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Carotid Angioplasty
Oscar A. Mendiz.MD.FACC.FSCAI
Jefe Cardiología Intervencionista
Mayo 2011
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Conflictos de Interes
Nombre: Oscar A. Mendiz
 Medtronic: Proctor para CoreValve.
 Elli Lilly; Speacker
 AstraZeneca: Advisory Board
 Sponsors para viajes a Congresos: Acher (Cook), Angiocor
(AGA), Cordis, BSCI, Cordis, Medikar, Sanofi.
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2
Carotid Artery Disease
Carotid Stenosis
Symptomatic: ~25%
Asymptomatic: ~75%
Normal Risk
High Risk
Normal Risk
High Risk
~15%
~10%
~50%
~25%
Modified from M Jaff, 2007
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Historical use only?
NASCET Trial: events at 5 years in asymptomatic patients
Although some data suggests you cannot use “>80%” as lone
criteria in asymptomatic pts, it is somehow arbitrary
Only 15% were
receiving lipid
lowering agents!!!!
Note:
1-45% of the neuro events were NOT
related to the carotid lesion
2-Similar events in >60 and >70% stenosis
Barnett HJM, et al. JAMA. 2000;283:1429-1436
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Medical Treatment Improvements
ACE- Inhibitors vs. Placebo
Cardiovascular Endpoints
Number of Events/
Total Patients
ACE-I
Relative Risk
(95% CI)
Placebo
Stroke
166/6060
240/6064
0.70 (0.57-0.85)
CAD
539/6060
672/6064
0.80 (0.72-0.89)
CHF
154/6060
183/6064
0.84 (0.68-1.04)
CV death
307/6060
416/6064
0.74 (0.64-0.85)
Total death 533/6060
632/6064
0.84 (0.76-0.94)
0.5
1.0
Blood Pressure Lowering Treatment Trialists’ Collaboration
Lancet, 2000; 355: 1955-64; HOPE, PART2; QUIET, SCAT
2.0
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Medical Treatment Improvements
Statins: Stroke Reduction in High Risk Ptes
Mark C Bates. www.tctmd.com
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Medical Treatment Improvements: Statins
Carotid Intima Media Thickness
reduction with Atorvastatin
Conclusion: „Marked LDL reduction (<100 mg/dl) with high
potency statins results in regression at 1 year‟
Taylor AJ et al. Circulation 2002; 106: 2055-2060
Improvements on TCD Outcomes
471 Patients with ACS
Received Mx
before 2003
199 pts
Received Mxm
after 2003
272 pts
HITS on TCD
12.6%
HITS on TCD
3.7%
Conclusion: With more intensive Mx, regression of carotid
plaque occurs in half our patients; this has resulted in
a marked decline of TCD microemboli and clinical
events among patients with ACS”.
J. David Spence,et al.. More Intensive Medical Therapy has Reduced Microemboli and
Cardiovascular Eventsin Patients with Asymptomatic Carotid Stenosis Abstract presented
AHA San Diego 2009
Mark C Bates. www.tctmd.com
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Annual TIA & Stroke rate reduction in
asymptomatic control arms of randomized trials
20%
18%
16%
14%
12%
10%
8%
6%
4%
2%
0%
Ipsilateral stroke/ TIA
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Caveats:
1. Different patient population (“low risk”)
2. Improved outcomes with medical therapy have been under the
microscope of a clinical trial driven strict follow-up. Patients are selected
based on their willingness to comply with these strict guidelines and
investigators are admonished for failing to monitor compliance
Ann L. Abbott. Stroke. published on-line Aug 20,2009
Mark C Bates. www.tctmd.com
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Improvements on CAS Outcomes over the time
Mark C Bates. www.tctmd.com
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Improvements on CAS Outcomes over the time:
Post Market registries
Stroke & Death
Incidence
95% CI
3.6%
6.4%
3.2%
3.2-4.1
4.8-8.4
2.8,-3.7
5.3%
2.9%
3.6-7.4
2.4-3.4
10.5%
4.4%
6.3-16.0
3.3-5.7
1.7%
2.7%
0.0-8.9
1.3-4.9
Patients (n = 6,320)
All
Symptomatic
Asymptomatic
<80 Years
Symptomatic
Asymptomatic
≥80 Years
Symptomatic
Asymptomatic
Unfavorable Anatomy
(Any Age)
Symptomatic
Asymptomatic
Gray W et al. Circ Cardiovasc Intervent 2009, 2: 159-166 March
Mark C Bates. www.tctmd.com
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30-day Composite Endpoint in US
Carotid Stenting Registries
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Asymptomatic Carotid Artery Stenosis
CEA
Best Mx
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Carotid Endarterectomy
What do we know about Surgery?:
Surgery for Carotid Stenosis
NASCET Collaborators. N Engl J Med 1994;325:445-453.
ACAS. J Am Med Assoc 1995;273:1421-1428.
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Stroke Risk Reduction According with Carotid
Stenosis: NASCET
% Reducción del Riesgo Absoluto
30
26
25
20
18
12
That15it is highly probably
not true in the current
practice!!!!!!!!!!!!
10
7
5
0
50-69%
70-79%
80-89%
90-99%
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ACAS Study: CEA Not Effective in Women
Stroke and Death @ 5 Years
Percent
14
12
10
8
6
4
2
0
Med
CEA
Men
Rothwel PM; et al. Lancet 2004:364:1122-3
Med
CEA
Women
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Revascularization for Asymptomatic Carotid Artery Stenosis
Background:
Approximately 20% of strokes are attributable to
carotid stenosis.
