatheter aortic valve replacement via
antegrade and retrograde approach utilizing a metallic stent based tissue
valve has been demonstrated. A novel inflatable fabric cuff supported tissue
valve has been developed for percutaneous delivery which permits accurate
positioning, repositioning, tight sealing to annulus and if necessary, retrieval.
Method: A new percutaneously delivered valve prosthesis has been
developed (Direct Flow Medical Inc.) using pericardial tissue mounted to
a fabric inflatable cuff similar to a surgical valve. The valve is delivered
retrograde via catheter and unsheathed just below the aortic annulus. The
fabric cuff supported valve is then expanded by inflating with contrast and
positioned at the annulus. Once proper positioning and function are confirmed,
a solidifying polymer is injected to replace the contrast followed by release
of the connecting tubing from the prosthesis. This next generation valve has
been implanted in a series of ovine models and positioning and function
are assessed radiographically, hemodynamically and by intracardiac echo.
Results: This inflatable fabric cuff supported tissue valve has been acutely
deployed successfully in healthy sheep with position and valve function
assessed by angiography, hemodynamics and intracardiac echo.Valve retention
was confirmed with epinephrine challenge. Clinical data will be presented.
Conclusion: This novel fabric cuff pericardial valve represents the next
generation transcatheter delivered aortic valve. Potential advantages include
accurate positioning, repositioning, excellent conformability to the annulus
to reduce perivalvular leak and retrieval, if necessary.
100H
Vascular Access and Complications
TCT-241
Comparison of Radial vs Femoral Approach for Coronary
Intervention in the Elderly
Asim N Cheema, Tony Hong, Robert J Chisholm, Warren J Cantor,
Michael J B Kutryk, Bradley H Strauss
St. Michael’s Hospital, Toronto, ON, Canada
Percutaneous coronary intervention from a transfemoral approach is
associated with increased risk of vascular complications in the elderly.
Although a transradial approach is an attractive alternative, its efficacy has
not been well established in this high risk population. We compared the
safety and efficacy of transradial approach for PCI in 228 elderly patients
(age ≥80) who underwent elective PCI from 5/2000 to 5/2004. Baseline,
procedural and follow up data were collected and compared for the two
groups. The patients in transfemoral group were older (83.2 vs 82.0 yrs,
p= 0.005) and had more females (47 vs 33%, p=0.04) compared to the
transradial group. There were no significant differences in body mass index,
presence of diabetes, rate of prior revascularization procedures or periprocedural use of glycoprotein IIb/IIIa receptor antagonist. The procedural
and follow up results are summarized in table.
Crossover to alternate site (%)
Access time (min, mean ± SD)
Cannulation time (min, mean ±SD)
Vessels treated/patient, mean ± SD
Guide catheters/patient, mean ± SD
Left guides
Right guides
Fluoroscopy time (min, mean ± SD)
Contrast volume (ml, mean ± SD)
Ambulation time (hours, mean ± SD)
Access site complication
Bleeding
Major (%)
Minor (%)
Hematoma (%)
Transfusion (%)
Vascular surgery (%)
Emergency CABG (%)
CVA (%)
Transfemoral
(n=131)
3.82
2.20±0.42
2.05±2.05
1.21±0.44
Transradial
(n=97)
11.34
2.36±1.36
3.10±2.96
1.24±0.45
p value
0.003
ns
0.01
ns
1.19±0.58
1.10±0.94
16.11±11.78
182.29±20.25
94.66
10.60±6.32
1.27±0.93
1.44±0.86
19.30±16.07
224.16±46.20
93.81
5.21±3.16
ns
0.05
0.01
0.04
ns
<0.001
3.05
11.45
3.82
4.58
0
0
0
1.03
3.09
1.03
1.03
0
0
1.03
0.02
0.003
0.02
0.001
ns
ns
ns
A transradial approach for coronary interventions in the elderly is associated
with technical difficulty, prolonged procedure time and a high crossover
rate to alternate access sites. These limitations of transradial approach are
offset by important clinical benefit of early ambulation and a significant
reduction in vascular complications.
TCT-242
A Comparison between Surgical Cut-Down vs. Pre-Close Technique
for Endovascular Treatment of Aortic Aneurysms
Marijke Skowasch1, Albrecht Roemer2, Wolf Seemann3, Klaus Lang2,
Ulrich Finke4, Matthias Tischendorf3, Horst Sievert1
1
CardioVascular Center Frankfurt, Frankfurt, Germany2Dept. of
Internal Medicine Sankt Katharinen Hosp., Frankfurt, Germany3Dept. of
Radiology/MRI Sankt Katharinen Hosp., Frankfurt, Germany4Dept. of
Surgery Sankt Katharinen Hosp., Frankfurt, Germany
Purpose: It is still common clinical practice to perform an arteriotomy for
endovascular treatment of aortic aneurysms due to the use of large bore
introducer sheaths (up to 27F). Since 03/01 we used the percutaneous
suture device Perclose (PVS) in order to reduce the invasiveness of
the vascular access site. The purpose was to evaluate the safety of both
methods and to assess possible beneficial effects on hospital stay.
Materials and Methods: Since 1995 we attempted to treat 133 consecutive
patients (age: 21-89y, 70±9) with either thoracic (n=15) or infrarenal (n=118)
aneurysm. In 114 femoral arteries surgical cut-down was performed, whereas
in 97 femoral arteries PVS was used. All patients were treated in local
anaesthesia and were anticoagulated with a minimum of 10.000 UI of heparin.
The size of the introducer sheath for the main body was 18-27F and 10-18F
for the contralateral limb. All patients underwent post-interventional clinical
controls (if necessary, add. duplex-Scan) and were followed regularly by CT.
Results: In 4.8% (5/104) of the arteriotomy group the following
complications occurred: 1 occlusion of the proximal superficial femoral
artery, 2 hematomas, 1 lymphocele, 1 secondary hemorrhage. The first
3 cases (2%) required surgery. The average sheath size for arteriotomypatients was 18±4.5 (12-27F) vs. 20.5±2.8 (12-24F) for the PVS patients
(n.s.). 6.2% (6/97) of the PVS- group had vascular complications: 1 AVfistula, 2 secondary hemorrhages (1x interventional implantation of a
Hemobahn, 1x surgical revision), 2 false aneurysms (1/2 pseudoaneurysms
developed within 3 month post-procedure). In one case (1%) a surgical
revision was needed. The mean length of the hospital stay in both groups
(surgical cutdown vs. PVS) differed highly: 102±117h vs. 48±116h,
corresponding to a median hospitalization of 51 vs. 17h (p<0.001). 71%
of the PVS-patients were discharged within 24hours post-procedure.
Conclusion: Our experience shows that the PVS can be alternatively used
to achieve hemostasis even if large bore introducer sheaths are used. By
using the PVS instead of surgical cut-down the length of hospital stay can
be significantly decreased and eventually, allows treatment in outpatients.
TCT-243
Perclose versus Manual Compression after PCI via the Femoral
Artery. Haematomafrequency, Advantages and Disadvantages
Mia P Schou1, Birthe Sindberg1, Kirsten Andersen2, Marianne
Bregendahl2, Leif Thuesen1, Jan Ravkilde1
1
Department of Cardiology, Skejby Hospital, Aarhus University Hospital,
Aarhus, Denmark2Department of Cardiology, Aalborg Hospital, Aarhus
University Hospital, Aalborg, Denmark
Background: Haematoma in the groin is the most common
complication after PCI via the femoral artery. Increasingly closure
devices are developed in order to reduce the frequency of haematomas.
The aim of this investigation is to compare the frequency of haematoma at the
femoral artery entry site after PCI using either Perclose or manual compression;
to be able to point out advantages and disadvantages in using Perclose and
manual compression; and to register the frequency of late haematomas.
Material and Methods: We randomised 719 patients at two centers;
in 358 patients were used Perclose and 361 manual compression. We
defined a haematoma as an accumulation of blood sensible at skin
level with a circumference of > 5 cm in accordance to similar studies.
Results: The haematoma frequency was 12.0 % and 11.1 % for Perclose
and manual compression, respectively. Using 40 variables including sex,
age, body mass index, systolic blood pressure, patient medical therapy, time
of application/compression, patient judgement of pain (Visual analogue
scale (VAS) score). In the major part variables no difference were seen.
The VAS-score from 5-10 was higher in the Perclose group (21.7% of
the patients) versus the manual compression group (5.8%). The duration
of application/compression was for Perclose 3.4 minutes and manual
compression 15.8 minutes. Failures in applicating Perclose was seen in
6.4%. Follow-up of 14days after discharge showed late haematomas in 0.3%.
Conclusion: We found no difference in the haematoma frequency between
Perclose and manual compression. Using Perclose the patient suffer more
pain, the closure device is expensive compared to manual compression,
however, advantage for Perclose is quick application leading to possible
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possible strain injury of hands and fingers of health personnel. Very few late
haematomas were seen.
TCT-244
Conclusions: Radial artery sheath insertion for coronary angiography or
angioplasty results in immediate and persistent blunting of FMD suggesting
severe vasomotor dysfunction. Radial artery sheath insertion has important
effects on radial artery function which must be considered when selecting
radial conduits for CABG.
Collagen-Plug vs. Suture-Based Femoral Closure Devices: A
Randomised Trial
John Cosgrave1, Pierfrancesco Agostoni1, Lei Ge1, Ioannis Iakovou1,
Giussepe Biondi-Zoccai2, Nicola Corvaja1, Giussepe Sangiorgi1, Antonio
Colombo1
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Milano, Italy
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Background: Randomised trials directly comparing collagenplug and suture-based arterial closure devices after percutaneous
procedures are lacking. We assessed the procedural success rates of
the most recent products of two commonly used closure devices.
Methods: From November 2004 up till now, all consecutive patients undergoing
percutaneous coronary procedures, either diagnostic or interventional, using
femoral access, were randomised to Angio-Seal or Closer S (Perclose). A
single operator with a large experience with both devices, (utilizing them both
more than 1000 times) performed all the femoral artery closure procedures.
The primary end-point was the rate of acute failure of the closure device.
Results: Overall, 214 patients were randomised either to Closer S (101) or
Angio-seal (113). The two groups were well balanced, apart from a higher
rate of diabetic patients in the Closer S group. The rate of acute failure
of Closer S 11 cases (11.3%) was significantly higher than Angioseal 3
cases (2.7%) (p=0.02). The overall rate of minor haematomas was similar
8.9% in Closer S and 11.5% in Angioseal p = 0.654. There were 2 major
complications all in the Closer S group (2%):1 thrombotic femoral artery
occlusion and 1 retroperitoneal haematoma not related to the closure device.
Conclusions: This is the first study, to our knowledge, to compare in a
randomised fashion a collagen plug vs. a suture-based closure device. Of
note all the procedures were performed by a single operator with a large
experience with both devices, despite this the acute failure rate of Closer S
was considerably higher than Angio-seal.
TCT-245
Radial Artery Cannulation for Coronary Angiography and
Angioplasty Results in Sustained Impairment of Radial Artery
Function
Jason M Burstein, Dominica Gidrewicz, Stuart J Hutchison, Kate Holmes,
Warren J. Cantor
St. Michael’s Hospital, Toronto, ON, Canada
Background: The radial artery is commonly used as a conduit for
coronary artery bypass grafting (CABG). As many patients considered
for CABG have had prior radial procedures it is important to understand
any effects radial sheath insertion may have on radial artery function.
Methods: Fourteen patients undergoing elective coronary angiography or
angioplasty with a 6 french sheath via the right radial artery were studied.
Radial artery function was assessed using ultrasound to measure flowmediated dilatation (FMD). Reactive hyperemia was produced by 5 minute
cuff inflation on the arm to suprasystolic pressures. Radial artery diameter
was measured at resting state and one minute post cuff deflation. FMD was
expressed as the % change in radial diameter relative to the resting state.
The left radial artery was studied as a control. Patients were studied pre
sheath insertion, immediately post procedure, and 6 weeks post procedure.
Results: The FMD of the cannulated arm was 13.2% pre sheath
insertion versus 1.8% immediately post procedure (p = 0.005), and
1.3% (p=0.02) at 6 weeks post procedure. There were no significant
changes in the non-cannulated arm at either time point (figure 1).
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TCT-246
Propensity Analysis of Vascular Complications after Cath and
Percutaneous Coronary Intervention 1998-2003
Robert J Applegate, Matthew T. Sacrinty, Michael A. Kutcher, Talal T.
Baki, Sanjay K. Gandhi, Renato M. Santos, William C. Little
Wake Forest University School of Medicine, Winston-Salem, NC
Context. Recent meta-analyses suggest that vascular closure
devices may be less efficacious compared to manual compression
for femoral artery access site management. However, substantial
heterogeneity within and between studies, and small study sizes
with limited operator experience may have biased the results.
Objectives. To evaluate the risk of vascular complications after manual
compression and vascular closure devices for femoral artery bypass
site management using propensity-matched case-control analysis.
Design, Setting, and Patients. 24,018 consecutive diagnostic
cath
(n=14,452)
and
percutaneous
coronary
intervention
procedures (n=9,566) performed via a femoral access at a single
site (WFUBMC) between 1998 and 2003 were evaluated.
Main Outcomes Measures. Propensity to receive a vascular closure
device was calculated, and propensity matching of vascular closure device
and manual compression was used to create case-control cohorts. The
absolute incidence of in-hospital vascular complications, the odds ratio
(OR), and 95% confidence intervals comparing the incidence of vascular
complication after VCD use and manual compression were assessed.
Results. The absolute incidence of any vascular complication was 1.3% for
vascular closure device use and 1.4% for manual compression, p=NS. After
propensity matching, the odds ratio for any vascular complication of vascular
closure device vs. manual compression (n=14,256) was 0.83 (0.62-1.10) for
the entire group, 0.70 (0.45-1.11) for diagnostic cath (n=7,556), and 0.93
(0.64-1.35) for percutaneous coronary intervention procedures (n=6,480).
Conclusion. In this large single center observational study, the absolute
incidence of vascular complications was low after both vascular closure
device use and manual compression. In well-matched patients, vascular
complications after vascular closure device use were similar to or lower
than manual compression in diagnostic cath and percutaneous coronary
intervention patients. These data confirm the safety of vascular closure
devices in an experienced program.
TCT-247
Rapid Ambulation Protocol in 606 Patients after Diagnostic Cardiac
Catheterization
Henry H Ting, Brent A Konz, Ryan J Lennon, John F Bresnahan,
Charanjit S. Rihal
Background: Current clinical practice in diagnostic catheterization
using the femoral approach requires 2 to 4 hours of bed-rest after
manual compression prior to patient ambulation. Prolonged bedrest may be associated with patient discomfort. Vascular closure
devices have shortened time to ambulation, but are associated with
catastrophic complications including arterial thrombosis and infection.
Methods: We studied the safety and efficacy of a rapid ambulation protocol
with 1 hour of bed-rest after manual compression. We report the outcomes
in 606 consecutive patients who underwent outpatient diagnostic cardiac
catheterization using a 5 French femoral sheath. Exclusion criteria included
severe peripheral vascular disease, patient not able to ambulate, and
activated clotting time >180 seconds. Ambulation was defined as the patient
being able to walk 100 feet in the recovery room area without assistance.
Results: After hemostasis was achieved by manual compression, the
median time to ambulation was 70 minutes (95%CI 69-71). Observed minor
complications included hematoma <4cm in 21 patients (3.5%, 95%CI 2.2%5.3%). Re-bleeds requiring repeat manual compression occurred in 4 patients
during bed-rest (0.7%, 95% 0.2%-1.7%), in 5 patients during ambulation
(0.8%, 95%CI 0.3%-1.9%), and in 1 patient after bed-rest and ambulation
(0.2%, 95%CI 0.01%-0.9%). No patients had major complications including:
hematoma >4cm, blood transfusion, retroperitoneal bleed, arterio-venous
fistula, pseudoaneurysm, infection, arterial thrombosis, and vascular surgery.
Conclusions: A rapid ambulation protocol after diagnostic cardiac
catheterization using a 5 French femoral approach is safe and effective,
achieving success in over 95% of patients. Only minor complications
including hematoma <4cm and re-bleeds were observed at rates comparable
to historical values. A rapid ambulation protocol limits the clinical and cost
utility of vascular closure devices in diagnostic cardiac catheterization.
roll-in (n=113), diagnostic (n=208), and interventional (n=275)
arms. This presentation reviews the data from the diagnostic and
interventional cohorts. Primary endpoints included incidence of major
vascular complications and time to hemostasis (TTH) through 30 days.
Secondary endpoints included minor vascular complications, device and
procedure success, and time to ambulation (TTA) and discharge (TTD).
Results: The 30-day results for the diagnostic StarClose cohort compared
favorably to the control. There were no major vascular complications.
The minor vascular complications were 2.2% (3/136) for the StarClose
group and 1.4% (1/72) for the control group (p=1.000). When compared
to manual compression, the StarClose device substantially reduced
median TTH from 15.00 to 0.28 minutes and average TTA from 269+135
to163+105 minutes (p<0.001). Furthermore, TTA and TTD suggest
that StarClose allows the subject to ambulate 2 hours earlier and be
discharged 2 hours earlier. Procedural success was 100% (136/136)
for each group. Results for the interventional arm will be presented.
Conclusion: The clinical results of this study concluded that the StarClose
Vascular Closure System is non-inferior to standard compression with
respect to the primary safety endpoint of closing arteriotomies in subjects
who undergo percutaneous diagnostic procedures. Data analysis of the
interventional arm will be performed and available in time for presentation
at the TCT meeting.
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TCT-248
The Safety and Efficacy of a Novel Femoral Closure Device: A
Randomized Trial of the StarClose™ Vascular Closure System in the
CLIP Study
James Hermiller1, Charles Simonton2, Tom Hinohara3, Daniel Lee4, Louis
Cannon5, Michael Mooney6, Charles O’Shaughnessy7, Harold Carlson8,
Richard Fortuna9, Carol Anne Yarbrough10, Michael Zapien10, Tony M
Chou10
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St. Vincent Hospital and Health Care Center, Indianapolis, IN;2Carolinas
Medical Center, Charlotte, NC;3Sequoia Hospital, Redwood City, CA;4St.
Mary’s Medical Center of Saginaw, Saginaw, MI;5Northern Michigan
Hospital, Petoskey, MI;6Abbott Northwestern Hospital, Minneapolis,
MN;7EMH Regional Medical Center, Elyria, OH;8Piedmont Hospital,
Atlanta, GA;9Scripps Memorial Hospital, La Jolla, CA;10Abbott Vascular
Devices, Redwood City, CA
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Background: The StarClose™ Vascular Closure System (Abbott Vascular,
Redwood City, CA) utilizes a small flexible nitinol clip to complete a
circumferential, extravascular close of a femoral arteriotomy. A randomized
trial of StarClose was undertaken. At the time of abstract submission, only
the diagnostic data has been analyzed and submitted to FDA. The StarClose
is an investigational device in the United States, limited by Federal law to
investigational use. The StarClose is CE Mark approved in the European Union.
Methods: A total 17 US sites enrolled 596 subjects randomized at a
2:1 ratio to receive StarClose or standard compression (control) of
the arteriotomy after the percutaneous procedure. The study included
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TUESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B)
Acute Coronary Syndromes
Tuesday, October 18, 2005, 9:00 am - 5:00 pm
TCT-249
Inverse Correlation of Culprit Lesion Calcification with Inflammation
in Patients Undergoing Coronary Intervention
Prospero B Gogo, Jr., David J Schneider, Edward F Terrien, Matthew W
Watkins, Burton E Sobel, Harold L Dauerman
University of Vermont, Burlington, VT
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Background:
Culprit
coronary
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calcification
(CLC)
has been associated with a greater risk of adverse events. The
relationship between CLC and adverse inflammatory, clinical,
and angiographic characteristics has not been well defined.
Methods: Sheath samples from 99 patients before PCI were obtained
in a prospective registry. The concentrations of osteoprotegerin and
several markers of inflammation were determined by ELISA. Images
adequate for quantitative coronary angiography were available in 97
patients, and CLC analysis was performed in 99. CLC was defined
as ‘present’ when the lesion could be visualized by x-ray without
contrast dye. All comparisons were made with the Mann-Whitney test.
Results: Patients with CLC were older (p<0.001), had a lower
hemoglobin (p=0.02), did not smoke (p=0.02), and had reduced
creatinine clearance (p<0.001). Procedural and angiographic
characteristics were similar for patients with (n=28) and without CLC
(n=71). The concentration of osteoprotegerin (a factor involved in bone
remodeling) was similar in patients with and without CLC (8.8± 3.7
vs. 7.9± 3.2, p=0.33). CLC was associated with reduced intensity of
inflammation before PCI, particularly soluble CD40 ligand (Figure).
Conclusions: Although CLC is associated with clinical variables
known to confer greater risk, culprit lesion calcification is associated
with decreased intensity of inflammation. This may reflect less
instability of calcified lesions compared with non-calcified lesions.
TCT-250
Serial Assessment of TIMI Risk Score at Emergency Department
Improves Indication to Immediate PCI in Chest Pain Patients Initially
Triaged as ‘Low-Risk’
Francesco Pelliccia1, Paolo Salvini2, Domenico Cartoni2, Bruno Polletta2,
Christian Pristipino1, Vincenzo Pasceri1, Vincenzo Pasceri1, Giuseppe
Richichi1, Pietro Tanzi2
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San Filippo Neri Hospital, Rome, Italy2San Camillo Hospital, Rome, Italy
Background: TIMI risk score is commonly estimated at Emergency
Department (ED) in patients with acute chest pain in order to identify those
at intermediate or high risk who need immediate PCI. However, it remains
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undefined if serial re-evaluations of the score during the ED stay are warranted
in patients initially triaged as ‘low-risk’. Accordingly, the aim of our study
was to assess prospectively the frequency and timing of changes in TIMI Risk
Score during the observation period at ED in this subset of chest pain patients.
Methods: Of a total of 4333 patients who were triaged at ED over a 1-year
period in 2003 because of acute chest pain, 1747 patients (40%) were riskstratified as ‘low risk’ on the basis of a TIMI risk score 0-2, and were managed
further at our CPU according to recently developed critical pathways. Pathways
include a protocol for ruling out myocardial infarction (i.e. q3 hour ECGs and
serum markers of myocardial necrosis for 6 hours) as well as pre-specified
indications for Doppler echocardiography, continuous 12-lead ST-segment
monitoring, and exercise stress testing. During the observation period at ED,
all patients had TIMI risk score re-evaluation every hour over a 6-hour period.
Results: During ED stay, TIMI risk score became 3 or higher in 1095
patients (63%, Gr.A), while it did not change in the remaining 652 patients
(37%, Gr.B). Timing of change in TIMI risk score was <1 hour from arrival
in 7.3% of patients, <2 hours in 9.1%, <3 hours in 11.7%, <4 hours in 17.7%,
and <6 hours in the remaining 16.8%. Compared to Gr.B, Gr.A patients were
significantly (p<0.05) more likely to be female (34% vs 21%), hypertensive
(44% vs 24%), hyperlipidemic (67% vs 33%) and to have had a prior MI (19%
vs 6%) or PCI/CABG (21% vs 3%). A greater proportion of Gr.A patients were
transferred to the cath lab for immediate PCI (10% vs 2%, p<0.05), while more
Gr.B patients were discharged home directly from ED (65% vs 32%, p<0.05).
Conclusion: TIMI risk score may change soon after arrival at ED in half of
patients with acute chest pain initially triaged as ‘low-risk’. Serial assessment
of the TIMI risk score during the ED observation period is mandatory to
improve indication to immediate PCI in this subset of chest pain patients.
TCT-251
Clopidogrel Effect in Patients with Acute Coronary Syndromes
without ST-Segment Elevation
Armando Perez de Prado, Felipe Fernandez-Vazquez, J. Carlos Cuellas
Ramon, Norberto Alonso-Orcajo, Cristina Pascual Vicente, Raul
Carbonell de Blas, Alejandro Diego Nieto, Antonio De Miguel Castro,
David Alonso RodrÃguez, Beatriz Samaniego LampÃ³n, Cristina Olalla
Gomez, Ramon G Calabozo
Hospital de Leon, Leon, Spain
Background: About 4% to 30% of patients treated with clopidogrel
do not achieve adequate antiplatelet response. Clopidogrel
resistance is a widely used term that remains to be elucidated.
Objective: To assess the degree of platelet aggregation inhibition (PAI)
obtained with clopidogrel treatment in patients with ACS without STsegment elevation and the potential influence of different factors.
Methods: Patients with ACS without ST-segment elevation with an early
coronary angiography at our center were included in this prospective,
observational registry; clopidogrel treatment consisted on a 300 mg-loading
dose on admission + 75 mg/day. PAI was analyzed before angiography
with Ultegra assay system (Accumetrics Inc.) and expressed in PAU
(platelet aggregation units) and % of PAI mediated by P2Y12-receptor
inhibition; specific kits allow to determine the basal aggregation level
(in absence of GP IIb/IIIa inhibitors) and clopidogrel-related inhibition.
Results: 65 patients were included (77% male, 69±10 years old,
28% diabetics, 29% previous MI, 24% previous PCI or CABG, 33%
multivessel disease). 62% of patients showed criteria of NSTEMI;
63% were classified as high-risk patients (TIMI risk score >3). PAI
followed a normal distribution with mean value of 45% of basal values
(SD 19%). The degree of PAI achieved was significantly lower among
patients treated with statins (43±18% vs 60±20%, p=0.01) and those
with shorter time on clopidogrel (less than 12 hours 35±17% vs the rest
45±18%, p=0.02). Patients with previous antiplatelet treatment (49%
of total) reached similar degree of PAI than those without it, although
they tended to have higher basal platelet aggregation levels (297±61 vs
272±40 PAU, p=0.06). No other significant relationship was detected.
Conclusion: In our series, the response to clopidogrel in patients with ACS
without ST-segment elevation treated with 300 mg loading-dose + 75 mg/d
dosis follows a normal distribution. Lower values of platelet inhibition were
observed in patients treated with statins and with shorter time on clopidogrel
treatment. Previous antiplatelet treatment didn´t seem to affect the degree of
platelet inhibition achieved.
TCT-252
Early Invasive Treatment Benefits Patients with Reduced Creatinine
Clearance in Unstable Coronary Artery Disease
Nina Johnston, Tomas Jernberg, Bo Lagerqvist, Lars Wallentin
Medical Sciences, Uppsala, Sweden
Background: Renal dysfunction is associated with a worse prognosis in
patients with unstable coronary artery disease (CAD). The effects of an early
revascularization in relation to different levels of renal function are unknown.
Methods: Patients (n=2457) with unstable CAD randomized to a noninvasive or invasive treatment strategy in the Fast Revascularisation
during InStability in Coronary artery disease trial (FRISC-II)
were stratified according to tertiles of creatinine clearance (CrCl
<69 ml/min, CrCl 69-90 ml/min, CrCl>90 ml/min) and followed
for 2 years regarding death and/or myocardial infarction (MI).
Results: In the non-invasive cohort the rate of death or MI at 2 years
was 22.4% at CrCl <69 ml/min, 14.6% at CrCl 60-90 ml/min and 11,6%
at CrCl >90 ml/min. In the invasive cohort, there was a reduction in the
rate of death or MI to 14.6 % (p=0.003) at CrCl <69 ml/min and to 9.9
% (p=0.048) at CrCl 69-90 ml/min but no significant reduction 11.2 % at
CrCl >90 ml/min. Two year mortality was higher 9.6 % at CrCl <69 ml/
min compared to CrCl 69-90 ml/min 2.4% and CrCl >90 ml/min 3.9% and
the corresponding rates were numerically lower in the respective invasive
subgroups 6.8% (p=0.138), 2,7% (p=0.758) and 1.3% (p=0.020). For MI
the findings were concordant with the results of the combined endpoint. In
a logistic regression analysis including several variables associated with
prognosis, CrCl <69 ml/min was independently associated with the risk for
future death and MI in the non-invasive group while only the independent
association to death but not to MI was maintained in the invasive group.
Conclusion: An early invasive treatment strategy reduces the long-term risk
of future death and MI in patients with unstable CAD and reduced CrCl.
TCT-253
Cornary Sinus Temperature Changes during Myocardial Ischemia
Hossein Eftekhari1,2, Saeed Payvar1,2, Amany Ahmed2, Muhammad S
Munir2, Shubha Asopa2, Navid Sadeghi1, Vishnu Reddy1, Abdi Rasekh2,
James M. Wilson3, Ali Massumi2, S. Ward Casscells1,2
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University of Texas Health Science Center -Houston, Houston, TX;2Texas
Heart Institute, Houston, TX;3Texas Heart Insitute, Houston, TX
Introduction: Diagnosis of myocardial ischemia is often missed
or confounded. Myocardial ischemia causes changes in the heat
production of the heart and almost half of the heat that is produced
by the heart is transferred by the coronary blood flow. We therefore
hypothesized that coronary sinus temperature (CST) monitoring can
help evaluate cardiac energetic and diagnose myocardial ischemia and
here we report the effect of transient coronary occlusion on coronary
sinus temperature during percutaneous coronary intervention (PCI).
Methods: We prospectively enrolled 18 patients who were undergoing
elective PCI. CST was continuously recorded using the temperature sensor
of Radi Pressure Wire (Radi Medical Inc., Reading, MA, USA), 100 samples
per second with a resolution of 0.05°C. Statistical analysis was done using
polynomial regression and linear mixed effects model. We compared the effect
of first, second and third occlusion of the angioplasty balloon to study the trend.
Results: Fifteen patients (83.33%) were male and 3 patients (16.67%)
were female. The mean age was 64.4 years and mean LVEF was
48.5%. Eleven patients (61.11%) had history of bypass surgery.
Fifteen interventions (83.33%) were done on the left coronary system
and nine (50%) of all interventions were done on grafted vessels.
CST monitoring revealed an increase in temperature by 0.0415°C
(P<.0001) during the first balloon occlusion, 0.0138°C (P<.0001)
during second, and 0.0294°C during the third occlusion respectively
with an average value of 0.0253°C (P<.0001). The decremental trend
of CST rise during subsequent balloon occlusions could indicate the
preconditioning effect of sequential balloon occlusions and/or can be
secondary to decrease in the severity of stenosis after first balloon inflation.
Conclusion: Myocardial ischemia is associated with an increase in coronary
sinus temperature. The study of coronary sinus temperature may provide
new information on the physiology of the heart function, and merits further
evaluations.
TCT-254
Baseline and Follow-Up Three-Vessel Intravascular Ultrasound
Evaluation of Culprit and Non-Culprit Lesions in Acute Coronary
Syndromes
Kenichi Fujii1, Gary S Mintz1, Satoru Sumitsuji2, Mitsuyasu Terashima3,
Hiroyuki Okura4, Toru Kataoka5, Motomaru Masutani6, Mitsumasa
Ohyanagi6, Kenei Shimada5, Haruyuki Taguchi4, Kojiro Awano7, Yuji
Yasuga2, Martin B Leon1, Stephane G Carlier1, Yoshio Kobayashi8
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Columbia Medical Center and Cardiovascular Research Foundation,
New York, NY;2Rinku General Hospital, Izumisano, Japan3Toyohashi
Heart Center, Toyohashi, Japan4Bell Land General Hospital, Sakai,
Japan5Osaka City University, Osaka, Japan6Hyogo College of Medicine,
Nishinomiya, Japan7Miki City Hospital, Miki, Japan8Chiba University,
Chiba, Japan
Background: Ruptured plaques are seen not only in culprit lesions, but
also in non-culprit lesions in acute coronary syndrome (ACS) pts. Studies
suggest that these non-culprit lesions lead to recurrent ACS episodes and/
or rapid progression requiring percutaneous coronary intervention (PCI).
Methods: The Japan-ACS trial is a prospective, multicenter trial of 3-vessel
intravascular ultrasound (IVUS) in ACS pts. IVUS was attempted in all 3
major coronary arteries (at least 2/3 of each artery) in a total of 120 pts with
a first ACS (myocardial infarction in 75%) at baseline and 6mos follow-up
(FU). Culprit plaque ruptures were treated with stent implantation; nonculprit plaque ruptures were left untreated if angiographically insignificant.
Results: Pre-PCI IVUS could be performed in 99 culprit and 208 nonculprit arteries; non-culprit arteries contained 232 moderate lesions (plaque
burden >50% and angiographic diameter stenosis <50%) in which PCI was
deferred. Plaque rupture morphology was observed in 47 culprit lesions
(47%), but in only 20 non-culprit lesions (17% of pts) of which 14/20 were
located in a non-culprit artery (6.7% of arteries). To date, 6-month FU
angiography has been performed in 88%, and FU IVUS in 69%. Among the
untreated, non-culprit plaque ruptures, there was no change in lumen area or
plaque burden (8.6±1.3 to 7.7±2.1mm2, p=0.3, and 65±7 to 70±8%, p=0.2).
However, FU IVUS also demonstrated 6 new plaque ruptures associated
with an increasing plaque burden (71±6 to 76±9%, p=0.10), but no change
in lumen area (4.9±1.9 to 4.9±1.6mm2, p=0.9). Although there were no
recurrent ACS episodes during FU, PCI was required in 13 pts (13% of pts
and 5.6% of moderate, non-culprit lesions) not because of plaque rupture,
but because of stenosis progression in the absence of new plaque rupture
(IVUS minimum lumen area decreased from 4.1±1.6mm2 to 2.6±0.7mm2,
p<0.001, and plaque burden increased from 72±06 to 81±2%, p=0.001).
Conclusions: Multiple plaque ruptures occur only infrequently in ACS pts.
Non-culprit plaque ruptures tend to remain stable, and additional plaque
ruptures are infrequent. Plaque rupture is not required for symptomatic
stenosis progression in these pts.
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TCT-255
Peroxisome Proliferator-Activated Receptor γ Ligands Activates
Platelets Nitric Oxide Synthase in Patients with Acute Coronary
Syndromes
Ge Junbo1, Kang Yao, Rongchong Huang, Xu Biao2, Gao Ling
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Cardiology,Gulou Hospital,Nanjing University, Nanjing, China
Background Platelet-derived nitric oxide is an important regulator of platelet
function. It has been shown that acute coronary syndrome(ACS)patients
have reduced basal platelet NO release, which may possibly contribute to the
thrombus formation. Recently peroxisome proliferator-activated receptor
γ(PPARγ) ligand have been shown to have direct antiatherogenic and
antithrombotic effects. The relationship between peroxisome proliferatoractivated receptor γ(PPARγ) ligand and platelets NO release in ACS patients
remains unclear until now. We here investigated effects of PPARγ ligand on
platelet NO generation in acute coronary syndrome patients and control subjects
Methods Platelets isolated from blood taken from thirteen ACS and ten
healthy control subjects of similar age were treated with rosiglitazone
(5,10,20 μmol/l), a PPARγ stimulator, or vehicle in the absence or presence
of histamine or nitro-L-arginine methyl ester (L-NAME). Platelet nitric
oxide synthase(NOS) activity was measured by L- [3H] arginine to L[3H] citrulline conversion, cyclic GMP content by radioimmunoassay,
and nitric oxide synthase type 3 expression by western blotting.
Results Basal platelet NOS activity was lower in ACS patients than in
control subjects, (385.2±24.6 pmol/108 platelets, vs. 805.7±78.2 pmol/108
platelets; p<0.05). Rosiglitazone significantly stimulated platelets
NOS and cyclic cGMP formation in a dose-dependent manner, and
treatment of platelets with rosiglitazone (10 μmol/L) for 1h significantly
increased serine phosphorylation level of eNOS in ACS patients.
Conclusions Platelet NO generation is impaired in ACS patients. PPARγ
ligand rosiglitazone could activate platelets eNOS and increase NO
production possibly through enhancing eNOS -serine phosphorylation.
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TCT-256
The Influence of Body Mass Index on Mortality Following
Percutaneous Coronary Intervention in Those Presenting with
Unstable Angina or non-ST Elevation Myocardial Infarction: Is There
an Obesity Paradox?
Jennifer A Tremmel1, Richard E Shaw2, David P Lee1
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Stanford University Medical Center, Stanford, CA;2Sutter Pacific Heart
Centers, San Francisco, CA
Background: Obesity is associated with excess morbidity and mortality,
yet there is evidence of a paradox in which overweight (BMI 25-29.9)
and obese (BMI ≥30) subjects have better outcomes following MI or PCI.
Methods: Using the ACC National Cardiovascular Data Registry,
we analyzed data on 357,510 consecutive UA/NSTEMI patients
undergoing PCI at over 400 US cath labs from 2001-2004.
Results: Subjects with a BMI <25 were more likely to present with renal
failure, lung disease, shock, EF <35%, and a history of CVA or PVD (all
p<0.000). They were also more likely to have severe CAD, require an IABP
or urgent/emergent PCI, and have worse peri- and post-procedural outcomes
including MI, shock, CHF, unsuccessful procedure with TIMI <3 flow, longer
hospital stay, and in-hospital death (all p<0.002). After risk adjustment with
a previously validated model, the higher mortality observed in those with
a BMI <25 was attenuated. However, those with a BMI ≥30 were found
to have a significantly higher adjusted than observed mortality (p<0.01).
Conclusion: This is the largest analysis of the obesity paradox in
patients with UA/NSTEMI undergoing PCI. With the exception of
the morbidly obese (BMI ≥40), overweight and obese patients have
the lowest in-hospital mortality. The adjusted mortality of the obese
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patients, however, is significantly higher than the observed mortality,
indicating the presence of a strong, unidentified risk contributor. This
contributor to mortality seen in obese patients may be obesity itself.
TCT-257
Target Lesion Remodeling Affects Long Term Clinical Outcome in
Patients with Acute Coronary Syndrome
Hiroyuki Okura, Haruyuki Taguchi, Tomoichiro Kubo, Kazuya Iwata, Shin
Mizoguchi, Iku Toda
Bell Land General Hospital, Sakai, Japan
Background: Although intravascular ultrasound (IVUS) studies
have shown that positive remodeling (PR) is a predominant
pattern of lesion remodeling in pts with acute coronary
syndrome (ACS), its impact on clinical outcome is unknown.
Objective: The aim of this study was to clarify impact of target lesion
remodeling on long term prognosis following stenting in pts with ACS. One
hundred and thirty four patients with ACS were enrolled. External elastic
membrane cross sectional area (EEM CSA) and lumen CSA were measured
by IVUS. Plaque plus media (P+M) CSA was calculated as EEM minus lumen
CSA. Final minimal stent area (MSA) was also measured after stenting. PR
was defined as EEM CSA at the target lesion greater than that of proximal
reference. Intermediate or negative remodeling (IR/NR) was defined as
EEM CSA at the target lesion less that or equal to that of proximal reference.
Results: IVUS revealed PR at the target lesion in 83 (62%) patients, and
IR/NR in 51 (38%) lesions, respectively. MSA following stenting was not
different between PR and IR/NR (8.3±2.6 vs. 8.3±2.3 mm2, p=NS) . During
2years of follow-up, event (death, MI, TLR and non-TLR)-free survival was
significantly lower in pts with PR than in pts with IR/NR (logrank p=0.001).
Conclusions:
Target
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TCT-259
Cardiovascular Disease Risk Factors
TCT-258
Relationship between Renal Insufficiency and Outcomes in Patients
Undergoing Percutaneous Coronary Interventions: A Report from the
National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry
Oscar C Marroquin1, Faith Selzer1, Suresh R Mulukutla1, Kevin E Kip1,
Michael Metzger1, Warren Laskey2, Robert L Wilensky3, Elizabeth M
Holper4, Howard A Cohen5, David O Williams6
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University of Pittsburgh, Pittsburgh, PA;2University of New Mexico,
Alburquerque, NM;3University of Pennsylvania, Philadelphia,
PA;4University of Chicago, Chicago, IL;5Lenox Hill Hospital, New York,
NY;6University of Rhode Island, Providence, RI
Introduction: End-stage renal disease (ation rates [GFR<10 ml/min/1.73m2)
is associated with adverse cardiovascular outcomes in patients undergoing
PCI. However, the impact of less severe renal dysfunction in PCI patients
is unknown. We hypothesized that milder degrees of renal dysfunction
are associated with adverse cardiovascular outcomes in PCI patients.
Methods: Six-month outcomes were prospectively collected on
3862 consecutive patients who underwent PCI in Waves 3 and 4
of the NHLBI Dynamic Registry between July of 2001 and June
of 2004. The GFR was estimated by means of the four-component
Modification of Diet in Renal Disease equation with patients
categorized into one of four groups according to their estimated GFR.
Results: Patients in the lowest GFR group (10-44.9) were older, had a
higher prevalence of diabetes, prior CABG, CHF, multivessel disease,
lower ejection fraction and more cardiogenic shock compared to patients
with higher estimated GFRs. Angiographic success and DES use was
similar in all GFR groups. The unadjusted risk of death (figure) increased
with declining estimated GFRs. After adjusting for baseline differences, a
low GFR (10-44.9) remained an independent predictor of 6-month mortality
(RR 2.04, 95% CI 1.04-4.02, P<0.05) when compared to a normal GFR
(>75). Conclusion: Moderate to severe renal dysfunction is an independent
predictor of death in PCI patients. Aggressive cardiovascular risk factor
modification should be considered in this high risk population.
Left Atrial Appendage Occlusion to Prevent Stroke in Suboptimal
Warfarin Candidates: European Multicenter Registry Trial
Michaela Leetz1, Heyder Omran2, Leif Thuesen3, Maximilian Pichler4,
Edward Rowland5, Antonio Bartorelli6, Pedro Brugada7, P. W. Serruys8,
Werner Budts9, Angelo Ramondo10, Alec Vahanian11, Peter Probst12, Gilles
Montalescot13, Jean-François Piéchaud14, Karl-Heinz Kuck15, Witold
Ruzyllo16, Jean Marco17, Thomas Wichter18, Eulogio Garcia19, Eustaquio
Onorato20, Stefan Ostermayer1, Yves Bayard1, Evelyn Fischer1, Hannelore
Lißmann-Jensen1, Horst Sievert1
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CardioVascular Center Frankfurt, St. Katharinen Frankfurt, Germany,
Frankfurt, Germany2Sankt Marien Hospital, Academic Center of the
University of Bonn, Bonn, Germany, Bonn, Germany3Skejby Sygehus,
Aarhus, Denmark, Aarhus, Denmark4Landeskrankenhaus Salzburg,
Salzburg, Austria, Salzburg, Austria5St Georges Hospital, London,
United Kingdom, London, United Kingdom6Centro Cardiologico
S.p.A., Milan, Italy, Milan, Italy7O.L. Vrouwziekenhuis, Aalst, Belgium,
Aslat, Belgium8Hartcentrum Rotterdam, Rotterdam, Netherlands,
Rotterdam, Netherlands Antilles9UZ Gasthuisberg, Leuven, Belgium,
Leuven, Belgium10Azienda Ospedaliera di Padova, Padova, Italy,
Padova, Italy11Groupe Hospitalier Bichat, Paris, France, Paris,
France12Allgemeines Krankenhaus Vienna, Vienna, Austria, Vienna,
Austria13Groupe Hospitalier Pitié-Salpêtrière, Paris, France, Paris,
France14Institut Cardiovasculaire Paris Sud, Massy, France, Massy,
France1515Allgemeines Krankenhaus St. Georg, Hamburg, Germany,
Hamburg, Germany16Institute of Cardiology, Warsaw, Poland, Warsaw,
Poland17Clinique Pasteur, Toulouse, France, Toulouse, France18Univers
itätsklinikum Münster, Münster, Germany, Münster, Germany19Hospital
General Universitario, Madrid, Spain, Madrid, Spain20Humanitas
Gavazzeni, Bergamo, Italy, Bergamo, Italy
Background: Anticoagulation with warfarin is the standard therapy
to decrease the risk of stroke in patients with atrial fibrillation who
at moderate to high risk for stroke. However, many of these patients
have a contraindication for warfarin therapy. More than 90 % of
thrombi accounting for cerebral ischemia form in the left atrial
appendage (LAA). Therefore, the PLAATO™ (Percutaneous Left
Atrial Appendage Transcatheter Occlusion) procedure is intended to
occlude the LAA in order to eliminate this source for thromboembolism.
Methods: The device is a self-expanding cage covered with ePTFE. It is
delivered through a 12 French transseptal sheath especially designed to
access the LAA. The PLAATO device is retrievable before release and
can be replaced by an alternate size to optimize occlusion and position. In
the PLAATO™ European registry, 180 patients were enrolled. Inclusion
criteria were atrial fibrillation (AF) with inability to take warfarin, prior
cerebral ischemia and/ or at least two clinical risk factors for stroke. Follow
up was performed with X-ray, TEE and NIH stroke scale at regular intervals.
Results: Device implantation was technically successful in 162 out of 180
patients (18 patients enrolled but not implanted due to challenging LAA
anatomy or large LAA diameter which did not allow for implantation).
In one patient, the device embolized but was successfully snared and
retrieved; a larger device was successfully implanted in the same procedure.
The average procedure time was 75min. At present, there are 83 years of
documented patient follow-up. According to the CHADS2 score, the
mean expected annual risk of stroke for the patients enrolled was 8.2%.
Of the patients implanted, only two patients suffered a stroke (1 at 27
days post implant and 1 at 15 months post-implant). Thus, the yearly
incidence of stroke after implantation is 2.4%. The estimated risk reduction
is 70.7%. During follow up, five patients died from unrelated causes.
Conclusions: Left atrial appendage transcatheter occlusion with the
PLAATO device is feasible and safe. This method should be considered to
decrease the risk of stroke in moderate to high risk AF patients if they have
a contraindication to anticoagulation therapy.
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TCT-260
Early and Late Results of Percutaneous Revascularization in Patients
with Ischemic Cardiomyopathy and Decreased Left Ventricular
Ejection Fraction- REHEAT Registry
Pawel Buszman1, Iwona Szkrobka1, Krzysztof Milewski1, Zofia Tendera2,
Agata Gruszka1, Bożena Białkowska1, Radoslaw Parma2, Wojciech
Wojakowski2, Marek Krol2, Andrzej Bochenek3, Michal Tendera2
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Acute Coronary Care Unit, Upper-Silesian Center of Cardiology,
Katowice, Poland23rd Department of Cardiology, Upper-Silesian Center
of Cardiology, Katowice, Poland31st Department of Cardiac Surgery of
the Silesian Medical Academy, Katowice, Poland
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Objective: REvascularization in Ischaemic HEart Failure Trial
(REHEAT) is a registry prospectively evaluating the outcomes of
percutaneous myocardial revascularization in postinfarction patients
with ischemic cardiomyopathy and various categories of surgical risk.
Methods: One hundred seventy consecutive postinfarction patients
with LVEF <40% and angiographically documented coronary stenoses
eligible for PCI were enrolled to the study. The study end-points
included: angiographic success of PCI, major adverse events at 30
days and 1 year after procedure, long-term survival, functional status
(CCS and NYHA class) and LVEF 12 months after the intervention.
Results: Angiographic success rate was 98.8% and complete
revascularization was achieved in 38.8% cases. No periprocedural
deaths were registered. Thirtieth-days survival was 97% and was better
in comparison to calculated survival for CABG patients; 1-year survival
was 94.4% and was not inferior to predicted survival after CABG.
In general study population a significant improvement of LVEF (27.6 ±7.0
to 37.4 ±13.6%) was shown (absolute change mean 8.16 ±10%). In low/
intermediate risk group the LVEF increase was lower (6.5 ±10.9) in comparison
to high risk group (10.3 ±9.6%). In both groups a significant and comparable
reduction of angina and heart failure severity was shown in 1-year follow-up.
Conclusion: PCI in postinfarction patients with markedly reduced LVEF
is associated with a significant increase of LVEF and favorable clinical
outcome (CCS and NYHA class). PCI is safe, feasible and can be an
alternative approach to CABG both in low/intermediate and high surgical
risk patients.
TCT-261
Myocardial Revascularization in Patients with Ischaemic
Cardiomyopathy and Low Left Ventricular Ejection Fraction:
A Comparison between Coronary Artery Bypass Surgery and
Percutaneous Coronary Interventions
Pawel Buszman1, Miroslaw Wilczynski2, Iwona Szkrobka1, Agata Gruszka1,
Radoslaw Parma3, Zofia Tendera3, Blanka Lesko3, Krzysztof Milewski1,
Wojciech Wojakowski3, Andrzej Bochenek2, Michal Tendera3
1
Acute Coronary Care Unit, Upper-Silesian Center of Cardiology,
Katowice, Poland21st Department of Cardiac Surgery of the Silesian
Medical Academy, Katowice, Poland33rd Department of Cardiology,
Upper-Silesian Center of Cardiology, Katowice, Poland
Purpose: to assess the hypothesis that surgical (CABG) and percutaneous (PCI)
revascularization in pts with ischaemic cardiomyopathy and low LVEF are
associated with comparable clinical outcomes and improvement of the LVEF.
Methods: The study population consisted of 141 pts with ischaemic
dysfunction of the LV and LVEF <40% and angiographically confirmed
CAD eligible for both CABG and PCI. Primary end-point was improvement
of LVEF 12 months after the intervention assessed in 2D echocardiography.
Secondary end-points were: in-hospital MAE, length of hospitalization,
exercise tolerance in ECG treadmill stress test after 12 months, 1-year survival,
1-year event-free survival, angina severity according to CCS scale and heart
failure severity according to NYHA class after 12 months. Case-controlled
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study included 55 patients in PCI and 54 in CABG group. Both groups did
not differ in respect to base demographic, clinical and angiographic data.
Results: The increase of LVEF after 12 months was comparable in both
groups [39.3 ±9.6% in PCI group (p=0.005 vs. baseline) and 39.2 ±8.8% in
CABG group (p=0.055 vs. baseline)] (p=0.541). The incidence of procedurerelated MAE was higher in CABG group in comparison to PCI group (7.4%
vs. 35.1%, p=0,001). The results of treadmill stress test were similar in both
treatment arms. The mean long-term survival was significantly better in PCI
patients than in CABG group, but the number of cardiovascular serious
adverse events occurring after 30 days post procedure was significantly higher
in CABG group in comparison to PCI (8 vs. 22%, p=0,08) and was mainly
related to repeat PCI. The total survival free of cardiovascular events during
the f-up of mean 13.4 ±9.6 months was comparable in both groups with a
trend towards better outcome in pts treated with PCI (F-Cox test: p=0,028).
Conclusions: In pts with ischaemic cardiomyopathy eligible for
revascularization, PCI is associated with a comparable improvement of LV
systolic function as surgical treatment and offers a better 1-year survival
than CABG, however the incidence of repeat revascularisation is higher in
the PCI group.
TCT-262
Advantage of Drug-Eluting Stents in Patients with Renal
Insufficiency: Analysis from the National Heart, Lung, and Blood
Institute (NHLBI) Dynamic Registry
Suresh R Mulukutla1, Oscar C. Marroqin1, Kevin Kip1, Elizabeth M.
Holper2, Howard A. Cohen3, Warren K. Laskey4, Faith Selzer1
1
University of Pittsburgh, Pittsburgh, PA;2University of Chicago, Chicago,
IL;3Lenox Hill Hospital, New York, NY;4University of New Mexico,
Albuquerque, NM
Introduction: Moderate or severe renal insufficiency (GFR<60 ml/
min/1.73 m2) is associated with adverse outcomes. Drug-eluting stents
(DES) are beneficial in many populations; however, randomized and
large observational studies have not assessed the benefit of DES in
those with reduced GFR. We assessed the hypothesis that 6-month
cardiovascular outcomes in percutaneous coronary intervention (PCI)
patients with reduced GFR and who receive DES would compare
favorably against patients who received bare-metal stents (BMS).
Methods: Using Wave 3 and 4 recruitment cohorts of the NHLBI
Dynamic Registry, comparisons were made between the Wave 3
BMS group(n=1400) and Wave 4 DES group (n=1261). Patients
with ST-segment elevation MI were excluded. GFR was calculated
using the Modification of Diet in Renal Disease equation. Six-month
outcomes included death, MI, CABG, repeat PCI, and MACE.
Results: Patients with reduced GFR (<60) were older than those with
normal GFR and had a higher prevalence of diabetes, congestive heart
failure, and multivessel disease. In multivariable analysis, patients with
reduced GFR treated with DES had significant relative risk reductions of
51%, 55%, and 43% for repeat PCI, repeat revascularization, and MACE,
respectively (Table). These risk reductions were of similar magnitude to
those observed in patients with normal GFR. Conclusions: While reduced
GFR predicts poor outcomes in PCI, this study suggests that DES provide a
significant advantage in this high-risk population.
TCT-264
Percutaneous Coronary Interventions in Octogenarians: Report from
the New York State Angioplasty Registry (2000-2001)
Dmitriy N. Feldman, Robert M. Minutello, Christopher L. Gade,
Alexander J. Slotwiner, Atul Sharma, Jessica Pena, Srihari Naidu, Manish
Parikh, Geoffrey Bergman, Mun K. Hong, S. Chiu Wong
New York Presbyterian Hospital-Weill Medical College of Cornell
University, New York, NY
TCT-263
Effect of Dialysis on Clinical Outcomes Following Percutaneous
Coronary Intervention in Patients with Chronic Kidney Disease
Bong-Ryong Choi, Seong-Wook Park, Bong-Ki Lee, Yong-Hyun Park, SeWhan Lee, Kyoung-Min Park, Kyoung-Ha Park, Young-Hak Kim, Cheol
Whan Lee, Myeong-Ki Hong, Jae-Joong Kim, Seung-Jung Park
BACKGROUND: Dialysis has shown to be related with poor
prognosis after coronary intervention in patients with chronic renal
failure (CRF). This study was designed to evaluate the effect of dialysis
on the clinical outcomes after coronary stenting in CRF patients.
METHODS: This study included consecutive 130 patients with 169
de novo coronary lesions who had CRF defined as a baseline creatinine
≥2.0 mg/dL or estimated glomerular filtration rate of <60 ml/min/1.73
m2, and were divided into 72 patients with dialysis (group I) or 48
patients without dialysis (group II). The composite of cardiac death,
myocardial infarction, target vessel revascularization (TVR) and
rehospitalization by angina recurrence at one year was monitored.
RESULTS: Use of drug-eluting stent was more often in the group I than
in the group II, but it did not reach statistical significance (41% vs. 28%,
p=0.09). By one-year, cardiac mortality rate was 11% in the group I and 8%
in the group II (p=0.76). The rates of TVR (8% in the group I vs. 2% in the
group II, p=0.24) and rehospitalization (10% in the group I vs. 10% in the
group II, p=0.94) were not different between two groups. Therefore, the
one-year rates of the composite events did not differ between two groups
(31% in the group I vs. 21% in the group II, p=0.24) and shown in Figure.
CONCLUSIONS: Our study demonstrated that dialysis was not associated
with adverse clinical outcomes in patients with CRF after coronary
stenting.
Background: Octogenarians have been underrepresented in percutaneous
coronary intervention (PCI) trials despite an increase in referrals for
PCI. As the US population ages, the number of high-risk percutaneous
coronary revascularizations in the elderly will continue to increase. We
sought to investigate if there is an age-associated incremental risk in
post-PCI complications in the emergent vs. non-emergent PCI groups.
Methods: Using the 2000/2001 New York State Angioplasty Registry, we
compared in-hospital death and MACE (death, stroke, or CABG) among 3
age-categories of patients: 10,964 patients undergoing emergent PCI (<60
yrs (n=5,354), 60-80 yrs (n=4,939), >80 yrs (n=671)) and 71,176 patients
undergoing non-emergent PCI (<60 yrs (n=24,525), 60-80 yrs (n=40,869),
and >80 yrs (n=5,782)). Patients were considered to undergo an emergent
PCI if they had an acute MI within 24 hours, thrombolytic therapy within
7 days, and those presenting with hemodynamic instability or shock.
Results: Patients in the >80 years age group had more cardiac and
comorbid noncardiac conditions, including more extensive coronary
atherosclerosis, hypertension, peripheral vascular disease, and renal
insufficiency. Octogenarians undergoing emergent PCI were less
likely to receive thrombolytics, and presented more frequently with
hemodynamic instability or shock. In the emergent PCI group, inhospital mortality (1.0% vs. 4.1% vs. 11.5%, p<0.05) and MACE (1.6%
vs. 5.2% vs. 13.1%, p<0.05) increased incrementally by age group. In
the non-emergent PCI group the rates of in-hospital complications were
considerably lower, with an incremental increase in mortality (0.1% vs.
0.4% vs. 1.1%, p<0.05) and MACE (0.4% vs. 0.7% vs. 1.6%, p<0.05).
Adjusted relative risk of in-hospital death for each increase in age category
was 2.1 for non-emergent PCI group and 3.0 for emergent PCI group.
Conclusions: In octogenarians, non-emergent PCI has favorable outcome
and acceptable short-term mortality. The adjusted relative risk of post-PCI
mortality for older patients, particularly octogenarians, was greater in the
emergent vs. non-emergent PCI group.
TCT-265
Intracoronary Ultrasound Assessment of Plaque Morphology and
Remodeling in Patients with Acute Coronary Syndromes and No
Significant Angiographic Lesion
Van Sy Hoang, Marie Jeanne Alibelli Chemarin, Didier Carrie, Jacques
Puel, Meyer Elbaz
CHU Rangueil, Toulouse cedex 9, France
Background: In patients with acute coronary syndromes
(ACS), positive remodeling is considered as characteristic
of lesions and as a precoce stage of atheroma. But it is not
prouved that this phenomenon is homogeneous along the lesion.
Objectives :This study aimed to evaluate the relationships between
plaque morphology, arterial remodeling and length of lesion in
patients with ACS and no significant coronary angiographic lesion.
Methods: Intravascular Ultrasound (IVUS) was performed in 54 pts
(47±13 years) after ACS with midly angiographic lesion (< 50% diameter
stenosis). Lesion composition was classified visually as soft, hard or
mixed. Plaque ruptures were identified. The longitudinal views were
linked to the individual cross-sectionnal images slices and computerized
planimetry was used to measure lumen CSA, EEM CSA every 0.3mm
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along the lesion and on proximal and distal reference sites. The arterial
remodeling was described by remodeling index (RI) calculated as lesion
EEM CSA / mean reference EEM CSA. Remodeling was considered as
positive if RI >1.05, negative si < 0.95 and intermediate if < 1.05 and
>0.95. The average RI on the lesion segment and RI at the worst narrowed
site (minimal MLD) were compared according to the length of lesion.
Results: One pt showed an intimal thickening. Soft plaques were present
in 27 pts (50%), hard plaque in 5 pts (9%) and mixed plaque in 22 pts
(41%).Plaque ruptures were visualized in 30 % pts with thrombus in
20 pts. A total of 15734 cross sections, 285±138/pt, were analyzed.
The total segment of the lesion showed an average RI at 1.05±0.16 .
Remodeling was positive in 20 pts (11 soft plaque, 7 mixed plaque and
2 hard plaque), intermediate in 18 pts and negative in 16 pts ( 9 soft
plaque, 6 mixed plaque and 1 hard plaque). According to the length, lesion
≥ 20mm showed average RI lesion at 1.04 ± 0.21 vs RI at the minimal
MLD at 0.91 ± 0.2 (p<0.05). Pts with short lesion showed an average
RI lesion at 1.05 ±0.14 vs 0.97 ± 0.17 (p=ns) at the minimal MLD.
Conclusion: Remodeling is not an homogeneous phenomenon along the
lesion. Positive remodeling is not the only characteristic of ACS with
vulnerable plaque : negative remodeling may occur earlier in the progression
of atheroma.
TCT-266
Sub-Intimal Necrotic Core Tissue in Close Contact with the Lumen
is an Independent Predictor of the Presence of Highly Deformable
Regions: Insights from Intravascular Ultrasound Radiofrequency
Data Analysis
Gaston A Rodriguez-Granillo1, Héctor M García-García1, Marco
Valgimigli1, Ravindra Pawar2, Pim de Feyter1, Patrick W Serruys1
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Thoraxcenter, Erasmus MC, Rotterdam, Netherlands, The
Netherlands2Cardialysis BV, Rotterdam, Netherlands, The Netherlands
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Background: Intravascular ultrasound (IVUS) palpography is a technique that
allows the assessment of local mechanical tissue properties. Spectral analysis
of IVUS radiofrequency data (IVUS-VH) is a precise tool to assess plaque
morphology and composition. We sought to explore in vivo the hypothesis that
high strain regions have necrotic core-rich plaques as sub-intimal substrate.
Methods: Palpography and IVUS-VH data were aquired using 20 and 30 MHz
catheters respectively. Palpography analysis defined high (>1.2% at 4 mm Hg
pressure difference) and low (<0.5% at 4 mm Hg pressure difference) strain
regions. Co-localization of the same spots was performed by 2 experienced
IVUS analysts blinded for the palpography results using side-by-side views.
Results: 123 cross-sections (CSs) (27 vessels) were successfully matched.
The mean strain value was significantly higher in CSs with necrotic core
(NC) in contact with the lumen than in CSs with no NC contact with the
lumen (2.75±1.1 vs. 2.33±0.8, p=0.026). Calcium (1.61±2.5 % vs. 0.25±0.7
%, p=0.001) and NC (15.64±10.6 % vs. 2.8±3.9 %, p<0.001) content were
significantly higher in the CSs with NC in contact with the lumen whereas
the inverse was seen for the fibrotic component of the plaque (64.16±11.6 %
vs. 75.75±13.7, p<0.001). The contact of NC with the lumen was identified
as the only predictor of high strain [OR 5.0 (CI 95% 1.7-14.1), p= 0.003].
Conclusion In the present study, the contact of NC tissue with the lumen
was found the only predictor of the detection of high strain spots. These
results suggest that combining these two techniques might be of interest in
order to assess the prognostic value of certain seemingly pejorative plaque
characteristics in prospective natural history studies provide.
TCT-267
Osteoprotegerin is a Dynamic Marker Inversely Associated with PeriProcedural Inflammation
Prospero B Gogo, Jr., David J Schneider, Burton E Sobel, Harold L
Dauerman
Background: Osteoprotegerin (OPG), a factor in bone remodeling,
is upregulated in conditions that confer vascular risk. We sought
to determine the relationship of OPG to clinical, angiographic, and
inflammatory markers associated with risk of adverse events after PCI.
Methods: Blood from 100 patients was obtained before PCI and at 24
hours. The concentration of OPG and several markers of inflammation was
determined by ELISA. Quantitative coronary angiography was performed.
Patients were divided into tertiles of pre-PCI OPG levels. Data were calculated
with age-adjusted ANOVA, and p values were calculated across the tertiles.
Results: Pre-PCI OPG increased significantly across the tertiles.
Patients in the 3rd tertile were older (p<0.001), had more diabetes
mellitus (p=0.02), and had reduced creatinine clearance (p<0.001).
Angiographic variables were similar across the tertiles. Initial sCD40L
levels were significantly reduced among patients in the 3rd versus
the lower tertiles of OPG (4.1±5.1 ng/ml (3rd) vs 7.6±5.8 (1 and 2),
p<0.05). OPG levels did not change pre- and post-PCI. All markers of
inflammation increased post-PCI. However, OPG levels in 3rd tertile
patients changed inversely compared to markers of inflammation (Figure).
Conclusions: OPG is associated with clinical variables that confer increased
post-PCI risk. However, initial and post-PCI OPG varies inversely with
inflammatory markers, suggesting a possible compensatory role for OPG
in PCI-related inflammation
TCT-268
Estimation of Collagen Content and Fibrous Cap Thickness in
Necrotic Core Fibroatheromas Using Laser Speckle Imaging
Seemantini Nadkarni, Brett Bouma, Guillermo Tearney
Harvard Medical School, Massachusetts General Hospital, Wellman
Center for Photomedicine, Boston, MA
Introduction: Necrotic-core fibroatheromas with thin fibrous caps depleted
of collagen comprise the majority of plaques that rupture. We have recently
developed a new optical imaging method termed laser speckle imaging (LSI)
and have demonstrated its ability to characterize atherosclerotic plaque
type with high accuracy. Due to the diffusion properties of light in tissue,
LSI measurements obtained as a function of distance from the position of
the illuminating beam should provide additional information on plaque
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structure. In the current study we investigate the capability of LSI to measure
collagen content and fibrous cap thickness in necrotic core fibroatheromas.
Methods: Time-varying Helium-Neon laser speckle images from 118
cadaveric aortic plaques were acquired at 240 frames per second using a
CCD camera. Laser speckle images of ten plaques that were histologically
confirmed as necrotic core fibroatheromas were selected for analysis. Timevarying intensity fluctuations in the laser speckle images were analyzed by
exponential fitting of the normalized cross-correlation of sequential speckle
patterns to obtain the speckle decorrelation time constant, T. To evaluate
fibrous cap thickness using LSI, the time constant, T, was plotted as a
function of distance, ρ, from the center of the speckle image. The distance,
ρ’, at which T(ρ) dropped to half its maximum value was then determined.
LSI measurements of T and ρ’ were compared with collagen content and
fibrous cap thickness measured from corresponding Histologic sections.
Results and Conclusions: Speckle decorrelation time constant, T,
correlated well with collagen content (R = 0.91, p < 0.001) measured from
Picrosirius Red stained sections. LSI measurements of ρ’ demonstrated
high correlation with fibrous cap thickness (R = 0.72, p < 0.05) measured
from Trichrome stained sections. These results demonstrate that LSI can
determine collagen content and fibrous cap thickness in necrotic core
fibroatheromas. Based on its ability to evaluate both the composition and
morphology of atherosclerotic plaques, we anticipate LSI will prove highly
useful in the identification of high-risk coronary lesions in patients.
TCT-269
Intravascular Magnetic Resonance Imaging of Atherosclerotic Lesions
in Hypercholesterolemic Rabbits
Renu Virmani1, Assef Weiss2, Kobi Hasharoni2, Erez Golan2, Eduardo
Acampado1, Kristi Skorija1, Elena Ladich1, Frank Kolodgie1
1
CVPath, Gaithersburg, MD;2Top Spin Medical, Lod, Israel
Background: Intravascular MR imaging (IVMRI) of coronary
arteries is a novel diagnostic modality. The present study
demonstrates IVMRI monitoring in-vivo of early changes in the lipid
composition of atherosclerotic lesions using a novel rabbit model.
Methods: The rabbits were divided into 6 atherogenic diet groups and one
control group; all animals underwent balloon injury. Lesion progression
went on for 5, 9, 13, 17 and 19 weeks. Injection of autologous erythrocytes
was carried out in order to stimulate the development of lipid rich lesions.
The IVMRI catheter incorporates all static and RF magnetic field sources without
the need for external magnets. The catheter is highly sensitive to molecular
diffusion in tissues, thereby allowing direct vessel wall lipid measurement.
In each rabbit aorta, an IVMRI measure of the lipid fraction
index (LFI) was carried out in several sites and was compared
to a quantitative lipid count obtained by histopathology.
Results: IVMRI LFI vs. lipid count is shown in Figure 1. The red group
corresponds to rabbits with balloon injury and normal diet; the green
and blue groups correspond to rabbits that underwent injury and 5 or
19-week atherogenic diet, respectively. RBC injection was carried
out in the blue group. Significant differences in IVMRI LFI can be
observed after 5 weeks between normal and atherogenic diet groups.
Conclusions: This study demonstrated the ability of IVMRI to accurately
monitor in-vivo early changes in the lipid composition of atherosclerotic
lesions.
TCT-270
Analysis of Collagen Birefringence in Atherosclerotic Plaques Using
Polarization Sensitive Optical Coherence Tomography
Seemantini K Nadkarni, Mark Pierce, Hyle Park, Johannes deBoer, Stuart
Houser, Jason Bressner, Brett Bouma, Guillermo Tearney
Harvard Medical School, Massachusetts General Hospital, Wellman
Center for Photomedicine, Boston, MA
Introduction: The measurement of collagen content within fibrous
caps of necrotic core fibroatheromas is an important indicator of plaque
stability. Tissues such as collagen, due to their structural organization,
exhibit birefringence, a property of a material that changes the polarization
state of light. Optical coherence tomography (OCT) has been recently
demonstrated to provide high-resolution cross-sectional images of coronary
atherosclerotic plaques in patients. A recently developed advance in OCT,
termed polarization-sensitive OCT (PS-OCT), evaluates tissue birefringence
by measuring the change in polarization state of light that has traversed
tissue. In this study we investigate the capability of PS-OCT to evaluate
tissue birefringence and measure collagen content in atherosclerotic plaques.
Methods: PS-OCT images of 84 aortic plaques were acquired from 20 human
cadavers. Tissue birefringence was measured from the PS-OCT images over
a 500 μm x 200 μm ROI located at the center of the plaque. For necrotic core
fibroatheromas with cap thicknesses less than 200 µm, the depth of the ROI was
matched to the fibrous cap thickness. Collagen content was morphometrically
measured from corresponding Picrosirius Red stained histological sections
and compared with tissue birefringence measured from PS-OCT images.
Results and Conclusions: PS-OCT images indicated regions of strong
birefringence corresponding to histologically confirmed locations of high
collagen density. Loss of tissue birefringence was evident in PS-OCT
images in regions of depleted and disorganized collagen as well as in lipidrich plaques. Linear regression analysis was performed which demonstrated
high correlation between PS-OCT measured tissue birefringence and
collagen content in all plaques (R = 0.64; p<0.0001) and in fibrous caps
of necrotic core fibroatheromas (R = 0.60; p<0.005). These results show
that PS-OCT measures tissue birefringence, which correlates with plaque
collagen content. Given its potential for intracoronary use, we anticipate that
quantitative PS-OCT measurements of collagen content will significantly
improve our ability to identify high-risk plaques in patients.
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TCT-271
Impact of Serum HDL-Cholesterol Level on Coronary Plaque
Morphology Assessed by Intravascular Virtual HistologyTM
Kenya Nasu, Etsuo Tsuchikane, Osamu Katoh, Yoshihiro Takeda, Yoshihiro
Takeda, Jean-Francois Surmely, Tatsuya Ito, Mariko Ehara, Yoshihisa
Kinoshita, Tetsuo Matsubara, Takahiko Suzuki
Background: The purpose of the present study is to evaluate the relation
between serum HDLcholesterol level and coronary plaque characterization
using intravascular ultrasound (IVUS) radiofrequency data analysis.
Methods: Fifty-four significant native coronary lesions in 52 patients
were imaged in vivo with a 20 MHz phased-array IVUS catheter with
motorized pull-back system. In vivo tissue histology sections were
reconstructed by radiofrequency data analysis and evaluated from distal
to proximal references of the target lesion. Radiofrequency signals were
classified into four component types: Dense Calcium; Fibrous; Fibrofatty; and Necrotic Core. For each image, the percent of the different
plaque components were analyzed. Then average of the value from all the
image slices for one lesion was calculated. Patients were divided into two
group, a low HDL-cholesterol group (HDL-cholesterol < 40 mg/dl, 18
patients with 19 lesions) and a control group with normal or high HDLcholesterol level (HDL-cholesterol > 40 mg/dl, 34 patients with 35 lesions)
Results: The low HDL group had significantly greater % area of
Necrotic Core compared with the control group (Table). Furthermore,
there were linear relationships between serum HDL-cholesterol
level and % area of Necrotic Core (r = -0.578, p < 0.0001).
Conclusions: The presence of greater Necrotic Core was observed in
the low HDLcholesterol group. This could indicate that HDL-cholesterol
influences plaque composition in favor of more stable plaque.
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Laboratory data and Virtual Histology analyses
Low HDL(n = 18) Control (n = 34) p value
182.8±35.8
199.2±32.3
NS
119.6±42.5
115.9±32.6
NS
38.2±3.8
58.8±10.1
< 0.0001
51.3±14.3
54.4±15.3
NS
54.8±11.4
62.6±15.2
NS
17.3±9.2
18.5±13.0
NS
15.7±5.0
10.1±5.3
0.0005
12.3±6.5
8.3±4.9
NS
Serum total cholesterol level, mg/dl
Serum LDL-cholesterol level, mg/dl
Serum HDL-cholesterol level, mg/dl
Plaque area, %
Fibrous area, %
Fibro-fatty area, %
Necrotic Core area, %
Dense Calcium area, %
TCT-272
Prognosis Linked to Non-Significant Coronary Lesion with PlaqueRupture at Long-Term Follow-Up
Patrick Ohlmann1, Sang-Wook Kim1, Gary S Mintz2, Jerzy Pregowski1,
Pawel Tyczynski1, Augusto D Pichard1, Lowel F Satler1, Kenneth M Kent1,
William O Suddath1, Ron Waksman1, Neil J Weissman1
1
Washington Hospital Center, Washington, DC;2Cardiovascular Research
Foundation, New-York, NY
Background: This study evaluated the clinical outcome of pts presenting with
an intravascular ultrasound (IVUS) identified plaque rupture (PR), not treated
by percutaneous coronary intervention (PCI) or coronary artery bypass surgery.
Methods: We retrospectively reviewed consecutive pts undergoing
IVUS at the Washington Hospital Center from 1994 to 2003 to
identify 17 pts who presented with a PR-containing lesion that was
not treated because the minimum lumen area (MLA) measured
>4mm2. Standard clinical, angiographic, and IVUS parameters were
assessed; pts were followed for 43 ± 25 months (range 13-86 months).
Results: Mean age was 68 ± 13 years. The indications for the initial procedure
were unstable angina/NSTEMI in 11 (65 %); stable angina in 2 (12 %);
recent myocardial infarction (MI) in 3 (18 %). MLA was 5.57 ± 1.51mm2,
and angiographic diameter stenosis was 33 ± 14 %. Eight patients (47 %)
underwent PCI of another lesion at the time of the procedure. At 1 year
there were no deaths, no MI, and only 1 revascularization for stable angina
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at 3 months related to the lesion under study. After a mean follow-up of 43
± 25 months, there was 1 death occurring after 69 months in a diabetic with
a left main coronary artery PR; no MI, and 1 additional revascularization
procedure at 67 months related to the lesion under study. Overall, the total
cumulative rate of events related to the untreated rupture plaque site was 18 %.
Conclusion: At long-term follow-up (up to 5 years), major cardiac events
related to non-flow limiting, non-lumen-compromising, untreated, plaquerupture-containing lesions are infrequent. These lesions do not seem to be
responsible for events and do not warrant routine treatment.
TCT-273
Influenza A Virus Infection Increases the Expression of Chemokines
and C-Reactive Protein by Human Coronary Cell Lines and This
Effect Can be Inhibited by an Antioxidant
Mehran Haidari1, Philip R. Wyde2, Igor V Stupin1, Muzammil Ali1, Ward
Casscells1, Mohammad Madjid1
1
University of Texas-Houston and Texas Heart Institute, Houston,
TX;2Baylor College of Medicine, Houston, TX
We have previously reported that influenza promotes atherosclerosis
and that influenza vaccination may reduce the risk of cardiovascular
events. We hypothesized that pro-inflammatory chemokines and
CRP may mediate the pro-atherosclerotic effects of influenza.
We tested the effects of influenza A infection on the expression of
chemokines, adhesion molecules and systemic pro-inflammatory
markers in the cellular components of human atherosclerotic lesions.
Methods: Human Coronary endothelial cells (HCEC), Human Coronary
Smooth Muscle Cells (HCSMC), Human monocytes cell line (THP1) and were infected with influenza A/HK H3N2 virus. Sixteen hours
(~2 viral proliferation cycles) after the inoculation, cells were harvested
and TaqMan real-time PCR technique was employed to assess the
expression of mRNA MCP-1, RANTES, IL-8, VCAM-1, ICAM-1,
E-selectin, e NOS , MCSF, LPPLA2 and C-reactive protein (CRP).
GAPDH, beta2-Microglobulin, and HPRT gene expressions were used to
standardize the quantity of total RNA in infected and not-infected cells.
Results: Expression of Chemokines (MCP-1, IL-8 and RANTES) and
adhesion molecules (VCAM-1, ICAM-1 and E selectin) were increased by
several folds (i.e. 3 to 35 times) following infection of HCEC and HCSMC
with influenza A virus. These increases were accompanied by a decrease in
E-NOS expression in HCEC indicating a gene expression pattern reported
in endothelial cell dysfunction. THP-1 cells reacted to the infection by an
increase in expression of IL-8 and, MCSF.CRP expression by HCEC and
LPPLA2 expression by THP-1 were also elevated following the infection.
Addition of an antioxidant (N-Acetyl Cystein, 50 ng/ml) inhibited the effect of
influenza on expression of IL-8, E-selectin and CRP in HCEC. The expression
of endothelial cell marker (CD31) smooth muscle cells marker (Smoothelin)
and macrophage marker (CD68) showed no alteration following the infection.
Conclusion: Influenza A infection can lead to over-expression of proinflammatory genes in HCEC and HCSMC. The alteration in endothelial
cell gene expression might explain the mechanism by which influenza
may exert its deleterious effects on the vascular wall, hence promoting
atherosclerosis.
TCT-274
Intracoronary Thermography of Culprit Artery Does Not Predict
Further Cardiac Events after Acute Coronary Syndrome
Lukasz Rzeszutko1, Dariusz Dudek1, Jacek Legutko1, Angela Richter2,
Michal Chyrchel1, Marcin Wizimirski1, Jacek S Dubiel1
1
Jagiellonian University, Krakow, Poland2Volcano Therapeutics, Rancho
Cordova, CA
Background: Coincidence of increased vessel wall temperature and
further cardiac events in patients with coronary artery disease has been
reported in one clinical study. The aim of this study was to assess the
relationship between culprit artery temperature profile in patients with acute
coronary syndromes (ACS) assessed with thermography system (Volcano
Therapeutics Inc, Rancho Cordova, USA) and further cardiac events.
Methods: 40 patients with ACS (24 pts with acute myocardial infarction
and 16 pts with unstable angina) in whom intracoronary thermography of
culprit artery was performed before percutaneous coronary intervention
of culprit lesion were followed up for one year. We used 3.5-F catheter
containing a self-expanding basket with 5 arms and a thermocouple
on each arm measuring vessel wall temperature, as well as a central
thermocouple measuring blood temperature, allowing detection of
differences of 0.05ºC. We assessed blood temperature (Tbl, ºC) and the
maximum temperature difference between blood and any thermal couple
(ΔTmax, ºC) during pullback (0.5mm/s). The incidence of major cardiac
events (death, myocardial infarction, target vessel revascularization (TVR),
non-target vessel revascularization (nonTVR), and refractory angina)
was correlated with vessel wall temperature profile of culprit artery.
Results: In 16 pts (40%) ΔTmax was ≥0,1ºC. In 23 pts (57,5%) the highest
ΔTmax was found in culprit segment and was significantly higher than
in non culprit adjacent segments (ΔTmax = 0.092±0.03 vs. 0.062±0.01,
p<0,001). In follow up period MACE occurred in 8 patients 20%. There
were no death and myocardial infarction. TVR was perfomed in 2 patients
(5%) and nonTVR in 3 patients (7.5%) due to atherosclerosis progression.
3 patients (7.5%) had refractory angina. We have found positive correlation
between baseline HsCRP (r=0,4, p=0,01) and MACE. We have not found
any correlation between any temperature measurements and MACE.
Conclusions: Cardiac events have not been correlated with temperature
profile of culprit artery in patients with ACS. The results do not confirm
clinical significance of thermography as diagnostic or prognostic tool in
patients with ACS.
TCT-275
Statins Fail to Significantly Improve Survival During Their First Year
of Use: A Meta-Analysis of 61,000 Subjects from Seven Randomized
Placebo-Controlled Clinical Trial
Mohammad Madjid1, Mir S Siadaty2, Imran Awan1, Ward Casscells1
1
University of Texas-Houston and Texas Heart Institute, Houston,
TX;2University of Virginia, Charlottesville, VA
Lipid lowering with HMG CoA reductase inhibitors (statins) is known to
reduce multiple cardiovascular events. However, data are not available on
the timing of their cardioprotective effects and whether they can prevent
death in a short time. We conducted a meta-analysis of seven published
statin cardiovascular clinical trials to test our hypothesis that statin
drugs do not reduce coronary death rate during their first year of use.
Method: PubMed, Cochran database, abstract booklets, and conference
proceedings were searched for the period of 1994-2005. We selected
published clinical trials which were randomized, used statin vs. placebo,
and included coronary or all-cause death as their outcome. Non-randomized,
non-placebo-controlled, or unpublished studies were excluded. Both primary
prevention and secondary prevention trials were included. We identified 7
studies which met our criteria. We used the survival curves published in
the respective papers and graphically captured the survival curves for each
study. We captured the coordinates of survival curves from each study,
then sampled from the points uniformly to the number of events for the
study. To combine the curves, after normalizing the y-axis, we used local
regression with simultaneous confidence bands. We computed percentage
of patients taking the drug and benefiting from it by a certain timepoint.
Results: At one year, the reduction in mortality did not reach the
statistical significance (pre-defined alpha=0.05). By end of the
first year, only about 40% of the subjects benefited in terms of
reduction in the coronary death rate. About 5% of the subjects
needed a time longer than 2 years for the drug effect to “kick in”.
Conclusions: We observed that, despite a significant benefit in terms of
mortality reduction over several years, statins fail to prevent coronary death
to a significant degree during their first year of use. This observation calls
for using additional preventive measures in high risk subjects especially
during the early years after initiation of preventive therapy.
TCT-276
Preprocedural hs-CRP Level Predicts Distal Microembolization
During Coronary Stenting
So-Yeon Choi, Hyoung-Mo Yang, Seung-Jea Tahk, Myeong-Ho Yoon,
Zhen-Guo Zheng, Byoung-Joo Choi, Gyo-Seung Hwang, Joon-Han Shin
Ajou University School of Medicine, Suwon, Republic of Korea
Background and Objectives: Elevated hs-CRP(high sensitivity C-reactive
protein) has been well known as a biomarker reflecting inflammatory process
that might evokes the potential for microembolization of atheromatous
plaque and imparts poor prognosis in patients with coronary artery disease.
We designed this study to evaluate whether preprocedural hs-CRP level is
associated with procedure-related myocardial injury after coronary stenting.
Subjects and Methods: We obtained plasma hs-CRP level from angina
patient who underwent coronary stenting within 24 hours before procedure and
divided patients into either normal CRP group(hs-CRP <3 mg/L) or elevated
CRP group(hs-CRP ≥ 3mg/L). We defined the reduction of TMP(TIMI
myocardial perfusion) grade as one or more decreases of TMP grade after
PCI in comparison with pre-procedural TMP. We also evaluate procedurerelated myocardial damage by measuring CK-MB leakage after stenting.
Results: 279 lesions in 226 patients who were divided into two groups:
normal CRP group (n=137, 1.28±0.71mg/L) and elevated CRP group(n=89,
6.89±4.23mg/L) were enrolled. The reduction of TMP grade was
significantly more prevalent in elevated CRP group(20 lesions, 17.4%)
compared to normal CRP group(6 lesions, 3.7%, p=0.001). Elevated
CRP level was related to an increase of CK-MB after stenting(elevated
CRP group; 23 patients, 25.8%, normal CRP group; 21 patients, 15.3%,
p=0.041). In a multivariable analysis, the only significant predictor
of reduction of TMP grade after stenting was the elevated CRP.
Conclusion: Systemically detectable inflammatory activity served by
plasma hs-CRP level is associated with procedure-related myocardial injury
assessed by reduction of TMP grade and CK-MB elevation after coronary
stenting.
TCT-277
Do Women Undergoing Elective Percutaneous Intervention (PCI)
Have Similar Late Outcomes Compared to Men at All Age Groups? A
REPLACE-2 Sustudy
Ken Mori1, Alexandra J. Lansky1, Ricardo A. Costa1, Gary S. Mintz1,
Eugenia Nikolsky1, Roxana Mehran1, George Dangas1, Martin Fahy1,
John A. Bittl2, Robert A. Harrington3, Neal S. Kleiman4, Frederick Feit5, A.
Michael Lincoff6, Gregg W. Stone1
1
Cardiovascular Research Foundation, New York, NY;2Munroe Regional
Medical Center, Ocala, FL;3Duke Clinical Research Institute, Durham,
NC;4Baylor College of Medicine, Houston, TX;5New York University
School of Medicine, New York, NY;6Cleveland Clinic Foundation,
Cleveland, OH
REPLACE-2 trial - a prospective, randomized trial comparing
heparin+routine GP IIb/IIIa blockade vs. bivalirudin+provisional GP IIb/IIIa
blockade during PCI at 233 hospitals showed that bivalirudin+provisional GP
IIb/IIIa blockade was non-inferior to heparin+planned GP IIb/IIIa blockade
during PCI. The impact of gender vs age on these benefits is unknown.
Methods: We analyzed clinical outcomes comparing women (n=1357)
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vs men (n=4473) in different age subsets (<60, 60-80, >80 yrs).
Results: Overall, women were older, had smaller body surface area, had
more diabetes and hypertension, less prior MI and PCI, less smoking and
lower baseline creatinine compared to men. Clinical outcomes are shown
in the Table. By multivariate analysis, female gender was an independent
predictor of major bleeding (OR=1.61; 95% CI, 1.14-2.29, p=0.007),
but not death. Randomization to heparin+planned GP IIb/IIIa blockade
was the strongest independent predictor of combined major+minor
bleeding among female pts (OR=2.17; 95%CI, 1.68-2.79, p<0.001).
Conclusions: In the REPLACE-2 trial, women had significantly higher
mortality in the 60-80 age group compared to men, however, mortality
was similar among younger and older pts. Major bleeding complications
increased with increasing age in both women and men.
have died in the interum. Bleeders were not more likely to have died vs
nonbleeders.
Variable Description
Age<60 Age 60 - 80 Age ≥ 80
P-value
Major Bleeding*, %
Male
2.0
3.0
5.7
0.0025
Female
3.0
5.2
8.7
0.0071
0.2170
0.0039
0.3679
p value (male vs. female)
Minor Bleeding†, %
Male
17.5
19.5
18.1
0.1723
Female
19.1
24.6
15.7
0.5177
0.4165
0.0015
0.6507
30 Days Death, %
Male
0.0
0.3
1.0
0.0033
Female
0.0
0.7
1.6
0.073
N/A
0.1242
0.6743
1 Year Death, %
Male
1.0
2.2
6.3
<.0001
Female
1.1
3.9
4.0
0.017
0.8608
0.0083
0.3780
*Major bleeding defined as intracranial, intraocular, or retroperitoneal hemorrhage,
clinically overt blood loss resulting in a decrease in hemoglobin of more than 3g/dL,
or transfusion of more than 4g/dL, or transfusion of 2 or more units of packed red
blood cell or whole blood. †Minor bleeding defined as clinically overt bleeding that
did not meet criteria for major bleeding.
TCT-278
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Anticoagulation and Percutaneous Intervention: Do Gender
Differences Persist?
Anita Arnold, Dianne Zwicke, Dana Kappel
St. Luke’s Medical Center, Milwaukee, WI
Background: There are gender differences in cardiovascular disease, but
there is little data regarding differences in outcome with percutaneous
coronary intervention (PCI) and the use of Glycoprotein iib/iiia inhibitors.
Conflicting data exist and some operators advocate limited use in women.
We evaluated antiplatelet therapy , GP iib/iiia inhibitors, in-hospital
adverse events and 1 year outcome related to their use with gender.
Methods: All data was collected via the ACC database. We evaluated all
patients treated with PCI from January 2002 until March 2003. The time
frame chosen was just prior to the introduction of drug eluting stents at our
institution. Data regarding patient demographics, adjunctive use of heparin
and post procedure complications were collected. There were 3560 patients
with 2262 (63.5%) males and 1298 females (36.4%) evaluated.
Results
GP iib/iiia use
Hypertension
Diabetes Mellitus
Prior MI
ASA
Prior PCI
Prior CABG
Post PCI vascular bleed
Male (2262)
1524 (67%0
1450 (64%)
600 (27%)
663 (29%)
2233 (99%)
935 (41%)
620 (27%)
28 (1.2%)
Female (1298)
805 (62%)
974 (75%)
400 (31%)
305 (24%)
1268 (98%)
456 (35%)
239 (18%)
52 (4.2%)
P-value
0.0002
<0.001
0.0137
0.0007
0.0288
0.0006
, 0.001
<0.0001
Baseline demographics are similar to those reported before.
Women continue to be older with more concommitant illness.
Conclusions: Given no contraindications women were less likely to receive
GP iib/iiia inhibitors or aspirin than men, and were more likely to have
vascular bleeding as a result of the PCI. Most patients received abciximab
and there were no differences in heparin usage. At one year follow-up there
were no differences in cardiac MACE, but women were more likely to
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Contrast Nephropathy and Contrast Agents
TCT-279
Correlations between Various Gradation of Serum Creatinine Rise
and Mid-Term Mortality after PCI
Annapoorna S. Kini, Paul Lee, Javed Suleman, Angelica M. Steinheimer,
Madhu Prattipati, Tirumalesh Venkatesh, Prakash Krishnan, Pedro R.
Moreno, Michael C. Kim, Samin K. Sharma
Background: Contrast-induced nephropathy (CIN) is defined as >25%
increase of baseline serum creatinine (BSC) in patients with chronic renal
insufficiency (CRI). CIN after PCI correlates with high in-hospital and
follow-up mortality. However, correlation of various gradation of serum
creatinine (SCr) rise with follow-up mortality is not well established. Also,
it is not known if similar relationship is true for patients with normal BSC.
Methods and results: PCI patients were analyzed for any rise in SCr: CRI
group (BSC ≥1.5 mg/dL) (n = 1853) and normal BSC group (n = 11144).
Incidence of CIN was 5.9%: 11.3% in the CRI gp vs. 5.1% in normal BSC
group (p <0.01). Patients in each group were analyzed based on the SCr
ratio (peak SCr/BSC) of >1.25, 1.25-1.5 and >1.5, and correlated with
follow-up mortality (Figure). SCr ratio >1.5 correlated with increased
mortality at follow-up in both CRI group as well as normal BSC group.
Conclusion: Current definition of CIN is not predictive of 1-yr mortality.
SCr ratio >1.5 (>50% rise in BSC) is a better threshold for predicting
follow-up mortality post-PCI, irrespective of BSC value.
TCT-280
Differential Predictors of Contrast-Induced Nephropathy in Patients
Undergoing Percutaneous Coronary Intervention with Normal vs.
Elevated Baseline Serum Creatinine
Annapoorna S. Kini, Paul Lee, Madhu Prattipati, Angelica M.
Steinheimer, Mary-Beth Duffy, Javed Suleman, Pedro R. Moreno, Michael
C. Kim, Samin K. Sharma
Background: Incidence and predictors of contrast-induced nephropathy
(CIN), defined as a >25% rise in baseline serum creatinine (BSC), in patients
with normal vs. elevated BSC undergoing PCI has not been described.
Methods: We evaluated all the patients who underwent PCI at Mount
Sinai Hospital for incidence and predictors of CIN and groups were
divided based on the normal (<1.5 mg%) vs. elevated (≥1.5 mg%) BSC.
Results: Data obtained from IRB approved large interventional database at
Mount Sinai Hospital. A total of 12997 patients were analyzed. Patients on
hemodialysis were excluded. Patients were divided into group I (n = 11144,
BSC <1.5 mg %) and group II (n = 1853, BSC ≥1.5 mg %). Overall incidence
of CIN was 5.9%, with 5.1% in group I and 11.3% in group II (p <0.0001).
Incidence of CIN amongst important predictors, along with odds ratios
(OR), is shown in the Table.
CHF Class III-IV (%)
3-vessel disease (%)
Acute coronary
syndromes (%)
Contrast volume >200
cc (%)
Baseline Hb <10 g/dL
(%)
Diabetes mellitus (%)
Group I
(n = 11144)
11
7
7
OR
1.59
1.61
1.65
Group II
P
(n = 1853)
0.004
13
<0.001
13
<0.001
13
OR
0.83
0.93
0.99
P
0.470
0.681
0.981
7
12
8
1.46
0.005
22
2.35
0.002
2.13
1.53
<0.001
0.008
14
16
1.12
1.30
0.602
0.169
Conclusion: Incidence of CIN during PCI in pts with normal BSC is higher
than previously reported and correlates with contrast volume and other
clinical parameters of generalized poor medical condition. Predictors of
CIN are different in normal vs. elevated BSC patients, with high contrast
volume being a significant predictor in both groups. Therefore, in patients
with multiple comorbid conditions every attempt should be made to
optimize clinical status pre- and post PCI, including low use of contrast
despite normal BSC.
TCT-281
Prevention of Contrast Induced Nephropathy by Short-Term Statin in
Patients with Renal Insufficiency Undergoing Coronary Angiography:
A Randomized Controlled Trial
Sang-Ho Jo, Bon-Kwon Koo, Tae-Jin Youn, Joo-Yong Hahn, Yong-Suk
Kim, Hyun-Jae Kang, Woo-Young Chung, In-Ho Chae, Hyo-Soo Kim,
Byung-Hee Oh, Young-Bae Park
Seoul National University Hospital, Internal Medicine, Seoul, Republic of
Korea
Background: The cause of contrast induced nephropathy (CIN) is not well
known. The oxidative stress caused by contrast media has been suggested
for one mechanism. The statin has been reported to have pleiotrophic
effects and one of these is thought to be antioxidant effect. We investigated
whether the statin has a preventive effect for CIN by its antioxidant effect.
Methods: We conducted randomized controlled prospective multicenter
trial to evaluate whether short-term simvastatin pre-treatment was effective
in prevention of CIN. Seventy consecutive patients with chronic renal
insufficiency (calculated creatinine clearance ≤ 60 mL/min) who underwent
coronary angiography (CAG) were enrolled. They were randomly assigned
to simvastatin group (simvastatin 40mg orally twice daily on the day
before CAG and the day of CAG) or placebo group. Half-saline was given
intravenously at a rate of 1ml/kg/hour at least for 8hours before and 8hours after
administration of contrast agent to both groups. The primary end point was
peak increase of the creatinine concentration from baseline within two days
after CAG, and secondary end point was development of CIN within two days
after CAG. CIN was defined as increase of 25% or more in serum creatinine.
Results: There were no differences in age, sex, incidence of diabetes,
baseline serum creatinine, or contrast media volume. The mean peak
increase of serum creatinine was significantly lower in simvastatin group:
-0.13±0.46mg/dL in simvastatin group VS 0.08±0.17mg/mL in placebo group
(p=0.018; the increase with simvastatin minus the increase with placebo=
-0.21mg/dL [95% CI, 0.04-0.37] ). The serum creatinine concentration
decreased from 1.34mg/dL to 1.21mg/dL in simvastatin group with no
significance (p=0.105), but increased significantly from 1.23mg/dL to 1.31mg/
dL in placebo group (p=0.013). CIN occurred only in 5.9% (2 of 34 patients)
in simvastatin and 11.2% (4 of 36 patients) in placebo group (p=0.674).
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These results may imply the usefulness of simvastatin for prevention of CIN.
Conclusion: The use of simvastatin may prevent CIN in renal insufficiency
undergoing CAG. The further study may elucidate clearly the effectiveness
of simvastatin for prevention of CIN.
TCT-282
In Vitro Interaction of Five Nonionic Iodinated Contrast Media with
Platelet Activation and Degranulation
Pierrick Auvray1, Vincent Hesry1, Julien Bertel1, Claire Corot2, Jean-Marc
Idee2
1
Cellis-Pharma, Saint Malo, France2Guerbet, Roissy-Charles de Gaulle
cedex, France
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Background: Contrast media (CM) may activate platelets and lead
to degranulation and release of procoagulant factors. The aim of this
study was to compare the platelet degranulatory potential of five
nonionic CM widely used during cadiac interventional procedures.
Methods: Ioxilan (Oxilan), iodixanol (Visipaque), iomeprol (Iomeron),
iobitridol (Xenetix) or iohexol (Omnipaque) (all CM at 300 mgI/mL
except iodixanol 320 mgI/mL) were mixed with blood from 6 human
healthy volunteers (50% vol/vol) and incubated during 1 min. at
room temperature (or 2 min. at 37°C for thrombin). Positive control
was thrombin (1 U/mL) and negative control was mannitol (5 g/L).
CD62P platelet expression was assessed by flow cytometry (Becton
Dickinson Bioscience, France) and β-thromboglobulin (β-TG) and
platelet-factor 4 (PF4) release was measured by ELISA method.
Results: Upon visual examination, both thrombin and iodixanol induced
a strong coagulation of blood. Thrombin induced a significant increase
in CD62P expression (32 + 21%) in comparison to mannitol (11 +
11%) (p < 0.05). No difference in CD62P expression was observed with
ioxilan (10.9 + 13.2%), iomeprol (30.8 + 20.9%) or iodixanol (18.2 +
26.5%) when compared with mannitol, unlike iohexol (58.7 + 12.1%, p
< 0.05vs. mannitol) or iobitridol (60.6 + 22.1%, p < 0.05 vs. mannitol).
Thrombin induced significant release of both β-TG and PF4 (respectively
297.4 + 56.9 IU/ml and 112.0 + 18.6 IU/ml) versus mannitol (respectively
230.5 + 86.9 IU/ml and 97.7 + 26.1 IU/ml) (p < 0.05). No significant
increase in β-TG and PF4 release was observed with ioxilan, iodixanol
or iomeprol versus mannitol, whereas iohexol (β-TG = 305.9 + 52.6 IU/
mL, PF4 = 109.7 + 13.6 IU/mL, p < 0.05) and iobitridol (β-TG = 297.4 +
53.2 IU/mL, PF4 = 107.3 + 10.7 IU/mL, p < 0.05) increased these factors.
Conclusion: Nonionic CM are not similar in terms of platelet activation.
Iohexol and iobitridol showed a higher in vitro degranulatory potential than
ioxilan, iomeprol or iodixanol. Furthermore, blood coagulation was noticed
with iodixanol in all test-samples. The interesting in vitro profile of ioxilan
on platelet functions deserves clinical evaluation
TCT-283
Relevance of Contrast Volume and Renal Function in ContrastInduced Nephropathy after Primary Angioplasty
Gianfranco Lauri, Giancarlo Marenzi, Emilio Assanelli, Ivana Marana,
Jeness Campodonico, Marco Grazi, Monica De Metrio, Franco
Fabbiocchi, Piero Montorsi, Antonio L Bartorelli
Contrast-induced nephropathy (CIN) occurs in 20% of AMI patients
undergoing primary coronary interventions (pPCI) and is associated with
a worse clinical course and increased mortality. We evaluated the role of
contrast volume and baseline renal function in CIN development in 384
consecutive patients (310 males; 186 anterior AMI) undergoing pPCI.
Serum creatinine (Cr) levels were measured at admission and daily in the
following 3 days. CIN was defined as an increase in Cr >25% from baseline.
For each patient, we calculated the maximal contrast volume according to
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the formula [(5ml x kg)/Cr], and the contrast ratio (CR) defined as the ratio
between the contrast volume effectively administered and that calculated.
Results. In the entire study population (baseline Cr= 1.1±0.3 mg/dl,
contrast volume= 276±128 ml), the incidence of CIN was 22% (n=85), and
in-hospital mortality was 5% (n=19). However, mortality was significantly
higher (20%) in patients with CIN than in those without CIN (0.7%; p<0.01).
Moreover, patients with CR>1 (n=90) showed higher CIN rate than those
with CR<1 (n=294) (42% vs. 16%; p<0.001), as well as higher in-hospital
mortality (12% vs. 2%; p<0.001). A significant relationship between CR,
incidence of CIN, and in-hospital mortality was found.
CR
< 0.5
0.6-1.0
1.1-1.5
> 1.5
n
118
177
65
24
p value
CIN
16 (14%)
32 (18%)
25 (38%)
13 (54%)
<0.001
Mortality
2 (1.7%)
5 (2.8%)
5 (7.8%)
6 (25%)
<0.001
Conclusions. CIN is a frequent complication of pPCI. CR evaluation may
predict CIN risk allowing to calculate the maximal contrast volume below
which low incidence of CIN and in-hospital mortality can be predicted.
TCT-284
Nephrotoxicity of Low-Osmolality Versus Iso-Osmolality Contrast
Agents: Impact of N-Acetylcysteine
Carlo Briguori1, Antonio Colombo2, Flavio Airoldi2, Nuccia Morici2,
Massimo Giuseppe Sangiorgi2, Davide D’Andrea1, Amelia Focaccio1,
Marco Boccalatte1, Bruno Ricciardelli3
1
Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples,
Italy2Laboratory of Interventional Cardiology, San Raffaele Hospital,,
Milan, Italy3Deparment Cardiology, Clinica Mediterranea, Naples, Italy
Background: Recent data support that iodixanol, an iso-osmolality
contrast agent, is less nephrotoxic than low-osmolality contrast agents
when hydration is the only prophylactic strategy used. We evaluated the
nephrotoxicity of iso- and low-osmolality contrast agents with prophylactic
administration of N-acetylcysteine (NAC) along with hydration.
Methods: Two hundred and twenty-five patients with chronic renal
insufficiency (serum creatinine >1.5 mg/dl or an estimated glomerular
filtration rate <60 ml/min/1.73 m2), referred to our institution for
coronary and/or peripheral procedures, were assigned to receive lowosmolality (Iobitridol group; n = 115) or iso-osmolality (Iodixanol group;
n = 110) contrast dye. In all cases prophylactic administration of 0.45%
saline intravenously and NAC (1200 mg orally twice daily) was used.
Results: Baseline creatinine levels were similar in the 2 groups (Iobitridol
group = 1.70 [IQR: 1.54-1.98] mg/dl; Iodixanol group = 1.73 [IQR: 1.562.00] mg/dl, p = 0.33). The risk score for contrast nephrotoxicity was 5.0 ±
1.6 in the Iobitridol group versus 5.0 ± 1.8 in the Iodixanol group (p = 0.44).
Increase of at least 0.5 mg/dl of the creatinine concentration 48 hours after the
procedure occurred in 4/115 patients (3.5%) in the Iobitridol group and 3/110
patients (2.7%) in the Iodixanol group (p = 1.00; OR = 0.78; 95% CI = 0.173.56). Amount of contrast media administration was similar in the 2 groups
(Iobitridol group = 167 ± 90 ml; Iodixanol group = 164 ± 82 ml; p= 0.61).
Conclusion: Nephrotoxicity of iso-osmolality and low-osmolality contrast
agents was similar when a prophylactic strategy of hydration plus NAC
was utilized.
TCT-285
Contrast Removal from Coronary Sinus Using Various
Extracorporeal Systems during Coronary Angiography in a Porcine
Model
Ichiro Michishita
Yokohama Sakae Kyosai Hospital, Yokohama, Japan
Background: Recently PCI has become a wide-spread and common
therapy for coronary artery disease. A large volume of contrast media is
sometimes used especially for PCI of chronic total occlusion. Moreover,
diabetic mellitus and diabetic nephropathy are more common in the Japanese
population. In order to prevent contrast-induced nephropathy (CIN),
we assessed contrast media removal from coronary sinus using various
extracorporeal systems during coronary angiography and intervention.
Methods: A 17F blood removal catheter was inserted into coronary sinus
via right cervical vein in a pig. The venous blood from the coronary sinus
was transferred into a hemoconcentrator in exp 1, a hemofiltration column
in exp 2 and a contrast-adsorbing column in exp 3 using a roller pump
during infusion of contrast media into left main coronary artery. The blood
through the column was returned into femoral vein in the pig. Total 400-577
ml of the contrast media was infused into the coronary artery for 90 minutes.
Results: The exp 1 using the hemoconcentrator showed severe
dehydration, loss of plasma and instable circulation in the animal, although
the contrast removal rate was efficient. The exp 2 indicated that the
ordinary hemofiltration system from the coronary sinus was not enough
to prevent elevation of iodine concentration in the blood because of the
low contrast removal rate. The results in the exp 3 using the contrastadsorbing column disclosed that iodine concentrations of the inlet of
the column were 5.26, 7.02, 8.89 and 5.87 mg-I/ml-plasma at 15, 30, 60
and 90 minutes, respectively. On the contrary, iodine concentrations of
the outlet of the column were 0.00, 0.09, 1.66 and 2.93 mg-I/ml-plasma.
Iodine concentrations in the femoral vein were 2.04, 2.79, 3.90, 6.12
and 5.89 mg-I/ml-plasma at 0, 15, 30, 60 and 90 minutes. No significant
adverse effects were observed throughout the experiments in the pigs.
Conclusion: The contrast media removal system from coronary sinus
using the contrast-adsorbing column can be more effective and safe during
coronary angiography and intervention to prevent CIN.
TCT-286
Design and Rationale for the Targeted Intra-renal Fenoldopam For
Avoidance of NephropathY (TIFFANY) Trial
Matthew J Price1, Lawrence Garcia2, Charles Davidson3, James McNeil4,
Mauricio G Cohen5, Vandana Mathur6, William F Fearon7, Giora Weisz8,
Campbell Rogers9, Hooman Madyoon10, Frederick Feit11, Reginald Low12,
Mark Reisman13, Paul S Teirstein1
1
Scripps Clinic, La Jolla, CA;2Beth Israel Deaconess Medical Center,
Boston, MA;3Northwestern University, Chicago, IL;4Vascular Surgery
Associates, Baton Rouge, LA;5University of North Carolina Chapel
Hill, Chapel Hill, CA;6MathurConsulting, San Francisco, CA;7Stanford
University, Stanford, CA;8Columbia University, New York, NY;9Brigham
and Women’s Hospital, Boston, MA;10Cedars Sinai Medical Center,
Los Angeles, CA;11New York University Medical Center, New York,
NY;12University of California Davis, Sacramento, CA;13Swedish Medical
Center, Seattle, WA
Background: While the CONTRAST trial demonstrated that intravenous
(IV) fenoldopam (FEN) was no more effective than placebo in reducing
the incidence of contrast-induced nephropathy (CIN), the dosing of FEN
was limited by hypotension and was likely inadequate to affect glomerular
filtration rate (GFR). The FEN-1 randomized controlled trial showed that
direct intra-renal (IR) infusion of FEN significantly increased GFR compared
to IV administration at a similar dose without affecting blood pressure. We
are therefore conducting a randomized trial to determine the optimal dosing
strategy of IR FEN to prevent CIN in high-risk patients undergoing angiography.
Methods: This is a randomized, placebo-controlled, open-label, doseescalation trial. A total of 64 high-risk patients undergoing coronary or
peripheral diagnostic and/or therapeutic procedures will be enrolled.
See Figure. The primary endpoint is the % change in creatinine
between baseline and 72 hours. IR drug infusion will be performed
using a bifurcated infusion catheter that allows simultaneous cardiac
or peripheral catheterization (Benephit Infusion System, FlowMedica,
Inc., Fremont, CA). All patients will receive peri-procedural Nacetylcysteine, protocol-standardized normal saline, and iodixanol.
Conclusions: Intra-renal drug delivery is a promising approach to prevent
CIN by providing therapeutic local drug levels without concomitant
systemic effects. The TIFFANY trial is currently enrolling, and data will
be presented.
TCT-287
Effects of Targeted Renal Delivery of Fenoldopam on Renal Function
and Systemic Blood Pressure in Patients Undergoing Cardiac
Catheterization: A Randomized, Placebo Controlled Trial
Matthew J. Price1, Hooman Madyoon2, Vandana S. Mathur3, Neil
Sawhney1, Donald S. Baim4, Paul S. Teirstein1
1
Scripps Clinic, La Jolla, CA;2Cedars Sinai Medical Center and Brotman
Hospital, Los Angeles, CA;3MathurConsulting and University of
California, San Francisco, Woodside, CA;4Brigham and Women’s Hospital
and Harvard Medical School, Boston, MA
Background: Although intravenous (IV) fenoldopam (FEN) failed to prevent
contrast nephropathy in the CONTRAST trial, the renal dose of this agent
may not have been effective due to dose limitation by associated systemic
hypotension. We hypothesized that selective intra-renal (IR) administration
of FEN would both increase local renal drug concentration -- causing a
greater increase in glomerular filtration rate (GFR) - and, due to first-pass
renal elimination, result in lower systemic drug levels with less hypotension.
Methods: We conducted a randomized, placebo-controlled, open-label,
partial crossover design trial. Thirty-three patients were randomized in a
2:1 ratio, to FEN (initially IV, then crossed over to IR FEN at the same
dose via a commercially-available bifurcated renal infusion catheter), or to
placebo. GFR and renal plasma flow were measured with inulin and PAH.
Results: Compared to IV fenoldopam, IR administration was associated
with significantly higher GFR (73.7 + 3.1 vs. 62.6 + 2.5 ml/min,
p=0.0007) and renal plasma flow (537.2 + 34.0 vs. 494.0 + 35.5 ml/
min , p<0.01), lower fenoldopam plasma levels (3.3 + 0.3 vs. 4.8 + 0.3
ng/ml, p<0.0001), and higher nadir systolic blood pressure (125.5
+ 3.6 vs. 117.4 + 2.8 mmHg, p<0.0001). Two hours following drug
discontinuation and ~200 cc of contrast, GFR in the fenoldopam group
remained higher than on placebo (+15.0 ml/min (+25%) vs. -8.0 ml/
min (-14.0%), p<0.05). No device-related adverse events occurred.
Conclusions: This trial demonstrates that intra-renal infusion of fenoldopam
is safe and practical, with greater increase in GFR, lower systemic drug
level, and less systemic hypotension compared to intravenous infusion at a
similar dose. It may thus be appropriate to restudy this renal vasodilator for
the prevention of contrast nephropathy, using selective intra-renal delivery.
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TCT-288
Prognostic Significance of Contrast-Induced Nephropathy after
Urgent Coronary Angiography and Intervention in Acute Myocardial
Infarction Patients
Junichi Yamaguchi, Kentaro Jujo, Kenji Obayashi,, Hiromi Inoue, Yukio
Tsurumi
Tokyo Women’s Medical University, Tokyo, Japan
The purpose of this study was to investigate the predictor of ContrastInduced nephropathy (CIN) and the prognostic significance of CIN in
acute myocardial infarction (AMI) patients undergoing urgent coronary
angiography. This study included 132 consecutive AMI patients from
January, 1999 to June, 2001. CIN was defined when serum creatinine
(sCr) increases => 0.5mg/dl or 25% from the baseline after 48 hours. CIN
occurred in 15 pts (11.5%). There was no statistical differences between
CIN patients and non-CIN patients in baseline characteristics except for
baseline sCr level. In-hospital and long-term mortality were significantly
higher in pts with CIN than those without (13.3% vs. 1.7%; p = 0.01, 26.7%
vs. 8.6%; p=0.02, respectively). The baseline renal dysfunction (sCr > 1.2
mg/dl) was associated with the occurence of CIN (p = 0.03). However, once
complicated with CIN even in pts with normal baseline sCr patients (8%: 8
patients out of 100 normal sCr patients), the short- and long-term mortality
rate caught up those of pts with renal dysfunction.
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Coronary Intervention, Restenosis and Complications
TCT-289
Race Does Not Affect Six-Month Outcomes after Percutaneous
Coronary Interventions: A Report from the National Heart, Lung and
Blood Institute (NHLBI) Dynamic Registry
Oscar C Marroquin1, Helen Vlachos1, Suresh R Mulukutla1, Kevin E
Kip1, Edward Tadajweski1, James Slater2, Robert L Wilesnky3, David O
Williams4, Warren Laskey5, Sheryl Kelsey1, Katherine Detre1
1
University of Pittsburgh, Pittsburgh, PA;2University of New York, New
York, NY;3University of Pennsylvania, Philadelphia, PA;4University of
Rhode Island, Providence, RI;5University of New Mexico, Alburquerque,
NM
Introduction: Racial disparities in cardiovascular outcomes are well
established. However, the relationship between race and short-term
outcomes after contemporary percutaneous coronary intervention (PCI)
is limited. We sought to investigate the hypothesis that 6-month outcomes
after PCI are different between African American and White patients.
Methods: Data for death, myocardial infarction (MI), coronary bypass
surgery (CABG), repeat PCI and repeat revascularization were collected
prospectively both in-hospital and at 6 months on 4679 (3692 White,
987 African American) patients who underwent PCI in Waves 1-4 of
the NHLBI Dynamic Registry between July of 1997 and May of 2004.
Sites with less than 5% African American patients were excluded.
Results: At the index procedure, African Americans were younger than
Whites (60.3 vs. 63.9), and had a lower prevalence of prior CABG (12.6% vs.
21.0%), higher prevalence of diabetes (41.2% vs. 28.4%), and renal disease
(11.5% vs. 5.9%) (P<0.001 for all comparisons). While African Americans
were more likely to present with an acute MI (31.4% vs. 23.7%, P<0.001),
have persistent flow reductions of treated lesions during the procedure
(1.8% vs. 1.1%, P<0.05), have lower overall angiographic success (95.9%
vs. 97.6%, P<0.05) and have a lower rate of stent implantation (77.1% vs.
83.5%, P<0.001) than Whites, they paradoxically had a lower rate of inhospital complications, including ventricular fibrillation (1.9% vs. 2.9%,
P<0.05) and death (0.7% vs. 1.7%, P<0.05). Rates of in-hospital MI and
CABG were, however, similar by race. Six-month cumulative incidence
rates of death (3.8% vs. 3.8%), MI (3.8% vs. 3.6%), CABG (3.3% vs. 3.9%),
and repeat revascularization (12.2% vs. 12.2%) were similar (P > 0.05 for
all comparisons) between African Americans and Whites, respectively.
Conclusions: Despite having more adverse baseline characteristics, more
acute MI, and less stent implantation, African Americans undergoing PCI
have better 30 day and similar 6-month outcomes compared to Whites.
Follow-up is on-going, which will allow for racial comparisons of longerterm events.
TCT-290
Anemia is Associated with Adverse Outcome after Non-Emergent
Percutaneous Coronary Intervention
Ganesh Raveendran, Henry H Ting, David R Holmes, Ryan J Lennon,
Patricia J M Best, Mandeep Singh, Malcolm R Bell, Charanjit S Rihal
Introduction: Reduced oxygen carrying capacity from anemia
and increased oxygen demand during percutaneous coronary
intervention (PCI) may exaggerate the mismatch. We hypothesized
that patients with anemia may have adverse outcome after PCI.
Methods: We identified 10,436 patients who underwent non-emergent
PCI from 1994-2004. Baseline characteristics and outcome were
obtained from the Mayo Clinic PCI registry. We divided patients into
quartiles based on pre-procedural hemoglobin (Hgb) concentrations
to evaluate the post PCI events. Thirty-day and long-term followup endpoints of death, myocardial infarction (MI) or target vessel
revascularization (TVR) were analyzed for outcome measurements.
Results: 9.5% of the patients had pre-procedural Hgb <10 gm/dl. Patients
with anemia were older, more likely to be females, and had higher
prevalence of diabetes, hypertension, congestive heart failure, and chronic
kidney disease. Short and long-term event rates decreased from the lowest
to highest quartile of Hgb (Table 1). In multiple regression analysis,
anemia was identified as an independent predictor of adverse outcome
at 30 days (odds ratio 1.5; 95% CI 1.2-1.8; p<0.001) and on long-term
follow-up after elective PCI (hazard ratio 1.5; 95% CI 1.4-17; p<0.001).
Conclusion: Anemia is not uncommon at the time of PCI. There is a strong
association between anemia and increased mortality, MI and TVR at 30
days and long term follow-up. Anemia is a graded risk factor for adverse
outcomes after an elective PCI.
Table 1:
1st Quartile 2nd Quartile 3rd Quartile
Hgb: 2.3 -11.3 Hgb: 11.4-12.8 Hgb: 12.9
gm/dl
gm/dl
- 14.0 gm/dl
N = 2536 N= 2690 gm/dl
N= 2601
30 days
327 (13%)
212 ( 8%)
185 ( 7%)
Long Term (K-M)
6 months
651 ( 26%)
490 ( 19%)
378 ( 15%)
12 months
790 ( 32%)
615 ( 24%)
472 ( 19%)
36 months
1109 ( 48%)
786 ( 32%)
617 ( 26%)
Death, MI or
TVR
4th Quartile
Hgb: 14.119.1 gm/dl P value
N= 2609
156 ( 6%) < 0.001
343 ( 13%) < 0.001
446 ( 18%)
683 ( 25%)
TCT-291
Preprocedural Creatinine Clearance and Long Term Survival after
Successful Coronary Stenting
Karam Souibri, Adolphe Shayne, Rémy Morello, Sabine Fradin, Gilles
Grollier, Jean-Philippe Ryckelinck, Martial Hamon
CHU Caen, Caen, France
Background: Little is known about the impact of mild renal insufficiency
(CrCl 30-60ml/min) on long term survival after successful coronary stenting.
Objectives: To examine the relationship between preprocedural
CrCl and the risk of death and other major adverse cardiovascular
events
(MACE)
after
successful
coronary
stenting.
Methods and Results: 1454 consecutive patients with successful coronary
stenting were enrolled in this prospective study between January 1997 and
January 1999. Using the creatinine level obtained before the angiogram,
renal function was assessed by the estimated CrCl using the CockcroftGault formula. Patients were categorized according to the level of CrCl.
1007 had a normal renal function (CrCl>60 ml/mn), 395 had a mild renal
insufficiency (CrCl 30-60 ml/mn) and 42 had a severe renal insufficiency
(CrCl <30 ml/mn). A mean follow-up period of 1050.9 +/- 449 days was
ensured for 99.8% of the whole study population, during which 133 (9.21%)
deaths were recorded: 126 (94.74%) were cardiac (either sudden death or
congestive heart failure) and 7 (5.26%) extra-cardiac ones. According to
CrCl, cardiac death rates were 30,95%, 13,41% and 5,95% for severe and
mild renal insufficiency, and normal renal function respectively (p<10-6). Of
note, there is no difference regarding the ischemic driven revascularization
rates in the different groups of patients. Beyond conventionnal risk
factors like age (RR = 1.72 [1.10-2.68] 95% CI ; p<0.018), or low left
ventricular ejection fraction (RR = 2.60 [1.72-3.94] 95% CI ; p<0.001),
mild (CrCl 30-60ml/min) renal insufficiency (CrCl 30-60ml/min) appears
to be a strong independent predictor of cardiac death after successful
coronary stenting (RR = 1.57 [1.03-2.40] 95% CI, p<0.034, respectively).
Conclusions: In patients with successful coronary stenting, preprocedural
creatinine clearance remains an important independent predictor of long
term cardiac death. These data reinforce the importance of widespread
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application of medical prevention strategies especially in patients with
coronary artery disease complicated by renal dysfunction.
TCT-293
The Radial Approach Allows a 4-Fold Decrease in Bleedings in
Percutaneous Coronary Interventions with Abciximab for Acute
Coronary Syndromes
Marco De Carlo, Roberto Bini, Bernardo Cortese, Gabriele Borelli,
Gherardo Gherarducci, Nicola Ciabatti, Alberto Balbarini, Anna S
Petronio
Cardiothoracic Department, University of Pisa, Pisa, Italy
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Background: The radial approach reduces access site bleedings in
elective procedures. Our aim was to compare procedural success
and bleeding rate of the radial and femoral approaches in urgent
percutaneous coronary interventions (PCI) performed in patients
with acute coronary syndromes (ACS) receiving abciximab.
Methods: 336 consecutive patients undergoing urgent PCI with
the radial (n=264) or femoral (n=72) access were enrolled. The
access site choice was non-randomized, the radial approach being
preferred by all the 4 operators, but in case of cardiogenic shock.
Results: The femoral approach group showed a higher Killip class (1.2±0.6
vs 1.8±1.1 p<0.001), and a greater infarct size (0.30±0.20 vs 0.38±0.22,
p=0.01). In 5 patients the radial approach failed (2.3%). Angiographic
success was 93.6% and 95.6% in the radial and femoral groups, respectively
(p>0.2). No difference was found in door-to-balloon and fluoroscopy time.
The bleeding complications are summarized in the Table. No intracranial
hemorrhages were observed. Overall major (haemoglobin loss >=5mg/
dL) and minor haemorrhages were significantly less in the radial
group, particularly in patients undergoing rescue PCI (1.2% vs 9.7%,
P=0.001). Access site bleedings were almost absent in the radial group,
while being the most common bleeding site in the femoral group.
Conclusion: In patients with ACS treated with PCI and abciximab, the
radial access markedly reduces overall and access site bleedings without
affecting procedural success.
Bleedings
Femoral
Overall(n=336) Radial(n=264)
(n=73)
35 (10.4%)
17 (6.4%)
18 (25%)
Total bleedings
17 (6.4%) 14 (19.2%)
Total minor bleedings (<5 g/dL) 31 (14.9%)
4 (1.2%)
0 (0%)
4 (5.5%)
Total major bleedings (≥5 g/dl)
Access site bleedings
11 (3.3%)
2 (0.8%)
9 (12.6%)
Access site minor bleedings
10 (3.0%)
2 (0.8%)
8 (11.0%)
Access site major bleedings
1 (0.3%)
0 (0%)
1 (1.4%)
P Value
<0.001
0.002
0.002
<0.001
<0.001
0.05
TCT-294
Transradial Approach for Coronary Angiography: Looking for the
Ideal Multipurpose Catheter. A Randomized Comparison between the
Amplatz Left and the Tiger Shapes
A Doganov1, H Benamer2, P Garot3, V Krastev1, V Gelev1, T Lefèvre4, T
Unterseeh3, Y. Louvard4
1
National Heart Hospital, Sofia, Bulgaria2Clinique La Roseraie,
Aubervilliers, France3Institut Cardiovasculaire Paris Sud, Quincy,
France4Institut Cardiovasculaire Paris Sud, Massy, France
Methods: the two catheters were randomly compared in
a
4-center
European
study
where
coronary
angiograms
were
performed
by
experienced
transradial
operators.
Population: 194 patients (pts), 70.6% male, 62,3+11,4 years old, 22,7%
diabetics, had TR CA for Stable (62,4%), Unstable angina (14,9%), Silent
ischemia (16,4%) or AMI (3,6%). The number of diseased vessels was
1.1+1.1 and LVEF 55.9+15.2%. No puncture failure occurred; cross over to
TF approach was necessary in 2 pts (1%). No complication occurred.
Catheter cross-over for LCA, %
Number of catheters used for LCA, n
Catheter cross-over for RCA, %
Number of catheters used for RCA, n
Total number of coronary catheters, n
Any catheter cross-over, %
Procedural duration, min
Contrast medium volume, cc
Number of cine sequences, n
X-ray duration, min
X-ray dose, total DAP, cGy.cm²
LCA angio quality, 1-5
RCA angio quality, 1-5
Amplatz left, n=97 Tiger, n=95
12.4
3.2
1.12±0.41
1.06±0.38
12.4
3.2
1.13±0.37
1.03±0.18
1.25±0.05
1.09±0.46
21.6
5.3
10.4±4.1
11.0±5.4
83±25
89±26
8.6±1.5
9.0±1.7
3.4±1.9
3.5±2.6
5683±2831
5314±2482
4.6±0.6
4.5±0.5
4.8±0.6
4.8±0.4
p
0.03
ns
0.03
0.019
0.022
0.002
ns
ns
ns
ns
ns
ns
ns
Conclusion: This multicenter randomized study confirms the very
high success rate of transradial coronary angiography (99%). It shows a
significantly favorable trend towards use of the Tiger as a multipurpose
catheter with a 95% success rate in both coronary arteries as opposed to
78% using the AL.
TCT-295
Results from a Large Coronary Stenting Registry with a Bare Metal
Stent in Real Life: The French EOLE Registry
Helene Eltchaninoff1, Damien Bouchayer2, Claude Charmasson3, Eric
Lefebvre4, Sabeur Mnif5, Xavier Tabone6, Robin Zelinsky7, Carmen
Braban8, Elisabeth Mouton8, on behalf of EOLE study group
1
University Hospital Charles Nicolle, Rouen, France2Infirmerie
Protestante, Caluire-et-Cuire, France3Cardiovascular Center Valmante,
Marseille, France4Clinic Les Sources, Le Mans, France5CMC Parly II, Le
Chesnay, France6CH Jacques Coeur, Bourges, France7Clinic St Sauveur,
Mulhouse, France8Guidant France, Rueil-Malmaison, France
Background: Direct coronary stenting (DS) is a safe technique associated
with a similar rate of major adverse cardiac events (MACE) and lower
costs, use of contrast and exposure to radiation in comparison to stenting
with pre-dilatation (PD) as reported in several randomized studies.
Population and methods:This clinical registry compared the primary
success at implant, and MACE rates at 1 month (M1) and 6 months (M6)
in recipients of Multi-Link Zeta™ stents with versus without PD. The
registry included 451 pts with 1-3 de novo lesions (L) treated with DS in
67.7% of the procedures (n= 306, 80.4% men) or after PD (n=120, 80.0%
men). In 25 pts, both DS and PD were performed. The demographics
and lesion characteristics of the 2 groups are shown in part I of the table.
Results: A primary success was achieved in 99.1% of pts treated by DS and
in 99.2% of pts after PD. No stent was lost. The overall rate of hierarchical
MACE was low in both groups: 2.1% in the DS group vs. 0.0% in the PD
group at M1 and 6.65% vs. 5.09% at M6 respectively. The clinically driven
target lesion revascularization rates (TLR) at M6 were 3.48% vs 4.24% as
presented in Part II of the table. 95% of the pts were followed at M6.
Background: Transradial (TR) approach for coronary diagnosis
and intervention reduces the rate of vascular complications
compared to femoral approach (TF) but, for coronary angiography,
procedural and X-Ray times remain slightly longer. Several
“multipurpose” catheters have been tested to reduce these extra times.
Purpose: To compare the well evaluated AL (Amplatz
left) catheter with a new “multipurpose” shape, the Tiger
(Terumo
company)
for
TR
coronary
angiography
(CA).
120H
SD: standard deviation, MI: myocardial infarction, Dia: diameter,D:death,*: Q-waveMI,**: nonQwaveMI
CHARACTERISTICS
B1,B2,C
Age,
Diabetes Prior MI >1 L LAD LCX L. length
L.Dia
ACC/
AHA
year (SD)
(%)
(%)
(%)
(%)
( %)
mm (SD) mm(SD)
(%)
DS
64.1 (11.51) 21.9
25.8
10.1 13.7
6.1
11.8 (5.1) 3.15 (0.39) 80.4
PD
67.08 (11.1) 22.5
28.3
10.4 25.6 17.25 13.2 (5.2) 3.12 (0.38) 97.0
Part II
MACE (%)
TLR TLR
D M1
D M6 MI M1 MI M6
MACE M1 MACE M6
M1
M6
DS
0.35
2.12
0.00* 0.00 * 1.05 3.48
2.10
6.65
0.70 ** 1.05**
PD
0.00
0.85
0.00 * 0.00 * 0.00 4.24
0.00
5.09
0.00** 0.00**
Part I
Conclusions: a) In clinical daily practice, DS was technically feasible in
the majority of pts with a primary success at implant in 99.1% of pts; b) Pts
treated by PD seemed to be at higher risk; c) Overall rates of MACE were
extremely low.
TCT-296
Mechanisms of Acute Lumen Gain and Recurrent Restenosis in
Diabetics Undergoing Coronary Stent Implantation: Results of a
Matched-Pair Analysis
Peter W Radke1, Klara Friese2, Andrea Buhr2, Axel Kaiser1, LarsChristian Harland1, Heribert Schunkert1, Rainer Hoffmann2
1
UK-SH Campus Luebeck, Luebeck, Germany2RWTH University, Aachen,
Germany
Aim of this study was to evaluate the mechanisms of acute lumen
gain and late lumen loss after elective coronary stent implantation
in diabetic and non-diabetic patients using a matched-pair analysis.
A total of 133 diabetic patients with 192 coronary lesions were included into
this analysis. From a database, a group of 192 lesions in 192 non-diabetic
patients were matched in a pairwise fashion stratifying for reference diameter
(RD), minimal lumen diameter (MLD) and lesion length (LL). All patients
underwent follow-up angiography (FUA) 5±2 month post intervention.
In addition to the preinterventional RD, MLD and LL, stent length,
stent diameter, and maximal implantation pressure were statistically
not different. The restenosis rate at FUA was 25% in the diabetes
group and 14% in the non-diabetes group (p<0.001). Quantitative
coronary angiography (QCA) data are summarized in the table (in-stent
analysis). The contribution of an exaggerated neointimal proliferation
to the lower net lumen gain in diabetic patients measured 50±16%.
Conclusion: Patients with diabetes mellitus show a significantly lower net
lumen gain as compared to non-diabetics with identical vessel dimensions.
Mechanistically, likely the increased plaque load leading to inferior
procedural results as well as an exaggerated neointimal proliferation are
quantitatively equally important for this process. These data, for the first
time, show that the mechanisms of inferior angiographic results in diabetics
are multifactorial.
Data in mm
Acute lumen gain
Late lumen loss
Net lumen gain
Loss index
No Diabetes (n=192)
1.56±0.38
0.55±0.36
1.01±0.71
0.39±0.40
Diabetes (n=192)
1.47±0.41
0.64±0.42
0.83±0.66
0.47±0.37
p-value
0.04
0.04
0.01
0.04
TCT-297
Angiographic and Intravascular Ultrasound Results of the
A.A.C.H.E.N. Trial: A Double-Blind, Randomised, Placebo Controlled
Multi-Center Clinical Trial to Evaluate the Effects of Candesartan
Cilexetil on Intimal Hyperplasia after Coronary Stent Implantation
Peter W Radke, A.A.C.H.E.N. Trial Study Group
UK-SH Campus Luebeck, Luebeck, Germany
The A.A.C.H.E.N. trial was a double-blind, randomised, placebo
controlled clinical multi-center trial to evaluate the effects of
candesartan on intimal hyperplasia after coronary stent implantation.
120 patients (61±9 yrs, 83% male) were randomised to receive either
32 mg Candesartan cilexetil (active) or placebo starting 7-14 days
before elective coronary stent implantation. Follow-up visits were
scheduled 4±1 and 12±2 weeks post intervention. Follow-up angiography
including intravascular ultrasound assessment of the target lesion was
performed 24±2 weeks after stent implantation. Major cardiac events
(MACE) were defined as death, acute myocardial infarction and
recurrent target lesion revascularisation before the final follow-up visit.
The mean stent length was 15.0± 4.9 mm (active) and 14.6±5.7 mm (placebo
group) (p= n.s.). MACE rates were not significantly different between
treatment groups (8% vs. 11%). Complete follow-up angiographic data were
available in 90 patients and IVUS data at follow-up in 77 patients (Table).
Conclusions: High-dose Candesartan cilexitil therapy is safe in patients
with symptomatic coronary artery disease undergoing coronary stent
implantation. This regimen, however, does not reduce clinical event rates,
restenosis rates or neointimal proliferation after elective stent implantation.
Longer ARB pretreatment or local delivery strategies to increase tissue
concentrations may be neccessary to achieve significant effects on
neointimal proliferation.
QCA (data in mm)
Reference diameter
MLD pre procedure
Late lumen loss
Restenosis rate (%)
IVUS data
Neointimal area (mm2)
Candesartan (n=51)
2.9± 0.5
0.9± 0.4
0.7± 0.6
31%
(n=36)
2.1± 1.0
Placebo (n=39)
2.9± 0.7
1.0± 0.5
0.6± 0.5
21%
(n=41)
2.1± 1.5
p-value
1.0
0.28
0.39
0.35
1.0
TCT-298
Emergency Coronary Artery Bypass Surgery for Percutaneous
Coronary Interventions: Incidence, Clinical Characteristics, and
Indications from 1979 to 2003
Eric H Yang, Richard J Gumina, Ryan J Lennon, David R Holmes, Jr.,
Charanjit S Rihal, Mandeep Singh
Mayo College of Medicine, Rochester, MN
Objectives: The purpose of the current study was to evaluate the
changes in incidence, clinical characteristics, and indications for
emergency CABG in patients undergoing PCI from 1979-2003.
Background:
Emergency
CABG
(within
24
hours)
after
percutaneous
coronary
intervention
(PCI)
is
associated
with
significant
morbidity
and
mortality.
Methods: Data from 23,087 patients who underwent PCI at Mayo
Clinic from 1979-2003 were analyzed. Patients were divided into three
groups: the “pre-stent” era, 1979-1994 (n=8905); the “initial stent era”,
1995-1999 (n=7605); and the “current stent era”, 2000-2003 (n=6577).
Results: Although patients in the recent time periods undergoing PCI had
more high-risk features, there was a significant decrease in the incidence
of emergency CABG from 2.9% to 0.7% to 0.3% across the groups (p <
0.001). Patients requiring emergency surgery in the recent time periods
had a higher prevalence of hypertension, prior revascularization, and
left ventricular dysfunction (ejection fraction < 40%) as well as more
complex coronary lesions. Fewer patients in the current stent era had
coronary artery dissections and abrupt vessel closure requiring emergency
CABG. During the stent-era (1995-2003) the strongest predictor for
emergency CABG was an emergent indication for PCI. Other significant
predictors were multi-vessel coronary artery disease, the presence of
peripheral vascular disease, lesion in an angulated segment (> 45°), and
history of tobacco abuse. The in-hospital mortality rate for emergency
CABG patients remains unchanged and ranges from 10 to 14%.
Conclusion: The current study demonstrates that despite the increase in
high-risk patients undergoing PCI, there has been a marked decrease in the
121H
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
incidence of patients requiring emergency CABG. However, the in-hospital
mortality rate for those requiring emergency CABG remains high and
unchanged.
TCT-299
Treatment of Recurrent and Diffuse Instent Restenosis with
Sirolimus-Eluting Stent : Long-Term Outcome
Imad Sheiban, Amedeo Chiribiri, Claudio Moretti, Walter Grossomarra,
Pierluigi Omedè, Filippo Sciuto, Emauele Meliga, Giampaolo Trevi
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
Background: Drug- eluting stents coated with anti-proliferative
drugs might represnt an effective treatment for in-stent restenosis
(ISR). In this study we report our experience in the use of sirolimuselunting stent (Cypher) for the treatment of recurrent and diffuse ISR.
Methods 136 consecutive patients (pts) (age 65±10 years; 69% male)
with diffuse and recurrent ISR in native coronary vessels were treated
with Cypher stent . Among coronary risk factors diabetes was present
in 37%. 34 pts (41% ) had a previous myocardial infarction and 18%
had a previous coronary artery surgery . A total number of 174 DES
(1,3 stent/patient) were implanted. Mean lesion lenght was 18±7 mm
(from 13 to 33 mm). Double antiaggregation therapy was continued for
at least 3 months following the procedure. Follow up visits were planned
at 1, 3, 6 and 9 months all pts. The following events were evaluated:
death, recurrence of angina,new myocardial infarction, SAT, target
vessel revascularization (TVR) or target lesion revascularization (TLR).
An elective 9-month angiographic follow up was planned in all pts
Results: Procedural success was 100%.No procedural MACE were
observed. One in-Cypher SAT occurred ( 0.7%) and was successfully
treated 2 days after DES implantation. Mean follow-up period was 458±
215 days. 74 pts were followed for at least 12 months 36 for at least 24
months. During follow-up : Cardiac death occurred in 3 pts ( 2.2%) and
Q-AMI in 1 pts (0.7%) . 18 pts underwent clinical-driven angiographic
control: 2 (1.5%) because of non-Q AMI , 8 pts (5.9%) for recurrent
angina , 8 pts (5.9%) for positive ischemia test. Angiopraphic control
revealed in-Cypher restenosis only in 6. The remaining 12 pts had disease
progression on native vessels. Thus TVR/TLR occurred in only 6 pts (
4.4%). 73 pts (54%) completed elective 9-month angiographic follow-up
All were free of symptoms . Only 2 patients had in Cypher restenosis. Thus
total angiographic control was performed in 91 patients : angiographic
restenosis was 8.8% . Total MACE during follow up was 17.6 %.
Conclusions: The treatment of ISR with Cypher stent is safe and very
effective. These results suggest that Cypher stent could be considered as
first choice option for the treatment of ISR.
TCT-300
Contemporary Outcome Trends in the Elderly Undergoing
Percutaneous Coronary Interventions: Results in 513 Patients
Carrié Didier, Moudens Grégory, Boudou Nicolas, Cherradi Rhizlan,
Lhermusier Thibault, Maupas Eric, Elbaz Meyer, Puel Jacques
Cardiology B, CHU RANGUEIL, Toulouse, France
Background: Older age has been shown to adversely affect clinical outcomes
in patients with acute coronary syndromes (ACS). There is currently
a paucity of data on the outcomes of electives PCI in elderly patients.
Objectives: We sought to define the risks facing elderly patients
undergoing contemporary percutaneous coronary interventions (PCIs).
Methods: From January 1st 2000 to December 31st 2001, we studied
clinical outcome of 513 patients > 75 years old undergoing elective
PCI in a monocentric registry of contemporary PCI. Clinical endpoints
evaluated included in-hospital mortality, major cardiovascular
events endpoint (MACE) defined as the composite of death,
122H
myocardial infarction, stroke and emergent bypass surgery within
the same hospitalization and clinical outcome at 3-years follow-up.
Results: The mean age was 79.06 ± 3.44 years with only 6.6 % of
stable angina, 18.1 % of acute myocardial infarction and 75.3 % of non
ST+ acute coronary syndrome. 48 % of patients have single vessel
disease and the mean left ventricular ejection fraction was 53.88 ±
12.99 %. PCI procedure consisted to implant 1.25 stent/patient. The
mean length of stay was 6.44 ± 4.41 days. In-hospital complications
rate was 10.9 % including death (4.3 %) and major cardiac events.
Mean follow-up was 38.2 ± 3.6 months for 491 patients (95.7 %).
The long term mortality was 24.75 % (cardiac death = 15.59 %) and MACE
rate was 51.85 % : stroke 4.29 % (n = 22), coronary artery bypass graft 2.73
% (n = 14), iterative PCI 20.07 % (n = 103) whose 46 patients for restenosis.
More over 5.45 % of patients suffered from neoplasy. Independent predictors
of mortality included peripheral vascular disease (odds ration (OR) 2.82
%, 95% confidence interval (CI) 1.47 to 5.41), extension of coronary
artery disease (OR 1.57, 95 % Cl, 1.17 to 2.11), age (OR 1.11, 95 % Cl,
1.06 to 1.16), and low ejection fraction (OR 0.94, 95% Cl, 0.92 to 0.96).
Conclusion: Despite stent era, outcomes in elderly patients undergoing
PCI are strongly influenced by comorbidities, extension of coronary artery
disease and low ejection fraction.
TCT-301
Xuezhikang, an Extract of Cholestin, Administration before
Percutaneous Coronary Intervention: Impact on Frequency of
Periprocedural Myocardial Injury
Li Yongjun1, Su Bianling2, Zhang Hui2, Zu Xiuguang2, Liu Suyun2, Hao
Yuming2, Du Jun2
1
Second Hospital,Hebei Medical University, Shijiazhuang, China2Second
Hospital, Hebei Medical University, Shijiazhuang, China
Background: An increase of cardiac biomarkers has been shown to occur
in 5-30% after successful percutaneous coronary interventions (PCI). It
has been demonstrated that the risk of subsequent cardiac events (death
or myocardial infarction) is related to the extent of cardiac troponin
or creatinine kinase MB isoform (CK-MB) increase. Xuezhikang,an
extract of Cholestin,a dietary supplement,has lipid-modulating
and antiinflammatory effects.we hypothesized that preprocedural
Xuezhikang therapy would decrease periprocedural myocardial injury.
Methods and results: Three hundred and fifty-three patients scheduled
for elective PCI and not on statins were randomly assigned to either no
treatment or to Xuezhikang treatment. Xuezhikang administration,2400mg/
day was started at least 7 days before the procedure.Incidence of
periprocedural myocardial injury was assessed by analysis of creatinine
kinase myocardial isoenzyme (CK-MB: upper limit of normal [ULN]
3.6 ng/ml) and cardiac troponin I (cTn I, ULN 0.10 ng/ml) before, 6 and
12 h after the intervention. The incidence of increased levels of CK and
CK-MB >3 times normal and the absolute increase in CK and troponin I
were compared between groups. The control group had significantly higher
periprocedural levels of CK. In the control group, 8.2% of patients had CK
increases >3 times the upper limit of normal compared with 2.5% in the
Xuezhikang group (p < 0.01). The control group had a higher frequency
of CK-MB increases >3 times the upper limit of normal (9.2% vs 3.3%,
p<0.01) and a higher levels of troponin I (5.21 vs 1.67 ng/ml, p< 0.05).
Conclusions: Pre-procedural Xuezhikang therapy reduces the incidence of
myocardial injury after PCI.
TCT-302
Minor Myocardial Damage During Percutaneous Coronary
Intervention Does Not Influence Long Term Prognosis
Joan Antoni, Jaume Maristany Daunert, Jose Gonzalez Costello, Marcos
Pascual Sastre, Ayman Sadek, Claudia Herrera Siklody, Emili Iraculis
Soteres, Francesc Jara Sureda, Angel Cequier Fillat, Enric Esplugas
Oliveras
H Universitari Bellvitge, Barcelona, Spain
Aims: To evaluate the long-term prognosis of minor myocardial
damage (MMD) during percutaneous coronary intervention (PCI).
Methods and results: We included consecutive patients in whom PCI
was performed. We excluded patients with baseline elevated cardiac
markers. ECG and cardiac markers were measured before and 12 and
24 hours after PCI. According to the value of cardiac markers after PCI,
we classified the patients in three groups: no damage (normal troponin
and CK-MB), MMD (elevated troponin value with normal CK-MB)
and myonecrosis (elevated troponin and CK-MB). During followup, death, myocardial infarction and repeat revascularization were
considered as major adverse cardiac events (MACE) and were collected.
In 757 patients included at study, MMD was detected in 249 patients
(33%), and myonecrosis in 46 patients (6.1%). During a follow-up
34±14 months, MACE occurred in 151 patients (19.1%) with no global
difference between the three groups. Survival curves showed an significant
increase in mortality in patients with myonecrosis (13%) respect the other
two groups (MMD 6% or no damage 3.5%); log Rank 10.01, p=0.0067.
Conclusion: MMD during PCI does not affect long term prognosis. In
contrast, myonecrosis increases mortality. This fact questions the prognostic
implications of the present definition of myocardial infarction after PCI.
between WBC and ISR and in-stent neointimal volume at sixmonth follow up in patients with stable angina treated with statins.
Methods: We prospectively studied 64 patients (pts) with stable angina,
who underwent angioplasty with bare metal stent implantation (PCI) for
the de-novo lesions in native coronary arteries. All subjects were treated
with statins. Peripheral blood was obtained from all patients immediately
before PCI, 24h and 48h after the procedure. Total WBC, netrophil and
monocyte fractions counts were measured with an automated hematology
analyser. At six-month follow-up, all patients underwent angiography with
quantitative coronary analysis (QCA) and intravascular ultrasound study
with volumetric evaluation. ISR was defined as ≥50% stenosis by QCA.
Results: At 6 months, ISR was found in 15 pts (23,8%). We have observed
no significant differences in preprocedural levels of total WBC, monocyte
and neutrophil fraction counts between ISR and no-ISR pts. The median
monocyte count 48 h after stent implantation was significantly higher in
subjects with ISR (640+/-28/mm3 vs 490+/-21/mm3; p<0.001). Monocyte
count 48 h after PCI showed a significant positive correlation with late
lumen loss (r=0,42; p<0,001) and in-stent neointimal volume (r=0,31;
p=0,013). Other analysed fractions did not correlate with late lumen
loss and in-stent neointimal volume. In multiple regression analysis
monocyte count 48h after PCI and stent length were proved to be the
only significant independent predictors of in-stent neointimal volume.
Conclusions: Post-procedural increase in plasma monocyte levels
correlates with the development of ISR and can be used as a predictor of
in-stent neointimal volume after coronary stenting. Our results confirm
that circulating monocytes play a crucial role in the process of in-stent
neointimal hyperplasia in the modern area of statin therapy.
TCT-304
High-Dose Atorvastatin Prevents RESTenosis AfteR Complex
Coronary inTervention. Final Results of the RESTART Study
Francesco PRATI1, Fabrizio Imola1, Pierfrancesco Corvo1, Tamer Fouad1,
Carmelo Cernigliaro2, Vito Ramazzotti1, Alessandro Manzoli1, Maria
Cera1, Alessandro Pappalardo1
1
Cath Lab, Rome, Italy2Cardiology Institute, Novara, Italy
TCT-303
In-Stent Neointimal Hyperplasia after Coronary Stenting is Predicted
by Periprocedural Circulating Monocytes Level in Patients with
Stable Angina Treated with Statins
Janusz Kochman1, Joanna Wilczynska1, Grzegorz J. Horszczaruk1, Zenon
Huczek1, Adam Rdzanek1, Krzysztof J. Filipiak1, Jaroslaw Walory2, Pawel
Grzesiowski2, Waleria Hryniewicz2, Grzegorz Opolski1
1
1st Chair and Department of Cardiology, Medical University of Warsaw,
Poland., Warsaw, Poland2National Institute of Public Health, Warsaw,
Poland
Background: Growing body of evidence supports the theory
that inflammatory process may contribute to pathogenesis of instent restenosis (ISR). Circulating white blood cells (WBC) levels
measurement is an accepted way of assessing inflammatory status.
Objectives: The aim of the study was to investigate the relationship
Background.
We
tested
the
efficacy
of
high-dose
atorvastatin
for
prevention
of
clinical
and
angiographic
restenosis after complex coronary intervention with stenting.
Methods. From Nov. 2003 through Feb. 2004, 91 consecutive pts
(152 lesions), at high risk of restenosis, underwent successful stenting
(158 stent; 1.7 stent/pts). Pts were eligible in presence of at least one
of the following criteria: diabetes mellitus (14.3%); acute myocardial
infarction (13.2%); lesion length >15mm (25.0%); lesion in small vessels
(<2.5mm)(30.8%); >2 treated lesions (58.2%); side-branch lesion (2.2%).
Atorvastatin (80 mg/die) was started on the same day of stenting and
continued for at least 8 months. Results. 4 pts (4.4%) had target vessel
revascularization. Angiographic follow-up was performed at 8.5 months in
71 pts (78.0%;125 stents). Binary angiographic restenosis was observed in
19/71 pts (26.7%) (in-stent 22.5%; in-segment 4.2%) and in 17/125 stents
(13.6%). All lesions were matched with 600 consecutive lesions treated
with stenting in the same period but without high dose statins. 117 lesions
were found to match according to the following variables: diabetes, acute
myocardial infarction, vessel treated, reference diameter, lesion length.
Late loss in the atorvastatin group was significantly lower (p=0.027).
Conclusion. The RESTART prospective registry showed that 80 mg
atorvastatin leads to excellent clinical and angiographic outcome. These
results were confirmed in a matched lesion comparison.
Atorvastatin
Control
MLD post
2.62±0.43
2.64±0.46
Ref post %DS post MLD FU Ref FU
%DS FU Late Loss
2.93 ±0.45 10.3 ± 8.0 2.06±0.58 2.89±0.47 28.1 ± 18.2 0.56±0.55
2.94 ±0.44 9.9 ± 8.0 1.86±0.78 2.88±0.48 37.2± 23.3 0.78±0.64
123H
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TCT-305
“Pharmacologic” Distal Protection Using Prophylactic, Intragraft
Nicardipine to Prevent No-Reflow and Non-Q Wave MI during SVG
Interventions
Tim A. Fischell, Raviprasad G. Subraya, Kamal Ashraf, Andrew J. Carter,
Benjamin Perry, Scott D. Haller
Borgess Heart Institute, Kalamazoo, MI
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Background: Coronary artery saphenous vein bypass graft (SVG) stenting
has been associated with up to a 30% rate of myocardial infarction (MI)
when performed with balloon pre-dilatation and without distal protection.
Methods: We evaluated the technique of prophylactic arteriolar
vasodilatation with intracoronary nicardipine (300 mcg) followed by
immediate direct stenting for degenerated coronary SVGs, without the use
of mechanical distal protection. Data were collected from 82 consecutive
elective SVG interventions in 65 patients (mean age 70+/-10.8 years).
Films were read by the Borgess angiographic core lab (CMS Medis
system). All patients received ASA prior to, and after the procedure,
and weight adjusted unfractionated heparin. IIB-IIIa inhibitors were
given in 53/65 (81%) of the procedures. ECGs and CPKs and CPK MBs
were obtained pre-procedure and at 12-18 hours after the intervention.
30-day follow-up data were obtained in 63/65 (97%) of patients.
Results: The average graft age was 11.7+/-6.6 years. Thrombus was seen
in 21/82 vessels (26%) prior to stenting. MLD improved from 1.09+/0.78 mm to 2.99+/-0.89 mm after stenting; and % DS improved from
67+/-20%(pre) to 14+/-19% after stenting. The primary adverse endpoint
of CPK >3X upper limit of normal (ULN), or CPK MB >3 x ULN was
seen in 2/65 (3.0%) and 3/65 (4.6%) patients, respectively. Mean TIMI
flow improved from 2.2+/-0.9 (pre) to 2.7+/-0.6 after stenting. Slow reflow
was observed transiently in 1/82 SVG interventions (1.2%). 1/65 cases had
associated minor ECG ischemic changes after stenting (1.8%). No patient
had a q-wave MI. 30-days MACE (death, MI (after discharge), repeat TLR)
were seen in 0 of the 63 patients with 30-day follow-up. The estimated
cost of nicardipine intervention was $6,733 (for all 82 interventions),
vs. a projected cost of $106,354 had distal filters been used in all cases.
Conclusions: 1) Prophylactic vasodilation with intragraft nicardipine,
followed by direct stenting appears to be a safe and effective means of
performing elective SVG revascularization. 2) This approach may provide
a safe, simple and time and cost-effective alternative, or adjunct, to distal
protection for elective SVG interventions.
TCT-307
Effect of Creatine Kinase-MB Fraction Elevation after Successful PCI
on One-Year Mortality
Ramin Ebrahimi
UCLA/GLAVA, Los Angeles, CA
Background: Percuatenous Coronary Intervention (PCI) is a very effective
and common treatment for symptomatic Coronary Artery Disease (CAD).
Creatine Kinase-MB (CKMB) elevation may be noted in a large percentage of
patients undergoing PCI. The effect of this cardiac enzyme elevation on long
term mortality after successful PCI has not been well studied and continues to
be subject of much debate. The purpose of this study is to evaluate the effect
of CKMB elevation above normal limits on mortality after successful PCI.
Methods: REPLACE 2 was a double blind prospective randomized
trial in patients undergoing PCI that compared different regimens of
antiplatelet/antithrombotic therapies. Patients were divided into not
successful PCI (residual stenosis>50%, final TIMI flow<3, unable to
cross or dilate) or successful PCI (all others). The effect of CKMB
elevation after successful PCI on the one year mortality rate was
assessed. The effect of the degree of this enzyme elevation on the one
year mortality was also investigated based on the one year follow up.
124H
Results: Of the 6002 patients, 5797 (96.6%) did have index PCI. Of these
5659 (97.6 %) were successful. In this group, 1249 (22.1 %) had CKMB
elevation above normal limits post PCI. The one year mortality in the groups
without and with CKMB elevations were 67/3668(1.8 %) and 32/1234(2.6
%) respectively, not a statistically significant difference (p=0.098). This
mortality difference did not reach statistical difference in those who had
enzyme elevations of 1-3X normal 20/872 (2.3 %), p= 0.366, those with
1-5X normal 24/1031 (2.3 %) p= 0.30, those with 1-8X normal levels
28/1125 (2.5%), p= 0.16 or even in those with >8X 4/109 (3.7%) p= 0.15.
Conclusions: This analysis suggests that CKMB elevation after successful
PCI may not have much effect on mortality for up to one year.
TCT-308
RAGE Gene Polymorphisms and Restenosis after Coronary Artery
Stenting in Non-Diabetic Korean Population
Chi Young Shim, Sungha Park, Hyun-Young Park, Chanmi Park, YoungGuk Ko, Dong-Hoon Choi, Yangsoo Jang, Namsik Chung
Cardiology Division, Cardiovascular Research Institute and
Cardiovascular Genome Center, Seoul, Republic of Korea
Backgrounds: AGEs-RAGE interaction in vessel wall may lead to
inflammation, smooth muscle cell proliferation, and extracellular
matrix production, culminating in exaggerated intimal hyperplasia
and restenosis. Many polymorphisms in the RAGE gene have
already been identified in diabetes or coronary artery disease, but
their association with development of neointimal hyperplasia and
in-stent restenosis after coronary artery stenting was not known.
We
investigated
the
possibility
that
single
nucleotide
polymorphisms
of
the
genes
encoding
RAGE
are
associated with in-stent restenosis after coronary stenting.
Methods: Our study included 334 consecutive non-diabetic patients with
symptomatic coronary artery diseased who underwent bare metal stent
implantation. Follow-up angiography was performed in 297 patients (88.9%),
six months after intervention. We screened the -1106 T/C, -443 T/C, -388 T/A,
-257 G/A, +557 G/A and +1704 G/T RAGE polymorphism in these patients.
Genotyping was performed by PCR fragment-length polymorphism assay
Results: A total of 355 target lesions were evaluated, in 297 patients. There
was no significant association of the -1106 T/C, -443 T/C, -388 T/A, -257
G/A, +557 G/A and +1704 G/T polymorphism with in-stent restenosis
after coronary artery stenting. The distributions of the dominant genotypes
were: 51.5% -1106TT; 77.8% -443TT; 65.7% -338TT; 90.6% -257GG;
75.1% +557GG; 68.0% +1704GG. We did not observe a significant
difference in minimal luminal diameter(mm), late lumen loss(mm), loss
index, diameter stenosis(%), and the rates of angiographic restenosis(%)
in these polymorphisms. In a multivariate analysis of angiographic
restenosis, we examined the possible influence of the baseline, lesionrelated, and procedural variables. The multivariate analysis did not
reveal an association of polymorphism with angiographic restenosis.
Conclusion: Our observation suggests that the RAGE gene
polymorphism
is
not
associated
with
in-stent
restenosis
after
coronary
artery
stening
in
non-diabetic
patients.
Keywords: In-stent restenosis, RAGE, polymorphism
TCT-309
Anemic Patients Undergoing Percutaneous Coronary Intervention
Have a Higher Mortality Even in the Absence of Major Bleeding
Complications
Michele D. Voeltz1, A. Michael Lincoff2, Frederick Feit3, Sunil V. Rao4,
Arshed A. Quyyumi1, John S. Douglas, Jr.1, Steven V. Manoukian1
1
Emory University School of Medicine, Atlanta, GA;2The Cleveland Clinic,
Cleveland, OH;3New York University School of Medicine, New York,
NY;4Duke University Medical Center, Durham, NC
Background: Anemia is an independent predictor of mortality and major
bleeding complications in patients undergoing percutaneous coronary
intervention (PCI). It is unclear whether this increase in mortality is driven
solely by an increase in major bleeding or due to other factors. We hypothesized
that anemic patients undergoing PCI would have a higher mortality than
nonanemic patients, even in the absence of major bleeding complications.
Methods: We reviewed the Randomized Evaluation in PCI Linking
Angiomax to Reduced Clinical Events (REPLACE)-2 Trial, which showed
that bivalirudin with provisional glycoprotein IIb/IIIa inhibitors was not
inferior to glycoprotein IIb/IIIa inhibitors plus heparin and resulted in
less major bleeding in urgent or elective PCI. Anemia was defined using
preprocedural hemoglobin levels and the World Health Organization
definition (hemoglobin <12 g/dL in women and <13 g/dL in men).
Results: Of the 5,869 patients evaluated from REPLACE-2, 1,371 (23.4%)
were anemic. Anemic patients with major bleeding had a significantly higher
mortality vs. anemic patients without major bleeding at 30 days (10.4% vs.
0.4%, p<0.0001) and one year (19.7% vs. 3.5%, p<0.0001). Nonanemic
patients with major bleeding had a higher mortality vs. nonanemic patients
without major bleeding at 30 days (2.4% vs. 0.1%, p=0.0007), but one year
mortality did not differ (2.4% vs. 1.4%, p=ns). Among patients with major
bleeding, mortality was 4-fold higher in anemic vs. nonanemic patients at
30 days (10.4% vs. 2.4%, p=0.0345) and 8-fold higher at one year (19.7%
vs. 2.4%, p<0.0001). In patients without major bleeding, mortality was
also significantly higher in anemic vs. nonanemic patients at 30 days
(0.4% vs. 0.1%, p=0.0348) and one year (3.5% vs. 1.4%, p<0.0001).
Conclusion: In percutaneous coronary intervention complicated by
major bleeding, anemic patients have a dramatically higher mortality
than nonanemic patients. More importantly, even in the absence of major
bleeding, anemic patients have a significantly higher mortality than
nonanemic patients. The impact of anemia on mortality in percutaneous
coronary intervention extends beyond its association with major bleeding
complications.
TCT-310
SYNTAX Run-In Phase: Insights into Contemporary Practice
Patterns in Europe and North America for 3-Vessel and Left Main
Coronary Disease
Patrick W. J. C. Serruys1, Friedrich W. Mohr2, Marie-Claude Morice3,
A. Pieter Kappetein1, David R. Holmes, Jr.4, Michael J. Mack5, Keith D.
Dawkins6, Elisabeth Stahle7, Antonio Colombo8, Jose L. Pomar9, Marcel
van den Brand1, Joerg Koglin10, Mary E. Russell10
1
Erasmus University Medical Center Rotterdam, Rotterdam, The
Netherlands2University of Leipzig Heart Center, Leipzig, Germany3Institut
Cardiovasculaire Paris Sud, Massy, France4Mayo Clinic, Rochester,
MN;5Medical City Hospital Dallas, Dallas, TX;6Southampton University
Hospital, Southampton, United Kingdom7University Hospital Uppsala,
Uppsala, Sweden8Ospedale San Raffaele, Milan, Italy9Hospital Clinico Y
Provincial, Barcelona, Spain10Boston Scientific Corporation, Natick, MA
Background: Due to the evolution of drug-eluting stents and improvements
in peri- and post-procedural therapy for both PCI and CABG, PCI is
challenging CABG as the gold standard for treatment of three vessel
(3VD) and left main (LM) coronary disease. SYNTAX is a novel,
randomized trial with nested registries comparing PCI with paclitaxeleluting TAXUS stents (Boston Scientific, Natick, MA) to CABG for
3VD and LM patients. To aid in site selection, we conducted a run-in
qualification phase to retrospectively collect data on the practice patterns
of interested centers. Additionally, we evaluated current contemporary
practice patterns for the treatment of 3VD and LM in Europe, US,
and Canada to identify any shifts from the use of CABG to PCI. The
purpose of this study is to report the practice pattern trends identified.
Methods: Both interventionalists and surgeons from qualifying centers
were asked to provide anonymous information related to all 3VD
and LM revascularizations performed at their sites from January to
March, 2004. These data will be compared to historical reimbursement
databases and published reports for insights into the current
contemporary practices for 3VD and LM treatment in various regions.
Results: During the run-in phase, data was collected on 12,072 patients
from 104 centers (77 European (EU) and 27 North American (NA)
sites) in 20 countries. 3177 patients were treated with PCI while 8895
were treated with CABG, resulting in an overall ratio of PCI to CABG
procedures of 1:3. On average, participating EU countries performed
twice as many 3VD PCIs per site compared to NA sites. Furthermore,
the ratio of PCI to CABG procedures for 3VD is significantly different
between the regions (EU - 1:2, NA - 1:5). Both regions reported a similar
number of LM PCIs per site (PCI to CABG ratio: EU - 1:3, NA - 1:4).
Conclusions: The primary revascularization strategy for 3VD and LM
disease remains CABG, although historical data from the last decade
demonstrate an increase in the PCI to CABG ratio for revascularizations
overall. Despite the lack of evidenced based data, PCI is increasingly being
used to treat 3VD and LM, with European countries using PCI nearly twice
as often as North America.
TCT-311
In-Stent Restenosis is Associated with Less Periprocedural Cardiac
Enzyme Elevation in Patients Undergoing Saphenous Vein Graft
Intervention
Ryan D Christofferson, Hitinder S Gurm, Patrick L Whitlow, Stephen G
Ellis, Deepak L Bhatt
Cleveland Clinic Foundation, Cleveland, OH
Background: Embolic protection devices are considered standard of care
for percutaneous intervention on saphenous vein grafts. Periprocedural
elevation of the myocardial band of creatine kinase (CK-MB) appears
to correlate with distal embolization, and late outcome. Since in-stent
restenosis is fibromuscular as opposed to thrombotic, such lesions may
be less likely to induce embolism and may not need embolic protection
devices. We sought to determine if the risk for periprocedural non-Q-wave
myocardial infarction is lower among patients with in-stent restenosis.
Methods: We analyzed the prospective interventional database at the
Cleveland Clinic Foundation from 1992 to 2005 to identify all cases of
saphenous vein graft intervention, with and without in-stent restenosis.
Cases with acute myocardial infarction or cardiogenic shock were
excluded. For those patients in whom an embolic protection device
was not used, in-stent restenosis was correlated with periprocedural
CK-MB elevation. The chi-square test was used to compare groups.
Results: A total of 1521 cases of saphenous vein graft intervention were
identified, where periprocedural CK-MB was available. Of these, 234 patients
(15%) underwent intervention for in-stent restenosis. A total of 90 patients had
an embolic protection device utilized, of which 9 had ISR. Among patients
where an embolic protection device was not used, we found a significant
difference in the rate of CK-MB elevation over three times the upper limit
of normal when comparing patients with in-stent restenosis to those without
in-stent restenosis (8% vs. 15%, P<0.003). This was also true for enzyme
elevation over five times the upper limit of normal (4% vs. 10%, P<0.001).
125H
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Conclusions: In our cohort of patients undergoing elective saphenous vein
graft intervention, there was a 50% decreased risk of periprocedural non-Qwave myocardial infarction in patients with in-stent restenosis compared to
those with de novo lesions.
TCT-312
Impact of Age and Choice of Procedural Antithrombotic Regimen
on Ischemic and Hemorrhagic Outcomes following Percutaneous
Coronary Intervention: Analysis from the REPLACE-2 Trial
Eugenia Nikolsky1, Gregg W Stone1, Roxana Mehran1, Ken Mori2, Judah
Weinberger1, George Dangas1, John A Bittl3, Robert A Harrington4, Neal
S Kleiman5, Frederick Feit6, Yingbo Na2, Tayo Addo1, Manuela Negoita2,
Yael Cohen2, A Michael Lincoff7
1
Columbia University Medical Center, New York, NY;2Cardiovascular
Research Foundation, New York, NY;3Ocala Heart Institute, Munroe
Regional Medical Center, Ocala, FL;4Duke Clinical Research Institute,
Durham, NC;5Baylor College of Medicine and Methodist Hospital,
Houston, TX;6New York University School of Medicine, New York,
NY;7Cleveland Clinic Foundation, Cleveland, OH
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Background. The impact of age on outcomes of percutaneous coronary
intervention (PCI) with different adjunctive antithrombotic regimens is
not well described. We therefore examined a relationship between age
and outcomes following PCI using different antithrombotic regimens.
Methods. In the REPLACE-2 trial, 6,010 pts were randomized to
unfractionated heparin plus planned GP IIb/IIIa inhibition (H+IIb/IIIa)
vs. the direct thrombin inhibitor bivalirudin with provisional GP IIb/IIIa
inhibition. Outcomes were stratified by age (<50, >50 to <60, >60 to
<70, >70 to <80 and >80 years) and adjunctive pharmacologic regimens.
Results Rates of major bleeding steadily increased with increasing age
(1.6%, 2.5%, 3.2%, 4.2% and 6.9%, respectively; Ptrend<0.0001). Compared
with H+IIb/IIIa, treatment with bivalirudin was associated with less
major bleeding at the majority of age groups (2.3% vs. 0.8%, P=0.14;
3.4% vs. 1.7%, P=0.04; 4.3% vs. 2.0%, P=0.08; 4.6% vs. 3.8%, P= 0.51
and 9.2% vs. 4.8%, P=0.18, respectively). Rates of minor bleeding were
significantly reduced with bivalirudin in all ages (P-value from 0.005 to
<0.0001). Older age was also associated with significantly increased 30day rates of ischemic MACE (death, MI, urgent repeat revascularization)
[6.4%, 7.2%, 7.7%, 8.1% and 11.9%, P=0.03] and the primary quadruple
composite endpoint (MACE plus major bleeding) [7.9%, 9.0 %, 9.5%,
10.9% and 16.6%, P=0.0001], without significant differences between
the two antithrombotic regimens across each of the age strata. By
multivariate analysis, older age was an independent predictor of major
bleeding (OR 1.04; P<0.0001), 30-day death (HR=1.12; P=0.0001)
and the primary quadruple composite endpoint (HR=1.01; P=0.0008).
Conclusions. Older age is associated with increased risk of PCI-related
bleeding and MACE. Patients of all ages benefit from bivalirudin by a
marked reduction in major and/or minor bleeding with similar rates of
ischemic complications.
TCT-313
Coronary Artery Perforation during Percutaneous Coronary
Intervention: Incidence and Outcomes in the New Interventional Era
Ravi K Ramana1, Dinesh Arab1, Dominique Joyal1, Lowell Steen1, Leslie
Cho1, Bruce Lewis1, Jayson Liu2, Henry Loeb2, Ferdinand Leya1
1
Loyola University Medical Center, Maywood, IL;2Hines VA Medical
Center, Hines, IL
Background: Coronary artery perforation (CP) is a serious complication
of percutaneous coronary intervention (PCI). We sought to define
the incidence and outcome of CP given the advance in interventional
techniques, devices, and use of glycoprotein inhibitors (GPIIbIIIa).
126H
Methods: We retrospectively reviewed the records of patients who underwent
PCI at our institution over a four-year period. The incidence of CP was
derived from patient records and then confirmed by reviewing the angiogram.
Perforations were classified as Type 1, 2, or 3 as previously defined.
Results: 4886 patients underwent PCI. Atherectomy devices were used in
329 patients and GPIIbIIIa in 2200 patients. Twenty-five CP were identified
(0.5% incidence). Six were Type 1 (24%), 10 were Type 2 (40%), and 9
were Type 3 (36%). 13/25 (52%) of the CP were Type C lesions, and 12/25
(48%) occured in calcified vessels. All Type 1 perforations were caused
by coronary wires and 4/6 CP occurred with use of hydrophilic and extra
stiff wires. Type 2 perforations were caused by coronary wires in 8/10 CP
and by stent deployment in 2/10. Two patients with Type 2 CP sustained
a non-ST elevation myocardial infarction. Type 3 perforations were
caused by stent placement in 4/9 CP, 3/9 by coronary wires, and 2/9 by
atherectomy devices. Four patients with Type 3 CP underwent pericardial
drainage, five patients had a myocardial infarction, and two patients died.
Conclusion: Type 1 and 2 perforations, are predominately caused by
hydrophilic and stiff wires and do not require pericardial drainage or surgical
intervention. Type 3 perforations are more often associated with stent and
device use. A majority of type 3 perforations can be initially managed by
percutaneous methods.
TCT-314
Anticoagulant Profile of TGN 255 during Simulated Mitral Valve
Repair Using Cardiopulmonary Bypass
Suresh Chahwala1, Anthony Kennedy1, Robert Dupe1, David Nelson2,
Theresa Fossum2, Chaman Chander1
1
Trigen, London, United Kingdom2DeBakey Institute, College Station,
Texas, TX
Background: Clinical application of heparin in cardiac procedures and
CPB may lead to manifestation of heparin-induced thrombocytopenia
(HIT). Direct thrombin inhibitors (DTI) such as bivalirudin have been
evaluated for anticoagulant properties in human patients. The purpose
of this investigation was to evaluate Trigen’s novel DTI, TGN 255
which is currently undergoing clinical development for intravenous
use. TGN 255 is a potent (Ki 7-22nM), reversible and selective DTI.
Methods: In preliminary studies, conscious beagle dogs were utilised
to determine the dosing regimen of TGN 255 that would produce
coagulation parameters suitable for anticoagulant therapy in surgical
procedures. In subsequent studies, six beagle dogs underwent CPB with
simulated mitral valve repair whilst receiving a dosing regimen of TGN
255 (2.5mg/kg bolus plus 10mg/kg/hr infusion) that was selected from
the preliminary studies. Blood samples were collected at various time
points and analysed for pharmacodynamic (PD) markers. Markers
included thrombin clotting time (TT), activated partial thromboplastin
time (aPTT), activated clotting time (ACT), ecarin clotting time (ECT),
whole blood thrombin clotting time, platelet counts and function tests.
Results: Analysis of the plasma samples revealed that the dosing regimen
of TGN 255 used led to plasma concentrations of ~10-20μg/ml. TGN
255 at a mean plasma concentration of 12μg/ml prolonged the ACT
and TT by 480 and 245 seconds respectively. The ACT was prolonged
by 11-fold above baseline. The aPTT was also prolonged by 3-fold
above baseline. The bolus administration of TGN 255 produced a 5-6
fold increase in ECT which was maintained throughout the course of
CPB surgical procedure. Termination of TGN 255 infusion led plasma
concentrations to decline rapidly with a corresponding reduction of all
PD markers. TGN 255, hence exhibits a suitable PK/PD relationship
when controlled anticoagulation is required in cardiac surgery.
Conclusions: All the animals underwent successful CPB using this dosing
regimen of TGN 255. These findings demonstrate that TGN 255 can be
successfully utilised as an anticoagulant during CPB with no evidence of
any bleeding or thrombotic complications.
TCT-315
Trans Radial approach in Overweight Patients (BMI > 35) (TROP
study) Compared to Femoral access for Coronary Angiogram or PCI
Hakim Benamer1, Yves Louvard2, Inga Narbute3, I Ungi4, Philippe Garot5,
Rj Ruiz-Salmeron6, Martial Hamon7, O Valsecchi8, David Hildick-Smith9
1
H.E.P. La Roseraie, Paris, France2ICPS, Massy, France3Riga, Riga,
Latvia4Szeged, Szeged, Hungary5ICPS, Quincy, France6Barcelona,
Barcelona, Spain7Caen, Caen, France8Bergamo, Bergamo, Italy9Brighton,
Brighton, United Kingdom
The incidence of overweight patients in industrialized countries has been
increasing. The rate of cardiovascular disease in this population is higher,
as is the reported rate of vascular and groin complications after transfemoral
(TF)coronary angiography (CA) or angioplasty (PTCA). The trans-radial
approach for CA or PCI may improve the prognosis of overweight patients.
We prospectively included in a Multicentric European Registry (13 Centres) of
overweight patients, with BMI ≥ 35, undergoing CA and/or PCI . This registry
was involve centres and/or physicians with a wide experience in the trans radial
approach (TR). The vascular approach was left to the operator’s discretion.
The primary end point was the occurrence of complications delaying
the hospital discharge. We also analysed the incidence of all
vascular complications, and procedural endpoints, like cross-overs,
procedural and X-Ray duration, Contrast medium use, success rate...
Results
:
(Preliminary
results)
346 pts: 97 TF and 249 TR (CA : 65%, PCI : 11%,
CA with PCI : 24%). 8 with closing device in TF.
Studied population: Mean Age : 61.2 +/- 10.9 years, Sexe
(Male): 52.9 %, Mean Weight: 108 +/- 15 Kg, Mean
Height: 1.67 +/- 0.1 m, Mean BMI 38.7 +/- 3.4 Kg/m2.
In conclusion, obesity is a factor of complication in diagnostic angiography
and coronary intervention, radial approach in obese patients reduces the rate
of vascular complications.
Nb Cath used Angio (n)
Contrast Total (ml)
Contrast Angio (ml)
Total Duration (min)
Angio Duration (min)
Hosp Stay (days)
Hosp stay after C (days)
Vascular Complications
(%)
Hematoma (%)
TR (n=243)
1.9 +/- 0.8
159 +/- 95
117 +/- 64
35.5 +/- 25.4
26.1+/- 19.0
3.7 +/- 4.1
1.7 +/- 2.2
3 (1.2)
4 (1.6)
TF (n=103)
2.3 +/- 0.7
189 +/- 102
122 +/- 70
55.6 +/- 23.3
31.3 +/- 17.7
4.4 +/- 4.6
2.7 +/- 4.3
3 (2.9)
9 (8.7)
variables correlated with perforation occurrence. Perforations were more
frequent following procedures for chronic total occlusions (CTO), (1.2%
of 1,454 CTO patients vs 0.3% of 10,422 non CTO patients: p<0.01).
Perforation occurred more frequently in complex lesions (0.1% of 3,006 type
A lesions vs 0.4% of 11,576 type B, C lesions: p<0.05) and a higher balloon
artery ratio (ruptured vessels/non ruptured vessels: 1.29±0.22/1.11±0.30).
In-hospital 8 patients (16.7%) had major adverse cardiac events. 6
patients (12.5%) had myocardial infarction, 2 patients (4.2%) emergency
CABG and no death. Clinical follow-up was performed for all 48 patients
after 26±16 months. Two patients had performed re-PCI and no death.
Conclusion: Coronary perforation occurred more frequently in patients
with complex lesions especially in chronic total occlusions and utilizing a
higher balloon/artery ratio.
p
0.0005
0.01
NS
0.0001
0.03
NS
0.02
NS
0.001
P
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TCT-316
Coronary Artery Perforations: Incidence, Predictors and Clinical
Outcomes: Multicenter Registry in Japan
1
Funabashi, Japan
A
B
S
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R
A
C
T
S
Background and Purpose: The Purpose of this study was to evaluate the
incidence of coronary perforations, factors associated with the occurrence of
these complications and in-hospital and late clinical outcomes of those patients.
Methods: Between Apr. 1999 and Jan. 2005, 11,876 patients with
14,582 lesions were treated in our centers (male 66.0%, mean age
70.0: POBA 2,687, stent 12,167, DCA 160, rotational atherectomy
884). Coronary perforations occurred in 48 patients (0.4%) and
were graded according to Ellis classification (38 class 2, 10 class 3).
Results: POBA 18 (37.5%), Rota 2 (4.2%), stent 10 (20.8%), Cutting
Balloon 4 (8.3%), guidewire induced 14 (29.2%). There are no clinical
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Drug Eluting Stents I
TCT-317
Intravascular Ultrasound Results from the TAXUS V Study: The
TAXUS Stent Reduces Neointimal Proliferation in Long Lesions and
Overlapping Stents
Neil J. Weissman1, Stephen G. Ellis2, Gary S. Mintz1, Louis A. Cannon3,
Thomas McGarry4, Joel Greenberg5, Tift Mann6, Michael A. Kutcher7,
Joerg Koglin8, Mary E. Russell8, Gregg W. Stone9, The TAXUS V
Investigators
1
Washington Hospital Center, Washington, DC;2The Cleveland Clinic
Foundation, Cleveland, OH;3Northern Michigan Hospital, Petoskey,
MI;4Oklahoma Heart Hospital, Oklahoma City, OK;5Florida Hospital,
Orlando, FL;6WakeMed, Raleigh, NC;7Wake Forest University Baptist
Medical Center, Winston-Salem, NC;8Boston Scientific Corporation,
Natick, MA;9Columbia University Medical Center, New York, NY
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Background: TAXUS V was a multicenter, randomized,
double-blind study
of
the polymer-based, paclitaxel-eluting
TAXUS stent in 1156 patients with complex lesions. We herein
report the results of the formal TAXUS V IVUS substudy.
Methods: The TAXUS V IVUS substudy enrolled 509 patients (255
control, 254 TAXUS) at 29 U.S. sites. Diabetes was present in 30.6% of
patients, mean lesion length was 17.7 ± 9.3 mm, mean vessel diameter was
2.70 ± 0.53 mm, mean study stent length was 28.0 ± 13.3 mm, and multiple
stents were required in 32.0% of cases. A standard imaging protocol
with motorized pullback and IC nitroglycerine was used at pre-specified
IVUS centers post initial stent implantation and at 9 month followup; images were volumetrically analyzed at a blinded core laboratory.
Results: At 9-months, the TAXUS stent increased lumen volume
(149.2±83.1 mm3 vs. 184.3±99.7 mm3, p=0.0015) and reduced neointimal
growth (68.1±51.9 mm3 vs. 30.5±34.2 mm3, p<0.0001) without a change
in-stent volume (p=0.78). This corresponded to a 59% decrease in %
in-stent net volume obstruction (from 31.8±15.1% to 13.2±12.0%,
p<0.0001). In the TAXUS group, there was no difference in the percent
net volume obstruction in sections of stent overlap as compared to nonoverlap sections (12.7±12.5% vs. 13.3±11.7%, respectively, p=0.72)
whereas the control group had increased neointima in the overlapping
section (34.6±17.2% vs. 39.9±18.3%, p=0.08). Late-acquired incomplete
apposition occurred with a similar frequency in both groups (4.1% control
vs. 8.7% TAXUS, p=0.27). Of the patients with late-acquired incomplete
apposition and overlapping stents, the area of incomplete apposition did
not occur in the overlap section of the stents in any patient. There were
no MACE events in patients with late-acquired incomplete apposition.
Conclusion: The TAXUS stent reduced in-stent neointimal tissue growth
by 59% in a complex patient population with long lesions and multiple
overlapping stents. The IVUS findings suggest that overlapping TAXUS
stents are effective at reducing neointima without adverse consequences.
128H
TCT-319
Evaluation of Relationship Between Apposition Patterns of SirolimusEluting Stent Strut to Vessel Wall and Neointimal Coverage of Strut
Using OCT
Mitsuyasu Terashima, Tatsuya Ito, Yoshihiro Takeda, Jean-Francois
Surmely, Osamu Kato, Tetsuo Matsubara, Etsuo Tsuchikane, Mariko
Ehara, Yoshihisa Kinoshita, Tomomichi Suzuki, Kenya Nasu, Nobuyoshi
Tanaka, Akira Murata, Koyo Sato, Kaori Suzuki, Atsuko Kodama,
Yasuyuki Suzuki, Takahiko Suzuki
Background: Previous animal study reported that the degree of vessel wall
injury induced by stent implantation related to the magnitude of following
intimal proliferation. The aim of this study is to analyze the relationship between
apposition patterns of Sirolimus-Eluting Stent (SES) strut to vessel wall and
neointimal coverage of strut using optical coherence tomography (OCT).
Methods: Using OCT, 12 SES in 10 patients at 2-month follow-up
were evaluated. OCT images of all stents were obtained by pulling back
OCT optical fiber automatically at 1.0mm per second, and analyzed at
intervals of 1mm. Every observed strut was classified into either covered
or uncovered. Neointimal thickness (NIT) was also measured at the site
of covered stent strut. Apposition patterns of stent strut to vessel wall
were evaluated as shown in figure (apposition with indentation: A+,
apposition without indentation: A-, incomplete apposition). Rate of stent
coverage and mean NIT were compared between A+ struts and A- struts.
Results: A+ was found in 651struts, A- in 611struts, and incomplete
apposition in 2 struts. Rate of stent strut coverage in A+ was higher
than that in A- (97.5% vs 71.4%, p<0.05). There was no difference
in mean NIT between A+ and A- (0.1 ± 0.04mm vs 0.06 ± 0.03mm).
Conclusion: This OCT analysis showed that apposition patterns of SES
strut to vessel wall were related to neointimal coverage of stent strut. Tight
apposition of strut to vessel wall would lead to favorable neointimal stent
coverage.
TCT-320
Bare Metal and Drug-Eluting Stents in Single Patients (“Hybrid
Approach”) Compared to Only Drug-Eluting Stents in Patients with
Mutivessel Disease: Immediate and Med-Term Clinical Outcome
Imad Sheiban, Claudio Moretti, Filippo Sciuto, Walter Grossomarra,
Alessandra Truffa, Premiano Lombardo, Pierluigi OMedè, Salvatore
Colangeli, Giampaolo Trevi
Background: Restenosis depends on patient- and lesion-related
factors. Consequently, in mutivessel disease patients (pts), based on
patient demographics and angiographic characteristics, bare metal
stents (BMS) could be used to treat lesion on low risk for restenosis
and drug eluting stents (DES) for those on high risk in the same
patient (Hybrid approach). In the present study we report on safety
and effectiveness of an “hybrid approach” in multivessel disease pts.
Methods: 279 consecutive pts with multivessel disease underwent PCI
with for clinical manifestation of myocardial ischemia. (Age 62,9±10 ,
males 79%) . In 158 pts (Group I ) onlyn DES were used for all lesions,
while the remaining 121 pts (Group II) were treated by the hybrid
approach. BMS and DES were implanted in the same vessel (minimal
distance >10mm ) or on different vessels in single patients. Major
cardiac events (MACE) were evaluated at 1, 3 , 6 , 9 months following
the ptocedure. Angiographic follow-up was planned at 9 moths in all pts.
Results : Group I (158 Pts): A total on 294 vessels and 369 lesions were
treated with only DES(Total implanted DES = 398).Procedural success
was 98% . Procedural and in-hospital MACE : no death , no Q-AMI, 6
( 3.8) non Q AMI , no SAT, no stroke. MACE during the follow up ( 6
to 24 months): 1 (0.6%) death, 1 (0. 6%) AMI, 7 (4.4%) recurrence of
angina, 6 (3.8%) TLR+TVF and 1 (0.6%) TVR . Total MACE during
Follow-up 14 (8.9%). Group II (121 pts): A total of 235 vessels and 309
lesions were treated with 190 BMS and 131 DES. Hybrid approach was
performed treating 56 lesions on the same vessel ricieving DES and 82
lesions located on different vessel. Procedural and in-hospital MACE: 4
(3.3%). No death, Q-AMI, Stroke, or SAT. MACE during the follow up (6
to 24 months): 1 (0.8%) death , 2 (1.6%) AMI, 19 (15.7%) TLR+TVR , 5
(4.1%) TVR. 7 /19 (37%) TLR+TVR were on DES stents and 12/19 (67%)
were on BMS. MACE during follow-up in this Group was 22 ( 18.2%).
Conclusions: These data suggest that the combination of BMS and DES in
the same patient with multivessel disease is safe. Considering the historical
data on multivessel PCI, med-term clinical outcome is also acceptable.
However; the use of only DES in these pts improves dramatically long term
clinical outcome.
TCT-321
Full Metal Jacket in Drug-Eluting Stent (DES) Era: Immediate and
Mid-Term Results When Routine Aangiographic Follow-Up is not
Performed
Kunadian Vijayalakshmi, Babu Kunadian, Robert Wright, James Hall,
Robert Morley, Andrew Sutton, Mark de Belder
The James Cook University Hospital, Middlesbrough, United Kingdom
Current approach to the treatment of coronary artery lesions using DESs
demands full lesion coverage. This strategy will increase the use of multiple
long stents (full metal jackets-FMJ) in diffuse disease in the same vessel.
We studied the safety and efficacy of this approach using drug eluting stents.
Methods: Between August 02 and November 2004, 933 patients
underwent percutaneous coronary intervention (PCI) with DES. Of
these, 52 patients were treated with FMJ. Of these, 36(69%) were men,
24(46%) patients had stable angina, 13(25%) patients were diabetic,
18(35%) had previous myocardial infarction, 7(13%) had previous CABG
and 5(9%) had previous PCI. 4(7%) patients underwent emergency PCI.
Results: In these patients, 180 DES were implanted (3.46±1 stents/patient).
PCI was attempted in 63 vessels and 83 lesions (1.61±0.79 lesions/patient).
PCI was performed in 12 left anterior descending arteries, 36 right coronary
arteries, 3 vein grafts and 1 circumflex artery. Calcified lesions were treated
in 35(67%), chronic total occlusions in 13(25%) and in-stent restenosis in
14(30%) patients. 51(98%) patients had glycoprotein IIb/IIIa inhibitors. The
mean reference diameter was 2.96±0.5 mm. The mean (±SD) lesion length
was 37.35±27 mm. The mean (±SD) pre and post PCI minimum lumen
diameter was 0.55±0.4mm and 3.2±0.5mm respectively (p=0.001). The
mean (±SD) pre and post PCI percentage stenosis was 81±14.2 and 3.2±0.5
respectively (p=0.001). The longest stented segment was 74.3±17.39 mm.
Complete procedural success (all lesions dilated to % DS <50%, no QMI, no emergency CABG, patient alive) was obtained in all (100%)
patients. In hospital MACE occurred in none. 1 patient (1%) died at 30day follow-up. 6-month data was available on 44(85%) patients. No
patient died at 6-month follow-up. TVR occurred in 2(3.8%) patients.
Conclusion: Full metal jacket stenting is associated with high immediate
procedural success rate. At six month follow-up, this was associated
with a low incidence of MACE and clinically driven target vessel
revascularisation.
TCT-322
Sirolimus-Eluting Coronary Stents in Small Vessels: A Comparison
between SIRIUS and SVELTE Trial
Ehud Grenadier1, Eduardo Sousa2, Giulio Guagliumi3, Aly Talen4, Frank
Van Den Branden5, Stephan Windecker6, Johannes A M te Riele7, Vassilis
Voudris8, Helene Eltchaninoff9, Bo Lindvall10, Bernhard Meier6
1
Rambam Medical Center, Haifa, Israel2Instituto Dante Pazzanese,
Sao Paolo, Brazil3Ospedali Riuniti di Bergamo, Bergamo,
Italy4genae associates, Antwerp, Belgium5AZ Middelheim, Antwerp,
Belgium6University Hospital Bern, Bern, Switzerland7Amphia Ziekenhuis,
Breda, The Netherlands8Onassis Cardiac Center, Athens, Greece9Hôpital
Charles Nicolle, Rouen, France10Huddinge University Hospital,
Stockholm, Sweden
Background: Vessel tercile analysis of the SIRIUS Trial revealed that the
majority of in-lesion restenoses and revascularizations in sirolimus-eluting
stent (SES) occurred in the smallest vessel subset. This study assessed the
effectiveness of the Cypher stent in de novo native coronary artery lesions in
small vessels by standardizing and controlling procedural aspects of stenting.
Methods: The SVELTE Trial is a multicenter, historically controlled
study conducted in 101 pts with de novo coronary artery lesions in small
vessels (RVD 2.25 - 2.75 mm visually estimated) treated with the Cypher™
stent compared to similar lesions treated with the bare metal (BMS) and
SES in the SIRIUS Trial. Patient matching was based on RVD, lesion
length and diabetes mellitus. Procedural guidelines for the study focused
on minimizing balloon trauma and full lesion coverage based upon the
lessons learned from the SIRIUS trial. Effectiveness was measured as
MACE free survival at each follow up (30 days, 6, 8, 9 months, and 1 and
2 years post-procedure) compared to the BMS arm of the SIRIUS trial.
Results: Clinical characteristics were similar between SIRIUS and SVELTE
patients. Post-procedural characteristics showed a significantly smaller
reference vessel diameter (RVD), minimal lumen diameter (MLD) and higher
% diameter stenosis (%DS) in the SVELTE group. Eight months angiographic
results showed an in-lesion late loss (LL) of 0.76mm in BMS, 0.27mm in
SES, and 0.20mm in SVELTE and an in-lesion restenosis rate of 39.0%,
11.6%, and 6.3% respectively. Major Adverse Cardiac Event (MACE)-free
survival at 1 year was 76.5% in BMS, 90.6% in SES, and 92.1% in SVELTE,
p= 0.0007 while TLR was 22%, 5.7 %, and 3%, p <0.0001, respectively.
Conclusion: One-year results of sirolimus-eluting stent in small coronary
vessels are excellent and suggest that proper technique aimed to limit vessel
injury and to assure a full coverage of the lesion can help to minimize the
restenosis rate, hereby reducing repeat revascularization rate. Two-year
results, focusing on major adverse cardiac events, will be available at the
time of the presentation.
TCT-323
TAXUS II 3-Year Clinical Results: Durability of the Benefit of
Polymer-Based, Paclitaxel-Eluting Stents in the Treatment of De Novo
Coronary Artery Lesions
Antonio Colombo1, Adrian Banning2, Sigmund Silber3, Karl E
Hauptmann4, Janusz Drzewiecki5, Eberhard Grube6, Anna Wijatyk7, Mary
E Russell7
1
EMO Centro Cuore Columbus, Milano, Italy2John Radcliffe
Hospital, Oxford, United Kingdom3Internistische Klinik Dr. Muller,
Munchen, Germany4Krankenhaus der Barmherzigen Bruder, Trier,
Germany5Samodzielny Publiczny Szpital Kliniczny Nr 7, Katowice,
Poland6Heart Center Siegburg, Siegburg, Germany7Boston Scientific
Corporation, Natick, MA
Background: TAXUS II demonstrated that both slow-release (SR) and
moderate-release (MR) polymer-based paclitaxel-eluting TAXUS stents
(Boston Scientific, Natick, MA) reduce restenosis versus bare metal control
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stents (BMS). Clinical benefits of TAXUS were maintained at 2 years as
shown by low target lesion revascularization (TLR) rates (5.5% SR and
3.9% MR vs. 15.5% BMS, p=0.0002). A 2-year QCA and IVUS substudy
demonstrated that the reduction in % net volume obstruction was preserved
and that QCA-determined MLD and late loss were stable from 6 months to
2 years. The purpose of the present study is to evaluate the durability of the
clinical benefits of TAXUS with the TAXUS II 3-year clinical follow-up.
Methods: TAXUS II is a randomized, double-blind clinical trial
conducted at 38 sites comparing TAXUS SR (n=131) and TAXUS
MR (n=135) stents to BMS (n=270) in patients with focal, de
novo lesions. Clinical follow-up is being conducted annually
for 5 years to assess the long-term stability of TAXUS benefits.
Results: The 3-year clinical follow-up, as adjudicated by an independent
Clinical Events Committee, has been analyzed to further evaluate long-term
clinical profiles of both drug-eluting stents and BMS. Overall, 94.2% of
patients completed the 3-year follow-up. From 2 to 3 years there were no
new TLRs in the TAXUS groups while 3 new TLRs were reported in BMS.
As a result, the TLR and overall target vessel revascularization (TVR) rates
were significantly lower for TAXUS versus BMS at 3 years (TLR: 5.5% SR
and 4.1% MR vs. 16.4% BMS, p=0.0001; TVR: 12.6% SR and 9.8% MR vs.
22.3% BMS, p=0.0038). Concordantly, overall major adverse cardiac event
rates remained low for TAXUS versus BMS (15.7% SR and 16.4% MR vs.
27.3% BMS, p=0.0096) at 3 years. Furthermore, there was 1 stent thrombosis
in BMS from 2 to 3 years, while there were none in the TAXUS groups.
Conclusions: The long-term TAXUS II results suggest that TAXUS stents
stably inhibit restenosis as demonstrated by significant reductions in TLR and
MACE rates out to 3 years. Furthermore, the excellent safety profile of the
TAXUS stents is maintained. The 3-year analysis is the first to evaluate late
clinical safety and efficacy outcomes of both SR and MR TAXUS stents.
TCT-324
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Two Year Results of the TROPICAL Study : A Multicenter NonRandomized Study of the Cypher™ Sirolimus-Eluting Stent in the
Treatment of Patients with an Instent Restenotic Native Coronary
Artery Lesion
Walter J R Desmet1, Franz-Josef Neumann2
1
UH Gasthuisberg, Leuven, Belgium2Herz-Zentrum Bad Krozingen, Bad
Krozingen, Germany
Background: In-stent restenosis remains a cumbersome problem,
with a high propensity for recurrence, even after intracoronary
brachytherapy
that
is
currently
the
standard
treatment.
Our objective was to assess the safety and effectiveness of the sirolimuseluting stent in patients with an in-stent restenotic native coronary artery lesion.
Methods: One hundred and sixty two patients with a single in-stent
restenotic lesion in a native coronary artery with a lesion length of ≤
45 mm and a vessel size ≥ 2.5 mm and ≤ 3.0 mm were treated with
sirolimus-eluting stents. To assess the long-term effectiveness of sirolimuseluting stents in the treatment of in-stent restenosis, we performed
a 2-year clinical follow-up, that will be completed in August 2005.
Results: At 6 month angiography, in-lesion late loss was 0.08 ± 0.47 mm ; inlesion late loss index was 0.03 ± 0.44 ; and the binary restenosis rate was 9.7
%. Clinically driven TLR was 2.5 % and total MACE were 3.7 %. The rate
of reintervention at 9 months was 7.4 % (12/162). We will present the 2-year
incidences of death, myocardial infarction and target vessel revascularization.
Conclusions: Sirolimus-eluting stents were highly efficacious in the
treatment of in-stent restenosis, with an average in-lesion late loss < 0.1 mm.
Compared with a historical brachytherapy control, sirolimus-eluting stents
substantially reduced angiographic restenosis and need for target vessel
revascularization at 9 months. The risk of peri-interventional infarction and
of stent thrombosis was low. Two year clinical follow-up will be presented.
This analysis will show whether the benefit of sirolimus-eluting stents in the
treatment of in-stent restenosis is maintained during 2-year follow-up.
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TCT-325
The TAXUS Paclitaxel-Eluting Stent in High-Risk Patients:
Global Usage Patterns and Clinical Outcomes in the “Real-World”
MILESTONE II Registry
Kari Niemela1, Bernard Chevalier2, Hans Stoerger3, Luc Bilodeau4, Fabio
Brito5, Mary E Russell6, on behalf of the MILESTONE II Investigators
1
Tampere Heart Center, Tampere, Finland2Centre Cardiologique du Nord,
St. Denis, France3Heart Center, Frankfurt, Germany4Montreal Heart
Institute, Montreal, PQ, Canada5Hospital Albert Einstein, Sao Paolo,
Brazil6Boston Scientific Corporation, Natick, MA
Background: Published data on drug-eluting stent usage and outcomes in
higher-risk patients and lesions in everyday clinical practice are limited.
Methods: MILESTONE II was a global registry of patients receiving the
paclitaxel-eluting TAXUS-SR stent in routine clinical practice. Patients
were treated according to local practice standards, with clopidogrel
for 6 months post procedure. Follow-up at 6 and 12 months assessed
TAXUS-related cardiac events (cardiac death, MI, target vessel reintervention) and stent thrombosis. Data monitoring was conducted
for 36% of enrolled patients and all patients with cardiac events.
Results: A total of 3688 patients were enrolled at 164 sites in 31 countries.
A majority (56.6%) of lesions were complex (AHA/ACC class B2/C).
TAXUS stent usage in high-risk subgroups included: 1254 (34.0%) patients
with diabetes, 147 (4.1%) patients with acute MI (<24 hrs), 896 (20.3%)
lesions in small vessels (≤2.5 mm), 896 (20.3%) long lesions (>20 mm),
and 276 (6.2%) lesions with total occlusions. Multiple TAXUS stents were
implanted in 1003 (27.2%) patients. The overall 12-month rate of TAXUSrelated cardiac events was 7.5%, with a re-intervention rate of 5.5% in
TAXUS-treated vessels. The 12-month stent thrombosis rate was 1.6%.
One-year outcomes in high-risk subgroups are shown in the table.
Diabetes
N=1254 pts
TAXUS-Related
Cardiac Adverse
Events
Cardiac Death
MI
Treated Vessel Reintervention
Lesion
Multiple
Acute MI
RVD
Total
TAXUS
Length >20
<24 hrs ≤2.5 mm
Occlusion
mm
Stents
N=147 pts N=822 pts
N= 244 pts
N=841 pts
N=1003 pts
9.4%
(103/1098)
8.3%
(11/132)
10.4%
(77/740)
7.3%
(56/766)
5.5%
(12/220)
8.8%
(80/909)
2.8%
(31/1098)
1.6%
(18/1098)
6.7%
(74/1098)
3.0%
(4/132)
2.3%
(3/132)
4.5%
(6/132)
2.0%
(15/740)
2.4%
(18/740)
8.0%
(59/740)
1.7%
(13/766)
2.2%
(17/766)
5.0%
(38/766)
1.4%
(3/220)
1.4%
(3/220)
3.2%
(7/220)
1.1%
(10/909)
2.4%
(22/909)
7.0%
(64/909)
Conclusions: The paclitaxel-eluting TAXUS-SR stent exhibits long-term
safety and efficacy in the uncomplicated and higher-risk patients and lesions
treated in everyday clinical practice.
TCT-326
Optical Coherence Tomographic Analysis of Neointimal Stent
Coverage in Sirolimus-Eluting Stent, Compared with Bare Metal
Stent
Tatsuya Ito, Mitsuyasu Terashima, Yoshihiro Takeda, Osamu Katoh,
Tetsuo Matsubara, Etsuo Tsuchikane, Mariko Ehara, Yoshihisa Kinoshita,
Tomomichi Suzuki, Kenya Nasu, Jean-Francois Surmely, Nobuyoshi
Tanaka, Akira Murata, Yasuyuki Suzuki, Koyo Sato, Kaori Suzuki, Atsuko
Kodama, Takahiko Suzuki
Background: Optical coherence tomography (OCT) is a high-resolution
(about 10 μm), catheter based imaging modality. The aim of this study was
to analyze the time course of neointimal coverage of Sirolimus-Eluting Stent
(SES) with this new imaging modality, compared with bare metal stent (BMS).
Methods: Using OCT, 12 SES and 4 BMS were evaluated at 2-month
follow-up, and 7 SES and 4 BMS were at 7-month follow-up. OCT images
of all stents were obtained by pulling back OCT optical fiber automatically
at 1.0mm per second, and analyzed at intervals of 1mm. Every observed
strut was classified into either covered (C-S) or uncovered (UC-S).
Neointimal thickness (NIT) was measured at the site of covered stent strut,
and mean and maximal neointimal thicknesses in each stents were obtained.
Results: Results are shown in Table. At both 2- and 7-month follow-up,
mean and maximal NIT in SES were significantly less than in BMS (At
2-month: p < 0.01, p < 0.01, at 7-month: p < 0.01, p < 0.01, respectively).
Beside, mean and maximal NIT were increased significantly from 2month to 7-month follow-up in both groups. Percentage of UC-S was
higher in SES compared to BMS, although not reaching statistical
significance in this small sample population (at 7-month, p = 0.089).
Conclusion: According to OCT analysis, neointimal formation in SES
was significantly less than in BMS. At 7-month follow-up, frequency of
uncovered stent struts in SES was still higher than in BMS. These findings
could possibly explain the occurrence of late thrombosis in SES.
mean NIT (mm)
maximal NIT (mm)
UC-S (%)
C-S (%)
DES 2M
0.05 ± 0.04
0.27 ± 0.09
12.1 ± 10.9
87.9 ± 10.9
DES 7M
0.09 ± 0.05
0.41 ± 0.12
5.3 ± 5.1
94.7 ± 5.1
BMS 2M
0.17 ± 0.03
0.57 ± 0.07
5.1 ± 7.0
94.9 ± 7.0
BMS 7M
0.48 ± 0.25
1.04 ± 0.45
1.0 ± 1.3
99.0 ± 1.3
TCT-327
Usage Patterns and Long-Term Clinical Outcomes with the TAXUS
Stent in Everyday Clinical Practice: The MILESTONE II Global
Registry
Kari Niemela1, Bernard Chevalier2, Hans Stoerger3, Luc Bilodeau4, Fabio
Brito5, Mary E Russell6, on behalf of the MILESTONE II Investigators
1
Tampere Heart Center, Tampere, Finland2Centre Cardiologique du Nord,
St. Denis, France3Heart Center, Frankfurt, Germany4Montreal Heart
Institute, Montreal, PQ, Canada5Hospital Albert Einstein, Sao Paolo,
Brazil6Boston Scientific Corporation, Natick, MA
Background: The safety and effectiveness of drug-eluting
stents have been demonstrated in randomized trials of single,
uncomplicated lesions. Data are limited regarding long-term
outcomes in unselected patients treated outside of controlled trials.
Methods: MILESTONE II was a web-based, global registry of patients
who received the paclitaxel-eluting TAXUS-SR stent in everyday
interventional cardiology practice. Eligible patients were candidates for
stenting according to local practice standards. Clopidogrel therapy was
mandated for 6 months post procedure. Clinical or telephone followup was performed at 6 and 12 months post procedure to obtain data on
TAXUS-related death, myocardial infarction (MI), stent thrombosis,
and target vessel re-interventions. On-site monitoring was conducted for
36% of enrolled patients and all patients with reported cardiac events.
Results: A total of 3688 patients were enrolled at 164 sites in 31 countries.
Mean patient age was 60.7 years, with 77.4% males, and 34.0% patients
with diabetes. Prior PCI was performed in 28.4% and prior CABG in 9.3%
of patients. There were 1.21 lesions treated per patient, with an average
total stented length of 26.0 mm. Multiple stenting was performed in 1003
(27.2%) patients. A majority (56.6%) of the treated lesions were complex
(AHA/ACC class B2 or C). TAXUS stent usage in high-risk groups included
147 (4.1%) patients with acute MI, 313 (7.0%) in-stent restenotic lesions,
276 (6.2%) lesions with total occlusions, 98 (2.4%) lesions in the left main
coronary artery, and direct stenting in 1207 (28.2%) lesions. At 12 months
post procedure, 57 (1.7%) patients had experienced an MI, 183 (5.5%) had
undergone re-intervention on a TAXUS-treated lesion, and 51 (1.5%) cardiac
deaths had occurred. The overall TAXUS-related cardiac adverse event rate at
12 months was 7.5% (n=248). The 6-month stent thrombosis rate was low at
1.3%. Between 6 and 12 months 0.3% of patients had a late stent thrombosis.
Conclusions: Use of the TAXUS-SR stent in the real world includes highrisk patients and lesions. Late clinical outcomes in the MILESTONE II
study corroborate the excellent safety and device performance established
in the TAXUS randomized trials.
TCT-328
First Four-Year Clinical Follow-Up from a Randomized Trial of a
Polymer-Based, Paclitaxel-Eluting Stent: TAXUS I
Eberhard Grube1, Sigmund Silber2, Karl-Eugen Hauptmann3, Mary E
Russell4, for the TAXUS I Investigators
1
Heart Center Siegburg, Siegburg, Germany2Klinik Dr. Mueller, München,
Germany3Krankenhaus der Barmherzigen Brüder, Trier, Germany4Boston
Scientific Corporation, Natick, MA
Background: Several randomized trials demonstrated that drug-eluting
stents reduce clinical and angiographic restenosis compared with bare
metal stents. The first human study evaluating the polymer-based,
paclitaxel-eluting, slow-release (TAXUS-SR) stent (Boston Scientific,
Natick, Mass.) showed continued safety and sustained reductions in target
lesion revascularization through 3 years post implantation. We now present
results from the first 4-year clinical follow-up of the TAXUS-SR stent.
Methods: TAXUS I was a prospective, multi-center, randomized study
enrolling 61 patients with single de novo or restenotic coronary lesions at 3
centers in Germany. Thirty-one patients received the TAXUS-SR stent and
30 received an identical-appearing bare metal stent (Control). Angiographic
inclusion criteria were lesion length ≤12 mm, 50% to 99% diameter
stenosis, and vessel diameter between 3.0 mm and 3.5 mm. The composite
clinical endpoint of major adverse cardiac events (MACE - cardiac death,
myocardial infarction, and target vessel revascularization) and stent
thrombosis were assessed at 1, 6, 12, 24, 36, and 48 months post implantation.
Results: The cumulative 3-year MACE rate was 3.7% in the TAXUS
group (1/27) versus 10.7% (3/28) for Controls. The single MACE in
TAXUS was a target vessel revascularization occurring outside the
target lesion 200 days post index procedure. No new MACE occurred in
TAXUS or Control between 1 and 3 years post index procedure. The low
MACE rate and absence of target lesion revascularization in the TAXUS
group were maintained at 3 years post stent implantation. No cases of
stent thrombosis were reported in either treatment group through 3 years
follow-up. The 4-year clinical follow-up data will be available in July 2005.
Conclusion: Absence of stent thrombosis through 3 years and no new
MACE after 1 year post stent implantation confirm the excellent, continued
long-term safety of this polymer-based, paclitaxel-eluting stent. The 4-year
analysis will further examine the durability of clinical safety over time and
provide insight into whether restenosis reduction in this first-in-man study
of the TAXUS-SR stent is sustained through extended long-term followup.
TCT-329
Results from the 4.0 mm Stent Subgroup of the TAXUS V Trial
Louis A. Cannon1, Stephen G. Ellis2, Michael Chang3, Carl Jacobs4,
Charles Brown4, Joshua Kieval5, Mark Turco6, Sriram S. Iyer7, Joerg
Koglin8, Gregg W. Stone9
1
Northern Michigan Hospital, Petosky, MI;2The Cleveland Clinic
Foundation, Cleveland, OH;3Mercy General Hospital, Sacramento,
CA;4Piedmont Hospital, Atlanta, GA;5JFK Medical Center, Atlantis,
FL;6Washington Adventist Hospital, Takoma Park, MD;7Lenox Hill
Hospital, New York, NY;8Boston Scientific Corporation, Natick,
MA;9Columbia University Medical Center, New York, NY
Background: Implantation of 4.0 mm bare-metal stents results in relatively
low restenosis rates. This study evaluated whether the 4.0 mm paclitaxeleluting TAXUS Express2 stent can further improve outcomes in large vessels.
Methods: In the TAXUS V multicenter, prospective, double-blind
clinical trial, 202 patients undergoing stent implantation in single,
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de novo lesions in large vessel lesions were randomized to receive
either a 4.0 mm paclitaxel-eluting TAXUS stent (n=99) or an Express2
bare metal stent (BMS; n=103; both Boston Scientific, Natick, MA).
Results: In the 4.0 mm stent subgroup, baseline demographics were well
matched between TAXUS and BMS patients. Mean reference vessel
diameter was 3.33±0.44 mm in the BMS group vs. 3.41±0.45 mm in the
TAXUS group. Mean lesion length was 16.20±8.21 mm, diabetes mellitus
was present in 25.7% of patients, mean stent length was 26.28±11.71 mm,
and multiple stents were required in 24.3% of cases. Despite good outcomes
in the BMS group, 9-month MACE was reduced by 57% with the TAXUS
stent (14.9% BMS, 6.5% TAXUS; p=0.07). The 9-month target lesion
revascularization rate was 5.0% following BMS implantation vs. 0.0% with
the TAXUS stent (p=0.06). Angiographic outcomes were also improved,
with significant reductions in in-stent late loss (0.87±0.60 mm BMS vs.
0.42±0.47 mm TAXUS, p<0.0001), in-segment late loss (0.54±0.57 mm
BMS vs. 0.22 ± 0.40 mm TAXUS, p<0.0001), and in-segment binary
restenosis (14.4% BMS vs. 3.5% TAXUS, p=0.016). Early and late rates
of death and myocardial infarction were similar. There were no stent
thromboses in either group up to 9-months post-procedure. In-stent %
net volume obstruction by IVUS was significantly reduced in the TAXUS
group (27.13%±15.51% BMS vs. 13.82%±10.67% TAXUS, p =0.0006).
Conclusion: While implantation of 4.0 mm Express2 bare metal stents in
large vessels results in excellent clinical outcomes, treatment with the 4.0
mm TAXUS stent further improves clinical outcomes with corresponding
significant reductions in restenosis.
TCT-330
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Impact of High versus Low Pressure Stent Implantation Techniques
on 30-Day and 9-Month Outcomes in the TAXUS V Trial
Patrick A. Cambier1, Stephen G. Ellis2, William Knapp3, George Heyrich4,
Timothy D. Henry5, Michael Mooney5, Joseph DeGregorio6, Joerg Koglin7,
Gregg W. Stone8
1
The Heart and Vascular Institute, Safety Harbor, FL;2The Cleveland
Clinic Foundation, Cleveland, OH;3St. Joseph’s Hospital, Atlanta, GA;4St.
Mary’s Medical Center, Langhorne, PA;5Abbott Northwestern Hospital,
Minneapolis, MN;6St. Michael’s Medical Center, Newark, NJ;7Boston
Scientific Corporation, Natick, MA;8Columbia University Medical Center,
New York, NY
Background: A wide range of inflation pressures are used in practice
for implantation of bare metal stents. The effect of high-pressure
deployment on polymer-based drug-eluting stents is unknown.
Methods: In TAXUS V, patients received either a bare metal Express2 stent
(BMS) or a paclitaxel-eluting TAXUS Express2 stent (Boston Scientific,
Natick, MA). A single inflation at 12-18 atm was used. Post-dilatation
was further performed in 44.8% of patients. Patients with maximum
inflation pressure (stent or post-dilatation balloon) < 14 atm (n=318)
were compared to patients with inflation pressure ≥ 14 atm (n=835)
Results: There were no significant differences in 30-day MI or stent
thrombosis between TAXUS and BMS, or between high- and low-pressure
patients. Relative to BMS, 9-month target vessel revascularization (TLR)
was reduced by 47% and 40% in TAXUS patients receiving high (TAXUSHP) and low (TAXUS-LP) inflation pressure, respectively. In-stent late loss
and in-stent net volume obstruction were also reduced in TAXUS patients
regardless of inflation pressure. BMS-HP patients had a 43% increase in TLR
(p=0.0225) and a 20% increase in in-stent late loss (p=0.0027) compared to
BMS-LP patients. In contrast, in the TAXUS group there were no significant
differences between patients receiving high- and low-pressure deployment.
Conclusions: Treatment with the paclitaxel-eluting TAXUS stent provides
a significant benefit compared to bare metal stents after both high- and lowpressure implantation.
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thrombosis
30 Day MI
Low Pressure (<14atm)
High Pressure (≥14atm)
BMS
BMS
TAXUS
TAXUS
P Value
P Value
(n=169)
(n=149)
(n=409)
(n=426)
0.6%
0.7%
1.00 0.5% (2/407) 0.7% (3/419) 1.00
(1/168)
(1/148)
4.2%
2.7%
3.2%
5.7%
0.55
0.09
(7/168)
(4/148)
(13/407)
(24/419)
10.3%
6.2%
18.0%
9.4%
0.22
0.0005
(17/165)
(9/145)
(72/401)
(39/413)
0.76±0.55 0.47±0.59
0.95±0.64 0.49±0.62
<0.0001
<0.0001
(140)
(129)
(352)
(364)
9m TLR
9m
Late
Loss (QCA)
(in-stent)
9m % InStent Net 30.42±13.78 10.90±9.71
32.29±15.66 13.87±12.55
<0.0001
<0.0001
Vo l u m e
(113)
(37)
(36)
(98)
Obstruction
(IVUS)
TCT-331
Cost Effectiveness in Patients Treated with Drug Eluting Stents vs.
Bare Metal Stent and Oral Rapamyci: In Hospital and One Year
Follow-Up
Carlos A Fernandez-Pereira, Sr., Juan Mieres, Sr., Cesar F Vigo, Sr.,
Maximo Rodriguez-Alemparte, Sr., Angeles Garcia, Valeria Curotto,
Alfredo E Rodriguez
Otamendi Hospital, Buenos Aires, Argentina
Background: This study was sought to compare in-hospital and one-year
follow-up costs of two studies simultaneously made in similar populations,
that received different strategies in percutaneous coronary interventions(PCI).
Methods: From July 2002 to December 2004, two simultaneous studies
were carry out:ORAR II, a randomized study that used conventional
bare stent and oral rapamycin during 14 days, and ERACI III, a
multicenter registry of patients(pts) with multiple vessel disease .In
ORAR II pts. were included those that received rapamycin (50pts.) and
in ERACI III were included ptes.(178pts). that received only drug eluting
stents(DES),ERACI III pts simultaneously treated with bare stents were
excluded. The primary end point was to compare safety and efficacy
parameters as: survival, acute myocardial infarction(AMI),target vessel
revascularization(TVR), and in-hospital and at one year follow-up costs.
Results: The basal clinical ,demographic and angiographic
characteristics were similar. Multiple vessel disease present in 100%
ERACI III and 88% ORAR II pts (p=ns) .1,4 stent in both groups
were used. The in-hospital and follow up results are shown in table.
Conclusions:Both strategies achieved similar safety and efficacy one year
outcome, however therapy with oral rapamycin was more cost/ effective
Hospital and One year Follow Up
ERACI III (n=178)
ORAR II (n=50)
94.3%
92%
Freedom from death and AMI
TVR
7.8%
8.3%
Hospital Costs (U$S)
8563+-2654
2921+-108
Follow Up Costs (U$S)
516+-1785
766+-1986
9080+-3597
3596+-2182
Total Costs(U$S)
p
0.792
0.835
0.0002
0.394
0.0002
TCT-332
Frequency and Severity of Plaque Prolapse within Cypher and Taxus
Stents: An Sequential Intravascular Ultrasound Analysis
Sang-Wook Kim1, Gary S Mintz2, Patrick Ohlmann1, Salah-Eddine
Hassani1, Stephen Fernandez1, Esteban Escolar1, William S Chu1, Guy
Weigold1, Augusto D Pichard1, Lowell F Satler1, Kenneth M Kent1, William
O Suddath1, Ron Waksman1, Neil J Weissman1
1
We used intravascular ultrasound (IVUS) to evaluate plaque prolapse
within 83 drug-eluting stents (41 Cypher and 42 Taxus Express stents).
Stents were expanded first @ 14atm and then @ 20atm with IVUS imaging
after each inflation. Plaque prolapse burden (%) was calculated as plaque
prolapse/stent area and graded: I (<5%), II, (5-10%), and III (10-20%).
Results:. Stent length was 23.0±5.9mm in Cypher vs 18.0±7.7mm in Taxus
stents (p=0.002). Reference lumen area was 6.34±1.47mm2 in Cypher vs
7.45±2.59mm2 in Taxus stents (p=0.057). The incidence of plaque prolapse
was 41% (17/41) in Cypher vs 24% (10/41) in Taxus stents @ 14atm (p=0.10)
and 37.5% (15/40) in Cypher vs 17.8% (5/28) in Taxus stents @ 20atm
(p=0.011); however, plaque prolapse area was never >20% of stent area
(Table). Of note, Cypher stent area was smaller than Taxus @ 14atm, but not
@ 20atm. Cypher, but not Taxus stent area increased significantly from 14 to
20atm (p=0.006) with a parallel effect on residual lumen area because plaque
prolapse neither increased nor decreased at higher (20atm) inflation pressures.
Conclusion: Plaque prolapse was frequent in both Cypher and Taxus
stents. However, the frequency and amount of plaque prolapse was neither
increased nor decreased by additional higher-pressure inflations.
Stent area (mm2)
Plaque prolapse
area (mm2)
Residual lumen
area (mm2)
Plaque prolapse
burden (%)
Grade I / II / III
prolapse burden (n)
Cypher
5.8±1.2
0.32±0.24
14 atm
Taxus
8.35±2.1
0.53±0.42
20 atm
pp-value Cypher
Taxus
value
0.0004 7.3±1.7 7.6±1.3 0.7
0.16 0.37±0.37 0.56±0.45 0.4
5.5±1.1
7.8±2.0
0.001
6.9±1.5
7.0±1.2
0.9
5.2±3.1
6.5±4.3
0.4
4.7±3.8
7.2±5.5
0.4
8/7/2
4/5/1
0.9
11 / 2 / 2
2/2/1
0.4
TCT-333
Short and Intermediate Term Follow-Up in Patients with Stents
Dilated above the Maximum Recommended Diameter
Sabu J George, Nicholas Skiadas, Benjamin Silverman, Malek Numeir,
Firas Alani, Rasveg Grewal, John Grammes, Juzer Lokandwala, Jahan
Zeb, Nicole Bruno, Ismail Dairywala, Bruce Bowers, Sheldon Goldberg,
Daniel McCormick, Daniel Dadourian
Hahnemann University Hospital, Philadelphia, PA
Background: The safety and efficacy of stent-upsizing beyond the
manufacturer’s recommended size has not yet been evaluated. Drugeluting stents (DES) are increased above the manufacturer’s suggested
diameter to provide proper apposition to the vessel wall.Outcomes
in these patients have not been previously investigated. This study
looked at short-term and intermediate term outcomes in these patients.
Methods: A single-center retrospective evaluation was conducted in 83
patients in whom stents were upsized. A comparison was made between
those upsized within manufacturer’s specified limits, and those dilated
beyond the specified maximum. Immediate follow up was available
in all 83 patients. Long term follow up was available in 86% (71/83)
Results: Mean age was 64 years with a mean follow-up of 264 days. A total
of 108 drug eluting stents 103 Cypher(Cordis), 5 Taxus(Boston Scientific)
were placed in 97 arteries. There were 9 left main, 35 left anterior descending,
2 diagonal, 11 circumflex, 4 obtuse marginal, 28 right coronary artery, 8
saphenous vein grafts, in 83 patients (1.3 stents per patient). Twenty-eight
stents in 22 patients were dilated beyond the manufacturer’s specifications.
The mean increase in diameter was 0.84 mm (range 0.25-2.0 mm). The mean
increase in diameter in stents dilated beyond manufacturer specifications was
1.59 mm, the mean increase in diameter in stents dilated within specifications
was 0.65 mm. Increased troponins were observed acutely in 7 patients (1
rotational atherectomy, 1 side-branch occlusion, 1 vein graft intervention with
Filterwire protection, and 1 angiographic thrombus pre-intervention). There
were no periprocedural or pre-discharge deaths.There were two deaths in
each group (p=non significant).Three of these deaths were non cardiac. One
of the deaths in the group dilated within manufacturer’s recommendations
had positive troponins with a patent stent demonstrated on angiography.
Conclusion: Upsizing of DES beyond the manufacturer’s recommended
diameter to ensure proper stent apposition appears to be efficacious. Dilation
of stents up to 5.5mm appears to be safe. Further evaluation with a larger
patient population is indicated.
TCT-334
Sirolimus-Eluting Stents in the Treatment of Intermediate Lesions:
Pooled Analysis from Six Randomized Trials and Registries
Eugenia Nikolsky1, Jeffrey W Moses1, Erick Schampaert2, Marie-Claude
Morice3, Joachim Schofer4, J Eduardo Sousa5, Roxana Mehran1, Martin
Fahy6, Martin B Leon1
1
Columbia University Medical Center, New York, NY;2Hospital SacreCoeur de Montreal, Montreal, PQ, Canada3Clinique Paster, Paris,
France4Centre for Cardiology and Vascular Intervention, Hamburg,
Germany5Institute Dante Pazzanese, São Paulo, Brazil6Cardiovascular
Background: Treatment of intermediate lesions (IL) in native
coronary arteries with bare metal stents (BMS) is not reasonable
due to high in-stent restenosis. We hypothesized that treatment of
IL with sirolimus-eluting stents (SES) may be justified to improve
outcomes of pts, but restenosis after SES in IL is poorly understood.
Methods:. Study involved 174 of 2074 pts (8.4%) with IL (diameter stenosis
<50% by QCA) from SIRIUS, C-SIRIUS, E-SIRIUS, RAVEL, DIRECT
and SVELTE. Endpoints included 8-month in-lesion binary restenosis
and in-hospital and 1-year MACE (cardiac death, MI, TLR and TVR).
Results: Pts with IL treated with SES (n=116) and DES (n=58) were
well matched with regard to age, gender, prior MI, diabetes, and LAD
target vessel. Mean reference vessel diameter was 2.79±0.42mm and
2.74±0.53mm, respectively, (p=0.49), and mean lesion length was
11.2±5.1mm and 10.8±3.8mm (p=0.61). In-hospital MACE (all nonQ wave MI) were very low and not related to stent type (0.9% vs 1.7%,
p=0.61). Treatment with SES was associated with significantly lower
8-month in-lesion late loss (0.20±0.46 vs 0.72±0.71mm, p<0.001) and
binary restenosis (3.8% vs 35.7%, p<0.001). At 1 year (Figure), pts
in SES arm had strikingly lower rates of TLR, TVR and MACE. There
were no cases of cardiac death or stent thrombosis in either group.
Conclusions: Treatment of intermediate lesions with SES was safe with
very low rates of early events. Compared to BMS, SES dramatically reduced
restenosis resulting in excellent clinical outcome at 1 year.
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TCT-335
Frequency of Off Label Drug Eluting Stent Use in Clinical Practice
Michael Y. Huang, Taha Akhtar, Yoshihito Sakata, Michael H. Salinger,
Thomas G. Frohlich, Timothy J. McDonough, David I. Koenigsberg, Alan
Kogan, Carl L. Tommaso, Timothy A. Sanborn, Ted Feldman
Evanston Hospital, Evanston, IL
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INTRODUCTION: The efficacy and safety of FDA approved Drug Eluting
Stents (DES) in simple lesions has been established in the SIRIUS and TAXUS
IV trials. In clinical practice, DES are used in more complicated lesions which
are outside of those originally approved by the FDA, so called off-label use.
We investigated off-label use of DES in the initial 1 year after their release.
METHODS: 486 patients who underwent coronary stent implantation from
7/1/2003 to 6/30/2004 were classified for DES implantation as on-label vs
off-label. On-label indications include de novo lesions, reference vessel
diameter 2.5-3.5mm, lesion length < 30mm, and implantation of < two
stents/vessel. Off-label uses included SVG, AMI, thrombus, bifurcations,
ostial, left main, ISR, multivessel disease, > two stents/lesion and CTO.
RESULTS: 683 lesions in 575 vessels were treated with 807 stents (mean 1.7
stents/patient, 1.4 stents/lesion, 1.2 stents/vessel). BMS & patients clinical
characteristics were not different. DES were used in 84% vs BMS in 16%.
Reasons for BMS use were thrombus rich lesions, long-term antiplatelet
intolerance, or PCI prior to non-cardiac surgery. 8% of all cases were
treated by both BMS and DES, in which BMS were added due to vessels too
small for DES (less than 2.5mm) or failure of DES delivery. Off-label DES
applications comprised of more than half of all DES use (on-label 46% vs offlabel 54%). Off-label uses of DES included SVG(11%), bifurcation(10%), instent restenosis (10%), multivessel disease(20%), three or more stents(5%),
ostial segment(4%), left main(10%), AMI(21%), lesion > 30mm(5%), and
atherectomy prior to DES implantation(2%). There were 23 total cases of instent restenosis; 6 were in drug eluting stents (1.5%). 3/404 patients treated
with DES has stent thrombosis (0.7%), 2 <30 days and 1 after 5 months.
CONCLUSIONS: The use of DES in an off-label fashion comprised more
than half of the total case load during the first year after release at our
institution. There is no excess SAT or ISR in this series with high frequency
off-label use.
used in complex lesions and was associated with larger luminal gain after
procedure than angiography-guided stenting. However, it was not translated
to better long-term outcomes of the IVUS-guided stenting.
* p < 0.05
Reference diameter, mm*
Pre-intervention MLD, mm*
Post-intervention MLD. mm*
Acute gain, mm*
Late loss, mm
Binary restenosis
Group I
2.95±0.49
0.97±0.58
2.88±0.47
1.91±0.59
0.33±0.64
95/1,172 (8.1%)
Group II
2.79±0.49
0.85±0.53
2.69±0.47
1.84±0.57
0.37±0.71
42/401 (10.5%)
TCT-336
Efficacy of Intravascular Ultrasound-Guided Drug-Eluting Stent
Implantation in the Real Practice
Kyoung-Min Park, Seong-Wook Park, Seung-Whan Lee, Bong-Ki Lee,
Kyoung-Ha Park, Il-Woo Suh, Eui-Seock Hwang, Young-Hak Kim, Cheol
Whan Lee, Myeong-Ki Hong, Jae-Joong Kim, Seung-Jung Park
BACKGROUND: It is not yet known whether intravascular ultrasound
(IVUS)-guided stenting has an addictive effect on clinical outcomes
than angiography-guided stenting in the drug-eluting stent (DES) era.
METHODS: We evaluated consecutive 1,795 patients (2,293
lesions) who underwent DES implantation with IVUS-guidance
(1,557 lesions, group I) or angiography-guidance (736 lesions,
group II). All analyses were performed on a per-lesion basis.
RESULTS: IVUS-guided DES implantation was performed in 1,225 lesions
(69%) of sirolimus-eluting stent and in 332 lesions (64%) of paclitaxel-eluting
stent implantations. The group I included more complex lesions such as left
main, in-stent restenosis, ostial, bifurcation and long lesions than the group
II. Procedural success rate was similar between the two groups (98.9% in
the group I vs. 98.3% in the group II, p= 0.25). Angiographic characteristics
are shown in Table. At 1-year follow-up, the rate of freedom from death,
myocardial infarction and target lesion revascularization was similar
between two groups (95.2% in the group I vs. 95.0% in the group II, p =0.53).
CONCLUSIONS: IVUS-guided DES implantation was more frequently
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TCT-338
Drug Eluting Stents in Diabetic Patients
TCT-337
Six-Month Assessment of Neointimal Hyperplasia in Diabetic Patients
Treated with Bare-Metal or Sirolimus-Eluting Stents: A ThreeDimensional Intravascular Ultrasound Study
Vinicius D Vaz, Alexandre Abizaid, Fausto Feres, Aurea Chaves, Andrea
Abizaid, Eduardo J Ferreira, Rodolfo Staico, Luis Mattos, Carlos E Silva,
Luis Tanajura, Marinella Centemero, Andrés Sanches, Amanda Sousa,
J.Eduardo Sousa
Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil
Background: Diabetic (DM) pts have higher in-stent restenosis, especially
insulin-requiring diabetics (IDM). Although sirolimus eluting stent (SES)
had significantly reduced restenosis in both DM and non-DM patients, little
is known about the impact of IDM on in-stent neointimal hyperplasia (NIH).
Objective: The purpose of the current analysis is to quantify and compare NIH
obtained by intravascular ultrasound (IVUS) in DM patients, insulin-requiring
or not, and in non-DM patients treated with bare-metal stent (BMS) or SES.
Methods: From our core-lab database, 337 pts treated with BMS or
SES, with 6-month angiographic and IVUS follow-up were selected.
Pts were divided according to the stent implanted (BMS or SES)
and regarding DM condition. Quantitative coronary angiography
(QCA) and 3D-IVUS analyses were performed at follow-up.
Results: Mean age was 58.4±9.7 years and 209 (62%) were male. A total of
220 (65%) patients receive BMS and 117 (35%) SES. QCA and 3D-IVUS
results:
QCA / 3DIVUS
RD (mm)
LL (mm)
Late Loss
(mm)
Restenosis
(%)
IVUS - VO
(%)
BMS
SES n=117
n=220
non-DM non-IDM
non-DM non-IDM
IDM n=51
n=110
n=59
n=51
n=48
2.80±0.3 2.69±0.4 2.67±0.4 2.75±0.3 2.81±0.4
17.5±4.5 17.1±3.5 17.4±4.1 18.8±2.6 20.4±3.9
0.92±0.6 1.0±0.6 1.2±0.56* 0.15±0.18 0.29±0.22
IDM n=18
2.91±0.5
20.9±3.2‡
0.31±0.13‡
16
19.7
23.8
2
4.1
0
35.8±11
39.7±19
48.1±19†
5.2±5.4
4.6±4.1
3.7±3.3
RD- reference diameter; LL- lesion length; VO luminal volume obstruction;
BMS subgroups: * p<0.05 non-DM vs. IDM; † p<0.05 between all subgroups
SES subgroups: ‡ p<0.05 non-DM vs. non-IDM and IDM.
Conclusion: In BMS, 3D-IVUS analysis showed that DM patients had
more NIH than non-DM and the highest amount of NIH was observed
in the insulin-requiring DM patients. On the other hand, SES suppressed
neointimal proliferation equally, in all subgroups of patients, irrespective
of diabetic status.
Clinical Consequences of Incomplete Stent Apposition after Sirolimus
Stent Implantation in Diabetic Patients: Insights from the DIABETES
Trial
Pilar Jimenez -Quevedo1, Manel Sabate1, Dominick Angiolillo1, Fernando
Alfonso1, Rosana Hernandez-Antolin1, Joan Antoni Gomez-Hospital2,
Camino Bañuelos1, Raul Moreno1, Javier Escaned1, Marco Costa3,
Francisco Fernández-Aviles4, Marcelo Sanmartín5, Carlos Macaya1
1
Hospital Clinico San Carlos, Madrid, Spain2Hospital de Bellvitge,
Barcelona, Spain3University of Florida, Shand Jacksonville, Jacksonville,
FL;4Hospital Clinico, Valladolid, Spain5Hospital do Meixoeiro, Vigo,
Spain
Background: The DIABETES (DIABETes and sirolimus Eluting Stent)
trial is a prospective, multicenter, randomized, controlled trial aimed to
demonstrate the efficacy of sirolimus-eluting stent (SES) as compared to bare
metal stent (BMS), on the inhibition of neointimal hyperplasia in diabetic
patients. The aim of this study was to assess the incidence of incomplete
stent apposition (ISA) and its clinical consequences at long-term follow up.
Methods: 160 patients (221 lesions) were included in the trial: 80
patients randomized to SES and 80 to BMS. A subset of 139 lesions
(63%) was assessed by intravascular ultrasound (IVUS; motorized
pullback at a speed of 0.5 mm/sec) immediately after stent implantation
and at 9-month angiographic follow-up. Qualitative IVUS analyses were
performed by an independent core laboratory that was blinded to treatment
allocation. ISA was defined as ≥1 strut clearly separated from the vessel
wall, with evidence of blood speckling behind the stent struts without
overlapping sidebranches, and was classified into 3 categories: resolved,
persistent, late acquired. Dual antiplatelet therapy (aspirin indefinitely
+ clopidogrel for 1 year) was routinely prescribed in all patients.
Results: Baseline clinical and angiographic characteristics were comparable
between groups. At 9-months, overall ISA rate was significantly higher in the
SES group as compared with BMS group (28.6% vs. 6.5%, p=0.001). This
was mainly due to an increased incidence of late acquired ISA in the SES
group (19.5% vs. 0%, p<0.001). There were no significantly differences in
resolved or persistent ISA between groups (SES vs. BMS: 0% vs. 3.2%, p=0.2,
and 9.1% vs. 3.2%, p=0.3, respectively). At one-year follow-up clopidogrel
treatment was withdrawn in all patients. Those patients with ISA did not
experience any death, myocardial infarction or stent thrombosis. Target lesion
revascularization was performed in 1 patient driven by the presence of ISA.
Conclusion: ISA is a frequent phenomenon after SES implantation in
diabetic patients. However, it is not associated with increased rate of clinical
adverse events at one-year follow-up.
TCT-339
Diabetes Mellitus is Associated with Higher Microvascular
Obstruction after Elective PCI: PREDICT (Prediction of CK-MB
RElease During Successful Stenting Correlating with Indicators of
Microvascular ObstruCTion) trial
Annapoorna S. Kini, Bradley Brown, Michael C. Kim, Paul Lee, Gloria
Manzanilla, Tirumalesh Venkatesh, Javed Suleman, Pedro R. Moreno,
Samin Sharma
Background: DM is associated with poor long-term outcome in pts with
CAD after PCI, partly due to microvascular disease. The microvascular
obstruction is heightened during PCI from plaque/thrombus distal
embolization, which might contribute to poor outcome. GP IIb/IIIa inhibitors
decrease distal embolization after PCI and improve long-term outcome.
DM pts are more prone to distal microvascular obstruction during PCI;
this can be assessed by measuring coronary flow reserve (CFR). PREDICT
trial compared the CFR and fractional flow reserve (FFR) in DM pts vs.
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non-DM post-stenting and correlated with CK-MB release and hs-CRP.
Methods and Results: PREDICT is a prospective randomized study
of 72 elective PCI pts with 36 DM pts. PCIs were done by conventional
technique, using Cypher stent and abciximab, and had CK-MB, TnI and
Hs-CRP measured pre- and post-PCI. Baseline and post-stenting CFR and
FFR were measured before and after IC adenosine administration (Table).
Angiographic and clinical success, vascular complications and 30-day
MACE were similar in two groups. Post-stenting CFR moderately correlated
with CK-MB and hs-CRP post PCI but did not correlate with 30-day MACE.
Conclusion: DM pts have lower CFR post stenting despite normal FFR
indicating higher microvascular obstruction post PCI compared to nondiabetics and correlated with CK-MB and hs-CRP levels. Therefore,
additional therapies to improve microvascular circulation in diabetics may
be needed to improve long-term prognosis of these pts.
FFR preFFR postCFR preCFR postAny CK-MB ↑ (%)
Any troponin ↑ (%)
hs-CRP (U/L)
Diabetics (n = 36)
0.77 ± 0.15
0.97 ± 0.03
1.36 ± 0.32
1.69 ± 0.30
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47
6.9 ± 5.6
Non-diabetics (n = 36)
0.76 ± 0.12
1.08 ± 0.50
1.49 ± 0.25
2.40 ± 0.67
6
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5.4 ± 10.2
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0.066
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0.39
0.63
0.43
TCT-340
Risk-Adjusted Modeling of In-Hospital Mortality for InsulinDependent PCI Patients Receiving Drug Eluting Stents: Experience
from the American College of Cardiology National Cardiovascular
Data Registry (ACC-NCDR)
Emir Veledar1, Paul Kolm1, Kathleen Hewitt2, Kristi Mitchell2, Ralph
Brindis3, Lloyd W Klein4, William S. Weintraub1
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Emory University, School of Medicine, Atlanta, GA;2ACC-NCDR,
Bethesda, MD;3Northern California Kaiser Permanente, Oakland,
CA;4Rush University Medical Center, Chicago, IL
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Background:The incidence of insulin-requiring diabetes who require
interventional procedures is increasing. Drug eluting stents (DES)
have decreased restenosis, potentially extending the applicability to
diabetics with multivessel disease. To date two DES have been approved
by United States Food and Drug Administration, the Sirolimus (SES)
and Paclitaxel (PES) stents. We constructed a model to predict inhospital mortality after PCI with DES in insulin requiring diabetics
to specifically query whether the type of DES used was predictive.
Methods:A total of 8182 procedures from the ACC-NCDR database
during the time period from February to September of 2004 were analyzed,
time period when both SES and PES became available. There were no
significant differences between the DES groups in regard to age, race, BMI,
angina class, NYHA class, history of heart failure, hypertension, chronic
lung disease, cerebrovascular disease, elevated cholesterol, previous MI,
peripheral vascular disease, renal failure, previous CABG, previous PCI,
previous valvular surgery, multi-vessel PCI, LVEF, non-elective procedure,
shock at PCI , angiographic success , unplanned CABG (0.27% SES, 0.12%
PES),actual hospital mortality ( 1.07% SES, 1.28% PES)and length of stay
(3.5 days for both DES). A model of in-hospital mortality included the risk
factors listed below. The c-index was 0.91.
Results:
Variable
DES paclitaxel
Age(per year)
EF (per 1% increase)
BMI
Cerebrovascular Disease
Renal failure
Non-elective procedure
Shock on PCI
High risk lesion
Odds Ratio
0.956
1.048
0.966
1.039
1.908
3.236
2.621
18.182
2.604
95% CI
0.565 - 1.617
1.022 - 1.075
0.949 - 0.983
1.001 - 1.078
1.086 - 3.356
1.880 - 5.587
1.377 - 4.990
9.091 - 35.714
1.511 - 4.484
P-value
0.8665
0.0003
<.0001
0.0416
0.0247
<.0001
0.0033
<.0001
0.0006
Conclusion: Our model had high predictive power, and type of DES used
was not a predictor of risk-adjusted in-hospital mortality.
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TCT-341
Is Paclitaxel-Eluting Stent a Valid Choice for Diabetic Patients?
Insights from the TRUE Study
Giuseppe Sangiorgi1, Pierfrancesco Agostoni2, Giuseppe Biondi Zoccai2,
David Antoniucci3, Corrado Tamburino4, Bernhard Reimers5, Carlo Di
Mario6, Eberhard Grube7, Antonio Colombo1, On behalf of the Taxus™ in
Real-life Usage Evaluation (TRUE) Study Investigators
1
EMO Centro Cuore Columbus, Milan, Italy2Interventional Cardiology
Unit, San Raffaele Hospital, Milan, Italy3Careggi Hospital, Florence,
Italy4Ferrarotto Hospital, Catania, Italy5Mirano Hospital, Mirano,
Italy6Royal Brompton Hospital, London, United Kingdom7Siegburg Heart
Center, Siegburg, Germany
Purpose: Preliminary data from post-hoc analyses of large randomized
trials suggested a very good performance of the Taxus™ paclitaxeleluting stent (PES) in diabetic patients, with major adverse cardiac
events (MACE) rates similar to non-diabetics. We thus assessed if
these results could be replicated in a real-life setting of high risk
patients with complex lesions, as those enrolled in the TRUE Study.
Methods: Consecutive high-risk patients undergoing Taxus stenting
were enrolled in 7 European centers. Inclusion criteria in the registry
were: left main (LM) disease, small vessel ( 28 mm) lesions, chronic
total occlusions (CTO), bi/trifurcations and diabetes. Clinical events
were adjudicated at 1 and 7 months and MACE, including death,
myocardial infarction (MI), target lesion (TLR) and target vessel
revascularization (TVR), were evaluated. We compared the outcomes
of diabetic patients undergoing PES implantation vs. non-diabetics.
Results: Across the 1050 included subjects, 315 (30%) were diabetics.
Non diabetics were more likely to be treated for LM disease (13% vs.
6%, p<0.01), long lesions (29.7% vs. 21.3%, p=0.005), small vessels
(42.1% vs. 35.6%, p<0.05) and bi/trifurcations (23.7% vs. 17.1%, p0.05
for all) for deaths (2.1% vs. 3.2%), MI (5.2% vs. 5.2%) and TVR (17.7%
vs. 13.1%), while the TLR rate was slightly lower (p=0.04) in diabetic
patients (7.5%) than in non-diabetics (13.1%). Finally, the cumulative
rate of stent thrombosis was also similarly low (0.8% vs. 0.9%, p=0.8).
Conclusions: Percutaneous treatment of coronary lesions with the Taxus
stent in diabetic patients showed excellent mid-term results with a TLR
rate <10%. The relatively worse results obtained in the control group of
non-diabetic patients (with a TLR rate of 13.1%) can be easily explained
by the inclusion criteria of the registry, as only patients with unfavorable
lesion characteristics (small vessels, long lesions, left main, chronic total
occlusions, bifurcations) were enrolled, if not diabetics. These data, in
any case, confirm the overall excellent clinical impact of PES in diabetic
patients as suggested by previous reports from patients with less complex
characteristics.
TCT-342
Diabetes is Not Associated with Angiographic Restenosis after Long
Sirolimus-Eluting Stent Implantation as Contrasted with Long BareMetal Stent Implantation
Seong-Wook Park, Young-Hak Kim, Seung-Whan Lee, Bong-Ki Lee,
Bong-Ryong Choi, Young-Hoon Jeong, Jung-Min Ahn, Cheol Whan Lee,
Myeong-Ki Hong, Jae-Joong Kim, Seung-Jung Park
BACKGROUND: Diabetes mellitus (DM) has been considered as an
independent predictor of angiographic restenosis after bare-metal stent (BMS)
implantation especially in long coronary lesions. However, the effect of DM
has not yet been elucidated in long sirolimus-eluting stent (SES) implantation.
METHODS and RESULTS: This study included 538 de novo long
coronary lesions treated with long (total stent length ≥28mm) SES
(n=337) or BMS (n=201) implantations from the “Long-DES” multicenter
study. Chronic total occlusion, acute myocardial infarction, and left
main lesions were excluded. The baseline and procedural characteristics
were similar between the DM and non-DM patients. Restenosis rates of
the SES group were lower than the BMS group in both DM and nonDM patients. In the BMS group, restenosis rate was higher in DM
patients than non-DM patients. However, in the SES group, restenosis
rate and late loss were similar between the DM and non-DM patients.
CONCLUSIONS: As contrasted with BMS, DM appears not to influence
on angiographic restenosis in long SES implantation. Moreover, the use
of SES is associated with more favorable angiographic outcomes than the
BMS in treatment of DM patients with long coronary lesions.
* p<0.05 SES-DM vs SES-Non DM; ** p<0.05 BMS-DM vs BMS-Non DM; #
p<0.05 SES-DM vs BMS-DM
SES (n=337)
BMS (n=201)
No DM
No DM
Lesion length, mm DM (n=106)
DM (n=69)
(n=231)
(n=132)
Lesion length, mm
36.6±15.2
34.7±13.9
31.5±12.3
32.2±12.3
Reference diameter,
2.70±0.38*,# 2.84±0.42
3.02±0.50
3.14±0.55
mm
Pre-intervention
0.78±0.46
0.76±0.48
0.83±0.51
0.75±0.55
MLD
Acute gain
1.91±0.53
1.94±0.63
2.06±0.65
2.16±0.67
Angiography
84 (79)
193 (84)
55 (80)
107 (81)
follow-up
Post-intervention
2.35±0.39#
2.41±0.45
2.56±0.50
2.62±0.50
MLD
Late loss
0.16±0.51#
0.15±0.51
1.03±0.75
1.02±0.62
Binary restenosis
8/84 (9.5)# 12/193 (6.2) 29/55 (53)** 39/107 (36)
TCT-343
Predictors of Restenosis after Drug-Eluting Stent Implantation in
Diabetic Patients
Soon Jun Hong1, Moo Hyun Kim2, Tae Hoon Ahn3, Jang Ho Bae4, Young
Keun Ahn5, Wan Joo Shim1, Young Moo Ro1, Do-Sun Lim1
1
Korea University Anam Hospital, Seoul, Republic of Korea2Donga
University Hospital, Pusan, Republic of Korea3Gachon University
Hospital, Incheon, Republic of Korea4Konyang University Hospital,
Daejeon, Republic of Korea5Chonnam University Hospital, Kwangju,
Republic of Korea
Background: With the introduction of drug-eluting stents (DESs),
the angiographic rates of restenosis at later months have reduced
dramatically but less prominently in diabetic patients. The
objective of this study was to identify parameters influencing the
likelihood of restenosis after DES implantation in diabetic patients.
Methods and Results: Stented patients (n=840) with DESs [sirolimuseluting stent (n=504) (Cypher, Cordis, Florida) and paclitaxel-eluting stent
(n=336) (Taxus, Boston Scientific, Massachusetts)] were retrospectively
reviewed for inclusion in the study from the PCI database. From this
database, 211 (25.1%) out of 840 patients with six-month angiographic
follow-up had diabetes. Restenosis (> 50% of the luminal diameter stenosis
during the six-month follow-up) occurred in 92 of 629 (14.6%) nondiabetic
and 44 (20.9%) of 211 diabetic patients (p <0.001). Multivariate parameters
for predicting restenosis in the diabetic group were longer stent length,
current smoking, higher C-reactive protein (CRP), smaller reference
diameter before DES implantation, and smaller reference diameter
and minimum lumen diameter (MLD) after DES implantation (Table).
Conclusion: Even with the introduction of DES, diabetes remains a
significant predictor of ISR especially in cases of small baseline and post
PCI vessel size, longer stent length, current smokers, and high level of
CRP.
Table. Logistic Regression Analysis for Predicting Restenosis in Diabetic Patients
Univariate
Multivariate
Parameters
p Value
OR
95% CI
p Value
OR
95% CI
Stable angina
0.016
0.408 0.197-0.846
NS
0.794 0.440-1.663
Hypertension
0.042
2.383 1.031-5.506
NS
1.677 0.740-7.556
Smoking
0.030
2.127 1.075-4.210 0.036
1.923 1.055-4.725
Pre-PCI
reference
0.004
0.306 0.138-0.680 0.040
0.501 0.110-0.965
diameter
Post-PCI
reference
0.003
0.283 0.123-0.653 0.026
0.455 0.120-0.814
diameter
Post-PCI MLD 0.001
0.131
0.047-0.369 0.039
0.447
0.068-0.876
Stent length
0.003
1.104
1.035-1.178 0.033
1.065
1.021-1.119
(mm)
CRP (mg/L)
0.016
1.218
1.037-1.430 0.043
1.031
1.011-1.075
TCT-344
Is There Any Difference in Vascular Responses at Proximal and
Distal Edges of Sirolimus-Eluting Stents in Diabetic Patients? A 3-D
Intravascular Ultrasound Analysis
Dimytri A Siqueira, Alexandre Abizaid, Aurea Chaves, Vinicius D. Vaz,
Fausto Feres, Luiz A. Mattos, Marcos Franchetti, Arturo R. Quizhpe,
Marinella Centemero, Rodolfo Staico, Amanda G.M.R. Sousa, Jose
Eduardo Sousa
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
Introduction : Sirolimus-eluting stents (SES) have been associated
with significant reduction in in-stent restenosis and target-vessel
revascularization (TVR) in diabetic (DM) patients when compared with
bare metal stents . Previous studies, however, have shown that higher
rates of restenosis and TVR were expected if analysis of stent edges where
included , suggesting untoward effects at adjacent segments of SES. Our
purpose was to investigate if vascular responses at stent edges differ in
diabetic patients treated with SES compared to non-diabetics (NDM).
Methods: 85 patients(pts) treated with SES were divided in
two groups: A-47 diabetic pts (77 edges) and B-38 non-diabetic
pts (71 edges) . Serial intravascular ultrasound was performed
immediately after the procedure and at 6-month follow-up. 5 mm
vessel segments proximal and distal to the SES were analysed.
Results: Mean age was 58,62 ± 9,35 years and 62,3 % were men. Clinical and
angiographic characteristics were comparable between the two groups. Stent
/ lesion length ratio was 1,65 in group A and 1,52 in group B (p=NS). Volume
changes for vessel, plaque, lumen and % of obstruction were calculated
as follow-up minus post-procedure values, and are shown in the table.
Conclusion:This IVUS study revealed no significant differences in vascular
responses at stent edges between diabetic and non-diabetic pts. This supports
the concept of stenting longer segments when implanting sirolimus-eluting
stents, even in high-risk group such as diabetic patients.
Proximal edge ( n= 65 )
Δ vessel volume (mm3)
Δ lumen volume (mm3)
Δ plaque volume (mm3)
Δ % obstrution
Distal edge ( n = 83 )
Δ vessel volume (mm3)
Δ lumen volume (mm3)
Δ plaque volume (mm3)
Δ % obstrution
DM ( n = 32 )
-2,15 ± 12,28
-0,73 ± 10,62
-1,41 ± 8,20
-0,10 ± 11,00
DM ( n = 45 )
+1,70 ± 14,10
+1,12 ± 7,66
+0,62 ± 9,86
-0,50 ± 9,88
NDM ( n = 33 )
0,18 ±18,33
0,48 ± 15,26
-0,30 ± 11,18
+ 1,50 ± 12,41
NDM ( n = 38 )
+0,55 ± 13,27
-1,48 ± 8,95
+2,02 ± 8,70
+ 2,86 ± 9,94
p
0,55
0,71
0,65
0,58
p
0,70
0,15
0,49
0,12
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TCT-345
Paclitaxel-Eluting Stents Reduce Neointimal Hyperplasia in Both
Diabetic and Non-Diabetic Coronary Arteries: A Volumetric
Intravascular Ultrasound TAXUS-IV Study
Stephane Carlier1,2, Neil J Weissman3, Gary Mintz1, Joerg Koglin4, Mark
Turco5, Joel Greenberg6, James T Mann7, Michael Kutcher8, Ronald
Caputo9, Roxana Mehran1,2, Mary E Russel4, Stephen G Ellis10, Gregg W
Stone1,2
1
Cardiovascular Research Foundation, New York, NY;2College of
Physicians and Surgeons, New York, NY;3Washington Hospital Center,
Washington, DC;4Boston Scientific Corp., Natick, MA;5Washington
Adventist Hospital, Tacoma Park, MD;6Florida Hospital, Orlando,
FL;7WakeMed, Raleigh, NC;8Wake Forest University Baptist Medical
Center, Winston-Salem, NC;9St. Joseph’s Hospital, Syracuse,
NY;10Cleveland Clinic Foundation, Cleveland, OH
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Background: Diabetes mellitus (DM) contributes to restenosis
after bare metal stents by increasing neointimal hyperplasia.
Whether the same is true with paclitaxel-eluting stents is unknown.
Methods: IVUS was used to compare diabetic vs. non-diabetic vascular
responses in the TAXUS-IV trial, a randomized comparison of the slow-release,
polymer-based, paclitaxel-eluting TAXUS stent (PES) vs. an equivalent
bare metal stent (BMS) (vessel diameter 2.5-3.75, lesion length 10-28 mm).
External elastic membrane (EEM), stent, lumen, and intimal hyperplasia
(IH=stent minus lumen) areas were measured every 1 mm at an independent
blinded core lab; stent volume obstruction was calculated as IH/stent volume.
Results: At 9-mo follow-up, volumetric IVUS was available in 82
PES and 80 BMS pts, 38 (23%) of whom were diabetic (11 requiring
insulin). Inhibition of IH formation by paclitaxel was similar in DM
and non-DM pts (table). There were no differences between insulin and
non-insulin requiring diabetics treated with PES (% stent obstruction
of 7±4 vs. 17±14, p=0.1) nor with BMS (32±15 vs. 26±18, p=0.4).
Conclusion: In this prospective, blinded, multicenter IVUS substudy, the
paclitaxel-eluting stent inhibited neointimal hyperplasia in diabetic similar
to that in non-diabetic patients . This suggests that PES interrupts restenosis
mechanisms implicated in diabetic syndromes but larger studies are required
to validate this hypothesis.
IVUS data
Follow up
PES (n=23)
Stent length (mm)
19.6±5.9
Mean EEM area (mm2)
16.0±5.5
Mean stent area (mm2)
7.6±2.3
2
Mean lumen area (mm )
6.6±2.6
Mean IH area (mm2)
1.0±0.9
% Stent obstruction
15.0±13.0
5.3±2.6
MLA (mm2)
DM
BMS (n=15)
19.8±3.7
15.2±4.2
7.9±2.4
5.9±2.4
2.0±1.2**
28.5±16.8**
4.3±2.0
No DM
PES (n=59) BMS (n=65)
18.8±4.6
18.1±4.6
15.1±4.5
15.1±4.2
7.5±2.2
7.9±2.2
6.6±2.2
5.7±2.0*
0.8±0.9
2.2±1.1**
10.9±12.1+ 29.6±13.5**
5.2±2.1
4.1±1.5**
MLA=minimum lumen area; * p<0.05 and ** p<0.01 PES vs BM; + p=0.18
DM vs No DM
TCT-346
Early and Mid-Term Results after Drug Eluting Stenting in Diabetic
Patients
Alessio La Manna, Nadia Garro, Alfredo Ruggero Galassi, Pier Giorgio
Masci, Maria Catalano, Rossella Barbagallo, Maria Elena Di Salvo,
Corrado Tamburino
Ferrarotto Hospital, Catania, Italy
Background: The clinical outcome of diabetic patients undergoing
percutaneus coronary revascularization is worse than non diabetic
subjects. Randomized clinical trials demonstrated that drug eluting
stents (DES) reduce the need for repeated revascularization in the
general population but only few data are available about the outcomes
in diabetic subjects. Aim of our study was to compare the immediate
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and mid-term (8-month) clinical outcomes of DES implantation in
non-insulin (NIDDM) vs insulin-dependent (IDDM) diabetic patients.
Methods: We report our series of 316 consecutive diabetic patients (pts)
with 526 coronary artery lesions who underwent PCI with DES (Sirolimus
or Paclitaxel eluting stents) from May 2002 to October 2004. Patients
were classified into two groups according to diabetes mellitus (DM)
status: 1) NIDDM (179 patients/308 lesions); 2) IDDM (137 patients/218
lesions). Mean age was 63±10 vs 65±10 y, (p= NS ), the ejection fraction
was 52±10% vs 50±10% (p= NS ); the number of pts with multi-vessel
disease (> 2 vessels) was 76% vs 80%, p= NS . Twenty-five pts (8%) had
ongoing myocardial infarction (6% vs 11%, p =NS) and 178 (56%) had
unstable angina (55% vs 58%, p =NS). Multivessel stenting was performed
in 119 pts (38%) (37% vs 38%, p =NS). A total of 650 DES (2.2±1.4 n/
pt vs 1.9±1 n/pt, p =0.003) were implanted in 526 lesions (1.7±1.0 n vs
1.5±0.7 n, p =0.01) with a lesion length of 23±18 vs 23±14 mm (p =NS)
and a reference vessel diameter of 2.8±0.4 vs 2.78±0.4 mm (p =NS).
Results: Procedural success was obtained in 99% of cases. In-hospital
MACE were: cardiac death 1.1% vs 4.3% (p =NS), q wave AMI 1.1% vs
0% (p =NS), non q wave AMI 1.1% vs 0.7% (p =NS), TVR (re-PTCA)
1.1% vs 0% (p =NS), CABG 0.6% vs 0% (p =NS); 9-month MACE
were: cardiac death 2.3% vs 7.6% (p =0.03), q wave AMI 0% vs 0.8%
(p =NS); non q wave AMI 0% vs 0% (p =NA), TVR (non-TLR) 5% vs
15% (p =NS), CABG 1.1% vs 0.8% (p =NS), TLR 4.5% vs 4.6% (p =NS).
Cumulative MACE at 9-month follow-up was 13% vs 15% (p =NS).
Conclusions: Thus, diabetic patients undergoing DES implantation have
similar cumulative MACE at 9-month follow-up but IDDM subjects show
an higher mortality.
TCT-347
Treatment of Complex Coronary Artery Lesions in Patients with
Diabetes: Nine-Month Outcomes from the TAXUS V Trial
Naim Z. Farhat1, Charles D. O’Shaughnessy1, Stephen G. Ellis2, S. Chiu
Wong3, Barry Rutherford4, Dean Kereiakes5, Patrick Hall6, Mary E.
Russell7, Gregg W. Stone8
1
North Ohio Heart Center, Elyria, OH;2The Cleveland Clinic Foundation,
Cleveland, OH;3New York Presbyterian Hospital, New York, NY;4Mid
America Heart Institute, Kansas City, MO;5The Lindner Clinical Trial
Center, Cincinnati, OH;6South Carolina Heart Center, Columbia,
SC;7Boston Scientific Corporation, Natick, MA;8Columbia University
Medical Center, New York, NY
Background: The risk of restenosis and repeat revascularization
following coronary artery stent implantation is increased in patients
with diabetes. This study evaluates the 9-month clinical, angiographic,
and IVUS outcomes in diabetic patients treated with paclitaxel-eluting
TAXUS Express2 stent vs. the bare metal control Express2 stent.
Methods: In the TAXUS V trial, 1156 patients were prospectively
randomized to the slow-release polymer-based paclitaxel-eluting
TAXUS stent or a bare-metal Express2 (BMS) stent (both Boston
Scientific, Natick, MA). A total of 356 patients (31%) had medically
managed diabetes mellitus, 102 of whom were treated with insulin.
Results: Patients with diabetes in TAXUS V were characterized by multiple
risk factors, with a mean lesion length of 17.4±9.7 mm, 46% with lesions
>18mm, mean baseline RVD of 2.57±0.56, 76% Type B2/C lesions,
and 31.5% overlapping stents. In the diabetic subset, treatment with the
TAXUS stent reduced 9-month target lesion revascularization (TLR) by
46% (17.5% BMS vs. 9.6% TAXUS; p= 0.04). This corresponded with
a 53% reduction in 9-month binary restenosis (38.4% BMS vs.18.2%
TAXUS; p<0.0001). In the insulin-treated subgroup, the TAXUS stent
significantly reduced angiographic restenosis by 55% (46.7% vs 20.9%,
p= 0.013). In-segment late loss was significantly reduced for the overall
diabetic population (0.62±0.61 mm BMS vs. 0.31±0.56 mm TAXUS;
p<0.0001) and for insulin-treated patients (0.59±0.57 mm BMS vs.
0.26±0.58 mm TAXUS; p=0.0085). Percent neointimal volume obstruction
by IVUS was significantly reduced for both the overall diabetic population
(34.08±15.18% BMS vs. 13.05±12.16% TAXUS; p<0.0001) and insulintreated patients (33.91±18.10% BMS vs. 12.69±14.61% TAXUS;
p=0.0017). Nine-month rates for cardiac death (1.2% TAXUS vs. 0.6%
BMS), myocardial infarction (6.4% TAXUS vs. 3.9% BMS) and stent
thrombosis (1.8% TAXUS vs. 0.6% BMS) were comparable between groups.
Conclusion: The paclitaxel-eluting TAXUS stent significantly reduces
neointimal proliferation and angiographic restenosis in patients with
diabetes, safely enhancing clinical outcomes in this difficult to manage
high-risk group.
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Endovascular Interventions
TCT-348
Contemporary Treatment for Critical Limb Ischemia: A Critical
Analysis Identifies a “Pathway to Amputation” Not a “Pathway to Limb
Salvage”
Barker1, Nancy Reaven3, Craig M Walker2
1
Institute of the South, Houma, LA;3Strategic Health Resources, La
Canada, CA
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Background: The incidence of critical limb ischemia (CLI) and amputations
are rapidly increasing with an estimated 222,000-240,000 major and minor
amputation performed yearly in the US/Europe with an alarming recent 4-5
fold increase in patients > 80-years. The 30-day periprocedural mortality and
morbidity post amputation ranges between 4-30% and 20-37% respectively
in the highest risk patient populations. A literature review suggests
appropriate initial treatment for CLI to be infrainguinal bypass surgery
(IBS) = 38%, percutaneous transcatheter revascularization (PTR) = 28%,
and primary amputation (PA) = 16%. Several recent reports show excellent
(> 85-90%) short-term (6-12 months) and good (> 60-70%) longer-term
(3-10 years) limb salvage rates with both IBS and PTR in advanced CLI.
Methods: Between 1999-2001 a reference amputation population (RAP)
of 417 CLI patients with an infrainguinal amputation were identified
from a 2.5 million US Medicare/insurance dataset. All clinical data and
medical claims for 18-months (6-months pre and 12-months post) were
analyzed for CLI treatment pathways including IBS, PTR, and PA. The data
collection and analysis was conducted by Strategic Health Resources®, an
independent consultant commissioned by the Spectranetics Corporation.
Results: Initial treatment for the CLI RAP were PA = 67%, IBS = 23%,
PTR = 10%. Only 35% of RAP had an ankle brachial index (ABI) and
shockingly only 16% underwent angiography before PA. A majority
of multiple procedures (37%) and complications occurred in the PA
RAP [wound = 80%, myocardial infarction = 7/9 (77.7%), stroke =
13/16 (81.2%), death = 2/2 (100%)]. The RAP consulting physician
analysis revealed the percentage of radiology, cardiology, and vascular
surgery services provided were 39%, 26%, and 21% respectively.
Conclusion: The most common contemporary treatment pathway in the US
is a “pathway to amputation” characterized by high rates of complications,
multiple procedures, PA without ABI or angiography, and < 50% physician
consultation for revascularization despite several recent reports of > 85%
limb salvage rates with revascularization. A “pathway to limb salvage”
must be globally advocated, adopted, and applied.
TCT-349
Plaque Excision for Treatment of Long Chronic Total Occlusion of the
Superficial Femoral Artery
Barry Weinstock1,2, Adriana Delacruz1
1
Mid-Florida Cardiology Specialists, Orlando, FL;2Florida Hospital,
Orlando, FL
a guidewire, CTO’s historically have been treated with angioplasty
(PTA) and/or stenting. Many physicians avoid these procedures due to
low long-term patency rates and the risk of stent fracture in extensively
stented vessels. Plaque excision with the SilverHawk device (FoxHollow
Technology, Redwood City, CA) has been used successfully in complex
SFA lesions and may be appropriate for treatment of SFA CTO.
Methods: Patients at a single center were offered plaque excision rather than
angioplasty or stenting for treatment of long CTO’s. Lesion length, vessel
diameter, residual stenosis, need for adjunctive therapy, and procedural
complications were studied. Clinical follow-up is being accumulated.
Results: Nineteen CTO’s in 17 patients were treated with plaque excision.
All patients had claudication. Mean patient age was 70 years, 53% of patients
were male, 35% were diabetic, 88% had hypertension and 65% were smokers.
Mean CTO length was 166+80 mm. Moderate or severe calcification was
common (89%). Reference vessel diameter was 5.2+0.8 mm. After plaque
excision, minimum lumen diameter (MLD) improved to 4.4+0.7 mm,
(residual stenosis 15.3+12.3%). Adjunctive therapy (one PTA, five stents)
was performed primarily for guidewire induced dissections. After adjunctive
therapy, MLD improved to 4.7+0.8 mm (11.8+12.3%). Only one minor
perforation occurred which resolved with PTA. There were no dissections
attributable to plaque excision. At follow-up of 2.3+2.9 months (range=0.3 to
10.6 months), one patient developed re-occlusion and one patient underwent
placement of covered stents for two asymptomatic, small SFA aneurysms.
Conclusion: Plaque excision as treatment of long SFA CTO appears
promising based on acute results and limited short-term clinical followup. This technique avoids placement of multiple, overlapping stents thus
preserving future surgical options and avoiding the risk of stent fracture.
Longer follow-up is needed to compare intermediate and long-term patency
rates to other revascularization procedures.
TCT-350
Symptoms of Peripheral Artery Disease are Effectively and
Persistently Improved following Percutaneous Revascularization
David M Safley, Casey Stoner, John A House, Steven B Laster, William C
Daniel, Steven P Marso
Mid America Heart Institute, Kansas City, MO
Background: Symptomatic peripheral artery disease affects 5
million Americans. There are over 150,000 peripheral endovascular
revascularization (PER) procedures yearly in the US. The magnitude
and durability of symptomatic improvement following PER is unknown.
Methods: Following informed consent, consecutive patients (pts)
undergoing PER were prospectively enrolled. Symptoms were assessed at
baseline, 1, 3, 6, and 12 months with the Peripheral Artery Questionnaire
(PAQ). The primary endpoint was improvement 12 months following
PER, assessed by the PAQ summary score. Scores range from 0-100;
higher scores represent fewer symptoms. PAQ Scores for Physical
Limitation, Symptoms, and Quality of Life were also compared.
Results: There were 300 pts enrolled. The average age was 68±13 years,
62% were male and 96% were Caucasian. Prior coronary artery disease
(64%), hypertension (69%), hypercholesterolemia (66%), diabetes
mellitus (39%), and current smoking (44%) were common. There were
improvements in Physical Limitation (20±21 vs. 49±33, p<0.001),
Symptoms (34±21 vs. 62± 30, p<0.001), and Quality of Life (37±22
vs. 65±28, p<0.001) 1 year following PER. PAQ summary scores are
displayed in the figure. As shown, there was a decrement between 1 and 12
months (p=0.007), but scores remained significantly higher than baseline.
Conclusions: There is a significant improvement in symptoms following
PER. Although there is a modest decrement between 1 and 12 months,
improvements are sustained for at least 1 year.
Background: Long chronic total occlusions (CTO) of the superficial
femoral artery (SFA) remain clinically challenging. Once crossed with
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TCT-352
Intermediate Patency Rate of the Viabahn Stent-Graft for Chronic
Total Occlusion or Long High-Grade Stenosis of the Superficial
Femoral Artery.
Sepideh Kazemi, Mohamed Djelmami-Hani, Anjan Gupta, Ramagopal
Tumuluri, Yoseph Shalev, Suhail Allaqaband, Tanvir Bajwa
Aurora Sinai/St. Luke’s Medical Centers, University of Wisconsin Medical
School-MCC, Milwaukee, WI
TCT-351
Ultrasound-Guided Percutaneous Radiofrequency Obliteration for
Treatment of Perforating Vein Incompetence
Alan Lumsden1, Eric Peden1, David Chang2, Steve Gale3
1
Baylor College of Medicine, Houston, TX;2Stanford University School of
Medicine, San Jose, CA;3Jobst Vascular Center, Toledo, OH
Background: Perforating vein (PV) incompetence affects 50-65% of
patients with advanced chronic venous insufficiency. Current available
treatments include surgical ligation, SEPS (subfascial endoscopic
perforator vein surgery) and sclerosant injection. This study evaluates a
new treatment option using percutaneous radiofrequency (RF) obliteration.
Methods: Four centers with institutional review board approval
contributed data. Incompetent perforating veins in symptomatic patients
were treated with a variety of configurations of radiofrequency stylet that
was introduced percutaneously using ultrasound guidance. Perforators
were treated subfascially, either intra- or extra-vascularly. Postoperative compression was applied. Patient follow-up included clinical
and duplex ultrasound evaluation at 72 hours, 3 weeks, and 6 months.
Results: Ninety seven PVs in 55 limbs (46 patients) were treated and
the follow-up is ongoing. When analyzing the relationship between RF
treatment time, electrode positioning and treatment efficacy, endovascular
treatment with treatment time ≥120sec demonstrated a vein occlusion
rate of 91.2% (31/34) at 3wks. Extravascular treatment or treatment
time less than 120sec resulted in significantly lower efficacy rate.
Asymptomatic calf muscle venous thrombosis was observed under
ultrasound in 2 limbs (2 patients), one at 3wk possibly relating to a long
distance flight of the patient, and one at 72h, the patient having previous
history of superficial thrombophlebitis. Both thromboses were treated
with anticoagulant therapy and resolved with no clinical sequelae.
Conclusion: Percutaneous radiofrequency obliteration offers a true
minimally invasive option for the treatment of perforator incompetence. An
improved treatment protocol was developed from the results this study. The
durability of the treatment will be demonstrated by the 6-month follow-up
data.
Background: Previous experience with percutaneous revascularization
of superficial femoral arteries using self-expanding or balloon-expanding
stainless steel stents has been disappointing with high restenosis
rate. The literature regarding patency of stent-grafts in superficial
femoral arteries in not clear, patency is reported to vary from 15%
to 75%. We evaluated the immediate success, complications, and
outcomes of Viabahn self-expanding stent-graft (W. L. Gore, Flagstaff,
AZ) in patients with superficial femoral artery occlusive disease.
Methods: This prospective study involved twenty-eight patients
at our institution who underwent percutaneous revascularization
of superficial femoral arteries with Viabahn stent grafts between
August 2004 to April 2005. Patients were followed clinically and
with Duplex scan at 1, 3, 6 and 12 months post procedure. In-stent
restenosis was defined as > 50% stenosis by Duplex. Patients with instent restenosis underwent angiogram for confirmation and therapy.
Results: Baseline clinical characteristics of the patients are shown
in the table. Initial technical success was 100%. There was no inhospital mortality or morbidity. All patients were discharged home on
ASA and Plavix. After a mean follow-up of 6 months, primary patency
rate was 100% by Duplex scan. There was no stent-graft thrombosis.
Conclusion: Percutaneous revascularization of superficial femoral arteries
with Viabahn stent graft is safe and feasible with excellent intermediate
results.
Baseline Clinical and Angiographic Characteristics
number of patients
28
gender
12 females, 16 males
age
mean 63.5±15
diabetes mellitus
14 (50%)
smoking
7 (25%)
total occlusion
13 (46%)
Fontaine class II or IIa
22 (80%)
non healing ulcer
6 (20%)
total number of stents deployed
57
initial technical success
100%
average stent length
10 cm (range 5-35 cm)
average stent diameter
6 mm (range 5-7 mm)
average number of stents per patient
2
mean follow-up
6 months
primary patency
100%
stent thrombosis
0%
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TCT-353
Percutaneous Transluminal Angioplasty and Stenting of Extracranial
Vertebral Artery Stenoses
Michel Henry1, Isabelle Henry2, Antonios Polydorou3, Admanda
Polydorou3, Michèle Hugel1
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Cabinet de Cardiologie, Nancy, France2Polyclinique, Bois-bernard,
France3Panteleimon General Hospital, Athens, Greece
Purpose: To evaluate the safety & efficiency of percutaneous
interventional
treatment
(angioplasty
/
stenting)
in
patients with symptomatic vertebral artery (VA) stenosis.
Methods: 65 VA angioplasties attempted in 62 vessels in 59 patients by
femoral approach using coronary techniques (M:43, F: 16) mean age 68,3
± 6,9 years (22-84) right 33 left 32. All patients had multivascular diseases
(carotid stenoses: 42, subclavian : 12, renal : 11, peripheral vascular diseases:
16, coronary diseases: 41). 63 atheromatous lesions, 2 inflammatory
diseases. Mean lesion length: 9,5 ± 2,5 mm (5-14), mean arterial diameter
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: 4,6 ± 0,6 mm (4-6). 58 lesions located at VO segment (ostium) 5 at V1
segment & 2 at V2 segment. Indications included: dizziness: 59, bilateral
weakness: 9, visual changes: 9, diplopia: 8, drop attacks: 8, TIA: 5, ataxia: 4
Protection device (filter) used in 3 patients. 11 subclavian artery angioplasties
performed at the same time of VA angioplasty, 2 carotid angioplasties.
Results: Technical success 63/65. Clinical success 57/59. 2 failures in elderly
patients (very tortuous calcified arteries). 6 lesions treated by angioplasty
alone (3 VO lesions in our first 3 patients, 2 V1 lesions & 1 V2 lesion). 1
patient with inflammatory disease treated by cutting balloon alone. 56 lesions
stented with balloon, expandable stents. 3 V1 & 1 V2 lesions were treated with
self expandable stents. We observed no per or post-procedure neurological
complications. Angiographic success, defined as ≤ 20 % residual stenosis
without in hospital emergency surgery, stroke and death: 58/60 lesions (97 %).
Post-procedure arterial diameter: 4,55 ± 0,8 mm (4-6). Mean residual
stenosis 2,2 ± 3,5 %. 4 patients developed symptomatic restenosis
during the follow-up (mean follow-up: 26,5 ± 26,3 months). 3 after
PTA alone, 1 after PTA & stent (1 occlusion treated medically,
the 3 stenoses successfully treated with balloon angioplasty).
Conclusion: Endovascular treatment of V.A.S. can be performed safely &
effectively with a high technical success rate, low complication rate, low
restenosis rate & a durable clinical success in patients with symptomatic
V.A.S. Stents seem to improve immediate & long-term results.
TCT-354
Percutaneous Transluminal Angioplasty of the Subclavian Arteries
Michel Henry1, Isabelle Henry2, Antonios Polydorou3, Admanda
Polydorou3, Michèle Hugel1
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Cabinet de Cardiologie, Nancy, France2Polyclinique, Bois-bernard,
France3Panteleimon General Hospital, Athens, Greece
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To
review
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and
longterm
results
of
sub-clavian
artery
angioplasty.
Methods: Over 14 years, 237 patients (males: 135, mean age: 64±12y)
underwent percutaneous treatment for sub-clavian artery occlusive disease.
Indications for treatment were upper limb ischemia (n=125) , vertebrobasilar
insufficiency (n=128), coronary steal (n=11) and anticipated coronary bypass
surgery in asymptomatic patients (n=26). 192 arteries were stenosed and 45
occluded. Mean % stenosis was 81.9±7.6, mean lesion length was 23.8±8.8
mm. Percutaneous techniques included retrograde femoral (n=163), brachial
artery (n=47) access or both (n=14), and in 4 cases, the “pull through
technique”. An isolated balloon angioplasty was performed in 59 cases.
We implanted 132 balloon expandable stents, 32 self-expandable stents.
Results: Technical success was obtained in 223 lesions (94%). Only 31
occlusions were recanalized (69%). Four periprocedural events occurred
(1.2%), 1 major (fatal) stroke, 1 T.I.A., 2 arterial thromboses. At follow-up
(mean follow-up: 65.8 months ± 33.5), we had 27 restenoses (12%). 13
occurred following angioplasty alone (18.8%) and 14 following angioplasty
and stent implantation (8.4%) . Primary (PI) and secondary (PII) patencies
on an intention to treat basis at 10 year follow-up were 78.1% and 84.5%
respectively. In patients without initial stent placement, the rates were 67.5%
and 75.5% while in those with stents, the rates rose to 89.7% and 96.9%
(P<0.01). PI for all recanalized lesions were 84.6%, 79.1% without stent,
89.7% with stent (P<0.04) and PII 91.6%, 88.5%, 96.9% respectively (P<0.02).
Conclusion: P.T.A. is currently the treatment of choice for subclavian artery
lesions. It is a safe and effective procedure associated with low risks and
good long-term results. Stents seem to limit the restenosis rate and improve
long-term results.
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TCT-355
Transluminal Endovascular Graft Placement with INOUE Stent Graft
for Thoracic Aortic Aneurysms and Dissections
Keita Odashiro1, Masakiyo Nobuyoshi1, Kanji Inoue2
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Kokura Memorial Hospital, Kitakyusyu, Japan2Shimabara Hospital,
Kyoto, Japan
Background: The feasibility and efficacy of transluminal endovascular
graft placement (TEGP) with Inoue stent graft(SG) for treatment
of thoracic aortic aneurysms and dissections was investigated.
Methods: From Aug.1997 to Apr. 2005, we performed TEGP with Inoue SG in
57 patients (pts.) and 57 cases (mean age , 71 years). Thirty seven pts.(65%) were
very high risk for open repair or good candidates for TEGP. The cases consist
of one ascending, 24 arch, 13 descending aneurysms, 19 aortic dissections.
Results: In all cases but one, SGs were implanted successfully to the
intended sites. Nineteen of the cases had straight, 23 had single branched,
8 had dual branched, 7 had triple branched grafts. There was only one
early death because of cerebral infarction in thrombus-rich distal arch
aneurysm case. The other major complications were 2 major stroke,
3 minor stroke, 1 supra-mesentric artery embolism and 2 paraparesis.
After Oct. 2001, there were no early deaths and major embolism by
using detachable filters and reduction of sheath size. During follow-up
period (mean 37 months, range 1 to 82 months), there were no aneurysmrelated deaths. Two dissecting cases with persistent endoleaks needed reTEGP after 6 months and 3 years. One distal arch aneurysm patient had
underwent surgical repair after 3 years because of late type I endoleak.
Conclusions: Inoue SG can be used in many types of thoracic aortic
aneurysms and dissections and is especially useful for high risk pts.
TCT-356
Sirolimus for Below the Knee Lesions: Mid-Term Results of SIKE
Study
Philippe Commeau, Pierre-Olivier Roquebert, Paul Barragan
Polyclinique Les Fleurs, Ollioules, France
Background: Treatment of infrapopliteal lesions remains uncertain
and controversial. Weak distal run-off and slow flow make long
term patency of revascularisation poor. Moreover, mortality
after amputation, in higher risk patients (pts), can reach 30%.
On the other hand, the use of coronary devices, particularly drug
eluting stents, may offer significant improvements ,as infrapopliteal
vessels are very similar to coronary arteries according to diameter.
Methods: Twenty five consecutive pts with critical limb ischemia (CLI),
category 3 to 6 of Rutherford classification, and multivessel disease of
infrapopliteal arteries (>= 2 vessels) were treated with sirolimus eluting
stent (SES). Forty two arteries were treated with 73 SES. Mean age was 75
+/- 14 y, 81% of pts were male and 36% diabetic.Three pts were booked for
limb amputation. The primary endpoint was clinical improvement or/and
healing of ulcers at 1 and 6 months. The secondary endpoint was primary
vessel patency rate ( angiographic or duplex assessment). All pts received
clopidogrel (75 mg daily) or ticlopidine (150 mg daily) for 2 months or longer.
Results: Angiographic and procedural success was achieved in all pts. At
6 months ( follow-up in 90 % of pts), toe amputation was made in only one
patient but limb salvage was obtained in 100% of pts, with a continued clinical
improvement in 80% after the first month. No death occurred. Primary patency
rate was 90% but re-angioplasty or surgery was not useful in any infrapopliteal
artery. The complete 6-month FU will be presented at the meeting.
Conclusion: SES implantation may be considered safe and effective as a
treatment of CLI due to severe lesions of “below the knee” arteries.
TCT-357
AngioJet Rheolytic Thrombectomy for Percutaneous Treatment of
Deep Venous Thrombosis: A Single Center Retrospective Study
Jose A. Rodriguez-Escudero, David M Shavelle, Murrad Abdelkarim, Guy
S. Mayeda, Steven Burstein, Thomas Shook, Ray V Matthews
Good Samaritan Hospital, Los Angeles, CA
Background: Previous small studies have shown the efficacy of AngioJet
rheolytic thrombectomy (RT, Possis Medical, Inc.) for the treatment of
extensive deep venous thrombosis (DVT). In this study, we sought to further
characterize the safety and efficacy of RT in the treatment of extensive DVT.
Methods: From August 2000 to May 2005, 28 consecutive patients (age
51.6+19.1, 32% male) underwent RT for extensive DVT. DVT location was
SVC-1, IVC-3, Iliofemoral- 14, Femoral-3, Femoral/Popliteal-4 and upper
extremity-8 patients. RT protocol included saline infusate alone 21/28
(75%), thrombolytic within effluent 2/28 (7%) and pulse-spray technique
5/28 (18%). RT was supplemented with lytic infusion in 26/28 (93%),
balloon angioplasty (PTA) in 13/28 (46%) and stenting in 5/28 (18%).
Duration of lytic (tPA) (mean + stdev) infusion was 18.5 + 17.7 hrs and
mean total dose was 45 + 46 mg. Initial and follow-up venograms were
evaluated for extent of thrombus resolution and establishment of flow. Inhospital complications including bleeding and renal failure were evaluated.
Results: Etiology for DVT included malignancy (50%), hypercoagulable
state (18%), trauma to affected limb (14%) and prolonged immobilization
(18%). Fluoroscopy time was 20.8 + 13.2 minutes; total contrast use was
106 + 49 mls. Following initial RT, thrombus burden decreased in 22/28
(79%). Partial and complete restoration of flow following initial RT occurred
in 20/28 (71%) and 5/28 (18%), respectively. With adjunctive therapy
including intravenous lytic infusion, PTA and stenting, partial and complete
restoration of flow occurred in 1/28 (4%) and 26/28 (93%), respectively.
Major bleeding complications occurred in 2/28 (7%). Acute renal
failure occurred in 7/28 (25%), with 2/28 (14%) requiring hemodialysis.
Conclusion: AngioJet RT combined with either lytic infusion, PTA and/or
stent placement is an effective treatment option for patients with extensive
DVT.
TCT-358
Variable Clinical Restenosis of Overlapping Nitinol Stents in Long
Lesions of the Superficial Femoral Artery Based on Stent Design
C. Dean Katsamakis, Justin F Haynie, Matthew N Weinberg, Clifford J
Kavinsky, Gary L Schaer, R Jeffrey Snell
Rush University Medical Center, Chicago, IL
Background: Symptomatic lesions of the superficial femoral artery
(SFA) are increasingly treated with self expanding nitinol stents.
Acceptable overall restenosis rates for these stents have been reported in
the literature. We compared the clinical restenosis rates of long lesions
treated with overlapping stents of a more open cell design (Absolute/
Dynalink, Guidant Corp., Indianapolis, IN) to lesions treated with stents
having a more closed cell design (SMART, Cordis Corp., Miami, FL).
Methods: We retrospectively reviewed clinical restenosis rates of long
SFA lesions (>100cm) treated with any combination of overlapping
stents. A total of 45 lesions in 42 patients were treated between October
2000 and April 2005 at a single institution. Patients were categorized
into two groups: 1) those treated with overlapping stents including an
Absolute/Dynalink and 2) those treated with overlapping SMART stents.
Clinical restenosis was defined as claudication of the treated leg at
any point during follow up. Clinical follow up was obtained on 93% of
patients (mean follow up=11 months). All patients with claudication had
repeat angiography confirming in-stent restenosis. Clinical restenosis
rates between the groups were compared using a two sample t-test.
Results: The overall clinical restenosis rate for the entire cohort was 40%.
A statistically significant difference was seen between the two groups. In
lesions treated with overlapping stents including an Absolute/Dynalink, the
clinical restenosis rate was 10/15(66%). In lesions treated with overlapping
SMART stents, the clinical restenosis rate was 6/26(23%) (p=0.0096).
Conclusions: Differential clinical restenosis rates were seen in long lesions
of the SFA treated with Absolute/Dynalink and SMART stents. Our data
suggests that restenosis of SFA lesions treated with multiple, overlapping
stents depends not only on lesion length and vessel diameter, but also on
differences in stent design and the complex biomechanical interactions of
these stents when placed in series. Further investigation into the mechanisms
of restenosis induced by overlapping stents will provide important insight
into the optimal stent design for treatment of SFA lesions.
TCT-359
SilverHawk Plaque Excision: One-Year Revascularization Outcomes
for Femoropopliteal Lesions
Venkatesh Ramaiah
Arizona Heart Institute, Phoenix, AZ
Background: Current non-surgical interventions in peripheral arterial
disease yield suboptimal long-term results. The superficial femoral artery
(SFA) in particular presents substantial treatment challenges, due to the
myriad forces exerted upon it during normal leg movement. Regardless
of treatment modality, high SFA restenosis rates are common. With the
development of the SilverHawk Plaque Excision System, peripheral
lesions can now be treated by precise removal of atherosclerotic plaque.
Methods: From June, 2003-January, 2005, 386 peripheral lesions
in 220 patients were treated via plaque excision. Duplex ultrasound,
ankle-brachial index (ABI) measurement and clinical evaluation were
or will be performed at 1, 3, 6 and 12 months. One-year follow-up has
been completed in 102 patients with 154 treated lesions. Here we
present one-year follow-up data for the 104 (67.5%) SFA lesions.
Results: Patient demographics included 50% coronary arterial disease,
45% diabetes, and 41% smokers. 38% of patients had rest pain and/or
tissue loss (Rutherford Becker score 4-6). 77% of lesions were TASC
B or greater. 40% of lesions contained moderate-severe calcification.
Technical success was achieved in 92.2% of SFA lesions as judged
by <20% residual stenosis. There were no major complications.
Seventy-eight percent (81 of 104) of SFA lesions received standalone
plaque excision. Adjunctive treatments included balloon angioplasty
(22%) and stent placement (8.6%). Each procedure collected an
average of 140 mg tissue, with a range from 30 mg - 410 mg.
Primary patency (<50% residual stenosis) determined via duplex ultrasound
at one year was 86%. Mean ABI increased from 0.57+.14 to 0.68+.18. 15
lesions experienced restenosis/occlusion and were treated with repeat plaque
excision plus PTA (2), stent-supported angioplasty (9), or bypass surgery (4).
Conclusions: Plaque excision achieved compelling patency rates in the
SFA at one year, especially when compared to historical PTA and stent
controls demonstrating 61-67% patency in the SFA at one year. Long-term
follow-up in larger numbers of patients and in patients with both SFA and
infrapopliteal disease is underway.
TCT-360
Peritoneal Dialysis Have Higher Rates of Hospitalization from
Peripheral Vascular Disease Compared with Hemodialysis Patients
Blaithnead M Murtagh, Austin Stack, Hoang Nguyen
UT Houston, Houston, TX
Background: Peripheral vascular disease (PVD) is common
among end stage renal disease patients in the United States.
Objective:
Compare
the
risk
for
hospitalized
PVD
among
HD
and
PD
patients
in
a
national
cohort.
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Method:We explored the association of dialysis modality with PVD
risk in a national cohort of Medicare-eligible dialysis patients who
began treatment between 1995-2000. Data on patient characteristics and
hospitalizations were obtained from the US Renal Data System Standard
Analysis Files. Crude hospitalization rates for PVD were compared for
HD and PD patients. Multivariable relative hazard ratios were compared
using non-proportional regression equations adjusting for baseline
differences with consideration of modality switch during follow-up.
Patients were censored at transplantation, death or loss to follow-up.
Results: 97,272 patients had complete data. The relative PD/HD
hazards ratios [RR] for first Hospitalized PVD for the intent-to-treat
model are shown in the table below.(*P<0.05, **P<0.01 Adjusted for
demographics and 17 comorbid indicators). The adjusted RR of first PVD
event in diabetics was significantly greater with PD, especially those
with preexisting CV disease (RR=1.32). The adjusted RR of first PVD
event also tended to be higher with PD for non-diabetics (RR=1.21).
Conclusion: The association of higher rates of hospitalized PVD among
patients treated with PD over HD suggests that the modality of PD
preferentially contributes to increased cardiovascular risk.
Group
Overall
Males
Females
Vascular Disease
ALL
Males
Females
No vascular Disease
ALL
Males
Females
Incidence Incidence
rates per rates per
Crude RR (PD/
1000
1000
HD)
person-yrs person-yrs
(HD)
(PD)
64.3
68
1.05 (0.94-1.17)
66.3
71.4
1.07 (0.92-1.25)
62.8
64.8
1.03 (0.88-1.20)
89.2
106.0
1.15 (0.99-1.33)
93.6
103.6
1.09 (0.89-1.34)
85.3
108.8
1.21 (0.98-1.50)
63.0
67.4
1.06 (0.95-1.19)
64.9
70.8
1.09 (0.93-1.27)
61.5
64.2
1.04 (0.89-1.21)
Adjusted RR (PD/
HD)
1.15 (1.03-1.29)**
1.12 (0.95-1.31)
1.18 (1.00-1.38)*
1.17 (1.01-1.36)*
1.10 (0.90-1.36)
1.27 (1.02-1.59)*
1.16 (1.03-1.29)*
1.13 (0.96-1.32)
1.17 (0.99-1.37)
TCT-361
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Treatment of Critical Limb Ischemia Using a Novel Plaque Excision
System
David Kandzari1, Roger Gammon2, Craig Walker3, David Allie3, Peter
Fail4, Venkatesh Ramaiah5, Joseph Cardenas5, Jose Vale6, Stefan Kiesz7
1
Duke University Medical Center, Durham, NC;2Austin Heart, Austin,
TX;3Cardiovascular Institute of the South, Lafayette, LA;4Terrebonne
General Medical Center, Houma, LA;5Arizona Heart Institute, Phoenix,
AZ;6Marion General Hospital, Marion, OH;7Northeast Methodist, San
Antonio, TX
Purpose: Critical limb ischemia (CLI) is associated with abbreviated
survival and considerable morbidity, often resulting in major lower
extremity amputation. Although amputation is sometimes unavoidable,
there remains a need to identify less invasive therapies capable of treating
extensive atherosclerotic disease with acceptable procedural risk in
these high-risk patients. In patients with CLI undergoing percutaneous
revascularization, this multi-center group examined the safety and efficacy
of a novel plaque excision (PE) catheter (SilverHawk Plaque Excision
System, FoxHollow Technologies) that removes atherosclerotic tissue
without plaque displacement, embolization, or vessel dilatation and injury.
Methods: Among patients with CLI (Rutherford category 5-6),
percutaneous revascularization using PE was performed, and clinical
outcomes were prospectively followed for 6 months. The primary endpoint
was major adverse events at 30 days (death, myocardial infarction,
unplanned amputation, or repeat target vessel revascularization). Visible
healing of ulcerated tissue, avoidance of any amputation, and performance
of less extensive amputation than initially planned were also assessed.
Results: PE was performed in 69 patients (76 limbs, 159 lesions).
Procedural success was achieved in 98.7% of cases. Major adverse events
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occurred in 1.4% of patients at 30 days and 23.2% at 6 months. The target
lesion revascularization rate was 3.8%, and there were no unplanned limb
amputations. Amputation was less extensive than initially planned or
avoided altogether in 92.1% of patients at 30 days and 81.6% at 6 months.
Conclusions: Catheter-based PE is a safe and effective revascularization
method for patients with CLI. High clinical patency rates, reductions in the
extent of amputation and/or avoidance of lower limb amputation altogether
support PE with the SilverHawk catheter as primary therapy for patients
with CLI.
TCT-362
The aSpire® Covered Stent in Complex Lesions: REAL SFA - 9
Month Results
K Rocha-Singh1, M Jaff2, V Kumar3, J Snell4, M Bates5, W Bachinsky6, F
Mendelsohn7, T Collins8, W Gray9, D Allie10, R Mulingtapang11, G Ansel12,
T Crabtree13
1
St. John’s Hospital, Springfield, IL;2VasCore, Boston, MA;3SoCentralReg
Medical Center, Laurel, MS;4Rush Medical Center, Chicago, IL;5CAMC,
Charleston, WV;6Moffitt Hospital, Wormleyburg, PA;7Baptist Hospital,
Birmingham, AL;8Ochsner Clinic, New Orleans, LA;9Swedish Medical
Center, Seattle, WA;10CIS, Layfayette, LA;11Northside Hospital,
St Petersburg, FL;12Riverside Methodist Hospital, Columbus,
OH;13Biostistical Consultant, Santa Rosa, CA
Background: The purpose of the REAL SFA trial was to evaluate “real
world” clinical experience with the aSpire® Covered Stent (Vascular
Architects, San Jose, CA) in the SFA. The study included an assessment
of stent fractures and their potential impact on clinical outcomes.
Methods: Patients with disabling claudication and SFA stenoses or
occlusions up to 40cm were prospectively enrolled into a multi-center
registry. Patients were treated with the aSpire stent, an ePTFE covered helical
nitinol stent, after failed/suboptimal PTA. Clinical variables were analyzed
for 9-month outcomes to determine the role of stenting in SFA disease.
Analysis included assessment of stent integrity with bent knee x-rays.
Results: 125 patients were enrolled at 11 U.S. centers. The mean lesion
length was 10.2 ± 8.3cm (range 1-34cm); 32% were total occlusions. TASC
lesion types included A (23%), B (26%), C (34%) and D (16%). Technical
success was 100%, with a 2% 30 day Target Lesion Revascularization
(TLR) rate. Lesion length was selected as a predictor of Target Vessel
Revascularization (TVR) rate and stent fractures based on the stepwise
regression analysis, (p<0.05). Accordingly, outcomes are presented in
aggregate and by lesion length.
Outcomes
Freedom from TVR*
Freedom from TLR*
Stent Fractures
REAL SFA - 9 Month Results
< 15cm
>15cm
p-value
n=99
n=26
78%
61%
0.01
83%
69%
0.02
7 (7%)
12(46%)
<0.01
Total
n=125
74%
80%
19 (15%)
*Kaplan-Meier
Estimates
Conclusion: Good results were achieved with the aSpire stent in complex
SFA lesions after failed/suboptimal PTA. Patients with lesions ≤ 15cm
treated with an aSpire stent achieved significantly lower TVR, TLR and
stent fracture rates when compared with longer lesions.
TCT-363
Phased Revascularization Utilizing Primary Cryoplasty for
Femoropopliteal Atherosclerosis: Reimbursement-Analysis Compared
with Primary Stenting
John H Rundback1, Kurshad Alam2, Joshua Weintraub1
1
Columbia University, Briarcliff Manor, NY;2Columbia University, New
York, NY
Purpose: To compare reimbursement for femoral revascularization
using a strategy of “phased revascularization” (initial cryoplasty
with secondary stenting, stent-graft placement, and) versus a
strategy of primary stenting (secondary stent-grafting and bypass).
Methods: An iterative analysis of sequential procedural payments for
both the initial and secondary interventions was performed for each
treatment strategy. Rates of (re)intervention were calculated for the index
procedure, and at 1-, 2- and 3-years follow-up. Patency assumptions
were extracted from cryoplasty IDE submission data, and published
results of cryoplasty, angioplasty, stenting and stent-graft placement.
Reimbursement data was derived from reimbursement schedules from
the U.S. CMS adjusted for inpatient and outpatient case-mix. A sensitivity
analysis for each strategy was performed using mid-range “base-case”
patency data as well as using best-case and worst-case comparisons.
Results: Three-year patency in this model was 90% for phased
revascularization vs. 85% for primary stenting. The number of interventions
and differential costs for each therapeutic strategy are shown.
Base-case
Best-case
Worst-case
Phased Revascularization
Primary Stenting
#
#
#
#
#
#
cryo stents grafts bypasses Tot cost # stents grafts bypasses Tot cost
91
51
17
7
$631,800
97
47
31
$1,451,975
93
48
9
5
$835,799
100
49
11
$1,252,204
91
56
33
22
$1,133,395
92
85
42
$1,794,210
Conclusion: A strategy of phased revascularization with cryoplasty as the
primary intervention appears to produce better patency and a savings of
$6600-$8200 per patient compared with primary stenting over a three year
period. Differential costs are preserved even if all procedures (excepting
bypass) were performed on an outpatient basis.
TCT-364
Endovascular Interventions in Takayashu Arteritis : An Experience of
107 Cases
Narendra N Khanna, Varin Arora, Badrul Badrul, Trilochan S Kler, Atul
Mathuir
Escorts Heart Institute, New Delhi, India
Background: Takayashu arteritis is a disease unique to Asian
countries and uncommon in Europe and United States of America.
This abstract reviews our experience of 107 consecutive patients
of Takayashu arteritis treated by endovascular techniques.
Methods: 107 patients of Takayashu arteritis treated by
endovascular techniques ( angioplasty and stents ) were
followed clinically , angiographically and by duplex scans.
Results: Of the 107 patients ( 79 females & 28 males ,mean age 21.48
( 8-48 )years )of Takayashu arteritis atreries were involved as follows ;
carotids -13, subclavian 18 ,renal -37 ,iliac-8, thoracic and abdominal
aorta-25 and coronary arteries -6. In 26 patients multiple arteries were
involved.47 patients had active disease as menifested by raised ESR,CRP
and mild fever.94 patients were symptomatic. Common presentations
were headache, dizziness,transient ischemic attacks ,stroke,vertigo,arm
claudication,hypertension and lower limb claudication.Stents were
used in 79 patients ,balloon angioplasty was done in 28 and surgery was
also done in 4 patients.At 6 months followup 94 patients were doing
well. 11 patients had recurrence and 2 patients died .Many of these
patients had active disease at the time of intervention or in followup.
Conclusions: Takayashu arteritis can be successfully treated by
endovascular techniques in a similar way as we treat atheroscelerotic
vascular and coronary disease.The immediate and intermediate results are
good. However we should pay attention to the disease activity and should
preferably intervene endovascularly when the disease is inactive.
TCT-365
Ultrasound Accelerated Thrombolysis in Peripheral Arterial
Occlusion: Complete Lysis Rates Using the EKOS Lysus® System in
the Same Day Setting
Thomas McNamara
UCLA Medical Center, Los Angeles, CA
Background: Thrombolysis for management of peripheral arterial occlusion
is associated with long lysis times, often exceeding 48 hours, to recanalize
and completely resolve peripheral arterial occlusions. Major bleeding
complications are reported to occur in 4-8% of patients. Ultrasound has been
demonstrated to accelerate clot lysis when combined with direct infusion
of thrombolytic drugs. This combination could facilitate same day lysis,
potentially reducing hospital costs and patient morbidity, and improving
angiography suite utilization. This study assessed early recanalization
and complete clot lysis in < 8 hours using ultrasound accelerated lysis.
Methods: The Lysus System (EKOS Corporation, Bothell, WA), a multitransducer ultrasound catheter system, was used to apply 2.2 MHz, low
intensity ultrasound to peripheral arterial occlusions in conjunction
with intra-arterial infusion of reteplase, alteplase, tenecteplase or
urokinase. Complete lysis was defined as >90%, and restoration of
antegrade flow categorized as early recanalization if accomplished in
less than 8 hours; both determined angiographically. Early recanalization
and complete lysis rates were documented in patients receiving
angiograms from 2 to 8 hours after initiation of EKOS treatment.
Results: A total of 28 arteries were treated in 27 patients in 7 centers.
Early angiograms (2-8 hours) were performed on 16 occlusions. Of those,
13 (81.3%) demonstrated complete clot lysis, and antegrade flow (early
recanalization) with a mean infusion duration of 5.2 hours. Complete lysis
was achieved in 26 of 28 occlusions (92.9%) with an average time of 15.4
hours to the definitive angiogram. None of the 27 patients demonstrated
distal embolization, major hemorrhage or other major complications.
Conclusion: This multi-center experience demonstrates that ultrasound
enhanced thrombolysis achieves more rapid recanalization and a higher
rate of early complete thrombus resolution than thrombolytic therapy
either alone or when combined with glycoprotein IIb,IIIa inhibitors, with
a reduction in bleeding complications. Ongoing multi-center results will
continue to be collected and analyzed for this promising new method.
TCT-366
Hybrid Treatment of Abdominal Aortic Aneurysm
Vinay Kumar
Endovascular Center, Laurel, MS
Purpose: To describe a combined open and endovascular
technique for the repair of AAA with short or wide proximal neck.
Material and Methods: Between march 2000 and may 2005, 373 patients
with Abdominal aortic aneurysms larger then 5 cm in diameter were treated
with variety of endovascular grafts. Of these 7 patients with high risk for
open repair due to multivessel coronary disease were offered a combined
procedure to prevent hemodynamic effects of aortic cross clamp. Procedure
included a midline mini-laparotomy and surgical construction of an
adequate proximal aortic neck utilizing non-absorpable vascular sutures
followed by placement of an endovascular graft via femoral approach.
Results: The procedure was successful in all patients. Average hospital
stay was 5.5d (4-8d). One patient developed abdominal wound dehiscence
on the 3rd post-operative day and needed repair. During 4 years follow up
one patient has died due to unrelated cause 2yrs later. Six patients have
been followed with CAT scans. No migration or endoleaks were observed.
Conclusion: AAA with short or wide proximal aortic neck can be
successfully treated utilizing hybrid procedure. Surgically created proximal
aortic neck appears to remain stable during short-term follow up.
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TCT-367
Takayasu’s Arteritis: A Single Center’s Experience in Percutaneous
Intervention
Emily L K Tan, Rosli MA, R Zambahari
National Heart Institute, Kuala Lumpur, Malaysia
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Background: Takayasu’s Arteritis is a rare idiopathic chronic
granulomatous vasculitis involving large arteries. Both endovascular
and open procedure has been advocated to restore vascular patency.
However, data on their efficacy and safety remains limited.
Aims: To evaluate patients with Takayasu’s Arteritis related vascular
occlusion who had undergone percutaneous intervention at our centre
in terms of the following: 1) Clinical and angiographic features 2)
Long term outcome of percutaneous angioplasty 3) Safety of procedure
Methods: Retrospective analysis of 20 Takayasu’s Arteritis patients with
percutaneous intervention done between January 2000 to May 2005 at
the National Heart Institute, Malaysia. Their case records were analysed
and data interpreted in accordance to standard statistical methods.
Results: The mean age at diagnosis was 23 ± 7 years with a female
preponderance (75%; p=0.025), ratio of 3:1. All the patients presented
with hypertension, 3 detected during pregnancy. Other less common
presentations include neurological and vascular symptoms. 80% of the
patients had renal artery involvement, 60% aortoiliac, 50% subclavian
artery, 40% carotid artery, 25% coronary artery, 20% axillary artery,
20% vertebral artery and 10% brachial artery. Vessel involvement was
4.6 ± 2.6 per patient. Angiographically, 75% of patients exhibited Type
III involvement, 15% Type IV and 10% Type III. Angioplasty alone was
performed to 2 vessels. Another 40 vessels received angioplasty with stenting
successfully. Mean ESR before procedure was 18.73 ± 2.51. 8 vessels had
significant instent restenosis : 2 at 6 months, 5 at 1 year and 1 after 2 years
of initial stent placement. There was one procedural related mortality due
to balloon rupture resulting in dissection and perforation of the vessel.
Conclusion: Takayasu’s arteritis is a rare vascular occlusive disease
involving mainly young ladies presenting with hypertension. It is readily
treatable with percutaneous angioplasty with good success rate and long
term outcome. It is also safe with low complication rate.
TCT-368
Cryoplasty Therapy for Peripheral Arterial Disease (PAD) of the
Superficial Femoral Artery (SFA): A Single Center Experience
David J Dobmeyer
Metro Heart Group, St. Louis, MO
Background: Cryoplasty (CryoVascular Systems, Inc., Los Gatos,
CA) is a new endovascular therapy. Standard PTA is performed in
conjunction with cold thermal energy to minimize injury and dissections
while stimulating apoptosis to diminish smooth muscle cells implicated
in the restenosis process. Data shows this technique moderates factors
associated with restenosis, including elastic recoil, constrictive remodeling
and neointimal hyperplasia. The high restenosis rate for stenting of the
SFA necessitates alternative therapeutic options. Data was gathered
on acute and long-term effectiveness in a single center experience.
Methods: A group of 25 consecutive patients (13 males, 12 females)
underwent cryoplasty treatment in 30 limbs for lesions of the SFA
(n=26), common femoral (n=2), tibeoperoneal trunk (n=1) and external
iliac (n=1). Lesion length ranged from 1-30 cm (mean = 8.6); pretreatment stenoses ranged from 80%-100%. Post-procedural angiographic
assessment was used to measure technical success based on successful
dilation with residual stenosis no greater than 30%. Symptomatic
improvement was measured by clinical assessment and ABI. Patency
criterion was freedom from revascularization of the treated lesion.
Results: The technical success rate was 97% with post-treatment residual
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stenosis measuring ≤ 10% in 23 limbs, 20% in 4 limbs, 30% in 1 limb and 40%
in 1 limb. Stents were placed in 4 limbs (13%) to address dissections. At follow
up ranging from 22 days to 1 year, 45 days, 26 of 28 limbs (93%) remained
patent. Claudication was resolved in 81% of limbs and ABI improved in 80%
of limbs for which pre- and post ABI readings were available. Two patients
were lost to follow up and 2 restenosed and underwent femoropopliteal
surgery. Additional data and longer-term follow up will be presented.
Conclusions: These early results indicate that cryoplasty is a viable
alternative to conventional endovascular treatments for PAD. It appears to
improve patency while reducing stent usage, minimizing the risks associated
with in-stent restenosis and preserving future treatment options.
TCT-369
In Vitro Performance Assessment of Cerebral Protection Devices in
Carotid Artery Stenting
Ender Finol1, Sanna Gaspard1, Mark Wholey2
1
Carnegie Mellon University, Pittsburgh, PA;2Pittsburgh Vascular
Institute, Pittsburgh, PA
Background: Over the past ten years Carotid Artery Stenting (CAS) has
become the standard treatment for Carotid Artery Disease (CAD) in high
risk patients. Though CAS is an effective treatment for high risk patients,
the procedure did not become main stream until the incorporation of distal
protection devices. The goal of all distal protection devices used during CAS
is to capture and remove embolic debris generated during the procedure. The
peri-operative embolic debris has the potential to cause occlusion of distal
intercranial vessels leading to ischemic stroke, brain damage, and paralysis.
Methods: The capture efficiency of the following devices are investigated
in vitro: RX Accunet Embolic Protection System (Guidant Corporation,
Indianapolis, IN), FilterWire EZ (Boston Scientific, Natick, MA),
Angioguard XP (Cordis Corp., Coral Gables, FL), and the Parodi AntiEmboli System (W.L. Gore & Associates, Flagstaff, AZ). To assess embolic
capture efficiency each device is introduced into a flow loop system under
physiological flow and pressure conditions. Utilizing a patient based silicone
carotid artery model each device is deployed in the internal carotid artery
and weighed synthetic embolic particles (PVA microspheres: d1=116μm,
d2=80μm) are injected into the flow. The embolic particles missed by
each device are captured and weighed to determine capture efficiency.
Results: The capture efficiency data validate our results obtained with prior
in vitro experiments on the effectiveness of distal protection filters in straight
silicone tubes with large polymer microspheres under peak systolic flow
conditions. The RX Accunet device had the single most overall filtration
performance (p < 0.005, based on Student t-test comparison with the appropriate
Bonferroni correction to account for multiple comparisons made between two
devices at a time) for the larger PVA microspheres (0.21% missed particles).
Conclusion: The current experiments are used to evaluate overall device
effectiveness, establish tangible failure modes, identify possible in vivo
complications, and to generate baseline design parameters for optimization
of future generations of cerebral protection devices.
TCT-370
TICLO - Ticlopedine versus Clopidogrel after Stenting of Internal
Carotid Artery Stenoses - a Randomized Trial
Alexander Kypta, Robert Hofmann, Clemens Steinwender, Klaus
Kerschner, Jürgen Kammler, Franz Leisch
General Hospital Linz, Linz, Austria
Backround:
Thienopyridines
in
combination
with
aspirin
has shown to be effective in prevention of stent thrombosis.
Objectives: We sought to evaluate the clinical effects of ticlopedine (TI)
versus clopidogrel (CL) in conjunction with carotid artery stenting (CAS).
Methods: Two hundred and three consecutive patients, with a mean age of
69,6 (46-87) years, undergoing elective CAS, were randomized to receive
either TI (n=100) or CL (n=103) in addition to aspirin. There were no
significant differences in the frequency of atherosclerotic risk factors in both
groups. Of the randomized P, 47% were neurological symptomatic before
CAS. Cl or TI was administered at least 1 day before and 4 weeks after the
intervention. After that further antithrombotic treatment of aspirin only, in 195
cases was administered. In 8 cases, antithrombotic therapy was replaced by
oral anticoagulation for prevention of embolic stroke due to atrial fibrillation
Results: The major cerebral complication rate at 30 days, in the CL group was
2.9% (1 major stroke, 2 minor strokes) and 1% in the TI group (1 minor stroke).
Mean follow up period was 26 ± 12 month. Ultrasound and clinical
follow-up could be performed in 202 (99.5%) of P. In the follow-up
period 9 P of the TI group and 7 P of the CL group died. One neurological
death occured 36 month after CAS in the CL group. In this P atopsie
showed a contralateral stroke with massive intracerebral bleeding.
Asymptomatic restenosis (≥50%) were observed in 19(8.3%)
P (9CL/10TI) of 202(99.5%) consecutive sonocrafically and
clinically controlled patients. Restenosis occurred 17 ± 15 month
after stenting in the TI group and 13 ± 10 month in the PL group.
Conclusion: Both thienopyridines, clopidogrel as well as ticlopedine are
both effective in the prevention of acute stent thrombosis in P undergoing
CAS. Acute and 30 day complications rate were not statistically significant
different between the two groups. In addition, during long term folluw-up
there was no statiscally significant difference demonstrated between CL and
TI treated P.
TCT-371
Unprotected Direct Carotid Artery Stenting with Balloon Expandable
Stents Compared to Protected Carotid Artery Stenting with
Selfexpandable Stents
Alexander Kypta, Robert Hofmann, Klaus Kerschner, Clemens
Steinwender, Jürgen Kammler, Franz Leisch
General Hospital Linz, Linz, Austria
Backround: Embolization of atherosclerotic debris with subsequent
stroke, remains the major risk of carotid artery stenting (CAS).
It is not fully clear, weather the stenting procedure itself or the
numerous manipulations with predilatation are respondsible for
embolization. Therefore, direct stenting (DS) was used on a routine
basis in our institution before filter devices have been available.
Objective: The aim of the study was to validate the method of DS by comparing
the current gold standard of self expandable stents (SES) with distal protection.
Methods and Results: In a retrospective analysis two types of stenting
techniques were compared: a total of 447 patients (P) with carotid artery
stenosis were treated. In 254 P the intention to treat was DS with a balloon
expandable stent (ACS-Ultra®Guidant INC). In 193 P, the intention to treat
was to implant a SES (ACCULINK®Guidant INC or PRECISE®Cordis
INC) under cerebral protection (Filterwire EX®Boston Scientific).
DS could not be performed in 12 patients due to long lesions with
severe calcification. In 242 P DS was successful in 252 of 253 vessels
respectively in 241 of 242 P (99.6 %). The mean degree of stenosis was
reduced from 84 ± 10% to 3 ± 6%. The major cerebral complication
rate was 1.9% (2 fatal strokes, 1 major stroke, 2 minor strokes).
In four P the implantation of a SES could not be performed. In those P
were the placement of the filter failed, the primary reason for failure
was unsuccessful vessel access. In another P it was possible to the
place the filter device, but the stent could not be put into the stenosis.
In 188 P SES placement was successful in 190 of 194 vessels (98%).
The mean degree of stenosis was reduced from 84.5 ± 9% to 4 ±
7%. The major cerebral complication rate was 1% (2 major strokes).
During follow up of 17 ± 14 month, 378 (85%) P could be
followed clinically and sonografically. Asymptomatic restenosis
(>50%) including 4 (1.8%) stent deformations, were observed
in 10 (3.9%) of 220 DS P and in 5 (3.1%) of 158 SES P.
Conclusion: DS offers relatively good primary results with low complication
rates. However, SES with cerebral protection shows a 50% risk reduction
even in our series with low complication. The incidence of restenosis is
similar in DS and in SES.
TCT-372
Previous Neck Radiation Increases the Risk of Carotid Stent
Restenosis
George Younis, Kamal Gupta, Neil Strickman, Ali Mortazavi, Emerson
Perin, Arup Achari, Zvonimir Krajcer
Baylor College of Medicine, Houston, TX
Introduction: Carotid artery stenting is a viable alternative to carotid
endarterectomy, particularly in patients with previous radiation
therapy to the neck (XRT). The incidence and management of carotid
stent restenosis in this population has not been extensively reported.
Methods: A retrospective, single-center review was conducted of
399 carotid stent procedures over 9 years. There were 35 carotid stent
procedures performed in patients with XRT with a mean follow-up of 31
months (range 5-100 months). Other clinical variables assessed included
age, gender, symptoms, hypertension, diabetes, tobacco use, renal
insufficiency, coronary artery disease, hyperlipidemia, peripheral vascular
disease, history of CEA, and history of XRT. Angiographic variables
assessed included reference vessel diameter, lesion length, post-stenting
residual stenosis, stent diameter, type of stent, and number of stents.
Results: Restenosis occurred in 15 of 399 pts (3.8%) in the whole cohort,
and 7 of 35 (20%) pts with previous XRT. Univariate analysis confirmed
a significantly elevated incidence of restenosis in patients with XRT (OR
11.3, p=0.00005). Restenosis was most often asymptomatic and detected at
routine ultrasound follow-up. Restenotic lesions were successfully treated
in 5/5 cases with repeat angioplasty and stenting. Two are being monitored
closely with ultrasound. No pts required surgical therapy for restenosis.
Conclusions: Patients with previous radiation therapy to the neck are at
increased risk of carotid stent restenosis. Restenotic lesions may be safely
treated with further percutaneous interventions.
TCT-373
Durability of Carotid Artery Stent Patency is Demonstrated by
Duplex Ultrasonography: 12-Month Results from the SECuRITY
Trials
Michael R. Jaff1, Patrick Whitlow2, Gary Roubin3, Sriram Iyer3, Rajesh
Dave4, Edward B. Diethrich5, Subbimaro Myla6, Donald Schwarten7, Tracy
Roberts7
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Massachusetts General Hospital, Boston, MA;2Cleveland Clinic
Foundation, Cleveland, OH;3Lenox Hill Hospital, New York,
NY;4Harrisburg Hospital, Harrisburg, PA;5Arizona Heart Institute,
Phoenix, AZ;6Hoag Hospital, Newport Beach, CA;7Abbott Vascular
Devices, Redwood City, CA
Background: Duplex ultrasonography (DUS) has been the mainstay for
determining patency of carotid arteries after carotid endarterectomy (CEA).
The utility of DUS after carotid artery stenting (CAS) in a prospective
multicenter trial has not been demonstrated in systematic fashion.
The SECuRITY trial is a prospective, single-arm, multicenter registry
of patients (pts) at high risk for CEA. All pts underwent DUS pre- and
post-CAS, and at 1, 6 and 12 months (m) with the Xact Carotid Stent and
Emboshield Embolic Protection System (EPS) (MedNova, Galway Ireland).
Methods: DUS images were analyzed by a core laboratory (VasCore,
Boston, Massachusetts). The primary composite endpoint was the incidence
of major adverse events (death, stroke and/or myocardial infarction)
at 30-days post procedure and the incidence of ipsilateral
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stroke at one-year post procedure. 88% of pts had at least
one high-risk criterion, 12% due to anatomic abnormalities.
Results: For the pivotal cohort of 305 pts, the 30-d endpoint was 7.5%; the
1-y
composite
endpoint
was
8.5%.
The
TLR
rate
was
0.6%
at
12
months.
DUS
data
are
shown:
Conclusion: CAS with the Xact Carotid Stent and Emboshield EPS is safe
and durable. DUS data demonstrates durable patency at 12-months.
ICA/CCA PSV
PSV MAX (cm/sec)
EDV MAX (cm/sec)
Ratio MAX
Pre343.15 ± 150
115.85 ± 73
5.43 ± 3.53
Post97.85 ± 43.82*
24.24 ± 13.19*
1.55 ± 0.55*
6 Months
95.46 ± 55.36^
25.85 ± 16.91^
1.62 ± 0.89^
12 Months
89.15 ± 32.15^
24.34 ± 13.06^
1.65 ± 0.77^
PSV=Peak Systolic Velocity; EDV=End-Diastolic Velocity; ICA/CCA PSV= Peak
Systolic Velocity Ratio of ICA vs distal CCA. All p values were calculated using the
Signed Rank Test
method.
*p<0.0001 compared to pre-procedure
^
p=NS compared to post-procedure
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148H
Interventional Pharmacology
TCT-374
A Comparative Study of the Effects of Prasugrel (CS-747, LY640315)
and Clopidogrel on Platelet Function in Healthy Subjects
Joseph A Jakubowski1, Fumitoshi Asai2, Kenneth J Winters1, Takashi
Hirota2, Nobuko Matsushima2, Hideo Naganuma2, Stephen Freestone3
1
Eli Lilly and Company, Indianapolis, IN;2Sankyo Co., Ltd., Tokyo,
Japan3Inveresk Clinical Research, Edinburgh, United Kingdom
Background: Antiplatelet agents, such as aspirin and clopidogrel (C),
are effective in the secondary prevention of atherothrombotic events.
In preclinical studies, prasugrel (P), a novel thienopyridine, showed
more potent inhibition of platelet aggregation (IPA) than C. This study
examined the tolerability, safety, and IPA profile of P compared with C.
Method: A double-blind, placebo-controlled, multiple-dose study
of healthy male volunteers randomized into 5 groups (n=6): P (5,
10 and 20 mg), C (75 mg), and placebo. Study medications were
taken once daily for 10 days. Platelet aggregation induced by 20
µM ADP was measured turbidometrically at selected intervals.
Result: Multiple oral dosing of prasugrel was well tolerated at doses of
5 to 20 mg for 10 days. For median maximum bleeding times, there were
no significant differences (p>0.05) between the active treatments. Twentyfour hours after the final dose, P dose-dependently increased IPA (39.2%68.3%), an effect for all P doses greater than that observed with C (15.7%;
p<0.05). Furthermore, 2 of 6 C-treated subjects demonstrated minimal IPA
at day 10.
Table. Levels of IPA assessed using 20 µM ADP 24 hours after 10th dose
Prasugrel Prasugrel Prasugrel Clopidogrel
Mean ± SE (n=6)
Placebo
5 mg
10 mg
20 mg
75 mg
9.2 ± 4.0 39.2 ± 4.4 58.2 ± 4.9 68.3 ± 5.4 15.7 ± 6.8
IPA (%)
p-value vs. Placebo
-< 0.001
< 0.001
< 0.001
< 0.001
p-value vs.
< 0.001
0.011
< 0.001
< 0.001
-Clopidogrel 75 mg
Conclusion: Prasugrel was well tolerated when administered to healthy
subjects as 10 daily doses of up to 20 mg. Platelet aggregation at day 10
in all P-treated subjects in all dose groups was consistently decreased,
contrasting the IPA observed with C (75 mg). These results form the basis
of ongoing studies assessing the safety and efficacy of prasugrel in patients
with atherothrombotic disease.
TCT-375
A Novel Effect of Fosinopril and Valsartan on Reducing Myocardial
No-Reflow in a Mini-Swine Model of Acute Myocardial Infarction and
Reperfusion
Yang Yuejin, Zhao Jinglin, Gao Runlin
8 in valsartan-pretreated (2mg/kg/d) for 3 days and 8 in sham-operated.
Acute myocardial infarction and reperfusion model were created with threehour occlusion of the left anterior descending coronary artery followed
by one-hour reperfusion. Endothelin-1 (ET-1) in blood sample, reflow
and no-reflow myocardium were also measured with radioimmunoassay.
Results: There was no significant difference in the ligation area among the
three groups (all P>0.05). Compared with the control group, both fosinopril
and valsartan significantly improved ventricular function, increased CBV
from 50.6±3.1% of the baseline to 72.1±3.8% and 70.1±2.6 %of the baseline
at 60 minutes of reperfusion respectively (both P<0.01), decreased area
of no-reflow (MCE: from 78.5±4.5% to 24.5±2.7% and 24.3±3.6%, Path:
from 82.3±1.9% to 25.2±3.2% and 24.9±4.4% of ligation area respectively,
all P<0.01), reduced necrosis size from 98.5±1.3% to 88.9±3.6% and
89.1±3.1% of ligation area respectively (both P<0.05), decreased the
blood ET-1 level from 169±13 to 143±21 and 145±18 pg/ml respectively
(both P<0.01), and decreased ET-1 from 78.3±11.1 to 57.8±9.8 and
63.4±7.6 pg/100mg respectively in the reflow myocardium (both P<0.05),
but had no effect on ET-1 in the no-reflow myocardium (both P>0.05).
In conclusion, as endothelial protection agents, fosinopril and varsartan
can reduce myocardial no-reflow after AMI and reperfusion in mini-swine.
TCT-376
A 60 mg Loading Dose of Prasugrel (CS-747) is Associated with
More Rapid Onset and Greater Magnitude of Platelet Inhibition in
Comparison to a 300 mg Loading Dose of Clopidogrel
John T Brandt1, Christopher D Payne1, Govinda J Weerakkody1, David S
Small1, Hideo Naganuma2, Joseph A Jakubowski1, Nagy A Farid1, Stephen
D Wiviott3, Kenneth J Winters1
1
Eli Lilly and Company, Indianapolis, IN;2Sankyo Co., Ltd., Tokyo,
Japan3Brigham and Women’s Hospital, Boston, MA
Background: This study compared the rate of onset and magnitude of
inhibition of platelet aggregation (IPA) achieved after loading doses (LD) of
prasugrel, a novel thienopyridine P2Y12 receptor antagonist, and clopidogrel.
Methods: Healthy subjects (n = 68) were randomized to receive
either a prasugrel 60 mg LD or a clopidogrel 300 mg LD. After a
washout period, they received the other treatment in a crossover
fashion. Maximal platelet aggregation (MPA) and IPA to 5 or
20 µM ADP were measured by turbidometric aggregometry.
Results: Prasugrel produced faster onset and greater IPA than clopidogrel.
Significantly greater IPA with prasugrel was evident as early as 15 minutes
after the LD in response to 5 µM ADP and was observed at all the following
time points (Figure, p<0.01). Prasugrel achieved near-maximal IPA (74 ±
13%) at 1.5 hours after LD, while clopidogrel reached near-maximal IPA (32
± 25%) at 6 hours after LD (p<0.001). Compared to prasugrel, the standard
deviations were higher at each time point for clopidogrel (F-test, p<0.01) and
fewer
subjects
treated
with
prasugrel
had
levels
of
IPA ≤ 20% at 4 and 24 hours using 20 μM ADP.
Conclusion: A prasugrel 60 mg LD achieved faster, higher, and more
consistent IPA compared to a clopidogrel 300 mg LD.
Both fosinopril and valsartan are effective in preventing from
ventricular remodeling after acute myocardial infarction, though
the exact mechanisms have not been fully clarified. Myocardial noreflow is associated with progressive left ventricular remodeling.
We hypothesized that both fosinopril and valsartan may reduce
myocardial no-reflow after acute myocardial infarction and reperfusion.
Methods: Coronary ligation area and the area of no-reflow was determined
with both myocardial contrast echocardiography (MCE) in vivo and
pathological means (Path) in thirty-two mini-swines randomized into 4
study groups: 8 in control, 8 in fosinopril-pretreated (1mg/kg/d) for 3 days,
149H
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TCT-378
Facilitated Percutaneous Coronary Intervention for ST-Elevated
Myocardial Infarction in Patients Transferred from Distances Greater
Than 60 Miles
David M Larson1, Christopher R Henry2, Marc C Newell2, Barbara Tate
Unger2, Scott W Sharkey2, Steven Mulder3, Mohammed Hussain4, M
Nicholas Burke2, Anil K Poulose2, Timothy D Henry2
1
Ridgeview Medical Center, Waconia, MN;2Minneapolis Heart
Institute Foundation at Abbott Northwestern Hospital, Minneapolis,
MN;3Hutchinson Area Health Care, Hutchinson, MN;4Kanabec Hospital,
Mora, MN
TCT-377
Medium to High Loading Dose versus Standard Dose Clopidogrel
Therapy in Patients Undergoing Percutaneous Coronary Intervention
in Asian Population
P
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T
S
Background: It has been demonstrated that clopidogrel (Plavix®) doses
of 525-600mg are needed to produce a potent inhibition of platelet
aggregation induced by adenosine diphosphate (ADP) within 2 hours.
However, it is unclear that whether the platelet inhibition provided by
high loading dose before percutaneous coronary intervention (PCI)
with drug-eluting stent (DES) is clinically safe and effective in terms of
clinical outcomes, bleeding and vascular complications, especially for
the Asian population whose body weight is less than western countries.
Methods: A total 296 patients (pts, Male 156, mean age, 62.3 ± 9.5 years)
were randomly assigned to receive 300, 450 and 600 mg of clopidogrel before
undergoing PCI. Aspirin 100mg and 50 U/kg of unfractionated heparin
were administered as the routine antiplatelet and antithrombotic regimen.
Medium to high loading dose (450 and 600 mg, n=152) group (Group 1)
was compared with Standard dose (300mg, n=144) group (Group 2) in terms
of in-hospital complications, bleeding and vascular access complications.
Results: Baseline characteristics including body weight (Group 1, 66.7
kg, Group 2, 64.5 kg, p=NS) were similar in both groups. Although mean
ACT level was higher in Group 1 (276.3±51.8 vs. 224.3±82.1 in Group
2, P=0.03), the incidence of major bleeding was not different between
the two groups (3.7% vs. 11.1% in Group 2, P=0.83). Vascular access
complications including AV fistula, pseudoaneurysm were also similar
between the two groups. Although it was not statistically significant,
Group 1 showed numerically lower rate of ischemic chest pain (5.9%
vs. 25.5%, P=0.89) and ischemic EKG changes (2.0% vs. 15.7%,
P=0.45). Early clinical outcomes such as death, myocardial infarction,
target lesion and vessel revascularization and major adverse cardiac
events were similar between the two groups up to 1 month follow up.
Conclusion: Medium to high loading dose (450 mg and 600 mg)
clopidogrel administration in pts undergoing contemporary PCI using DES
in Asian population seems to be clinically safe and feasible compared with
the standard dose clopidogrel (300mg) without increasing overall bleeding
and vascular complications.
150H
Background: Primary PCI is superior for STEMI if performed in a
timely manner at experienced centers. For pts transferred from non
PCI hospitals the benefit of primary PCI over fibrinolysis may be lost.
Combined reduced dose fibrinolytic prior to transfer results in earlier
reperfusion and may provide outcomes similar to primary PCI centers.
Methods: Abbott Northwestern (ANW) Hospital is a tertiary cardiac center
in Minnesota with referral relationships with 35 community hospitals.
We compared clinical outcomes, door-balloon times and pre-procedural
TIMI flow in STEMI pts who were transferred for facilitated PCI from
distances of 60-200 miles to those who presented to ANW directly.
Results: From 7/03-5/05, 147 STEMI pts were transferred to ANW for
facilitated PCI (½ dose TNK). During the same period, 145 STEMI pts
presented to ANW directly. No pts were excluded including cardiogenic
shock (11%) and cardiac arrest (8%). Facilitated PCI pts had longer doorballoon times (117 vs 67 mins) but also greater infarct artery patency
pre-PCI (70% vs 31%, p=0.0002) than pts with direct PCI. There was no
significant difference in mortality.
Pre
Post Stroke at Reinfarction
TIMI 3/2
TIMI 3 30 days at 30 days
(%)
Facilitated 40/30
95%
0
0
ANW
15/16
94%
1.4%
2.8%
Target
vessel
revasc
0
2.1%
Mortality
Major
at 30
bleeding
days
4.0%
0
6.2%
0
Conclusion: Rapid transfer of STEMI pts from distances of 60-200 miles
for facilitated PCI using a protocol of reduced dose fibrinolytics is safe
with equivalent outcomes to those who present to a primary PCI center
directly. This “real-world” study confirms previous trials demonstrating
earlier reperfusion using facilitated PCI.
TCT-379
Effect of Intracoronary Anisodamine on No-Reflow Phenomenon after
PCI in Mini-Pig with AMI
Xianghua Fu, Xinshun Gu, Jun Liu, Yunfa Jiang, Guozhen Hao, Jiaan Sun,
Shiqiang Li
The 2nd Hospital of Hebei Medical University, Shijiazhuang, China
Background: Anisodamine is an inhibitor of M-cholinergic receptor
with strong antispastic effectiveness, which was refined from a traditional
Chinese herb Anisodus Tonguticus produced in ST. Tangula Mountain,
Tibet. Since 1970s, many basic and clinic studies proved that Anisodamine
has the effects of release microvessel spasm, improve and dredge the
microcirculation, inhibit platelete aggregation, decrease blood viscosity,
and increase the tolerance of myocardium to ischemia. Its effects may be
beneficial for the improvement of no-reflow phenomenon during PCI for
AMI, so we first evaluate the effect of intracoronary anisodamine to correct
the no-reflow phenomenon during AMI on no-reflow minipig model made
by superselective LAD with 4F catheter then injection of micro thrombus.
Method: Fourteen no-reflow minipig models were randomized to
intracoronary saline (4ml), diltiazem (1mg diluted to 4ml) and anisodamine
(2mg to 4 ml) groups. CAG was performed at 1, 3, 5, 10th minute after
intracoronary injection. Corrected TIMI frame count and coronary artery
diameter were obtained by QCA, meanwhile ECG and homodynamic
parameters (HR, LVEDP, intracoronary MAP,) were recorded.
Results: The corrected TIMI frame count in Anisodamine group was
significantly decreased by 13.2%, 25.3%, 35.6%, 33.6% at 1, 3, 5,
10 th minute compared with saline group, while decreased by 10.6%,
20.4%, 14.3%, 21.5% at 1, 3, 5, 10 th minute compared with diltiazem
group(, respectively). The medial LAD diameter in Anisodamine
group increased from 2.12±0.38mm to 2.60±0.43mm (P<0.05) while
to 2.51±0.42mm in diltiazem group as compared before(P<0.05).
HR and intracoronary MAP were increased and LVEDP reduced at
1, 3, 5, 10 th minute after administration of anisodamine, which had
significance compared with group NS (125±20 vs 140±25bpm,95±12 vs
126±13mmHg,P<0.05), accompanied with HR increasing (P<0.05). It was
very important that No serious side effect and toxic reaction were found.
Conclusions:Intracoronary anisodamine might reduce and correct the noreflow phenomenon after PCI-AMI with the dilation of coronary vessel
and homodynamic improvement, as well as no serious side effect and toxic
reaction.
TCT-380
The Antiproliferative Activity of Emodin is through ROS- and P53Dependent Pathway in Human Smooth Muscle Cells
Xiangfei Wang, Junbo Ge, Keqiang Wang, Yunzeng Zou
Shanghai Institute of Cardiovascular Diseases, Shanghai, China
Background: Emodin (1, 3, 8-Trihydroxy-6-methylanthraquinone), a
natural anthraquinoid compound, has the remarkably suppressing activity
on the various tumor cells proliferation. However, the mechanism of effect
of emodin on the smooth muscle cells has remained largely unknown.
Methods and Results: Human vascular smooth muscle cells (VSMCs)
were cultured in M199 medium supplemented with 15% fetal bovine
serum. Emodin inhibited VSMCs proliferation and induced apoptosis in
a dose- and time- dependent manner. Increased cellular reactive oxygen
species (ROS) was correlated with emodin concentration and the level
of ROS was very stable in a period of 72h. At the same time, cellular
antioxidant activity was insignificantly difference. NADPH oxidase
inhibitor diphenylene iodonium (DPI, 5 μM) can significantly inhibit ROS
generation (48.53±5.78 vs. 19.17±4.96, p<0.05) and the apoptotic response
of VSMCs (apoptotic cells: 14.55±2.29% vs. 8.77±0.83%, p<0.05; necrotic
cells: 1.18±0.14% vs. 1.25±0.28%, p>0.05) induced by 25 μg/ml emodin.
However, other free radical scavenging agents including cyclosporin A
(CsA), 1-aminobenzotriazole (ABT), α-naphthoflavone (α-NF) and Nacetyl-L-cysteine (NAC) showed no preventive effect on emodin-induced
ROS generation and apoptotic responses. On the other hand, emodin-induced
unscheduled DNA synthesis (UDS), the symbol of DNA damage, can not be
eliminated by DPI. Emodin up-regulated the mRNA and protein level of p53
in a dose-dependent manner. Cells growth was only delayed in 1.6-3.1 μg/
ml emodin group and senescent VSMCs significantly increased in 6.3-12.5
μg/ml emodin group. In addition, transmission electron microscope showed
that lumpy chromatin condensation and lysosomes increased. Laser confocal
microscope showed that the distribution of emodin was obviously selective:
most of emodin in the cytoplasm and a little of emodin in the nucleus.
Conclusions: These findings suggest that emodin has antiproliferative
effect on human VSMCs. Cytoplasmic emodin can induce apoptosis via
ROS originated from NADPH oxidase and intranucleus emodin causes
growth arrest, cell senescence, and apoptosis via DNA damage.
TCT-381
Inhibition of Platelet Aggregation to High Dose Clopidogrel
Quantified Using a Novel Platelet Aggregation Assay, is Unaffected by
Diabetic Status and Glycemic Control
Sandeep Nathan1,2, Arun Kumar1, Raed Al Dallow2, Amit Amin2, Russell F
Kelly2, Lloyd W Klein1, James E Calvin1, George L Bakris1
1
Rush University Medical Center, Chicago, IL;2John H Stroger Jr Hospital
of Cook County, Chicago, IL
BACKGROUND: Significant interindividual variability has been noted in
the inhibition of platelet aggregation (IPA) induced by clopidogrel, however it
remains unclear if diabetic platelet dysfunction (thrombocytopathy) impacts
IPA. This study evaluated antiplatelet response to high-dose clopidogrel
in diabetic (DM) vs non-diabetic patients with stable CAD, stratified
by glycemic control (HbA1C) and systemic inflammation (hs-CRP).
METHODS: IPA was quantified in 20 pts (10 DM, 10 non-DM) undergoing
elective cardiac catheterization using a point-of-care whole blood assay
(RUOP2Y12, Accumetrics, San Diego, CA) which quantifies IPA as a function
of light transmittance to 4 µmol iso-TRAP and 20 µmol ADP stimulation,
buffered to isolate ADP P2Y12 activity. IPA data analyzed included platelet
reactivity units (PRU-baseline, ΔPRU, ΔPRU%) and % P2Y12 inhibition (IPA
referenced to iso-TRAP). All pts received ASA 325mg qd for > 7 days. IPA
was quantified at baseline and 4-6 hours after 600 mg oral load of clopidogrel.
RESULTS: DM and non-DM pts were similar with respect to
baseline variables except homocysteine [9.6 vs 13.1 mg/dL, p=0.046],
fasting glucose [187.5 vs 96.2 mg/dL, p=0.0009] and HbA1C [9.8%
vs 6.0%, p=0.0064]. Baseline PRU [275.5 vs 275.7] was similar
in both groups (p=NS). Overall 15% of pts evidenced clopidogrel
nonresponse (<10% decrease in IPA - 2 DM, 1 non-DM, p=0.55). Δ
PRU was comparable between DM and non-DM pts [-102.3+79.5 vs 104.3+79.9, p=0.762] as was Δ PRU % [-37.1+33.0% vs -37.8+30.2%,
p=0.650]. IPA was not correlated to hs-CRP, HbA1C or fasting glucose.
CONCLUSIONS: Degree of IPA observed within 4-6 hours of clopidogrel
600 mg was similar in DM and non-DM pts and comparable to published
estimates using light transmittance aggregometry. Among DM pts, glycemic
state, glycemic control and in all pts, systemic inflammation did not impact
the magnitude of IPA. Clopidogrel non-response was seen in 15% of pts
studied, without any clear predictive clinical or metabolic correlates. To our
knowledge, this is the first study to evaluate differential IPA in DM vs nonDM pts stratified by glycemic control and systemic inflammation. Further
validation of these findings is currently underway.
TCT-382
Assessment of P2Y12 Blockade with a New Point-of-Care Test and
Conventional Optical Aggregometry before and after Clopidogrel
Loading
Nicolas von Beckerath1, Gisela Pogatsa-Murray1, Robert Hillman2, Albert
Schömig3, Adnan Kastrati3
1
1. Med. Klinik, Klinikum rechts der Isar, München, Germany2Accumetrics,
San Diego, CA;3Deutsches Herzzentrum München, München, Germany
Background: Despite its efficacy in the prevention of ischemic events,
the variable drug response to a fixed dose of clopidogrel is concerning.
Clopidogrel-resistance is believed to be associated with the occurrence
of ischemic events. Thus, a fast reliable and simple method to assess the
degree of pharmacologic P2Y12 blockade would be of great value to
assess the antiplatelet effect of clopidogrel and other P2Y12 antagonists.
The aim of this study was to compare platelet function testing with a new
point-of-care test (“VerifyNowTM P2Y12”, Accumetrics, San Diego, CA)
and optical aggregometry. Methods: Platelet function was evaluated with
the VerifyNowTM P2Y12 assay and conventional optical aggregometry
before and 4 hours after administration of a clopidogrel loading dose.
151H
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All patients included (n=30) participated in the ISAR-CHOICE trial,
a double blind randomized comparison of the antiplatelet effects of
three different loading doses of clopidogrel (300, 600 and 900 mg).
Results: The correlation between platelet response units (PRUs) obtained
with the VerifyNowTM P2Y12 assay and the results of conventional optical
aggregometry is demonstrated in the Figure. The best correlation was
observed with no or little platelet function inhibition and thus high PRU
and aggregometry values. Conclusion: The results obtained with this pointof-care test correlate well with conventional optical aggregometry; thus this
point-of-care test may be useful in the rapid assessment of the response to
clopidogrel.
TCT-383
Relative Inhibitory Effects of Unfractionated Heparin, Eptifibatide,
and Bivalirudin on Thrombin-Induced Activation of Platelets
Friederike K Keating, Prospero B Gogo, Deborah A Whitaker, Patricia Q
Baumann, Burton E Sobel, David J Schneider
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Background: To elucidate the relative impact of commonly used
antithrombotic agents on activation of platelets by thrombin, a powerful
agonist, we obtained blood from patients (n=7) with symptomatic
coronary artery disease at the time of cardiac catheterization.
Methods: Immediately before cardiac catheterization blood was taken
from an arterial sheath and spiked in vitro with therapeutic concentrations
of unfractionated heparin (UFH, 1.2 U/ml) alone and in combination with
eptifibatide (E, 1.7 μg/ml) or bivalirudin (8 μg/ml). An activated clotting time
(ACT) was determined. Subsequently, activation of platelets was induced with
thrombin (0, 5, 15, and 40 U/ml) and assessed with the use of flow cytometry.
Fibrin polymerization was prevented by the addition of the peptide GPRP
(Gly-Pro-Arg-Pro). Activation of glycoprotein IIb-IIIa and surface expression
of P-selectin were identified with antibodies (PAC-1 and anti-CD62).
Results: The ACT was 237±27 (SD) sec with UFH alone, 387±16 sec
with UFH+E, and 336±23 sec with bivalirudin. Binding of PAC-1 was
suppressed with either bivalirudin or UFH+E (15 U/ml thrombin-induced
PAC-1 binding UFH alone=32±31% of platelets, UFH+E=9±13% of
platelets, bivalirudin=2±2% of platelets, p=0.04 for bivalirudin compared
with UFH alone). Bivalirudin prevented thrombin-induced surface
expression of P-selectin more effectively than UFH alone or UFH+E
(15 U/ml thrombin-induced anti-CD62 binding UFH alone=48±33% of
platelets, UFH+E=29±25% of platelets, bivalirudin=2±2% of platelets,
p<0.05 for bivalirudin compared with either UFH alone or UFH+E).
Conclusion: Therapeutic concentrations of bivalirudin inhibit thrombininduced activation of platelets to a greater extent than therapeutic
concentrations of UFH alone and inhibit thrombin induced P-selectin
expression to a greater extent than UFH+E.
152H
TCT-384
Statin Therapy Inhibits Neointimal Hyperplasia after Coronary
Stenting in Patients with Elevated Preprocedural High-Sensitivity
C-Reactive Protein Levels
Young Joon Hong, Myung Ho Jeong, Weon Kim, Ju Han Kim, Jeong Gwan
Cho, Jong Chun Park, Jung Chaee Kang
Background: Statins are effective lipid lowering and anti-inflammatory
agents. Several clinical studies have shown that pre-procedural CRP is a strong
prognostic factor of mortality and subsequent cardiac events including clinical
restenosis. However, few studies performed to date have used intravascular
ultrasound (IVUS) to examine the effects of statin therapy on the inhibition
of neointimal hyperplasia (NIH) in patients with high inflammatory state.
Methods: This study included 80 patients with elevated high sensitivity Creactive protein (hs-CRP > 0.5 mg/dL) who underwent stent implantation.
Patients were divided into two groups; statin group, n=44, 54.7±10.7 years,
male 80%, vs. non-statin group, n=36, 57.5±11.2 years, male 78%. 6-month
follow-up quantitative coronary angiography and IVUS data were analyzed.
Results: The baseline hs-CRP level was 1.29±0.38 mg/dL in the statin
group and 1.30±0.31 mg/dL in the non-statin group. At six-month followup, the restenosis rate was 22% in the statin group and 30% in non-statin
group and repeat revascularization was performed in 20% in statin group
and 27% in non-statin group (p=0.032, 0.038, respectively). At 6-month
follow-up, the remodeling index was significantly higher in the statin group
than that in the non-statin group (1.05±0.35 vs. 0.93±0.27, p=0.025) and
the NIH cross-scetional area (CSA) at the minimal lumen CSA was smaller
in the statin group (2.1±1.4mm2 vs. 2.8±1.8mm2, p=0.032) and the lumen
CSA was larger in the statin group (5.6±1.6mm2 vs. 4.7±1.5mm2, p=0.034).
Conclusion: Statin therapy may induce positive remodeling of vascular
segments containing atherosclerotic plaques and reduce NIH and restenosis
rate after stent implantation in patients with elevated preprocedural hs-CRP
levels.
TCT-385
The Influence of Diabetes on Platelet Reactivity and Inflammation in
Patients Undergoing Percutaneous Coronary Intervention with Either
Eptifibatide Plus Unfractionated Heparin or Bivalirudin
Friederike K Keating, Prospero B Gogo, Deborah A Whitaker, Harold L
Dauerman, Burton E Sobel, David J Schneider
Background: Patients with diabetes mellitus (DM) have greater platelet
reactivity and a higher rate of adverse events after coronary intervention (PCI).
Methods: We compared platelet function and inflammation in patients
with (n=29) and without (n=37) DM undergoing PCI. Patients were
assigned randomly to treatment with either unfractionated heparin plus
eptifibatide (UFH+E, n=30) or bivalirudin (n=36). Platelet reactivity
was assayed by flow cytometry 8±3 minutes after initiation of treatment
and 1 day later. Leukocyte myeloperoxidase (MPO), C-reactive
protein (CRP) and interleukin-6 (IL-6) were determined by ELISA.
Results: One µM ADP-induced binding of fibrinogen to platelets was
less in those treated with UFH+E compared with bivalirudin (Table 1).
By contrast, 0.2 µM ADP-induced surface expression of P-selectin and
MPO were greater in those treated with UFH+E. Differences in P-selectin
expression were more pronounced in those without DM (2.3-fold increase
compared with 1.5-fold). CRP and IL6 increased 1 day after PCI to a similar
extent with either treatment in those with and without DM.
Platelet function and leukocyte activation 8 +/- 3 minutes after treatment with UFH+E or
bivalirudin
All
no DM
DM
Patients
(n=37)
(n=29)
(n=66)
UFH+E Bivalirudin
p UFH+E Bivalirudin p UFH+E Bivalirudin p
GPIIb-IIIa
activation
(%platelets
22
38
23
37
20
40
<0.01 (±22)
0.06 (±17)
0.01
binding
(±20)
(±22)
(±21)
(±24)
fibrinogen,
means±SD)
P-selectin
expression
6.2
3.3
6.1
2.6
6.3
4.1
<0.04 (±7.7)
0.3
(%platelets,
(±7.2)
(±3.7)
(±1.8) 0.05 (±7.0)
(±5.2)
mean±SD)
MPO
concentration
5.2
3.7
5.5
3.6
4.7
3.6
0.01 (±3.2)
0.2
(ng/ml,
(±2.9)
(±1.7)
(±1.7) 0.03 (±2.5)
(±1.7)
means±SD)
Conclusions: During PCI, GPIIb-IIIa activation is suppressed to a greater
extent with UFH+E, whereas platelet P-selectin expression and leukocyte
activation are less with bivalirudin. The presence of DM does not appear
to influence the suppression of agonist-induced GPIIb-IIIa activation
or leukocyte activation but does appear to influence platelet P-selectin
expression.
TCT-386
High Dose, Single-Bolus Eptifibatide is Effective in Preventing Non-Q
Wave Myocardial Infarction with Minimal Bleeding Complications in
Elective Coronary Stenting
Tim A. Fischell, Tamer A. Attia, Santosh G. Rane, Waddah Salman
Borgess Heart Institute, Kalamazoo, MI
Introduction: Adjunctive pharmacotherapy with eptifibatide, a
glycoprotein (GP) IIb/IIIa inhibitor, as an intravenous bolus followed
by an infusion has been shown to improve outcomes in elective
percutaneous coronary interventions (PCI). However, bleeding
complications, and costs have limited the routine adoption of this regimen.
Purpose: The goal of this study was to examine the safety, efficacy
and cost-effectiveness of high- dose, single-bolus eptifibatide, without
post-intervention infusion, in patients undergoing elective PCI.
Methods: We retrospectively evaluated 302 patients, with stable and
unstable angina, who were treated with a high dose, single vial (10 ml;
2mg/ml) bolus of eptifibitide (20 mg) just prior to the start of the PCI.
Unfractionated heparin (average dose of 73 units/kg), was given in
96% of patients. All patients received clopidogrel or ticlopidine, plus
ASA for a minimum of 30 days after PCI. Exclusion criteria included:
recent Q-wave or non-Q-wave MI (within 48 hours); stenting of bypass
graft(s); rotational atherectomy; and/or brachytherapy. Adverse clinical
events were defined as 30-day incidence of; death from any cause, Qwave or non-Q-wave MI, repeat target vessel revascularization; major
bleeding complications and/or bailout GP IIb/IIIa inhibitor therapy.
Results: Relevant demographic and procedural characteristics, included;
mean age - 65± 11.2; male -193/302 (64%); number of vessels treated per
patient - 1.34 ±0.55; and number of stents deployed per patient- 1.78± 0.95.
Non-Q-wave MI (CPK and or CPK MB > 3 x upper limit normal) occurred
in 3/302 patients (0.98)%. Major bleeding complications were seen in
1/302 patients (0.33%). No patient received additional bailout GP IIb/IIIa
inhibitor therapy. The average eptifibatide cost (to hospital) was $74/patient.
Conclusions: 1) Intravenous eptifibitide, administered as a high-dose single
bolus, is a safe and highly cost-effective alternative to the conventional
regimen of weight adjusted double bolus with prolonged infusion in patients
undergoing elective PCI. 2) Our findings suggest a need for a randomized,
controlled, clinical trial to confirm the results of this large, real-world
registry.
TCT-387
Lower Body Mass Index is a Risk Factor for Hemorrahagic
Complications fFollowing Percutaneous Coronary Interventions:
Analysis from the REPLACE-2 Trial
Eugenia Nikolsky1, Michael A Lincoff2, Roxana Mehran1, John A Bittl3,
Robert A Harrington4, Hitinder Gurm2, Lenuta Micsa5, Lenuta Micsa5,
Vijaya Kesanakurthy6, Yingbo Na6, Tayo Addo1, Susheel Kodali1, Dennis
John Mercado6, Gabriela Turcanu6, Gregg W Stone1
1
Columbia University Medical Center, New York, NY;2Cleveland Clinic
Foundation, Cleveland, OH;3Ocala Heart Institute, Munroe Regional
Medical Center, FL;4Duke Clinical Research Institute, Durham,
NC;5Cardivascular Research Foundation, New York, NY;6Cardiovascular
Background. Relationship between body mass index (BMI) and complications
following PCI with different adjunctive antithrombotic regimens is
unknown. We evaluated outcomes of pts undergoing PCI as a function of
BMI and antithrombotic strategy in the large contemporary randomized trial.
Methods. In REPLACE-2 trial, among 6,010 pts randomized to
unfractionated heparin+planned GP IIb/IIIa inhibition (H+IIb/IIIa)
vs. bivalirudin (Biv) with provisional GP IIb/IIIa inhibition, 1,195 pts
(19.9%) were normal-weight (BMI<25 kg/m2), 2,371 (39.5%) were
overweight (>25 to <30 kg/m2), and 2,434 (40.5%) were obese (>30 kg/m2).
Results. In the entire cohort, normal-weight compared to overweight and obese
pts had higher rates of major bleeding (4.7%, 2.9% and 2.9%, respectively,
p=0.01). Treatment with Biv. was associated with reduction in major bleeding
by 28%, 51% and 46%, reaching significance only in overweight and obese
(Figure). Minor bleeding was markedly increased with H+IIb/IIIa regimen
at all BMIs (24.8% vs. 14.0%; 23.2% vs. 12.9%; and 28.1% vs. 13.6%;
all p<0.0001). Thirty-day MACE (death, MI, urgent revascularization)
were similar with 2 antithrombotic regimens across each of the BMI strata.
Conclusions. Lower BMI is associated with increased risk of PCI-related
bleeding. Major hemorrhagic events are decreased when PCI in overweight
and obese pts is performed with Biv rather than H+IIb/IIIa. Pts of all BMIs
benefit by a marked reduction in minor bleeding with similar rates of
ischemic complications.
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153H
TCT-388
Prasugrel (CS-747) Achieves Significantly Higher Inhibition of
Platelet Aggregation and a Lower Rate of Nonresponders Compared
with Clopidogrel in Aspirin-Treated Patients with Atherosclerotic
Vascular Disease
Kenneth J Winters1, Tomas Jernberg2, Philip T Leese3, Lars-Goran
Nilsson4, Christopher D Payne5, Christelle Darstein1, John T Brandt1,
Joseph A Jakubowski1, Agneta Siegbahn2, Lars Wallentin2
1
Eli Lilly and Company, Indianapolis, IN;2University Hospital, Uppsala,
Sweden3Quintiles Phase I Services, Lenexa, KS;4Quintiles AB Phase I
Services, Uppsala, Sweden5Eli Lilly and Company, Windlesham, United
Kingdom
Background: Lower levels of inhibition of platelet aggregation
(IPA) with clopidogrel (Clop) have been reported to be
associated with increased thrombotic events. This study analyzed
IPA and nonresponder rates with prasugrel (Pras), a novel
P2Y12 antagonist, vs. Clop in aspirin (ASA)-treated patients.
Methods: After 7 days on ASA 325 mg, 101 patients were randomized
to 1 of 5 dosing regimens, a loading dose (LD) on day 1 and a daily
maintenance dose (MD) on days 2-28: Pras - 40 mg LD/5 mg MD, 40
mg LD/7.5 mg MD, 60 mg LD/10 mg MD, or 60 mg LD/15 mg MD
or Clop - 300 mg LD/75 mg MD. IPA to 20 μM ADP was measured by
turbidometric aggregometry. Nonresponders were defined as those not
achieving ≥20% IPA at 4 hours after LD and at pre-dose during MD.
Results: At 4 hours after LD, IPA with Pras 40 mg (60.6%) and 60 mg
(68.4%) was higher than with Clop 300 mg (30.0%, p<0.0001). At day 28,
higher pre-dose IPA was also observed with Pras 10 mg (57.5%) and 15 mg
(65.8%) vs. Clop 75 mg (31.2%) (p<0.0001). Nonresponder rates with Clop
LD (52%) and Clop MD (45%) were markedly greater than either Pras LD
or Pras 10 and 15 mg MD (figure).
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Conclusions: In ASA-treated patients, Pras 40 or 60 mg LD and 10 or 15
mg MD achieve higher IPA and a lower rate of nonresponders compared to
standard Clop LD and MD.
TCT-389
Intra-Renal Infusion of BNP has Greater Renal Enhancing Actions
Compared to Systemic infusion in a Canine Model of Overt CHF
Horng H Chen, John A Schirger, Alessandro Cataliotti, Fernando L
Martin, John C Burnett, Jr.
Mayo Clinic College of Medicine, Rochester, MN
Background: BNP is a cardiac peptide with vasodilating, natriuretic and
renin inhibiting properties. There is development of renal resistance to BNP
in overt congestive heart failure (CHF). One strategy to overcome this renal
resistance is to increase the dose of BNP administered, however systemic
adverse effects such as hypotension is a limiting factor. The objective of the
154H
current study is to test the hypothesis that intra-renal (IR) delivery of BNP
will overcome the renal resistance without the systemic adverse effects of
hypotension in a canine model of overt CHF with cardiorenal syndrome.
Methods: We defined the cardiorenal and humoral effects of intravenous
(IV) (n=6) or IR (n=6) administration of low (0.01μg/kg/min) and
high (0.05μg/kg/min) doses of canine BNP in two separate groups
of dogs with pacing induced overt CHF (240 bpm for 10 days). We
used a commercially available small (3.1 Fr) bifurcated renal catheter
(Flowmedica) for direct infusion into the renal arteries. * P<0.05
Results: IR BNP resulted in a greater natriuresis (103±6 vs 63±32 μEq/
min*), diuresis (1.7±0.6 vs 0.6± 0.2 ml/min*) and increase in glomerular
filtration rate (GFR) (128±72 vs 47±26 % change*) as compared to IV BNP.
IR BNP suppressed plasma renin activity and angiotensin II to a greater
extend than IV BNP. IR BNP also resulted in increased delivery of BNP
to the kidney as evident by increased urinary BNP excretion (from 24±10
to 70±10 pg/min*) associated with a decrease in distal reabsorption of
sodium,which was not observed with IV BNP (16±7 to 23±4 pg/min). Most
importantly, at both doses, IR BNP did not result in a significant decrease in
mean artery blood pressure (MAP)(from 98±2 to 99±1 and to 98±1 mmHg)
that was observed with IV BNP (from 100±3 to 91±5 and to 87±4 mmHg*).
Both IR BNP and IV BNP decreased pulmonary capillary wedge pressure.
Conclusion: In experimental CHF, IR BNP has greater renal enhancing
effects as compared to IV BNP that was associated with greater suppression
of renin and angiotensin II and no significant change in MAP. Therefore IR
BNP is a novel strategy which may overcome the renal resistance to BNP in
overt CHF by increasing local delivery of BNP to the kidneys without the
systemic side effects of hypotension.
TCT-390
Effects of Platelet Glycoprotein IIb/IIIa Inhibition with Abciximab
on Thrombin Generation (PF1+2) during Elective Percutaneous
Coronary Intervention. The ENFORCED Study Group
Rajaram Anantharaman1,2, Srinivasan Manivannan1, Somnath Kumar1,
Paul Kelsey1, Munir Pirmohammed2, Anoop Chauhan1, David H Roberts1
1
Blackpool Fylde & Wyre Healthcare NHS Trust, Blackpool, UK,
Blackpool, United Kingdom2University of Liverpool, Liverpool, United
Kingdom
Background: Abciximab (c7E3Fab, Reopro) has been shown to reduce
thrombin generation in vitro and in vivo in Acute Coronary Syndrome (ACS)
patients undergoing percutaneous coronary intervention (PCI). Whether the
same effect exists in elective PCI patients has not been studied before. We
studied the effect of either bolus or bolus plus 6 hour infusion of abciximab
on thrombin generation (Prothrombin Fragment 1+2) in elective PCI.
Method: In this prospective, randomized study 120 consecutive patients
were included in the thrombin generation (PF1+2) sub study and randomized
to Group1 (n=40): no abciximab, Group2 (n=40): bolus abciximab (0.25mg/
kg) and Group3 (n=40): bolus (0.25mg/kg) plus 6 hour infusion (0.125µg/
kg/m) of abciximab. All patients were pre-treated with Aspirin 300mg and
Clopidogrel 300mg 12 to 24 h pre-procedure. Heparin 2000 units was used
at the start of the procedure and and further doses were given during the
procedure to keep ACT >200. Blood samples were collected for PF1+2 at
baseline(time 0), 15minutes, 4h and 24h after study drug was given. Inhibition
of platelet aggregation (IPA) was measured using Ultegra RPFA-TRAP assay
(Accumetrics, USA) at 15 minutes and 4 hours post study drug administration
Results: There was no significant difference between the 3 groups in
baseline, angiographic characteristics, hematocrit and platelet count. The
results showed mean PF1+2(nmol/L)(22.30, 22.75 p=0.89, 20.49 p=0.52)in
groups 1,2 and 3 respectively. The PF1+2 results represents the mean value
obtained after combining all the time points observed using Area Under
Curve (AUC). The IPA% (15 minutes, 4h mean±standard deviation) were
90.9±9.8, 78.1±10.7 and 92.8±6.0, 84.1±5.3 in groups 2 and 3 respectively.
Conclusion: Addition of either bolus or bolus plus 6 hour infusion of
abciximab in patients pre-treated with Aspirin 300mg and Clopidogrel 300mg
12 to 24 hours pre-procedure and standard dose heparin during procedure
is not associated with significant decrease in thrombin generation(PF1+2
release) during moderately complex elective PCI. This support the lack of
benefit seen with abciximab in elective PCI patients pre-treated with high
dose clopidogrel in recent clinical studies.
TCT-391
A Prospective, Randomised, Controlled Trial to Study the Effect of
Intra Coronary Injection of Verapamil and Adenosine on Coronary
Blood Flow during Percutaneous Coronary Intervention following an
Acute Coronary Syndrome
Kunadian Vijayalakshmi, Babu Kunadian, Robert Wright, Andrew Sutton,
James Hall, Mark de Belder
The James Cook University Hospital, Middlesbrough, United Kingdom
Background: Various factors influence blood flow through the coronary
arteries. Although the administration of intra coronary drugs such as verapamil
and adenosine can increase coronary blood flow through the coronary
arteries, there are no comparative studies to determine relative effect after
percutaneous coronary intervention following an acute coronary syndrome.
Aims: We studied the impact of the use of these medications into the coronary
arteries on TIMI frame count and myocardial blush grades after percutaneous
coronary intervention (PCI) following an acute coronary syndrome.
Methods: A prospective, randomised, controlled study of the intracoronary
administration of normal saline vs. verapamil vs. adenosine in patients
undergoing PCI in the setting of an acute coronary syndrome, even when flow
is visually established to be normal or near normal. Following completion of
the PCI procedure, patients were randomised to receive verapamil (n=49),
adenosine (n=51) or normal saline (n=50). Quantitative angiography, TIMI
flow grade (TFG), TIMI frame count (TFC) and myocardial blush grades
(MBG) were assessed pre PCI, post PCI and after the administration of
the study medications. Wall motion index was measured at days 1 and 30.
Results: A total of 9 patients in the verapamil group developed transient
heart block, not seen with adenosine (p=<0.001). Compared to saline, there
was a significant improvement in the coronary flow measured by TFC and
wall motion index with both the verapamil (p=0.02, 0.02 respectively) and
the adenosine groups (p=0.002, 0.04 respectively). There was no significant
difference in the improvement in TFC and wall motion between the verapamil
and the adenosine groups (p=0.2, 0.6 respectively). The myocardial
blush grade was not affected by the administration of these medications.
Conclusion: Administration of verapamil or adenosine significantly
improves coronary flow and wall motion index after PCI in the setting of
an acute coronary syndrome. There was no significant difference on flow
and wall motion index between verapamil and adenosine but verapamil was
associated with the development of transient heart block.
TCT-392
Phosphodiesterase-5 Inhibitors in Eisenmenger Syndrome: A New
Therapeutic Option
Saibal Mukhopadhyay, Manish Sharma, Jamal Yusuf, Ramakrishnan S,
Mohit D Gupta, Vijay Trehan, Sanjay Tyagi
septal defect) (age: range 18-42 years, mean 25.4 ± 7.7 years; weight: 4265 Kg, mean 46.1 ± 7.9 Kg) on optimal medical therapy underwent cardiac
catheterization after 6 minute walk test (6MWT).After baseline study, all
patients were given Tadalafil (40 mg) orally and restudied after 90 minutes.
Patients with >20% fall in PVR were defined as responders. All including
non-responders (NR)were put on 40mg/day tadalafil under supervision in
hospital with monthly follow up and repeat catheterization at 12 weeks.
Result: Of 14 patients,11 were responders. There was significant decrease
in PVR (WU) (22.8 ± 6.1 to 17.6 ± 6.4, p= 0.004), mean pulmonary artery
pressure (mm Hg) (84.6 ± 12.8 to 79.4 ± 11.1, p = 0.02), right to left shunt
(Lt/min) (2.1 ± 1.1 to 1.3 ± 0.5, p = 0.004) and improvement in systemic
oxygen saturation (%) (85.1 ± 5.3 to 88.9 ± 3.3 p=0.002). There was no
change in SVR (systemic vascular resistance) (WU) (22.4 ± 7.3 to 23.9
± 7.1, p=0.21). None of the patients showed worsening of SaO2. Seven
patients have completed 12 weeks follow-up study (including 2 NR).
All 5 responders have shown improvement in functional class by ≥ 1,
significant increase in 6MWT without further fall in PVR than that achieved
acutely. Both NR have shown improvement in NYHA class, 6MWT and
no further increase in PVR. No adverse effects of the drug were seen.
Conclusion: Interim results suggest that PDEI-5 in ES is well tolerated,
improves symptoms, and produces either significant decrease or arrest in
progress of PVR. It may be considered a new therapeutic option in patients
of ES. Three months follow-up data of all patients will be presented in
meeting.
TCT-393
Statin Administration Prior to Percutaneous Coronary Interventions
Reduces Adverse Cardiovascular Events - A Meta-Analysis
Ramin Ebrahimi, Atman P Shah, Nitin Wadhani, Jahandar R. Saleh,
Edward Toggart
UCLA School of Medicine - West Los Angeles VA, Los Angeles, CA
Statins are known to possess anti-inflammatory and anti-thrombotic properties
beyond lipid lowering. Percutaneous coronary interventions (PCI) have been
associated with periprocedural myocardial infarctions (PMI) possibly due to
further disruption of the culprit plaque. This meta-analysis was performed to
determine whether statin use prior to PCI, regardless of baseline lipid levels, is
associated with lower major adverse cardiovascular events (MACE) or PMI.
Methods: A search of the BIOSIS+/RRM, MEDLINE, The Cochrane
Library Database, and proceedings from several professional
societies from January 1976 to March 2005 was performed to identify
prospective, peer-reviewed trials addressing the effect of pre-PCI
use of statins on PMI and MACE (death, nonfatal MI, emergent
revascularization {RV}, or target vessel RV) at 180 days. MI was defined
by elevation of troponin I, CK-MB, or myoglobin above normal limits.
Results: Six trials (n=2996) were included in this meta-analysis and were
analyzed for PMI. Four trials (n=7661) were analyzed for the effect of
pretreatment on MACE. Pre-PCI use of a statin was associated with a 73%
reduction of PMI (8.3% vs. 3.1%; RR 0.184, 95% CI 0.21-0.62, p<0.001) and a
34% reduction in MACE (11.3% vs. 7.5%; RR 0.51, 95% CI 0.11-0.67, p<0.03).
Conclusions: Statin use prior to PCI is associated with significant reduction
in PMI and MACE. Further randomized prospective trials are warranted
to validate these findings as well as to address possible mechanisms of
action.
Background:Pulmonary vascular pathology is similar in Eisenmenger
syndrome (ES) and primary pulmonary hypertension(PPH).
Phosphodiesterase-5 inhibitors (PDEI-5) have produced significant
reduction in pulmonary vascular resistance (PVR) in PPH.The present
study assessed acute hemodynamic and short-term (3 months) effects
of Tadalafil (PDEI-5) on symptoms/exercise capacity.in patients of ES.
Method: Fourteen symptomatic (NYHA class II and III) patients of ES (8
with ventricular septal defect, 4 with patent ductus arteriosus, 2 with atrial
155H
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TCT-394
Curcumin Attenuates TNF-α Induced Cytokine Expressions in
Human Endothelial Cells via Inhibition of NF-κB, p38, JNK, and
STAT-3
Yong Sook Kim, Youngkeun Ahn, Soo Yeon Joo, Moon Hwa Hong, Myung
Ho Jeong, Jung Chaee Kang
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Background: Curcumin, a yellow pigment of tumeric in curry with antiinflammatory and anti-oxidation properties, is reported to interfere with NFκB. NF-κB is a well known transcription factor responsible for inflammatory
and extracellular stress responses. This study was designed to investigate the
underlying pathway of the action of curcumin on endothelial inflammation.
Methods: Human umbilical vein endothelial cell (HUVEC) was stimulated
with TNF-α (10 ng/ml) in the presence or absence of curcumin (10
μM). Intracellular level of reactive oxygen species (ROS), monocyte
adhesion, activation of signal transducer and activator of transcription
(STAT)-3, and c-Jun N-terminal kinase (JNK) were examined. Cytokine
expressions were analyzed by RT-PCR, western blot, or ELISA. NF-κB
activation was determined by immunocytochemistry using p65 antibody.
Results: Intracellular ROS level, monocyte adhesion, and phosphorylation
of JNK and STAT-3 were increased in TNF-α stimulated HUVEC. TNFα also increased the expressions of vascular cell adhesion molecule
(VCAM)-1, intracellular cell adhesion molecule (ICAM)-1, monocyte
chemoattractant protein (MCP)-1, and interleukin (IL)-8 at both
transcription and translation level. Pretreatment of curcumin reduced
intracellular ROS (79.6 %, p=0.008) and monocyte adhesion (46.6 %,
p=0.001), as well as the phosphorylations of JNK and STAT-3. Curcumin
also reduced mRNA levels of VCAM-1, ICAM-1, and MCP-1, and protein
levels of VCAM-1 and ICAM-1 in a dose-dependent manner. Nuclear
translocation of p65 by TNF-α was inhibited in curcumin treated cell.
Conclusions: Curcumin inhibited the NF-κB pathway to control the
inflammatory response, which play a leading role in atherogenesis, through
JNK and STAT-3 in endothelial cell.
156H
Miscellaneous
TCT-395
Genomic Association of Patency of Saphenous Vein Grafts and the
Left Internal Thoracic Artery in Coronary Artery Bypass Surgery
Michael S Chen1, Gang Jia1, May M Luke2, Dongming M Liu2, Eric J
Topol1, Bruce W Lytle1, Stephen G Ellis1
1
Cleveland Clinic, Cleveland, OH;2Celera Diagnostics, Alameda, CA
Background: The left internal thoracic artery (LITA) and saphenous
vein grafts (SVGs) are common conduits used in coronary artery bypass
graft (CABG) surgery. We aimed to determine whether particular single
nucleotide polymorphisms (SNPs) are associated with graft patency
of both LITA-left anterior descending artery (LAD) grafts and SVGs.
Methods: At the time of coronary angiography (performed for clinical
indications), blood was obtained. Genotyping analysis was performed
of 168 SNPs from 150 candidate genes. Our study cohort comprised
282 patients with SVGs and 230 patients with LITA-LAD grafts. Graft
patency (stenosis < 70% without coronary intervention), at 5 and 10
years was assessed. Ordinal logistic regression analysis assessed the
association between graft patency and each SNP. Regression models for
LITA-LAD analysis were adjusted for ejection fraction and age at CABG,
and models for SVG analysis were adjusted for gender, age, LDL and
redo-CABG. Other baseline and clinical factors were not independently
associated with graft patency after adjustment for above variables.
Results: Median age was 63 years old and 37% were diabetics. Of 230
subjects with LITA-LAD grafts, 30 had a stenotic or occluded graft at 5 years
and 11 had a patent graft at 5 years that was stenotic or occluded at 10 years.
Of 282 subjects with SVGs, 116 had ≥ 1 occluded graft at 5 years and 77 had
all patent SVGs at 5 years but ≥ 1 occluded SVG at 10 years. Of 168 SNPs, 1
SNP on the VTN gene was associated with a significantly (p < 0.05) higher
rate of SVG and LITA-LAD graft failure, and 2 SNPs on 2 genes, IGF1R and
BIRC5, had a significantly (p < 0.05) higher rate of graft patency for both
LITA-LAD and SVGs. All 3 mutations were missense mutations. VTN affects
cell adhesion and spreading, while IGF1R and BIRC5 inhibit apoptosis.
Conclusions: We have identified 1 SNP associated with a higher rate
of both LITA-LAD and SVG graft failure and 2 SNPs associated with a
higher rate of both LITA-LAD and SVG patency. The functions of the
genes associated with these 3 SNPs suggests that cellular proliferation and
neointimal hyperplasia may be one common mechanism of LITA-LAD and
SVG graft failure.
TCT-396
Transfusion of Red Blood Cells Induces Increased Platelet Activation
and Reactivity in Patients with Coronary Artery Disease
Friederike K Keating, Prospero B Gogo, Burton E Sobel, David J
Schneider
Background:
Anemia
correlates
positively
with
adverse
outcomes in patients with coronary artery disease (CAD). We
hypothesized that one reason may be adverse effects of transfusion
including increased activation of platelets and platelet reactivity.
Methods: Platelet function was characterized with the use of flow cytometry
in 6 patients with CAD before and one day after a clinical decision to
transfuse packed red blood cells (PRBC). We report the results from this
small sample because of the magnitude of changes and the potential clinical
implications. The capacity of platelets to bind fibrinogen (reflecting activation
of glycoprotein [GP] IIb-IIIa) and platelet surface expression of P-selectin
were quantified in the presence and absence of 1 µM adenosine diphosphate
(ADP). Results were compared with the use of a one-tailed paired T test.
Results: The hemoglobin concentration before transfusion ranged
from 6.6 to 9.8 g/dl. Patients were transfused with 1 - 3 units of PRBC.
Activation of GP IIb-IIIa associated with the binding of fibrinogen in
the absence of agonist increased from 0.8±1.0% [SD] of platelets before
to 5.2±5.7% of platelets after transfusion (average increase of 4.8 ±2.3
[SEM], p<0.05). Agonist-induced binding of fibrinogen tended to be
greater after transfusion, increasing from 45±25% to 55±25% of platelets
(average increase of 7.2±4.8, p=0.07). Platelet activation reflected by
platelet surface expression of P-selectin tended to increase after transfusion,
from 1.2±1.4% to 2.4±2.0% of platelets (average increase of 1.3 ±1.0,
p=0.1). Platelet reactivity reflected by ADP-induced surface expression
of P-selectin increased after transfusion (from 18±12% of platelets before
to 26±13% of platelets after, average increase of 9.5 ±4.3, p<0.05).
Discussion: Transfusion of packed red blood cells in patients with CAD
activates platelets and increases their reactivity, potentially predisposing to
cardiac events.
TCT-397
The “Pocket Protector” Study: An Evaluation of Hematoma
Formation in the Prepectoral Pocket During Placement of a Pulse
Generator
Fawwah Shoukfeh1, Andrew Merliss2, David Slotwiner3
1
Covenant Medical Center, Lubbock, TX;2Bryan LJH Harding Memorial
Hospital, Lincoln, NE;3Long Island Jewish Medical Center, New Hyde
Park, NY
Prepectoral pocket complications are evidenced in hematoma formation,
infection, wound dehiscence, and/or pain. In the general population
hematomas are often considered minor. However, anti-coagulated patients
are at increased risk for development and severity of a hematoma.
A prospective, randomized, multi-center clinical trial evaluating the
treatment effect of the commercially available D-Stat® Flowable Hemostat
(Vascular Solutions, Inc., Minneapolis MN) as an adjunct to hemostasis in
a new indication to reduce hematoma incidence rates and assess adverse
events was conducted. Control patients were treated by current standard-ofcare to achieve hemostasis of the pocket. Investigation patients were treated
with the same standard-of-care and D-Stat. Assessments were performed at
baseline, through discharge, 15-days, and 8-weeks. The study, overseen by an
independent Data Safety Monitoring Board, maintained adjudication of adverse
events and hematomas by a separate qualified Clinical Events Committee.
This investigation evaluated 269 anti-coagulated subjects (136
investigation/133 control). The study population treatment groups
were homogenous and consisted of 68.4% (184/269) males and 31.6%
(85/269) females. Mean age in the Control and Investigation groups were
72.21 years and 73.27 years respectively. Pulse generator distribution
yielded the following pacemaker/ICD ratios: Control: Pacer 27.1%/
ICD 22.3%; Investigation: Pacer 27.5%/ICD 23.0%. The primary
effectiveness endpoint, designed to show superiority, was demonstrated
in a statistically significant (p=0.02) reduced rate of clinically relevant
hematomas experienced by the Investigation Group (11.76%; 16/136)
compared to the Control Group (22.56%; 30/133). Similar rates (p0.0366) for major procedure/device related events were observed between
treatment groups (Control: 6.8%, 9/133; Investigation: 10.3%, 14/136).
The 48% reduction in hematoma formation observed in the Investigation
Group compared to the Control Group, and the low overall major event
rates, demonstrate this adjunct device provides a safe and effective means
to impact anti-coagulated patient outcomes for this procedure.
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TCT-398
IVS Evaluation By Interventional Cardiologists
A Novel Rabbit Model of Accelerated Carotid Atherosclerosis Induced
by Hyperhomocysteinemia and Hypercholesterolemia
Sasidhar Guthikonda1, Daryl G Schulz2, Tetsu Satow3, Albert E Raizner2,
Greg L Kaluza2
1
Baylor College of Medicine, Houston, TX;2The Methodist Hospital,
Houston, TX;3National Cardiovascular Center, Osaka, Japan
Introduction: Current animal models of atherosclerosis have limited utility
in testing diagnostics and therapeutics, because lesions are not prominent
and complex. We investigated whether hyperhomocysteinemia (HH), in the
presence of hypercholesterolemia (HC) and endothelial denudation (ED),
reproducibly enhances atherosclerotic plaques in rabbit carotid arteries.
Methods: Diet supplemented with 1% methionine and deficient in
vitamins folate, B12 and B6 was used to induce HH, and a 1% cholesterol
diet for HC. Nineteen New Zealand white rabbits were randomized into
3 diet arms - 7 rabbits fed HH/HC diet; 6 rabbits fed HC diet; and 6
rabbits fed regular chow. All rabbits underwent balloon ED of one carotid
artery 1 week after diet initiation, and sacrificed after 7 more weeks. Ten
sequential sections were taken from each carotid artery for histology.
Results: Rabbits fed HH/HC diet developed more severe atherosclerosis
with mean luminal stenosis of 65 ± 2% compared with 36 ± 4% in HC fed
rabbits, and 2 ± 1% in regular diet rabbits (p<0.0001). Each sequential section
of the carotid artery also showed more consistent and significant plaque
development with HH/HC compared with HC and regular diet (Figure).
Conclusions:
HH
greatly
enhances
atherosclerotic
plaque
development over traditional HC, and may be useful as a
consistent and reproducible model of accelerated atherosclerosis.
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TCT-399
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Interventional Vascular Simulation is Mostly Beneficial for Training
of Fellows and Teaching the Use of New Devices and Procedures
Giora Weisz1,2, William Gray1,2, Lisa Hathaway2, Patricia Knipper2, Chad
Bertling2, Michelle Gong2, Yingbo Na2, Gregg Stone1,2, Martin Leon1,2
1
Center for Interventional Vascular Therapy, New York,
NY;2Cardiovascular Research Foundation, New York, NY
Introduction: Interventional Vascular Simulation (IVS) is an emerging
technology in medical education, but its full role has not been
established yet. We report the evaluation of IVS in various training
categories done by a large group of interventional cardiologists.
Methods: During TCT 2004, attendees could participate in hands-on
introductory sessions on 23 simulators made by 6 different manufacturers
(CATHI, Immersion Medical, Medical Simulation Corporation, Mentice,
Simbionix, Xitact) that simulated coronary, carotid, and renal interventions.
At the end of the session, participants evaluated the simulators
and educational sessions, and graded IVS as a training instrument.
Results: A total of 379 interventional cardiologists filled the
evaluation form, of whom 75% were attending physicians, with
mean experience of 8 years of interventional practice, and mean of
200 interventions per year. The Table summarizes the evaluation of
IVS. Values are given on a scale of 1-5 (5=best, 1=worst). A total of
92% of the fellows and 95% of the attending physicians believed that
simulator training should be implemented prior to training on patients.
Conclusions: As evaluated by large cohort of interventional cardiologists,
IVS may provide the largest benefit for fellows in training and for guiding
the use of new devices and procedures. The current technology status and
resemblance of IVS to actual cases were rated as fair. Further studies are
needed to validate the benefit of IVS for training and credentialing.
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TCT simulation session rating
Resemblance of simulation to actual cases
Current technology status
Benefit for fellows in cardiology
Benefit for fellows in interventional cardiology
Benefit to experienced interventionalists
Benefit for training for new device/procedure
Benefit to patients
Objectivity in credentialing process
Grading
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TCT-400
Ischemia-Modified Albumin is a Highly Sensitive Serum Marker of
Transient Myocardial Ischemia Induced by Coronary Vasospasm in
Variant Angina Patients
Dae Kyoung Cho1, Je Sang Kim1, Wang-Soo Lee1, Jae Hyuck Choi1,
Myoung Sun Choi1, Jin-Ho Choi1, Sang-Chol Lee1, Hyeon-Cheol Gwon1,
Sang Hoon Lee1, Jeong-Euy Park1, Chang-Seok Ki2
1
Department of Medicine, Sungkyunkwan University School of Medicine,
Division of Cardiology, Cardiac and Vascular Center, Samsung Medical
Center, Seoul, Republic of Korea2Department of Laboratory Medicine,
Sungkyunkwan University School of Medicine,Samsung Medical Center,
Seoul, Republic of Korea
Background:
Ischemia-modified
albumin
(IMA;
Ischemia
Technologies, Inc), a new marker of myocardial ischemia, is known
to elevate during ischemia induced by percutaneous coronary
intervention (PCI). However, it is not known whether IMA elevates
also during transient coronary vasospasm in variant angina.
Methods: We compared IMA levels in patients undergoing
intracoronary ergonovine provocation test, elective PCI, and diagnostic
coronary angiography with normal coronary angiogram. Blood
samples were taken from the arterial sheath before procedure, just
after balloon inflation or procedural completion, and 6 hours after
procedure. IMA was measured by the albumin cobalt binding test.
Results: In normal group, mean IMA levels did not change significantly
after coronary angiography (N=8, 106.1±11.2 vs 113.9±9.6U/ml,
p=NS). IMA levels elevated significantly after PCI (N=15, 119.9±21.3
vs 176.3±56.4U/ml, p=0.001). Positive provocation test was defined by
at least two of following components including typical ischemic chest
pain, ST segment elevation, or occluded coronary artery with TIMI grade
flow less than 2. In these patients, IMA levels elevated significantly from
baseline (N=9, 103.4±9.7 vs 170.1±70.3U/ml, p=0.008), which is coequal
with the IMA elevation after PCI. Furthermore, one patient who developed
catheter-induced spasm showed significant elevation of IMA (118.0 vs
153.0U/ml). Meanwhile, IMA levels did not elevate significantly in patients
with negative provocation test (N=7, 107.6±7.7 vs 114.0±5.7 U/ml, p=NS).
IMA levels returned to baseline at 6 hours after procedure in all patients.
IMA elevation higher than 9.0U/ml after provocation test could detect the
presence of coronary vasospasm, with an area under the ROC curve of 0.825
(95% CI, 0.62-1.03), a sensitivity of 88.9%, and a specificity of 57.1%.
Conclusion: The present study suggest that IMA is not only a sensitive
marker of myocardial ischemia induced by PCI but also can be used as a
reliable biological serum marker for transient myocardial ischemia induced
by coronary vasospasm in variant angina patients.
TCT-401
Pregnancy-Associated Plasma Protein A : An Indirect Marker of
Endothelial Dysfunction in Patients with Coronary Atherosclerosis
Flyer May
The 1st Affilated hospital of Sun Yat-Sun University, Guangzhou, China
Background: A growing body of evidence suggests that endothelial
dysfunction is associated with cardiovascular events. We investigated the
relationship between circulating pregnancy-associated plasma protein
A (PAPP-A), a novel marker of atherosclerotic plaque activity, and
vascular endothelial function in patients with coronary atherosclerosis.
Methods and Results: Sixty-four patients, 34 with stable angina pectoris
(SAP group) and 30 acute coronary syndrome (ACS group), were measured
endothelial function by detecting the brachial artery flow-mediated
vasodilation (FMD), the levels of high-sensitive C-reactive protein (hsCRP), endothelin (ET), and nitric oxide (NO). Serum PAPP-A levels were
determined by sandwich enzyme-linked immunosorbent assay as well.
There were significant differences between SAP group and ACS group in
terms of PAPP-A (6.39±4.68mIu/L vs. 19.30±12.76mIu/L, P=0.013), hsCRP (0.49±0.31mg/L vs. 3.57±2.15 mg/L, P=0.001), NO (57.46±4.07µmol/
L vs. 44.54±5.15µmol/L, P=0.046) and FMD (5.96±0.79% vs. 3.30±1.20%,
P=0.028). By stepwise multiple linear regression and correlation analysis,
we found that LnPAPP-A was related to Lnhs-CRP and FMD atα=0.10. The
constant of the model was 5.57, unstandardized partial coefficient for LnhsCRP was 0.333 (95% CI: 0.138~0.527, P=0.006), FMD -0.623 (95% CI:
-1.144~ -0.102, P=0.032), respectively. In patients with elevated PAPP-A
levels (>11.094mIu/L), hs-CRP was higher (4.18±5.31 mg/L vs. 0.56±1.32
mg/L, P<0.001)and FMD was lower (3.30±2.40% vs. 6.18±3.59%,
P=0.047) than those without elevated PAPP-A levels (≤11.094mIu/L).
Conclusions: PAPP-A is a possible marker for evaluating endothelial
dysfunction in patients with coronary atherosclerosis, which is comparable
to circulating CRP.
TCT-402
1,010 Percutaneous Coronary Interventions without On-Site Cardiac
Surgery: Acute and Long-Term Outcomes
Henry H Ting, Ganesh Raveendran, Charanjit S Rihal, Katherine L
Boutchee, Ryan J Lennon, Mandeep Singh, Douglas L Wood, David R
Holmes
Background: Performing elective and acute myocardial infarction
(AMI) percutaneous coronary interventions (PCI) without on-site cardiac
surgery remains controversial. We performed 1,010 elective and AMI PCI
without on-site cardiac surgery and tracked acute and long-term outcomes.
Methods: Immanuel St. Josephs Hospital (ISJ) is located 85 miles
from Mayo Clinic, the nearest center with on-site cardiac surgery. All
components of the Mayo Clinic PCI program were replicated at ISJ,
including a telemedicine system to enable real-time consultation with
interventional cardiology and cardiac surgical colleagues during procedures.
Low and intermediate risk patients, based on clinical and angiographic
variables, were eligible to undergo PCI without cardiac surgical back-up.
Results: From March 1999 to May 2005, 1010 patients underwent PCI
at ISJ. 27 patients declined authorization to medical records and were
excluded from this analysis. Among the remaining 983 PCI patients, 692
patients underwent elective PCI and 291 patients underwent AMI PCI.
For elective PCI, procedural success was achieved in 688 (99%, 95%CI
99% - 99.9%) patients with 2 (0.2%) in-hospital deaths and 4 (0.5%) inhospital myocardial infarctions. At mean follow-up of 19 months, 13
(1.9%) patients died from cardiac causes, 38 (5.4%) patients suffered
recurrent myocardial infarctions, and 48 (6.9%) patients required target
vessel revascularization. For AMI PCI, procedural success was achieved
in 274 (94%, 95%CI 91% - 97%) patients with 8 (2.7%) in-hospital deaths
and 15 (5.2%) in-hospital myocardial infarctions. At 30 days followup, 1 (0.3%) patients died, and 5 (1.7%) suffered recurrent myocardial
infarctions. No elective or AMI PCI patients required transfer to another
facility for emergent cardiac surgery from a procedure related complication.
Conclusions: Elective and AMI PCI can be performed with safety and
efficacy at a community hospital without cardiac surgical capability by
following rigorous standards for training of staff, maintenance of skills and
volumes, and case selection.
TCT-403
Congenital Coronary Artery Anomalies: A 10-Year Angiographic
Experience from 1994 to 2004 at St. Luke’s Medical Center
Cesar Antonio V Zulueta
St. Luke’s Medical Center, Quezon City, Metro Manila, Philippines
Background: Congenital anomalies of the coronary arteries
are not common, They comprise less than 0.46% of congenital
malformations of the heart. Clinically they are asymptomatic
or may result in increased cardiac morbidity and mortality.
Objective: To determine the incidence and describe anomalous
congenital
coronary
arteries
in
patients
who
underwent
coronary angiography at SLMC from 1994 up to 2004
Methodology: This is a descriptive study of all patients who
underwent coronary angiography from 1994 to 2004 at SLMC
suspected for coronary artery disease. The angiograms were
reviewed to look for anomalous congenital coronary artery.
Results: From 1994 to 2004, there were 9,766 patients who underwent
coronary angiography at SLMC. Sixty-eight patients (0.69%) were found to
have anomalous congenital coronary artery. There were 43 ( 63.2%) males
and 25 ( 36.7%) females with a mean age of 55 years . Chest pain was present
in 47 (69%) patients . Associated co-morbid conditions were hypertension
41 (60%), dyslipidemia 21 (35%) and diabetes in 24 (31%). Sixteen patients
(23%) had inducible ischemia on stress test. Anomalous origin of the right
coronary artery (RCA) from left coronary sinus was found in 24 patients
(35%), coronary fistula 24 (35%); anomalous origin of left coronary artery
from right coronary sinus 8 (12%); absent left main (LM) trunk 4 (6%) ;
congenitally absent RCA 2 (3%) and absent LCx 2 (3%) and 1 anomalous
origin of left coronary artery from main pulmonary artery, 1 anomalous
origin of OM from LAD, 1 anomalous origin of RCA from aorto-superior
portion of right sinus, and 1 anomalous origin of LM above aortic ridge.
Right coronary artery dominance was found in 58 (85%) patients and type
II LAD in 49 (72%). Significant coronary artery disease was present in 29
(43%) patients while 21 (31%) patients had normal coronary angiograms.
Conclusion: The incidence of congenital coronary artery anomaly is
< 1% (0.69%) in our population. The most common anomaly noted was
anomalous origin of right coronary artery from left coronary sinus and
coronary fistula.
TCT-404
Decellularized Cardiac Extracellular Matrix - A Scaffold for Cardiac
Tissue Engineering
Harald C Ott, Thomas S Matthiesen, Tanya M Feldberg, Saik-Kia Goh,
Doris A Taylor
Background: Cardiac tissue engineering requires two components,
cells and extracellular matrix (ECM). We hypothesize that
appropriate perfusion decellularisation of cadaveric rat heart will
effectively remove cellular components and generate a cardiac
ECM scaffold sufficient for engineering functional cardiac tissue.
Methods: Adult F344 rats were euthanized after systemic heparinisation.
Hearts were removed and mounted on a Langendorff perfusion
apparatus. Three different detergent based decellularisation protocols
were compared (SDS, Triton-X, PEG). Decellularisation was evaluated
by histology (H&E, DAPI, immunofluorescence, trypan blue perfusion).
Biocompatibility was assessed by coculture of ECM with multiple
myogenic (C2C12 and rat skeletal myoblasts) and endothelial cell types
(bovine pulmonary endothelial cells, HUVECs), by perfused organ
culture and by heterotopic transplantation of the decellularised ECM.
Results: By histology, PEG and Triton-X treated hearts showed intact
vascular and valvular structures as well as ECM components, but stained
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positive for cellular proteins including (troponinT, myosin heavy chain,
DAPI, and nucleus). SDS treated hearts, stained negative for these cellular
components, but positive for major ECM proteins (fibronectin, collagen
I, III, IV, laminin, elastin) and a functional vascular (positive staining by
trypan blue perfusion) and valvular matrix. Coronary flow dynamics were
altered 10-fold more by PEG and Triton-X than by SDS treatment (coronary
resistance after decellularisation relative to baseline; SDS: +50%, TritonX: +417%, PEG: +525%). In coculture experiments myogenic, as well as
endothelial cells engrafted within SDS decellularised ECM and aligned with
the matrix fiber orientation. Preliminary results of ECM in perfused organ
culture showed successful engraftment of HUVECs within the vascular
bed. Heterotopic transplantation experiments are currently ongoing.
Conclusion: SDS-based perfusion decellularisation of cadaveric hearts
preserves major ECM components including a functional vasculature and
valvular matrix and generates a biocompatible matrix scaffold for cardiac
tissue engineering.
TCT-405
Emergency Extracorporeal Membrane Oxygenation (ECMO)Supported Coronary Revascularization in Cardiac Arrest or
Cardiogenic Shock
Il Rhee, Hyeon-Cheol Gwon, Kee-Ik Sung, Jin Ho Choi, Sang Hoon Lee,
Kyung Pyo Hong, Joung Euy Park
Cardiac and Vascular Center, Sungkyunkwan University School of
Medicine, Samsung medical center, Seoul, Republic of Korea
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Background: Extracorporeal membrane oxygenation (ECMO) provides
passive support of gas exchange and perfusion, allowing the use of
other methods of care that are intended to result in organ recovery, and
saves lives of patients with severe cardiopulmonary failure in a wide
variety of clinical setting. We summarized close to 5 years of data on
single center’s total patient experience with ECMO in ischemic heart
disease for days or weeks to support life in moribund patients whose
condition had continued to deteriorate despite maximal inotropic support.
Methods: We retrospectively reviewed the 16 consecutive patients who
were received ECMO for resuscitation from 2000 to 2004. Biopump
(Medtronic, Inc, Minneapolis, MN) in 4 patients, Roller pump in 3 patients
and the self-priming, heparin-coated circuit of EBS (Terumo, Japan) was
used in remaining 9 patients. Cannulation was performed via femoral artery
and vein percutaneously, and long venous cannula of DLP (Medtronic inc.
Minneapolis, MN) or RMI (Edwards’s lifescience LLC, Irvine, CA) was used
with arterial cannula from 14Fr to 21Fr and venous cannula from 17Fr to 28Fr.
Results: Among the 16 consecutive patients who were severely compromised
and received ECMO for the purpose of resuscitation, comprised of 10 cardiac
arrests and 6 cardiogenic shocks in which by-pass surgery was performed in
9 patients and 7 ongoing PCIs, all of them revascularizations were performed
under the percutaneous cardiopulmonary support (1 for CABG, 6 for PCI).
The mean support time on the ECMO was 36 ± 50 hours. Of the 16 patients
implanted with ECMO, 10 patients (63%) have had the ECMO removed
successfully; overall, 6 of these patients (38%) have been discharged from
hospital in an average surviving time for 28±18 days after removing of ECMO
and surviving well with more than 33months of follow-up after discharge.
Conclusion: ECMO may be considered when the risk of mortality despite
other treatment is high and the prognosis for recovery to normal health is
minimal. The use of ECMO appears to provide hemodynamic restoration,
allowing salvage of patients in cardiac arrest or cardiogenic shock who
would otherwise not survive, and patients receiving ECMO had a relatively
long-term survival.
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TCT-406
Elective High-Risk Percutaneous Coronary Interventions Supported
by Extracorporeal Life Support
Jindra Vainer1, Vincent van Ommen1, Jos Maessen2, Gijs Geskes2,
Johannes Waltenberger1
1
Dept. of Cardiology, University Hospital, Maastricht, The
Netherlands2Dept. of Cardiothoracic Surgery, University Hospital,
Maastricht, The Netherlands
Background: Extracorporeal life support (ELS) represents modified
cardiopulmonary bypass enabling mechanical support to failing circulation
independent of cardiac output or rhythm. Aim of this study was to
evaluate the feasibility of high-risk percutaneous coronary intervention
(PCI) in hemodynamically unstable patients (pts) supported by ELS.
Methods: Over a 2 years period, 11 pts (8 male, 3 female, mean age 73±
4years) not eligible for coronary artery bypass grafting because of high
co-morbidity, underwent elective high-risk PCI supported by ELS. ELS
perfusion cannulas in the femoral artery and vein were surgically inserted
and removed. All lesions were technically challenging (i.e. sole circulation,
unprotected left main). Mean ejection fraction was 36±15 %; all pts had
NYHA class III-IV angina and a history of prior myocardial infarction. Three
pts had previous cerebrovascular accidents, 3 pts had diabetes mellitus,
reduced renal function was in 4 pts and 3 pts had bypass surgery in the past.
Results: On average 2.2 vessels were dilated and 2.1 stents were placed
per patient. Four pts received drug-eluting stents. Left main coronary artery
was dilated in 9 pts, left anterior descending artery in 7, left circumflex
artery in 7 and right coronary artery in 6 pts. A venous bypass graft was
treated in 2 pts. Procedural success was achieved in 10 out of the 11 pts.
Two pts suffered from electromechanical dissociation during PCI, but ELS
generated adequate support until mechanical cardiac activity was restored.
Mean fluoroscopy time was 26±14 minutes. Mean perfusion duration
was 93±40 minutes and all pts were weaned from the ELS directly in the
catheterisation laboratory. Blood transfusion was given in 8 pts. The pts
were ventilated for 5.5±3.4 hours. Apart from 2 groin bleedings no other
complications occurred and the pts left our hospital after 3.5±2.8 days. During
12.6±10 months follow-up 3 pts died, one of them of non-cardiac cause.
Conclusion: In highly selected pts not eligible for bypass surgery, ELS
supported PCI can be performed with promising short- and long-term
clinical outcome. This complex procedure can be used safely whenever all
other options for coronary revascularization are exhausted.
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B)
Chronic Total Occlusions
TCT-407
Role of CT-Coronary Angiography in the Assessment and
Percutaneous Revascularization of Chronic Coronary Total
Occlusions (CTO)
Kean H Soon1, Nicholas Cox1, Aaron Wong2, Debra Kerr1, Kevin W Bell1,
Yean L Lim1
1
Western Hospital, Melbourne, Australia2National Heart Centre,,
Singapore, Singapore
Introduction:The success rate of percutaneous coronary intervention (PCI)
of chronic total occlusions (CTO) is lower than the overall success rate of
standard PCI. Potential factors contributing to the failed PCI include length
of occlusion, absence of distal vessel beyond the occlusion, and vessel
calcification. Conventional selective coronary angiography (SCA) is limited
in the assessment of these factors. We aimed to assess the usefulness of
non-invasive CT coronary angiography (CT-CA) in the evaluation of CTO.
Method:Patients with CTO (defined as occlusion > 30 days) were scanned
with a 16 slice CT (GE LightSpeed-16) prior to PCI. CT-CA images
were assessed in multiplanar reconstruction view, maximal intensity
projection and cross-sectional view by a cardiologist blinded to the SCA.
Calcification in the occluded segment was scored as “heavy calcification”
if calcium occupying more than 50% of the CT cross-sectional area.
A separate cardiologist was asked to read SCA blinded to CT-CA.
Results: Preliminary results in 18 patients showed that CT-CA was able
to provide more information on those aforementioned factors than SCA;
CT-CA was able to assess occlusion and lesion lengths in all patients (only
12 patients with SCA); CT-CA was able to visualize the occluded tracks
and distal vessels in all patients (Only 6 occluded tracks and 12 distal
vessels were visualized on SCA). CT-CA could easily assess the degree
of calcification in 14 patients (only 4 patients on SCA). There were 12
cases of successful wiring of occluded segments (67%). Five out of 6
failed CTO wiring procedures were associated with heavy calcification
in the occluded segment as seen on CT-CA. The odd ratio (OR) of heavy
calcification associated with the failure of wiring CTO was 25.0 (95% CI:
1.8-346.7; p=0.026). In those cases without visible track or distal vessel on
SCA, CT-CA facilitated the PCI procedure by providing a roadmap, and
estimating the occlusion length useful for choosing the size of stents used.
Conclusions:CT-CA has potential as a useful investigation for assessing
and facilitating successful PCI of CTO. Heavy calcification visualized on
CT-CA is an important predictor of failed PCI of CTO.
TCT-408
Durable Clinical Benefit following Sirolimus-Eluting Stent (Cypher™)
Deployment on the Outcome of Patients with Chronic Total
Occlusions: Multicenter Registry 3-Year Results
1
late (≥3 years) durability of Cypher™ stent benefit is still unknown.
Methods: Complete clinical follow-up to 3 years is being analyzed for 106
patients, 122 lesions who received Cypher™ stents in patient with CTOs
(male 73.6%, mean age 70.6) (defined as TIMI flow grade 0 and the age of
occlusions was more than 3 months; LAD 50.8%, LCX 26.2%, RCA 23.0%).
Results: See table for clinical results.
MACE at 30 days (%)
Restenosis rate at 12 months (%)
106/122
100
0
2.88 ± 0.70
2.70 ± 0.72
2.73 ± 0.69
2.71 ± 0.70
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3.8
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Conclusions: Clinical benefit provided by the Cypher™ stent is durable
and late net benefit appears to be incremental.
TCT-409
Treating Chronic Total Occlusions Using “Subintimal Tracking and
Re-Entry”: The STAR Technique
Ioannis Iakovou, Iassen Michev, Mauro Carlino, Alaide Chieffo, Gloria
Melzi, John Cosgrave, Flavio Airoldi, Antonio Colombo
EMO, Centro Cuore Columbus, Milano, Italy
Introduction:
Successful
recanalization
of
coronary
total
occlusions (CTOs) remains an area were improvements are
needed. We sought to evaluate a novel method of recanalization
of CTOs in which prior conventional attempts had failed.
Methods: We propose an approach, similar to the one utilized
in the treatment of some peripheral artery occlusions, aimed to
create a subintimal dissection with distal re-entry. A 0.014 inch
hydrophilic wire with a J configuration is utilised for this purpose.
Results: We applied this technique to CTOs of native coronaries in 47
patients where standard approaches failed either in previous procedures
[in 30 (64 %) cases] or during the same procedure [in 17 (36%) cases].
The right coronary artery (RCA) was the index vessel in 76% of patients.
Recanalization of the vessel and of most of distal branches was achieved
in 32 (68%) patients, in 15 (32%) of them there was patency of only one
major distal branch. Drug-eluting stents (DES) were implanted in 56% of
patients. Six patients (12%) had vessel perforation without consequences
(only myocardial staining). Six patients (12%) had in-hospital nonQ wave myocardial infarction (CK-MB>3 times the upper limit of
normal). At a mean follow-up time of 9.8 ± 3.7 months (6-month clinical
follow-up was available in all patients), target lesion revascularization
(TLR) occurred in 9 (19%), target vessel revascularization (TVR) in
14 (30%) and major adverse cardiac events (TLR, TVR, myocardial
infarction and death) in 15 (32%) patients. Angiographic follow-up
was performed in 38 (81%) patients: 17 (45%) developed restenosis,
which was occlusive in 4 (10%) and focal in 13 (34%) of the cases.
Conclusions:. This technique appears a promising approach to recanalize
total occlusions which failed conventional techniques, particularly
occlusions localized on the RCA which has the most important side
branches located distally.
Background and Purpose: We already reported that utilizing
Sirolimus-eluting stent (SES) in patients with chronic total occlusions
(CTO) demonstrated on dramatic reduction of restenosis. However,
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TCT-410
Impact of Tornus TM Vascular Microcatheter in Chronic Total
Occlusion
Masahiko Ochiai, Kazuhiro Ashida, Hiroshi Araki, Nobuhiko Ogata,
Chiaki Obara
Showa University Northern Yokohama Hospital, Yokohama, Japan
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Objective: The Tornus (Asahi Intec, Aichi, Japan), a novel vascular
microcatheter made from eight woven fibers of stainless steel, can be
advanced through a chronic total occlusion (CTO) in the manner of a screw
turning counterclockwise to produce a small, smooth channel. We evaluated
usefulness of this catheter in percutaneous coronary intervention for CTO.
Methods: Between February 2004 and April 2005, 140 consecutive
patients (63±11 years, 119 males) with 145 CTO (including 48 reattempts;
Japan 71, Taiwan 22, Korea 21, Singapore 8, Hong Kong 7, Malaysia 7,
Indonesia 6, China 3) underwent Percutaneous Coronary Intervention
(PCI) by a single experienced operator. The duration of the CTO was
38±55 months, although it was unknown in 112(77%). Wiring was
performed according to the penetration strategy. The Tornus was used
either if penetration through the CTO could not be achieved with Confiaza
Rro(9gr) or Pro 12gr wires (Asahi Intec), or if passage of a 1.5-mm
balloon across the CTO was or appeared difficult after successful wiring.
Results: Wire passage was achieved in 126 CTO (87%), and successful
completion of the entire procedure in 125 (86%). The Tornus was used in 18
CTO involving difficult wire passage. Among the 18, 12 achieved successful
wire passage (67%). Specific indications related to wire penetration,
together with results, were as follows (success/total attempts): to encroach
the proximal part of CTO, enhancing back-up support for wire penetration
(3/5); to reach a focally patent segment of the true lumen, then replacing
Confiaza wires with other types (5/5); to debulk the arterial wall between the
side branch and the main vessel (2/6); or to re-enter the true lumen from the
false lumen at the proximal end of the distal collateral (2/2). After successful
wire passage, this device was used to facilitate balloon passage in 34 CTO.
The Tornus crossed 30 of these CTO (88%). After the passage of Tornus,
1.5mm balloon could be passed in 29 (97%). Among 4 CTO where Tornus
was not successful, final dilatation was achieved in 3 (1 with Rotational
atherectomy and 2 with “a child guiding catheter in a mother” system).
Conclusions: The Tornus device is effective in performing complex PCI
for CTO.
TCT-411
Pioneer Catheter: A New Novel Device for Re-Entry in Percutaneous
Revascularization of Long Chronic Total Occlusions
Brijeshwar S Maini, Steven Jones, David Chang, Christine Scheaffer, Sung
Jin Park, William Bachinsky
Pinnacle Health @ Harrisburg, Harrisburg, PA
Chronic total occlusions (CTOs) continue to pose significant challenges
to interventionists. In the case of CTOs, however, conventional
guidewires cannot be consistently and reliably placed across the
lesion, the technical success in crossing lesions in this manner has been
reported to be approximately 80%. The Pioneer Catheter (Medtronic)
facilitates the accurate targeting necessary to safely return a guidewire
to the true lumen of a target vessel from a subintimal position. The
catheter contains a precisely constrained needle oriented in a fixed
relationship with an integrated intravascular ultrasound guidance system,
and facilitates delivery of a 0.014-inch guidewire into the true lumen.
Methods:
Consecutive
CTOs
presenting
to
our
institution
were
treated(n=118)
percutaneously.
Results: Initial success using conventional techniques was 82 %. Initial
success with the Pioneer catheter was 90 %. Of the 2 failed Pioneer
catheter patients, one was referred for surgical revascularization and
162H
the other was successful with conventional techniques at the second
atempt . 1 patient developed iliac artery rupture at postdilation and
was treated successfully with a Viabahn Stent(A L Gore). There was
1 death post procedure from a large retroperitoneal bleed and acute
coronary syndrome in a patient with severe ischemic cardiomyopathy.
Conclusions: Use of the Pioneer catheter significantly increases the acute
success rate of percutaneous revascularization of CTOs.
SFA
ILIAC
POPLITEAL
INFRAPOPLITEAL
SUBCLAVIAN
AXILLARY
BRACHIAL
n=118
65
17
12
14
7
1
2
TABLE 1
INITIAL SUCCESS
n=97
53
11
10
14
6
1
2
PIONEER SUCCESS
n= 19
10
6
2
0
1
0
0
TCT-412
Paclitaxel and Sirolimus-Eluting Stents for the Treatment of Chronic
Total Occlusions
John Cosgrave1, Ioannis Iakovou1, Giussepe Biondi-Zoccai1, Gloria
Melzi2, Lei Ge1, Giussepe M Sangiorgi1, Flavio Airoldi2, Alaide Chieffo2,
Antonio Colombo1
1
EMO Centro Cuore Columbus, Milano, Italy2Ospedale San Raffaele,
Milano, Italy
Background: Percutaneous intervention in chronic total occlusions (CTO)
using bare metal stents is associated with high rates of restenosis (50%). There
is some initial encouraging data available utilizing drug eluting stents (DES).
We sought to test the hypothesis that both currently available DES platforms
perform well and have similar restenosis rates when implanted in CTO.
METHODS: We identified all patients successfully treated with
a DES in a CTO between March 2003 and October 2004. Lesions
located in vein grafts and restenotic lesions were excluded. The end
points analyzed were per patient MACE and per lesion TVR and TLR.
RESULTS: 88 lesions in 83 patients were treated with paclitaxel eluting
stents (PES) and 92 lesions in 88 patients underwent sirolimus eluting
stent (SES) implantation. The two groups were well matched for clinical
and lesion characteristics apart from a larger stent diameter in the PES
group (3.07±0.31 vs 2.88±0.41mm p=0.001). Angiographic follow up
was available in 75.9% of the PES group and 75% of the SES group. The
angiographic restenosis rate was 23.5% in PES compared with 24.3%
in SES p = 1.0. During a median follow up of 11.7 months there were a
total of 3 deaths; 2 in PES both non cardiac and one from a cardiac arrest
in the SES group. Myocardial infarction occurred in 2 PES patients and
1 SES patient. 14 lesions (15.9%) underwent a TVR in the PES cohort
and 16 (17.4%) in SES p = 0.31. Similarly there was no difference in the
occurrence of TLR, 11 (12.5%) and 13 (14.1%) respectively p = 0.828.
CONCLUSIONS: DES implantation in CTO is safe and associated with
favorable results when compared to historical data on bare metal stents.
When comparing the two currently available DES platforms there are no
significant differences in the clinical outcomes.
TCT-413
Clinical Experience and Efficacy of the Novel Penetration Catheter
for Severe Coronary Lesions
Takashi Muramatsu, Yasuhiro Ogura, Hirohiko Suzuki, Kentaro
Yamashita, Kazumasa Unno, Masayuki Shimano, Kunihiro Matsushita,
Mamoru Nanasato, Yukihiko Yoshida, Naoya Tsuboi, Haruo Hirayama
Nagoya Daini Red Cross Hospital Cardiovascular Center, Nagoya, Japan
Background: Recent developments of techniques and devices for percutaneous
coronary intervention (PCI) have enabled the treatment of complex
coronary lesions. However, many problems still remain in the conventional
PCI procedure, such as the unsuccessful crossing of a conventional balloon
or micro catheter. In such cases, we used a novel penetration catheter called
Tornus (Asahi Intecc Co. Ltd., Japan). The main shaft of Tornus is a coreless
stainless steel coil that is constructed in a clockwise fashion. 8 stainless
wires are stranded together in a coil. The outside diameter is 0.70 mm,
and inside is 0.46 mm which is compatible with a 0.014 inch guide wire.
It can pass through severe stenosis easily with counterclockwise rotation
along the guide wire. The tip profile is 0.62 mm, and it is made of stainlessplatinum alloy, which provides tip strength and is radiopaque. Following
is our report the clinical experience and initial outcome of using Tornus.
Methods and Results: Tornus was used in 48 patients(male gender 77.1%
, 65.4±10.9 years old , mean global LVEF 61.8±15.1%) with severe
coronary lesions that no 1.5 mm conventional balloon or micro catheter
could cross following the successful crossing of a 0.014 inch guide wire.
Of these 48 patients, 17 had CTO (defined as TIMI flow grade 0 and an
occlusion duration of more than 3 months) and 31 had severe calcified
stenosis. Procedural success was obtained in 43 cases (90.0%) and Tornus
was successfully crossed through lesions in 35 cases (72.9%). Rotational
atherectomy was performed in 8 cases. For other cases, Tornus made 1.5
mm balloon catheter able to cross the lesion. Finally in 74.4% (32/43) of
the cases, those in which rotational atherectomy or balloon dilatation were
performed, bare metal stents (BMS) or sirolimus eluting stents (SES) were
implanted. Complication was observed in only 1 case, where some difficulty
was encountered when attempting to remove the Tornus. Other major
complications, such as distal embolism, coronary perforation, or dissection
were not observed.Conclusion: In severe coronary lesions such as CTO or
severe calcified stenosis, the novel penetration catheter will allow for easier
and more successful PCI procedures.
TCT-414
Chronic Total Occlusion Intervention Using the Novel
Multidirectional Double Lumen Catheter
Tae Soo Kang, Young-Guk Ko, Donghoon Choi, Yangsoo Jang
Yonsei University, College of Medicine, Seoul, Republic of Korea
Background: Failure of guidewire passage is the most common
cause of procedural failure in chronic total occlusion(CTO).
We have developed this novel supporting catheter(Multid
irectional
double
lumen
catheter(Ashai,Japan)
with
arrow
shaped tip allows for manipulation of two guidewires with the
torquability and two wide bevels on the opposite side of catheter.
Methods: We used this catheter in consecutive 12 pts
with
CTO
and
investigated
procedural
outcomes. Target
lesion localized in LAD 58%, RCA 34% and LCx 8%.
Results:
Initial
technically
success
rate(TIMI
3
distal
flow) was 91.6%.(11/12) In one patient, wire was not reentered into the true lumen during subintimal approach.
Conclusion: Our preliminary result shows the multidirectional double
lumen catheter may be a useful device for the treatment of CTO.
TCT-415
Incidence and Location of Coronary Calcification in Chronic Total
Occlusions: An Intravascular Ultrasound Study
Kenichi Fujii1, Masashiko Ochiai2, Gary S Mintz1, Stephane G Carlier1,
Yoshifumi Kan3, Kojiro Awano4, Motomaru Masutani5, Kazuhiro Ashida2,
Daizo Kawasaki5, Shinobu Ichikawa4, Sachiko Ura3, Hiroshi Araki2,
Joanna Lui1, Koichi Sano1, Masashi Kimura1, Jose de Ribamar Costa, Jr.1,
Gregg W Stone1, Martin B Leon1
1
Columbia Medical Center and Cardiovascular Research Foundation,
New York, NY;2Showa University Northern Yokohama Hospital,
Yokohama, Japan3Shin-Yukihashi Hospital, Fukuoka, Japan4Miki City
Hospital, Miki, Japan5Hyogo College of Medicine, Nishinomiya, Japan
Background: Coronary calcification may be associated with procedure
failure in percutaneous treatment of chronic total occlusion (CTO).
However, the pattern of CTO calcification has not been well studied.
Methods: We analyzed a 4-center experience with 67 native artery CTO
lesions in which intravascular ultrasound was performed just after the lesion
was crossed with a guidewire (n=7) or after dilation with a 1.5mm (n=46)
or 2.0mm (n=14) balloon. We counted the number of calcium deposits
throughout the length of the CTO lesion and measured the maximum arc and
the length of each calcium deposit. For each deposit, a calcium index (CI)
was calculated as the maximum arc (1=0-90º, 2=91-180º, 3=181-270º, and
4=271-360º) multiplied by the length (1=0-6mm, 2=6-10mm, and 3 ≥10mm).
For the entire CTO lesion, calcium indices of each deposit were added.
Results: Median CTO duration was 6.3 mos (range 4 wks to 11 yrs).
Median CTO length was 12.8mm (range 3-28mm). IVUS detected
calcium somewhere in the CTO in 96% - at the proximal end of the
CTO in 78%, and at the distal end of the CTO in 59%. The number of
calcium deposits and maximum arc and length of calcium were 3.6±1.9,
145±85º, and 5.2±3.8mm, respectively. The total lesion CI was 7.0±5.0;
however, in 68% calcium was mild (CI=1). In lesions with a side branch
(SB) arising from the proximal stump (64%), calcium (if present) was
located opposite the side branch take-off in 74%, perpendicular in 23%,
and concordant in 3%. Similarly, calcium was located opposite a SB distal
to the CTO in 57%, perpendicular in 29%, and concordant in 14%. The
arc of calcium at the proximal end of the CTO was larger in lesions with
abrupt vs a tapered type occlusion (91.2±78.6º vs. 54.7±68.0º, p=0.05).
Conclusions: Most CTO lesions had multiple calcium deposits somewhere
in the lesion. Although typically mild in severity, CTO calcium location
may influence the ability to successfully treat a CTO.
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TCT-416
Aneurysmal Formations in Sirolimus-Eluting Stenting for Chronic
Total Coronary Occulusions (CTO)
Hwang Hweung-Kon1, Choi Rak Kyeong1, Jeong Seung Mook1, Hong Suk
Keun1, Yu Cheol Woong1, Kazuaki Mitsudo2
1
Sejong General Hospital, Puchon, Republic of Korea2Kurashiki Central
Hospital, Kurashiki, Japan
Background: The pathology of chronic total occulusion(CTO) characterized
negative remodeling of the vessel wall with aptotic cells, large organized
thrombus and huge lipid core may contribute the formation of aneurysm
in sirolimus eluting stent(SES) for CTO. The purpose of this study is
to evaluate the safety and effectiveness of SES for treatment of CTO.
Methods: 24 patients with successful percutaneous coronary
intervention(PCI) for CTO of greater than or equal to 3 months of duration
were enrolled. Major adverse cardiac events(MACE) and follow up
coronary angiographys were evaluated at 3 months and 12 month after PCI.
Results: The rates of MACEs at 3 month and 12 month are 12.5% and
16.7%. In 3 month and 12 month follow up angiography the binary restenosis
rates were 8.3% and 16.7%, instent late loss were 0.09±0.58mm and
0.24±0.56mm, cases of aneurysm were 5(20.8%) and 9(37.5%), respetively.
Conculusion: The SES in CTO can be used to prevent restenosis effectively,
however considering high frequency of aneurysm formation in follow up
angiographic study, enhanced surveillance for late complications such as
late stent thrombosis are warranted.
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Guide Wire Path during Treatment of Chronic Total Occlusion under
the Standardized “Penetrating” Wire Technique: An Intravascular
Ultrasound Assessment
Yoshihiro Morino1, Kazuaki Mitsudo2, Toshiya Muramatsu3, Yasushi
Asakura4, Yoshisato Shibata5, Osamu Doi6, Takehiro Yamashita7
1
Tokai University School of Medicine, Isehara, Japan2Kurachiki
Central Hospital, Kurashiki, Japan3Kawasaki Social Insuarance
Hospital, Kawasaki, Japan4Keio University School of Medicine, Tokyo,
Japan5Miyazaki Medical Associaton Hospital, Miyazaki, Japan6Shizuoka
Prefectual General Hospital, Shizuoka, Japan7Hokkaido Ohno Hospital,
Sapporo, Japan
GW (GETZ BROS., Japan) with/without seesaw/parallel wiring.
Methods: From the CONQUEST registry trial, 21 procedural success
cases were eligible for this intravascular ultrasound (IVUS) investigation.
All lesions were treated with prescribed GW technique and predilated with 1.25 - 2.0 (1.6±0.2) mm diameter balloon, prior to IVUS
imaging. Representative IVUS cross-sections (CSs) were selected
every 1mm-interval throughout the occluded segments referring to
angiography. Axial position of GW and grade of plaque type (grade
1: soft, 2: soft-fibrous, 3: fibrous, 4: fibrous-calcified, 5: calcified) at
either semicircle with or without GW were assessed in every IVUS CS
Results: Mean angiographic occlusion length was 19.4±18.8mm. 49 IVUS
CSs (2.3±1.8/ case) were investigated. All axial GW positions located
inside EEM, including at center (81.6%), at pericardial side (14.3%), and at
myocardial side (4.1%). Grades of plaque type at semicircles with GW were
lower compared with those without GW. (2.1±1.1 vs 2.7±1.3, p<0.0011)
Conclusion: GW tends to pass center and relatively soft part of occluded
plaque compositions, independent to vessel curvature. This observation
may provide meaningful aspects to elucidate the impacts and mechanisms
of proposed GW technique for CTO treatment.
TCT-418
The FACTOR (Flowcardia’s Approach to Chronic Total Occlusion
Recanalization) US IDE Study Design and Results
Louis A Cannon
Northern Michigan Hospital, Petoskey, MI
Occluded coronary arteries account for approximately 20-30% of CAD in
cath labs today. Occlusions > 30 days old are typically referred to as CTOs.
Approximately 40% of the cases are managed by PCI, with a 30-90%
success rate. CTOs have long been the “Achilles Heel” of interventional
cardiology and until recently no CTO technology has proven more effective
than good wire skills and patience. The CROSSER™ System, a High
Frequency Mechanical Recanalization device developed by FlowCardia
which utilizes an ultrasound generator to produce high frequency vibration
which is propagated to the tip of a 1mm. The catheter is advanced to
an CTO and activated to facilitate recanalization. Initial success in a
large multi-center European study has led to a US IDE FACTOR study.
Methods: The FACTOR Study has been designed to confirm the system can
safely and effectively facilitate the crossing of coronary CTOs. The study
encompasses a 175 patient multi-center 2-phase prospective registry design.
Patients are enrolled in the study following a failed attempt with conventional
guidewire CTO recanalization techniques. We will present the technology,
the study design and study progress to-date. Enrollment, follow-up and
data analysis has been completed for the forty five patient feasibility phase.
Results: Ccomprising 45 occlusions were enrolled in eight US sites
from January 2004 to December 2004. Single vessel CTOs were enrolled
following failure with conventional techniques either at a prior procedure
(37%) or a concurrent attempt (63%) with standard guidewire approaches
for a minimum of 5 minutes (average 7.6 min) of fluoroscopy time.
Successful recanalization following failure with conventional guidewires
was achieved in 55.6% of the cases. Success rates and occlusion
characteristics were confirmed by core lab analysis. Three MACE events
(6.7%) were encountered (3 non-Q-wave MI by >2x CK elevation). No
instance of clinical perforation was noted by investigator or core lab review.
Conclusions: The CROSSER System appears to be a safe and effective
technology to support recanalization of CTOs We look forward to reporting
the results of the US pivotal study.
Purpose: This study was designed to investigate “guide wire (GW)
paths” during treatment of chronic total occlusion (CTO) under the
standardized “penetrating” wire technique, defined as starting with
the intermediate GW and moving to the Conquest ProTM tapered
164H
TCT-419
Cardiac MRI Predicts Functional Improvement in Patients
Undergoing Percutaneous Revascularization of Chronically Occluded
Vessels
Manesh R Patel, Thomas M. Todoran, Burkhard Sievers, Peter Cawley,
Michele Parker, Robert M. Judd, Raymond J. Kim, David E. Kandzari
Duke University, Durham, NC
Background: Considering the challenges and risks associated with
percutaneous coronary intervention (PCI) of chronic total occlusions
(CTO), identifying patients (pts) who may benefit prior to attempted
revascularization is critical. We hypothesized that myocardial viability
assessed by delayed-enhancement magnetic resonance imaging (DEMRI) would predict functional improvement in CTO pts undergoing PCI.
Methods: From 1/2003 to 1/2005, consecutive pts were
prospectively evaluated with DE-MRI before attempted CTO PCI
and following successful PCI (mean 119 days). All images were
interpreted in random order by two masked observers for transmural
extent of scar, regional wall motion, and ventricular function.
Results: Among 36 pts enrolled, 27 (75%) had successful PCI of a CTO
vessel. Ten pts did not have repeat MRI due to repeat revascularization, or
defibrillator implantation. Of the remaining 17 pts (60.4±13.3 years, 76%
male) 9 (53%) had no history of prior myocardial infarction. The ejection
fraction (EF) was 43.2±8% and 31.9% of segments in CTO regions were
dysfunctional but viable (<50% transmural scar). Wall motion improvement
after PCI was statistically related to number of viable but dysfunctional
segments p<0.0001 (Figure). The EF increase after PCI (43.2% pre vs.
47.6% post, p=0.008) was also related to number viable segments, p=0.001.
Conclusion: Viability by DE-MRI predicts functional improvement in
pts undergoing percutaneous revascularization of chronically occluded
arteries.
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Drug Eluting Stents Comparisons
TCT-420
Analysis of Clinical and Angiographic Outcomes between Cypher and
Taxus: Multi-Center Experience in Korea
1
Republic of Korea
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Background: The aim of this study was to compare the sixmonth clinical and angiographic outcomes between the sirolimuseluting stent group (SES) and the paclitaxel-eluting stent
group (PES) from 5 different cardiovascular centers in Korea.
Methods and Results: This was an observational retrospective study
including consecutive symptomatic patients (n=2038) stented with either
SES (n=1322) (Cypher, Cordis) or PES (n=716) (Taxus, Boston Scientific).
Table shows baseline patient characteristics. Six-month angiographic followup was performed in 793 (38.9%) of 2038 patients. Restenosis (> 50% of
the luminal diameter stenosis) occurred in 123 (15.5%) of 793 patients [53
patients (10.4%) in the SES (508 patients) vs. 70 patients (24.6%) in the
PES (285 patients), p<0.001]. During the six-month follow-up period, 7.0%
(n=92) in the SES needed repeated target lesion revascularization (TLR)
compared with 10.2% (n=73) in the PES (p=0.011). Rates of death [0.9%
(n=12) in the SES vs. 0.8% (n=6) in the PES, p=0.872] and myocardial
infarction [3.7% (n=49) in the SES vs. 4.3% (n=31) in the PES, p=0.489]
were similar between 2 groups during the six months follow-up period.
Conclusion: Although some of the risk factors and lesion types were
different between 2 groups, TLR was significantly lower in the SES group
compared with that of the PES group in Koreans. Prospective randomized
clinical and angiographic long-term follow-ups are warranted to validate
the long-term efficacy of SES and PES in Koreans.
Parameters
Age (years)
Male sex
LVEF (%)
Body mass index (kg/m2)
Diabetes mellitus
Hypertension
Hypercholesterolemia
Current smoking
B2 or C type of lesion
Baseline Patient Characteristics
SES group (n = 1322) PES group (n = 716)
60.8 ± 10.2
60.3 ± 10.6
914/1322 (69.1 %)
488/716 (68.2 %)
55.8 ± 11.5
58.2 ± 11.8
22.9 ± 13.5
22.7 ± 18.8
380/1322 (28.7 %)
240/716 (33.5 %)
546/1283 (42.6 %)
323/614 (52.6 %)
314/965 (32.5 %)
129/420 (30.7 %)
396/1322 (30.0 %)
250/716 (34.9 %)
1022/1243 (82.2 %)
475/608 (78.1 %)
p Value
0.293
0.648
< 0.001
0.855
0.025
0.001
0.503
0.022
0.035
TCT-421
Outcome in the Real-World of Coronary High-Risk Intervention with
Drug-Eluting Stents (ORCHID) - A Single-Centre Study Comparing
Sirolimus-Eluting and Paclitaxel Eluting Stents
Somnath Kumar, V Suresh, BD Prendergast, NH Brooks, RD Levy, SG Ray,
DH Bennett, HS Lee
Wythenshawe Hospital, Manchester, United Kingdom
Data were collected on 439 stent implantations in 312 consecutive patients.
The clinical outcome at 6 months of SES stent implantation in a consecutive
cohort of 156 patients was compared to a subsequent 156 consecutive
cohort who underwent PES stent implantation. The primary endpoint was
defined as a composite of major adverse cardiac events (MACE) which was
cardiac death, myocardial infarction, Coronary artery Bypass Grafting or
target vessel revascularization (TVR) at 6 months. Multivariate analysis
was used to predict the Odds Ratio (OR) & confidence intervals for TVR.
The 2 groups were similar in baseline demographic & clinical characteristics.
In each group,33% of patients were treated for stable angina,Glycoprotein
IIBIIIA inhibitors were used in 75%.and the incidence of Chronic Total
Occlusions(CTO) was 20%. Multivessel intervention(PES 29%,SES
10%,p<0.001), bifurcation(PES 22%,SES 16%,p=NS)& small vessel
stenting were commoner in the PES group. The mean stent length per lesion
was 19.4+/-7.1mm in PES & 22.3+/-7.6mm in SES group.More complex
lesions were treated in the PES group(B249% vs 46.3%;p<0.01). The 6 month
outcome was similar in both groups with a TVR of 1.9 %( SES) & 2.6 %(
PES, p= NS), MACE (PES 3.2%, SES 4.5%, p= NS). The incidence of sub
acute stent thrombosis (SAT), related to inadequate dual antiplatelet therapy
was 1.9% in both groups . TVR was commoner in diabetics, bifurcation
stenting & vein graft intervention (OR 3.7, 4.2 & 6.9 respectively). TVR
was less common in patients with longer stent length (OR 0.4) or small
vessels (OR 0.6). Ostial location, CTO or previous ISR did not predict TVR.
The ORCHID study shows similar efficacy & safety of PES & SES (in a
similar cohort of patients)with a low TVR, MACE & SAT rates in complex
coronary intervention. By including more complex patients it provides
complementary information to the REALITY study.
TCT-422
The Risk of Stent Thrombosis in Paclitaxel Stents Compared to
Sirolimus Stents
Anthony A Bavry1, Dharam J Kumbhani2, Thomas J Helton1, Deepak L
Bhatt1
1
Cleveland Clinic Foundation, Cleveland, OH;2University of
Pennsylvania, Philadelphia, PA
Introduction Numerous studies have examined the risk for
stent thrombosis in drug-eluting stents compared to bare-metal
stents. To present, no systematic analyses have compared the risk
for stent thrombosis in head-to-head drug-eluting stent studies.
Methods We conducted an analysis on patients with coronary artery disease
who received paclitaxel stents versus sirolimus stents. We calculated risk ratios
(RR) for stent thrombosis for paclitaxel stents compared to sirolimus stents.
Results In all, there were 7 studies available for analysis in 6,070 patients
(paclitaxel = 3,133) and (sirolimus = 2,937). Clinical follow-up ranged
from 9 to 12 months. There were 47 thrombotic events in paclitaxel patients
(incidence 1.5%) and 27 thrombotic events in sirolimus patients (incidence
0.92%). The risk for stent thrombosis was increased for paclitaxel stents
compared to sirolimus stents (RR = 1.72, 95% CI 1.07 to 2.76, p = 0.024).
Conclusions In conclusion, the overall risk for late stent thrombosis is
infrequent. However while absolute rates are low, paclitaxel stents appear
to be at increased risk for stent thrombosis compared to sirolimus stents.
The Paclitaxel (PES) & Sirolimus eluting stents (SES) differ in the
drug, delivery, vehicle platform & mechanism of action but it is is not
known if this would be reflected in their efficacy. We present 6 month
follow up data on the comparative outcome of PES & SES stents
in unselected high-risk individuals from our single centre registry.
166H
TCT-424
Sirolimus and Paclitaxel Eluting Stent Implantation for Diffuse
Coronary In-Stent Restenosis
Flavio Airoldi1, Carlo Briguori1, Ioannis Iakovou1, Goran Stankovic1,
Mauro Carlino1, Giuseppe Biondi-Zoccai1, Alaide Chieffo1, Matteo
Montorfano1, John Cosgrave2, Giuseppe Massimo Sangiorgi2, Antonio
Colombo2
1
San Raffaele Hospital, Milan, Italy2EMO Centro Cuore, Milan, Italy
TCT-423
Comparison of Short and Long-Term Outcomes between CYPHER
and TAXUS Stents in Patients with Complex Lesion
Ji-Lin Chen, Run-Lin Gao, Yue-Jin Yang, Shu-Bin Qiao, Xue-Wen Qin,
Min Yao, Bo Xu
Cardiovascular Institute & Fu Wai Hospital,Chinese Academy of Medical
Science, Beijing, China
Background Up to now, there was no large scaled study
on the effect of DES in treating complex lesions. Although
REALITY trial just published in ACC congress 2005, the entry
criteria for lesions was limited to one or two de novo lesions.
Objective To compare the short and long-term clinical outcomes
between sirolimus-eluting stent (CYPHER stent) and paclitaxeleluting stent (TAXUS stent) in patients with complex lesion.
Methods From April 2002 to Dec 2004, 1043 patients
(1128 lesions) were treated with 1232 CYPHER stents,688
patients (820 lesions ) were treated with 942 TAXUS stents.
Results According to the sorts of target lesions, diffuse lesion
(length>20mm) was the most common morphology, there were 352 sites
(31.2%) and 225 sites (27.4%) in CYPHER group and TAXUS group
respectively. Bifurcation lesions was the second, 271 sites(24.0%)and 163
sites (19.9%) respectively (P<0.05). There were 152 sites (13.5%) and 120
sites (14.6%) with chronic total occlusion lesions, 132 sites (11.7%) and
91 sites (11.1%) with lesions of in-stent restenosis, 97 sites (8.6%) and
79 sites (9.6%) with lesions in ostia, 31 sites (2.7%) and 29 sites (3.5%)
with lesions in left main stem in CYPHER group and TAXUS group
respectively. In total, according to the types of target lesions (ACC/AHA),
complex lesions(B2+C) was 79.5% in CYPHER group and 78.4% in
TAXUS group. Success rate of stent implantation was 99.3% and 99.0% in
CYPHER stent group and TAXUS stent group respectively. The incidence
of acute occlusion of side branch (diameter ≤2.5 mm) after stenting in main
branch for bifurcation lesions in TAXUS group was significantly higher
than that in CYPHER group (11.93% versus 6.94%, P<0.05). The major
adverse cardiac events (MACE), including death, AMI, TLR, etc., during
in-hospital and 6-8-month follow-up were 1.92% and 1.90% in CYPHER
stent group versus 2.49% and 3.25% in TAXUS stent group. There was no
significant difference in MACE rate between these two groups. Restenosis
rate was a little higher in TAXUS stent group than that in CYPHER
stent group (9.0% vs 12.7%), but there was no significant difference.
Conclusion This study showed that CYPHER and TAXUS DES were safe
and effective in patients with complex lesion.
Background: Drug eluting stents (DES) reduce restenosis
recurrence in patients with in-stent restenosis (ISR) inside bare
metal stents, in comparison to balloon angioplasty. Few data
are available about this therapy in case of diffuse restenosis.
Objectives: we evaluated the outcome of sirolimus and
paclitaxel eluting stent (SES and PES) implantation in diffuse
ISR
and
determine
predictors
of
restenosis
recurrence.
Methods: 161 consecutive patients with 194 diffuse ISR lesions
(>10 mm) treated with DES implantation were evaluated.
Major adverse cardiac events (MACE) were defined as death,
myocardial infarction, need of target lesion revascularization.
Results: During a mean follow-up period of 8.2±3.4 months, the
cumulative incidence of MACE was 19% in the SES group and 24% in
the PES group (p=0.56). Angiographic follow-up was performed in 80%
of the lesions. Overall restenosis rate was 22% and was not significantly
different between lesions treated with SES (20%) or with PES (25%,
p=0.55). The incidence of restenosis was higher in diabetics (32%) than
in non-diabetics (16%) OR 2.5; CI 95% 1.1-5.5, p=0.02; see table) By
multivariate analysis, diabetes was confirmed to be the only independent
predictor of recurrent restenosis (OR 3.38; CI 1.42-8.03, p=0.006).
Conclusions: DES implantation for diffuse ISR is associated with acceptable
clinical and angiographic results. The association of diffuse restenosis and
diabetes is an unfavourable condition leading to a high risk of recurrences.
*=p<0.05 for comparisons to non diabetics
Non diabetics Non diabetics
Stent type
SES
PES
8/57
7/4
Restenosis rate (%)
(14%)
(17%)
Late loss (mm)
0.32±0.62
0.44±0.76
Diabetics
SES
10/35
(29%)*
0.62±0.72*
Diabetics
PES
9/24
(37%)*
0.60±0.82*
TCT-425
Three-Dimensional Intravascular Ultrasound Evaluation of
Neointimal Proliferation in Diabetic Patients. A Randomized
Investigation of Coronary Lesions Treated by CypherTM or TaxusTM
Stent
Andrés Sánchez Esteva, Ricardo Silva, Alexandre Abizaid, Eduardo
Ferreira, Áurea Chaves, Andrea Abizaid, Fausto Feres, Rodolfo Staico,
Luiz Alberto Mattos, Luiz Fernando Tanajura, Ibraim Pinto, Amanda
Sousa, J. Eduardo Sousa
Dante Pazzanese Institute of Cardiology, São Paulo, Brazil
Background: Sirolimus and Paclitaxel eluting-stent had demonstrated
its effectiveness in suppressing neointimal hyperplasia post
stent implantation. However, diabetes mellitus (DM) is still an
independent predictor of in-stent restenosis, even in the drugeluting era and mostly due to exaggerating neointimal proliferation.
Methods: Fifty-two patients were randomized for the treatment
of a de novo native coronary artery lesion. Twenty-five patients
with 36 lesions for the CypherTM group and 27 patients with also
36 lesions for the TaxusTM group. Patients were divided according
to the diabetes status. Angiographic and 3D-IVUS evaluation were
performed immediately post stent placement and at 8-month follow-up.
Results: In overall, the mean age was 60±10 years and 32 (61%) patients
were men. There were no significant differences in relation to baseline
167H
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
demographic characteristics between the groups. IVUS and QCA results:
QCA
Reference Diameter, mm
Lesion Length, mm
Stent Length, mm
Binary restenosis
Late Loss, mm
3-D IVUS
NIH mm3 / stent mm
Stent Obstruction Volume, %
Cypher™
(lesions=36)
Taxus™
(lesions=36)
p value
2.73±0.37
20.94±9.68
33.7±12
2 (5.6%)
0.24±0.21
2.68±0.33
22.65±9.46
33.7±9.5
2 (5.6%)
0.41±0.30
0.60
0.44
0.99
0.99
0.006
0.38±0.32
6.2±4.1
0.96±0.88
14.1±13.5
0.006
0.0009
Conclusion: This analysis demonstrates that the diabetic patients have more
neointimal hyperplasia, either with Cypher TM or Taxus TM, when compared
with non diabetic patients.
TCT-426
Differential Inflammatory Effect of Sirolimus Eluting Stent and
Paclitaxel Eluting Stent in Porcine Chronic Isquemic Model
Emerson C Perin1, Guilherme V Silva1, Javier Lopez1, Franca Angeli1,
Edie Olivera1, Pilar Jimenez-Quevedo1, William K Vaughn1, Fred J
Clubb1, Nancy Scroggins1, Robert Faloticco2
1
Texas Heart Institute, Houston, TX;2Cordis Corporation, Miami Lakes,
FL
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
Background: Drug eluting stents have been shown to dramatically
reduce restenosis rates as compared with bare metal stents.There is
much controversy regarding possible untoward effects of Sirolimus
eluting stents (SES) and paclitaxel eluting stents (PES) such as
subacute stent thrombosis. The present study was designed to
compare the local effect of SES vesus PES in a pig restenosis model.
Methods: In 10 pigs utilizing a coronary restenosis model
(balloon/artery ratio=1.2/1) 8 SES and 8 PES were alternately
deployed into LAD and LCx. Animals were sacrificed at 30-days.
Parametric and non-parametric histological analysis was performed.
Results: There was no difference in neo-intimal thickness
(0.22±0.06vs0.19±0.07;p=0.96)
or
percentage
of
stenosis
(24.0%vs22.0%;p=0.79) between both stents. PES(s) had statistically
significant higher indices of inflammation and fibrin (fig1) but no
difference in vascularization score (0.03±0.08vs0.02±0.05,p=0.92).
Conclusion: PES is associated with significant more inflammation than
SES. These preliminary findings might give new insight into the local effect
leading to thrombosis of SES and PES stents.
TCT-427
Comparison of the Effectiveness of Sirolimus versus PaclitaxelEluting Stents for Small Coronary Vessel Lesions
Kyoung-Ha Park, Seong-Wook Park, Bong-Ki Lee, Bong-Ryong Choi,
Kyoung-Min Park, Jae-Sik Jang, Se-Whan Lee, Young-Hak Kim, Cheol
Whan Lee, Jae-Joong Kim, Myeong-Ki Hong, Seung-Jung Park
168H
Background: In small coronary artery lesion, few studies have
compared the sirolimus-eluting stent (SES) and paclitaxeleluting stent (PES) in order to determine which one is superior.
Methods: We identified 197 patients with 245 de novo
small coronary artery lesions (≤2.75mm) who underwent
stenting using the SES (156 lesions) or PES (89 lesions).
Results: A six-month angiographic follow-up was performed on 170
patients and revealed 135 SES lesions and 76 PES lesions. A 6-month
angiographic follow-up, the SES group showed lower angiographic
restenosis rate than the PES group (6.7% vs. 27.7%, p<0.01). During
follow-up period, death or myocardial infarction did not occur in the
two groups. The 9-month target lesion revascularization (TLR) rate was
lower in the SES group than the PES group (3.3% vs. 14.4%, p<0.01).
The Kaplan-Meier estimate of freedom from TLR at nine months
was 96.7% for SES patients and 86.5% for PES patients (p<0.01).
Conclusions: Implantation of the SES appeared more effective in reducing
restenosis and TLR for small coronary artery lesions compared to the PES.
TCT-428
Angiographic Patterns of In-Stent Restenosis Are Different between
Sirolimus-Eluting Stents and Paclitaxel-Eluting Stents
1
Republic of Korea
Background: Sirolimus-eluting stent (SES) and paclitaxel-eluting
stents (PES) have different drug-release kinetics and polymers with
different delivery systems; therefore, different patterns of in-stent
restenosis (ISR) might be expected. The objectives of this study were
to compare the angiographic patterns of ISR between the SES group
and the PES group and to compare six months clinical outcomes.
Methods: This was an observational retrospective study including
consecutive symptomatic patients (n=842) assigned to the SES
group (n=557) (Cypher, Cordis, Florida) and the PES group (n=285)
(Taxus, Boston Scientific, Massachusetts). Patients with previously
untreated de novo atherosclerotic lesions were included in this study.
Angiographic follow-up was scheduled at six months post-procedure,
and Mehran classification was used for description of ISR patterns.
Results: During the six-month follow-up period, 9.3% (n=52) in the SES
group and 17.9% (n=51) in the PES group developed ISR (see Table).
Major adverse cardiac events (MACE) (death, myocardial infarction,
and the need for repeated target lesion revascularization) were 6.5%
(n=36) in the SES group and 8.4% (n=24) in the PES group (p=0.296).
Conclusion: Different pharmacokinetics of drugs and polymers used for
coating the stents may have contributed to the different angiographic patterns
of ISR between two groups with no signicant differences in MACE.
Type I
Type IA
Type IB
Type IC
Type ID
Type II
Type III
Type IV
Patterns of ISR in the SES and the PES Groups
Sirolimus-eluting stents(n
Paclitaxel-eluting stents(n
= 52)
= 51)
43 (82.7 %)
25 (49.0 %)
0 (0.0 %)
0 (0.0 %)
4 (7.8 %)
6 (11.5 %)
33 (63.5 %)
11 (21.6 %)
4 (7.7 %)
10 (19.6 %)
5 (9.6 %)
15 (29.4 %)
3 (5.8 %)
10 (19.6 %)
1 (1.9 %)
1 (2.0 %)
p value
< 0.001
1.000
0.741
< 0.001
0.092
0.011
0.041
1.000
TCT-429
The Real-world Eluting-stent Comparative Italian retrosPective
Evaluation (RECIPE) Study: A Multicenter Comparison of Cypher vs
Taxus in over 2200 Patients
Giuseppe Sangiorgi1, Corrado Tamburino2, Massimo Margheri3, Rossella
Barbagallo2, Guido Vittori3, Elena Falchetti3, Ilaria Ricceri3, Giuseppe
Biondi Zoccai4, Pierfrancesco Agostoni4, Antonio Colombo1, from the
Realworld Eluting-stent Comparative Italian retrosPective Evaluation
(RECIPE) Investigators
1
EMO Centro Cuore Columbus, Milan, Italy2Ferrarotto Hospital, Catania,
Italy3Careggi Hospital, Florence, Italy4Interventional Cardiology Unit,
San Raffaele Hospital, Milan, Italy
Purpose: Cypher and Taxus effectively reduce the risk of restenosis. However,
there is uncertainty on their comparison in unselected patients. We thus
evaluated a large cohort of patients undergoing Cypher and Taxus implantation.
Methods: Consecutive patients treated from April 2002 to May
2004 were enrolled. Patients underwent 1- and 6-month clinical
follow-up and 4 to 9-month angiographic follow-up as clinically
indicated. Clinical outcomes included all-cause death, Q-wave
myocardial infarction (MI), target vessel revascularization (TVR),
target lesion revascularization (TLR), and stent thrombosis (ST).
Results: 2286 patients were included (1227 Cypher vs 1059 Taxus) with
3945 treated lesions (2265 vs 1680) for a total of 4503 implanted drug-eluting
stents (2606 vs 1897). Of those, 26.8% (614) were diabetics, 9.4% (214) with
acute myocardial infarctions, and in 4.2% (98) patients the target vessel was
an unprotected left main. Final angiographic success was respectively 99.6%
and 99.5%. Overall 1-month major adverse cardiovascular events (MACE)
occurred in 1.1% (25) of patients, with death in 0.7% (15), MI in 0.3% (7)
and TVR in 0.4% (9), without significant difference between Cypher vs
Taxus at unadjusted analysis (P>0.05). Similar event rates for the 2 stent
types were also present at unadjusted 6-month analysis, with overall MACE
at 5.9% (127), death at 1.4% (30), MI at 0.7% (16), TVR at 4.3% (91) and
target lesion revascularization (TLR) at 3.1% (67) (P>0.05). ST rates were
0.9% for intraprocedural ST, 0.7% for subacute ST, and 0.3% for late ST
(0.1% for Cypher vs 0.5% for Taxus, p=0.07). Propensity adjusted analysis
showed that both Cypher and Taxus provided a similarly low risk of TLR at
6-months follow-up (odds ratio 0.78, 95% confidence interval 0.46-1.32).
Conclusions: Results from this large multicenter study comparing Cypher
vs Taxus show that both Cypher and Taxus stents are safe and effective in
patients undergoing percutaneous revascularization, including unselected as
well as high-risk subjects. Propensity analysis, applied to reduce imbalances
between the 2 patient populations, suggests that Cypher and Taxus were
associated with similar rates of mid-term adverse events.
TCT-430
of Patients with Small Coronary Arteries: Multicenter Registry in
Asia
1
Background and Purpose: Both Sirolimus-eluting BX velocity stent
(Cypher™, Cordis) and Paclitaxel-eluting Express stent (TAXUS™, Boston
Scientific) have been reported to be effective in preventing neointimal
formation and in-stent restenosis. However, little is known about long-term
efficacy of these 2 stents in patients with small vessel disease (reference
diameter ≤25 mm). The aim of this study is to compare the safety and efficacy
of these 2 stents on the outcome of patients with small coronary arteries (SC).
Methods: A prospective analysis of 1,410 patients with SC (808
Cypher™ and 602 TAXUS™) in five high volume Asian centers after
successful stenting for SC (Cypher™: LAD 46.8%, LCX 26.0%, RCA
19.9%, HL 7.3%. TAXUS™: LAD 48.5%, LCX 22.6%, RCA 19.9%, HL
9.0%) was performed. The study endpoints were major adverse cardiac
events (MACE) at 30 days, 12 months and restenosis rate at 12 months.
Results:
The
baseline
clinical
characteristics
between
2 groups were similar. See table for clinical results.
Conclusion: The use of both stents in patients with small coronary arteries
was equally safe with low acute complication and low incidence of
restenosis.
Number of patients
MACE at 30 days (%)
Lesion length (mm)
MLD post (mm)
Restenosis rate (%)
Cypher™
808
99.8
0.4
2.40 ± 0.55
12.6 ± 5.8
2.42 ± 0.62
2.10 ± 0.60
7.4
7.4
TAXUS™
602
99.7
0.7
2.40 ± 0.80
11.3 ± 5.9
2.45 ± 0.70
2.08 ± 0.71
13.0
11.6
p
NS
NS
NS
NS
NS
NS
NS
NS
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
169H
Drug Eluting Stent Complications
TCT-431
Importance of Negative Remodeling as a Mechanism of Drug-Eluting
Stent Underexpansion: An Intravascular Ultrasound Analysis
Sang-Wook Kim1, Gary S Mintz2, Patrick Ohlmann1, Salah-Eddine
Hassani1, William S Chu1, Esteban Escolar1, Guy Weigold1, Augusto D
Pichard1, Lowell F Satler1, Kenneth M Kent1, William O Suddath1, Ron
Waksman1, Neil J Weissman1
1
P
O
S
T
E
R
A
B
S
T
R
A
C
T
S
We used intravascular ultrasound (IVUS) to evaluate factors responsible
for drug-eluting stent underexpansion in 42 in pts treated with Taxus
stents. Stents were expanded at 14atm, subsequent stent underexpansion
was defined as minimal stent area (MSA) <5 mm2 or MSA <80% of
the reference lumen. Pre-intervention images at the site of subsequent
minimal stent area (MSA) were assessed (Table). Negative remodeling
was defined as a remodeling index (lesion/reference arterial area) <0.95.
Results. Pt age was 64±10yrs; 53% were males; 46% were diabetic.
Stent length was 18.0±7.7mm. MSA showed no calcium in 19 (45%); in
these 19 non-calcified lesions, negative remodeling was found in 16/19
overall and 14/16 of underexpanded stents. In the other 23 lesions with
calcified plaque, MSA was mostly located at the site of maximal calcium
arc in 16 (70%); however, even in calcified plaques (1) there was no
correlation between MSA vs measured arc of calcium and (2) negative
remodeling was also seen in 64% overall and 75% of underexpanded stents.
Furthermore, the arc of calcium was similar and the remodeling index
smaller in the overall cohort of underexpanded vs well-expanded stents.
Conclusion: Negative remodeling is an important factor contributing to
drug-eluting stent underexpansion.
Lesion length(mm)
Mean reference lumen area (mm2)
Minimal lumen area (mm2)
Plaque area ( mm2)
Remodeling index
Calcium arc (°)
Plaque burden (%)
Underexpanded
(n=29)
14.69±6.90
7.46±2.57
2.9±1.0
6.28±3.41
0.82±0.17
82.2±49.8
65.7±9.82
Well-expanded
(n=13)
13.15±7.81
7.40±2.88
3.7±1.6
8.38±3.40
0.96±0.13
75.1±55.1
68.1±9.81
p-value
0.5
1.0
0.055
0.078
0.045
0.8
0.5
TCT-432
Incidence and Characteristics of Coronary Aneurysm after DES
Implantation
Background: Drug-eluting stents (DES) may induce toxic effects on
the coronary arterial wall such as aneurysm formation, incomplete stent
apposition, stent thrombosis and vessel rupture based on the experimental
studies. We investigated the incidence and characteristics of arteriopathy
at 6 month routine angiographic follow up after DES implantation
regardless of clinical events in a single center unrestricted DES registry.
Methods: A total 296 consecutive patients (pts, Male 158, mean
age, 62.1 ± 4.2 years) who has treated with DES (Sirolimus-eluting
stent, SES and/or Paclitaxel-eluting stent, PES) were enrolled. We
performed routine angiographic follow up at 6 months regardless
of clinical events and IVUS was done in case of angiographic
170H
aneurismal change at the DES implanted site was observed.
Results: Conventional coronary risk factors were not different compared
with control study population. The incidence of coronary aneurysm was
1.7% (5/296). Among the 5 coronary aneurysm patients (pts, Male 4,
Age 55.8± 8.1 years), 4 pts treated with SES and 1 PES to cover 3 left
anterior descending arteries, 1 left main and 1 right coronary artery
(Type C lesions, 80%). Mean DES diameter and length were 2.77 ± 0.4
mm and 19.8 ± 7.6 mm, respectively. Mean intimal growth % was 22.2
± 19.2 % and there were no binary restenosis. Three pts had single
aneurysm (mean diameter 2.4 mm) and two had multiple aneurysms
(mean number 3.5, mean diameter 2.5 mm). There was one aneurysm
developed at the edge of SES. PES aneurysm was single and minimal
(diameter 1 mm). IVUS demonstrated focal lack of contact between
DES and coronary vessel wall without malapposition in all pts. All the 5
pts were asymptomatic and there were no clinical events up to 6 months.
Conclusion: The incidence of aneurysm formation after DES implantation
in a real world DES registry at 6 months was 1.7%. Although cytotoxic
effect of drugs may responsible for development of DES arteropathy, the
aneurysm was commonly small in size and not related to stent thrombosis,
rupture or other major adverse cardiac events up to 6 months. SES appears
to be more related to DES arteriopathy compared with PES and need more
evaluation with larger study population.
TCT-433
Hemocompatible Coatings Reduce Drug Eluting Stent Thrombosis
Joseph A Chinn1, Sean M. Stucke1, David E. Babcock1, Ralph A. Chappa1,
Robert. S. Schwartz2,3
1
SurModics, Inc., Eden Prairie, MN;2Minneapolis Heart Institute and
Foundation, Minneapolis, MN;3Minnesota Cardiovascular Research
Institute, Minneapolis, MN
Purpose: While polymers are generally more hemocompatible than
metals, deadly sub-acute thrombosis (SAT) associated with DES use is of
concern because inhibiting vascular smooth muscle cells delays healing.
Therefore, we evaluated the thrombogenicity of several hemocompatible
coatings on DES, both in vitro and in an animal model of thrombosis.
Methods: Coronary and peripheral test stents were coated with either a
stable or a biodegradable matrix containing a model drug compound
(sirolimus, paclitaxel, or dexamethasone). DES variants were modified
with different hemocompatible coatings containing heparin or ligands
with high affinity for either albumin or plasminogen (proteins that do not
mediate platelet adhesion). One heparinized DES variant was evaluated
in a novel aggressive porcine carotid crush model of stent thrombosis.
Results: In vitro albumin and plasminogen adsorption from human
plasma to DES modified with albumin or plasminogen binding ligands
was 4-fold (albumin) and 11-fold (plasminogen) greater than control. In
vitro bioactivity of heparin modified DES ranged from 20-80mU/cm2.
We observed more frequent and more massive adherent thrombus on all
non-heparinized stents tested 1hr after placement in the porcine model, but
on only one of three heparin-modified stents. Thrombi on control stents
were more massive compared with that on treated stents (see figure).
Conclusions: These unique hemocompatible coatings may help address
stent SAT and give hope for improved patient outcomes.
TCT-435
A Contemporary Review of the Mayo Clinic Risk Score for InHospital Complications after Percutaneous Coronary Intervention
Using the ARRIVE 1 Safety Surveillance Registry for Patients Treated
with the TAXUS Paclitaxel-Eluting Coronary Stent System
John M Lasala1, David A. Cox2, Mary E. Russell3
1
Washington University School of Medicine, St. Louis, MO;2Mid-Carolina
Cardiology Presbyterian Hospital, Charlotte, NC;3Boston Scientific
Corporation, Natick, MA
TCT-434
Drug-Eluting Stent (DES) Failure is Increased in High-Risk Patients
Megumi Taniuchi
Washington University School of Medicine, St. Louis, MO
Background: Randomized trials demonstrating the efficacy of drugeluting stents (DES) for percutaneous coronary intervention (PCI)
excluded patients with clinical and anatomical characteristics that
would increase the risk for stent thrombosis or restenosis. The safety
and efficacy of DES in these “high-risk” (HR) groups have not been
compared to the “non high-risk” (NHR) groups studied in the trials.
We therefore examined the acute and intermediate-term outcomes of
DES implantation in HR groups and compared them to NHR cases.
Methods: All cases of patients receiving DES from April, 2003, through
September, 2004, at Barnes-Jewish Hospital/Washington University, St.
Louis, MO were followed prospectively for in-hospital events and for 9-month
clinical follow-up. Cases were divided into HR and NHR groups for analysis.
Results: A total of 1970 patients received 2560 DES (1.3 DES/patient).
Sirolimus-eluting Cypher stents constituted 80% of the stents. At least one
HR characteristic which would have excluded the patient from SIRIUS was
present in 53% of the cases: acute MI (17%); bifurcation lesion (15%);
ostial lesion (10%); left ventricular dysfunction (10%); saphenous vein
graft (7%); thrombus (7%); intrastent restenosis (ISR, 6%); chronic total
occlusion (3%). Technical success was similar in the HR and NHR groups
(99.2% and 99.8%). Acute and subacute stent thombosis rates were low for
both HR (0.7%) and NHR (0.2%). However, at 9-month clinical followup the target lesion failure (TLF) for HR cases was greater than for NHR
(2.5% vs 0.5%; p<0.005). The TLF for DES implantation to treat ISR
(9.8%) was significantly higher compared to the entire HR group (p=0.01).
DES implantation after failed brachytherapy had the highest TLF at 33%.
Conclusions: In an open practice of DES implantation, the majority of
patients would have been excluded from SIRIUS. The overall safety and
efficacy of DES in these HR cases are slightly lower compared to the NHR
cases, but are favorable compared to historical results with bare-metal
stents. Patients receiving DES for intrastent restenosis are at highest risk for
TLF, particularly those who have failed brachytherapy.
Background: The Mayo Clinic risk score uses 8 clinical and
angiographic predictors of in-hospital procedural complications from
percutaneous coronary intervention (PCI) (Singh, et al. J Am Coll
Cardiol 2002;40:387). This model was developed and validated with
data obtained prior to the use of drug-eluting stents (DES). The current
study assessed applicability of the model to stenting with DES, using
data from the ARRIVE 1 multicenter US safety surveillance registry for
patients receiving the TAXUS® Express2™ Paclitaxel-eluting Coronary
Stent System (Boston Scientific, Natick, MA) in routine clinical practice.
Methods: In-hospital procedural complications were defined as death,
Q-wave myocardial infarction, emergent or urgent coronary artery
bypass graft surgery, or cerebrovascular accident. Statistical procedures
followed the Mayo model. Predictors included cardiogenic shock, left
main disease, renal disease, urgent or emergent PCI, congestive heart
failure (CHF), thrombus, multi-vessel disease, and age. A logistic
regression was used to derive the procedural complication risk score
for all eligible patients and specific subgroups. The odds ratio, 95%
confidence interval (CI), and p-value were calculated for each predictor.
Results: The analysis included 1661 (64%) eligible patients; overall
procedural complication rate was low (1% [16/1661]) compared to that in the
Mayo study (4%; referenced above). There was a trend towards increasing
event rate with higher risk score; however, the CI for each risk score
stratum was wide. In the multivariate analysis, CHF was the sole significant
predictor (p=0.037); renal disease was borderline significant (p=0.059). For
each risk predictor, event rates in patients with or without the condition
were similar and consistently lower than those reported in the Mayo study.
Conclusion: Six of eight predictors identified in the Mayo risk model did
not predict procedural complications in routine clinical practice with the
TAXUS stent. A seventh was borderline significant. The overall low rate of
complications in ARRIVE 1 as compared to that in the Mayo study could
reflect differences in patient populations and available treatments, including
DES.
TCT-436
Serial Intravascular Ultrasound Analysis of Vascular Remodeling at
Sites of Incomplete Stent Apposition after Sirolimus-Eluting Stent
Implantation
Masashi Kimura, Stephane G. Carlier, Gary S Mintz, Joanna Lui, Jose de
Ribamar Costa, Jr., Koichi Sano, Hideo Takebayashi, Takenori Yasuda,
Kenichi Fujii, Roxana Mehran, George Dangas, Gregg W. Stone, Jeffrey
W. Moses, Martin B. Leon
Columbia University Medical Center, New York, NY
To assess mechanisms of incomplete stent apposition (ISA) after sirolimuseluting stent implantation (SES), we studied 150 consecutive pts (182
lesions) in whom intravascular ultrasound was performed at index &
follow up (6.5±2.4mos). ISA was ≥1 stent struts separated from the vessel
wall with evidence of blood speckle behind the strut, not overlapping a
side branch. Effective lumen area=intra-stent lumen+ISA area. In 31
lesions, there were 61 acute ISA sites, but only 6 new late ISA sites. At
follow up at acute ISA sites, effective lumen area decreased significantly
as a result of a significant increase in peri-stent plaque, with no change in
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vessel area (Figure); Δeffective lumen correlated with Δperi-stent plaque
(p<0.0001, R2=0.783), but not with Δvessel (R2=0.008). Conversely,
new late ISA sites had an increase in effective lumen area secondary
to positive remodeling (increase in vessel area) with no increase in
peri-stent plaque; Δeffective lumen correlated strongly with Δvessel
(p<0.0001, R2=0.999), but not with Δperi-stent plaque (R2=0.091).
Conclusions: Post-SES implantation, mechanisms of acute ISA resolution
vs new late ISA depend on totally different vascular responses. Acute ISA
resolution is the results of an increase in plaque behind the stent (presumably
peri-stent intimal hyerplasia), not negative vessel remodeling (decrease in
vessel area). Conversely, new late ISA (less common) is the result of positive
remodeling (increase in vessel area), with no increase in peri-stent plaque.
TCT-437
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Coronary Aneurysms after Drug Eluting Stent Implantation - An
Unusual and Potentially Life Threatening Complication
Ranjan Kachru1, Ripen Gupta1, Rakesh Rai Sapra1, Nikhil Kumar2, Vinay
Jetley3, Ramdeo Yadave1, Upendra Kaul1
1
Batra Hospital & Medical Research Centre, New Delhi, India2R & R
Hospital, New Delhi, India3Base Hospital, New Delhi, India
Background: There has been concern regarding long term
safety of drug eluting stents. Coronary aneurysm formation after
drug eluting stent implantation is known but its time course,
mechanism and clinical implication is not clearly elucidated.
Methods & Results: Since June, 2002 we have implanted 2408 drug eluting
stents (1252 sirolimus eluting CypherTM stent and 1156 paclitaxel eluting
TaxusTM stents). Among these patients we have observed four instances
of coronary aneurysm formation (3 in CypherTM stents and 1 in TaxusTM
stents). Two of these patients presented early (within 2 weeks) after drug
eluting stents implantation and the other two patients presented 6 months
or later after stent implantation. All the aneurysms occurred in the stented
segment. The two patients who presented within 2 weeks of sirolimus drug
eluting stent implantation had acute coronary syndrome with chest pain.
Evaluation revealed both of them to have pericarditis. Coronary angiography
revealed intraluminal filling defects associated with formation of coronary
aneurysms. Both the patients underwent urgent surgical intervention. Third
patient had exertional chest pain 6 months after sirolimus stent implantation
and coronary angiography revealed large coronary aneurysm involving
whole of the stented segment with significant restenosis at both the ends of
the aneurysm and required surgical intervention. Fourth patient was detected
to have multiple small aneurysms in the stented segment (paclitaxel eluting
stent) with proximal peristent restenosis at 18 months after index procedure.
The restenotic segment was treated with angioplasty and the aneurysmal
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segment, which on IVUS appeared to be late malaposition, was left alone.
Conclusion: Coronary aneurysm formation following drug eluting stent
implantation have a varied time course. Development of coronary aneurysms
early after drug eluting stent implantation is very unusual, the mechanism of
which is not clear but they require urgent reintervention.
TCT-438
Late Incomplete Apposition after Implantation of Drug-Eluting Stents
Incidence and Long-Term Adverse Clinical Events
Dimytri A Siqueira, Alexandre Abizaid, Fausto Feres, Luiz A. Mattos,
Andrea C. Abizaid, Rodolfo Staico, Pedro B. de Andrade, Ana C. Seixas,
Luiz F. Tanajura, Amanda G. M. R. Sousa, Jose Eduardo Sousa
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
Introdution : Late incomplete stent apposition ( ISA ) have been
documented after drug-eluting stent implantation . Incidence and
clinical outcomes of patients who presented with this vascular alteration
remains controversial . The aim of our study was to investigate the
incidence and clinical consequences of late ISA after implantation of
sirolimus- or paclitaxel-eluting stents in an unselected population .
Methods : From our clinical and core intravascular ultrasound ( IVUS )
laboratory databases , we identified 195 patients who underwent drug-eluting
stent placement ( 173 with sirolimus- and 22 with paclitaxel-eluting stents )into
native artery lesions and who had IVUS performed at index and after 6-month
follow-up . Late ISA was defined as separation of at least 1 stent strut from
the vessel wall in a segment without a side-branch and where the immediate
post-implantation IVUS revealed complete apposition of stent struts .
Results : We identified 10 patients ( 5,2 % ) with late ISA , 3 patients
after paclitaxel- and 7 patients after sirolimus-eluting stents . ISA was
localized almost exclusively at mid-portion of the stents ( 9 / 10 ) and
mean ISA area and length was 5,64 ± 0,61 mm2 and 4,19 ± 2,12 mm2 ,
respectively . There was an increase in vessel volume ( 385,52 ± 135,88
to 452,32 ± 145,19 mm3 , p = 0,30 ) and plaque volume ( 204,58 ± 48,40
to 259,73 ± 72 mm3 , p =0,059 ) in patients who presented with ISA.
After 19 ± 9 months of follow -up , 2 patients who presented with ISA
had late stent thrombosis ( 331 and 1152 days after stent implantation ) .
Conclusions : Although uncommon ( 5,12 % ) , late ISA could be associated
with adverse clinical events at long-term follow-up .
TCT-439
An Intravascular Ultrasound Analysis of Different Mechanism of Late
Stent Malapposition between Sirolimus- vs. Paclitaxel-Eluting Stents
Myeong-Ki Hong, Cheol Whan Lee, Young-Hak Kim, Bong-Ki Lee, DukHyun Kang, Sang-Sig Cheong, Jae-Kwan Song, Jae-Joong Kim, SeongWook Park, Seung-Jung Park
Compared to bare metal stent, late stent malapposition (LSM) has been
more frequently observed in the era of drug-eluting stent (DES). We
evaluated the different mechanisms of LSM after DES implantation in
85 lesions with LSM between sirolimus-eluting stents (SES, n=71) and
paclitaxel-eluting stents (PES, n=14). There was an increase of external
elastic membrane area (17.1±3.6 to 21.4±4.8mm2, p<0.001) that was
greater than the increase in plaque area (9.3±2.5 to 10.5±2.7mm2, p<0.001).
We performed quantitative post-intervention and 6-month follow-up IVUS
analysis at LSM sections. Quantitative measurements included external
elastic membrane (EEM), stent, plaque and media (P&M), intra-stent
lumen, intimal hyperplasia, and LSM area. At 6-month IVUS follow-up,
there was a tendency for a smaller increase in EEM CSA (p=0.19) and a
statistically smaller increase in P&M CSA and intimal hyperplasia CSA
in sirolimus-eluting stents (p=0.016 and 0.029, respectively) (Table).
Conclusions: The mechanism of LSM in SES was a greater suppression of
peri-stent neointimal hyperplasia (supported by the smaller amount of intrastent neointimal hyperplasia) while the mechanism of LSM in PES was a
greater amount of peri-stent positive remodeling
CSA: cross-sectional area, EEM: external elastic membrane and LSM: late stent
malapposition
SES
PES
P-value
Number of lesions
71
14
4.1±2.2
5.0±2.4
0.19
ΔEEM CSA (mm2)
1.1±1.0
1.8±1.3
0.016
ΔPlaque and media CSA (mm2)
-1.2±0.5
-2.0±1.2
0.023
Δ Intra-stent lumen CSA (mm2)
1.2±0.5
2.0±1.2
0.029
Intimal hyperplasia CSA (mm2)
3.0±1.9
3.2±1.9
0.8
LSM CSA (mm2)
TCT-440
Analysis for the Cause of Thrombosis after Implantation of DrugEluting Stents
Ji-Lin Chen1,2, Bo Xu1, Yue-Jin Yang1, Shu-Bin Qiao1, Xue-Wen Qing1,
Run-Lin Gao1
1
Cardiovascular Institute & Fu Wai Hospital, Beijing, China2Fu Wai
Hospital, Chinese Academy of Medical Science, Beijing, China
Background: Stent thrombosis has been regarded as a severe
complication of PCI therapy , but it is not sure whether drug-eluting
stents (DES) have higher thrombosis rate than that of bare metal stent.
Methods: This study is single center , no limitation of entry criteria for using
DES in patients with CHD. From Nov. 2001 to May 2005, 2479 consecutive
patients who underwent implantation with Cypher stent (1595 patients,
1702 lesions, 1961 stents) or TAXUS stents (884 patients, 1087 lesions,
1261 stents) in our hospital . 9 months follow-up was completed in 1296
patients (775 patients with 856 lesions used 906 Cypher stents, 521 patients
with 629 lesions used 694 TAXUS stents). All patients were pretreated
with Aspirin and clopidogrel according to the ACC/AHA guideline.
Results: 4 patients had acute stent thrombosis (0.14%): 3 in the sirolimus
group, 1 in the paclitaxel group (0.18% vs 0.113% P>0.99 ), 6 patients had
subacute thrombosis (0.38%) : 4 in the sirolimus group and 2 in the paclitaxel
group (0.25% vs 0.22% P=0.99), 5 patients had late thrombosis: 1 in the
sirolimus group and 4 in the paclitaxel group (0.06% vs 0.45% P=0.058)
Subacute thrombosis occurred within 1 week of the PCI in all 6 patients.
The late thrombosis occurred within 6 months in 3 patients, and the
22nd and 23rd month after the procedune in 2 patients. 4 cases (26.7%)
presented with death, 6 cases presented wtih nonfatal MI. The stent
thrombosis was demonstrated by angiography in 11 patients (73.3%).
Acute and subacute stent thrombosis were related to suboptimal stenting
in 5 patients including 4 patients with bifurcation lesion (one case using
crush technique but no- final kiss balloon inflation, one case using
modity “Y” stenting), and related to uncover the lesions in two patients.
Late thrombosis were related to discontinue clopidogel in two case and
related to poor left ventricular function in 3 cases with OMI history.
Conclusion: Our study showed that suboptimal stenting (especially
bifurcation lesions) was the main cause of acute and subacute stent
thrombosis and left ventricular disfunction and premature discontinuation
of antiplatelet therapy were main reason of late thrombosis.
TCT-441
“Black Holes” in Sirolimus-Eluting Stent Failures: A Marker of an
Aggressive Variant of Restenosis
Jose de Ribamar Costa, Jr.1, Stephane G. Carlier1, Gary S. Mintz1, Kenichi
Fujii1, Masashi Kimura1, Koichi Sano1, Jie Qian1, Kaoru Tanaka1, Joanna
Lui1, Judah Weimberger1, George Dangas1, Michael Collins1, Edward M.
Krepp1, Gregg W. Stone1, Jeff W. Moses1,2, Martin B. Leon1
1
Cardiovascular Research Foundation, New York, NY;2Columbia
University Medical Center-New york Presbiterian Hospital, New York, NY
Background:In-stent intima hyperplasia (IH) typically has a homogenous
echoreflective appearance during intravascular ultrasound (IVUS)
imaging. However, the IH of some brachytherapy (VBT) failure lesions
contain a very echolucent, dark zone that has been termed a “black
hole” (BH) - well-formed proliferative tissue, consisting predominantly
of spindle-shaped mesenchymal cells with little collagen and elastin.
Methods: We used IVUS to study a prospective, consecutive series
of 102 SES failures (69 edges and 33 intra-stent) to investigate the
frequency and determinants of “black holes” after sirolimus-eluting stent
(SES) implantation. All cases of BH were intra-stent, so for the statistical
purpose only the 33 intra-stent restenosis were taken into account; and
pts were divided into 2 groups: 8 pts with BH vs 25 pts without BH.
Results: 50% of the BHs occurred in saphenous vein graft lesions
while all non-BHs were in native arteries; and 3 pts in each group had
previous VBT failure (p=0.1). Compared to non-BH cases, a greater
proportion of BH cases occurred after SES treatment of bare metal ISR
(75% vs 32%, p=0.035). BH cases presented earlier (89.9±34.3 vs
161.3±78.8 days, p=0.001) with more severe in-stent restenosis (ISR)
as indicated by greater absolute and relative amounts of IH. (Table).
Conclusions: Echolucent ISR tissue (“black hole”) is more often observed
in SES failures after treatment of SVG lesions or treatment of bare metal
ISR. It occurs early and is more severe than “typical” SES failures.
BH Cases
(n=8)
Female gender
3 (37.5 %)
Diabetes mellitus
4 (50%)
Unstable angina
1 (12.5%)
Time from SES implantation to failure 89.9 ± 34.3
(days)
6 (75%)
Treatment of Bare Metal ISR
Previous vascular brachytherapy
3 (37.5%)
Stent length (mm)
41.2 ± 17.4
7.54 ± 3.50
Reference lumen CSA (mm2)
2.98± 0.99
Minimum lumen CSA (mm2)
5.61± 1.58
Minimum stent CSA (mm2)
IH volume (mm3)
41.3± 10
%IH
29.6± 6.8
Non-BH Cases
(n=25)
5 (28 %)
14 (60%)
5 (20%)
161.3 ± 78.8
8 (32%)
3 (12%)
43.6 ± 17.2
7.70± 4.30
2.75± 0.82
5.59 ± 2.1
26.9± 19.5
10.4± 7.9
P
0.6
0.5
0.5
0.001
0.035
0.1
0.8
0.9
0.5
0.9
0.012
<0.001
TCT-442
Safety and Efficacy of Repeat Drug-Eluting Stent Implantation in
Patients with Drug-Eluting Stent Failures
Jenny Z Qin1, Donna LaMonica1, Kristen Cresenzo1, Gary S Mintz2,
Teraza Conway1, Kenichi Fujii3, Jie Qian4, Paul J Boland1, Mary Ann
Kral1, Roxanna Mehran1, Jeffery W Moses1, Martin B Leon1
1
Columbia University Medical center, New York, NY;2Columbia University
Medical Center /Cardiovascular Research Foundation, New York,
NY;3Columbia University Medical center/Cardiovascular Research
Foundation, New York, NY;4Columbia University Medical Center/
Cardiovascular Research Foundation, New York, NY
Drug-eluting stents (DES) have reduced, but not completely eliminated
in-stent restenosis (ISR). While the treatment of bare metal in-stent
restenosis has always been challenging and has involved various
approaches (intracoronary brachytherapy, cutting balloon angioplasty,
directional coronary atherectomy, rotational coronary atherectomy, and
DES implantation), the optimum strategy for treating this new entity, DES
failures, is completely unknown. From August 2004 to May 2005, 52 pts
presented to Columbia University Medical Center with 65 DES failure
lesions: 58 Cypher failures, 6 Taxus failures, and 1 pt with an unknown
type of DES. Mean pt age was 62±11 yrs, 76% were male, 33% presented
with unstable angina, and 42% had diabetes. Lesion location was left main
(n=1), LAD (n=24), LCX (n=10), RCA (n=19), and SVG (n=11). Thirteen
Cypher failures were treated with repeat Cypher implantation, 39 Cypher
failures were treated with a Taxus stent, 5 Cypher failures were treated with
balloon angioplasty, and 1 percutaneous treatment of a Cypher stent failure
was unsuccessful. Five Taxus failures were treated with a Cypher stent, and
1 Taxus failure was treated with repeat Taxus stent implantation. The one
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patient with failure of an unknown type of DES was treated with balloon
angioplasty. There were no in-hospital events or troponin-I elevations.
All patients are being contacted at 6 months. To date there has been only
1 patient with non- ST-elevation myocardial infarction who required
revascularization. Six month follow-up will be completed in October 2005
and will be included in this analysis.
TCT-443
Stent Thrombosis in a Large Single-Center Drug-Eluting Stent
Registry
Daniela Trabattoni, Stefano Galli, Franco Fabbiocchi, Giovanni Teruzzi,
Piero Montorsi, Giuseppe Calligaris, Alessandro Lualdi, Antonio L
Bartorelli
Stent thrombosis (ST) is a rare complication associated with high morbidity
and mortality. ST after drug-eluting stent (DES) implantation may be
more frequent in “real world” than in control randomized trials (CRT).
Aim
of
study:
To
prospectively
assess
the
incidence
of ST after DES implantation in “real world” patients.
Methods: Between April 2002 and December 2004, DES were implanted
in 867 out of 1733 (50%) pts. Of them, 618 received sirolimus- (SES) and
249 paclitaxel-eluting stents (PES). Clinical f/u was obtained at 1 and 6
months after the procedure. ST was considered to have occurred in case
of cardiac death or angiographic evidence of stented vessel closure (TIMI
grade 0-1 flow) within 24 hours (acute), 30 days (subacute) and > 30 days
(late). Results: Patient and lesion characteristics were similar between
groups. No difference in diabetes (13.2% SES vs. 10.8% PES), small vessel
stenting (18.8% SES vs. 18.9% PES), mean stent per patient (1.89±0.69
SES and 1.75±0.69 PES) and total stent length (27.9±31.8 mm SES and
23.8±29.5 mm PES) weas observed. Total ST rate was 0.8% (0.4% SES,
1.6% PES, p=0.10).
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Results
SES Thrombosis Data
Age/
N°
Vessel
n°
Sex
Stents
#1 63/M LCx
2
LAD/
#2 82/M
4/2
D1
#3 63/M PL
1
PES Thrombosis Data
#1 74/M LAD
1
#2 65/M LCx
1
#3 53/F LAD
1
#4 65/M LAD
1
Total
Stent
Asa/
Stent
Symptoms Days Death
Size
Clopidogrel
Length
41 mm
2.5
Angina
10
no
yes/yes
62/31 mm 3.0/2.5 Q-MI/shock 21 yes withdrawn
23 mm
3.5
non-Q MI
7
no
yes/yes
16 mm
32 mm
28 mm
24 mm
2.5
3.0
2.75
3.0
Q-MI/shock 110
non-Q MI
5
angina
0
angina
1
no
no
no
no
no/yes
withdrawn
yes/yes
yes/yes
Conclusions: This single center registry showed that ST rate after DES use
in “real world” patients is low and similar to that reported in CRT and after
bare-meta

The American Journal of Cardiology

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