However,Can
the number
of
asymptomatic
patients
We Improve it ????
needed to prevent one stroke or death with CEA is
high at 17 to 32.
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Carotid Angioplasty: Fundación Favaloro Experience
Patient Selection:
Traditionally:
Inclusion Criteria: (“anatomic”)
Symptomatic Patients with 70% carotid stenosis.
Can We Improve
Asymptomatic
Selection???
Asymptomatic
Patients 80%Patient
carotid stenosis.
Who Benefit More With Revascularization????
Exclusion Criteria.
Patient with dementia or disabling Stroke.
Recent Major Stroke (<30days).
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Carotid Disease
Risk of Stroke in Symptomatic Ptes.
% Stenosis &
Plaque Characteristics
Risk of Stroke
95 % & non Ulcerated
21%
95 % & Ulcerated
73 %
NASCET
Ulcerated & Thrombotic Plaque
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High-Risk Asymptomatic Carotid Stenosis:
Ulceration on 3-D Ultrasound vs. Transcranial Doppler Microemboli
Prospective analysis of 253 ACS ptes with >60% carotid stenosis
3-Year Outcomes
(incidence)
> 3 Ulcers
(4%)
< 3 Ulcers
Microemboli
(3%)
NO
Microemboli
Stroke (%)
18.2
1.7
20.0
1.7
Stroke or Death (%)
18.2
2.1
13.3
1.7
Conclusion: The presence of ulcers or microemboli identify Ptes with
Asymptomatic carotid stenosis who will benefit from revascularization
rather than optimal medical therapy alone.
Madani A, et al. Neurology 2011;77:744-750
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Silent Cerebral Events in Asymptomatic Carotid Stenosis
Aim: to examine the evidence for subclinical microembolization and silent brain infarction
in the prediction of stroke in asymptomatic carotid stenosis using transcranial Doppler
(TCD), computed tomography (CT), and magnetic resonance imaging (MRI).
Outcomes: 58 full text met inclusion criteria.
Follow-Up
Microemboli
Positive
Microemboli
Negative
p
Stroke or TIA
28%
2%
0.001
Stroke
10%
1%
0.004
A specific pattern of silent CT infarctions was related to future stroke risk (odds ratio [OR] = 4.6; confidence
interval [CI] = 3.0-7.2; P < .0001). There are no prospective MRI studies linking silent infarction and stroke risk.
CONCLUSIONS:
There is level 1 evidence for the use of TCD to detect microembolization as a risk stratification tool.
However, this technique requires further investigation as a stroke prevention tool and would be
complemented by improvements in carotid plaque imaging.
Jayasooriya G, et al. J Vasc Surg. 2011 Jul;54(1):227-36
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Carotid Interventions: Safety!
Carotid Endartherectomy:
Guidelines... Acceptable Morbidity and Mortality.
Ad Hoc Committee, AHA.
Symptomatic
<6%
Asymptomatic
<3% !
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Carotid Angioplasty – Fundación Favaloro Experience
October 1995 – May 2011
In-Hospital Results related to previous symptoms:
n=746
Symptom
231(21)
Asymptom
515 (69)
p
With Distal Protection (%)
185 (80)
456 (88.5)
0.003
Procedure Success (%)
Major Stroke (%)
Minor Stroke (%)
215 (93)
9 (3.9) #
6 (2.6) #
501 (97.3)
2 (0.4)
8 (1.6)
0.01
0.006
0.3
8 (3.5)
3 (0.6)
0.005
3 (0.8)*
1 (0.2)
13 (2.4)*
11 (2.1)
1
1
0.007
0.005
Number of Procedures (%)
TIA (%)
Death (non-related to carotid stenting) 1 (0.5)
Related Death
Any Stroke or All Death (%)
16 (6.9)
Any Stroke or Related-Death (%) 15 (6.5)
•non-related death. CV surgery the same day.
# 9 cases in feasibility studies of new stent or Angioguard
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30-day Composite Endpoint in US
Carotid Stenting Registries
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Operator Experience and Carotid Stenting
Outcomes in Medicare Beneficiaries
24,701 procedures performed by 2,339 operators, 2005 to 2007.
Patients treated by very low-volume operators (< 6 procedures) had higher 30day mortality than patients treated by operators performing 24 or more annual
cases (adjusted OR 1.9; P < 0.001)
Mortality also was higher among patients treated early vs. later as operators
gained experience (adjusted OR 1.7; P < 0.001)
Operators with less experience and volume also were less likely to use
embolic protection
Implications: Collecting detailed data about operator experience and volume in the
early dissemination of CAS may help optimize outcomes.
Nallamothu BK, et al. JAMA. 2011;306:1338-1343.
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Mendiz O, et al, Vasc Endovasc Surg 2011, accepted
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Radial Approach
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Early outcome of carotid angioplasty and stenting
with and without cerebral protection devices:
Meta-analysis:
N° Patients
Results at 30-days
Stroke & Death (%)
Minor Stroke (%)
Major Stroke (%)
Death (%)
With
839
Without
2357
p
1.8
0.5
0.3
0.3
5.5
3.7
1.1
0.8
<0.001
<0.001
ns
ns
Kastrup A; et al. Stroke 2003 Mar;34(3):813-19
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CAS in Octogenarians: 30-day Outcomes
November 1995 – May 2011
CAS in Ptes. > 80 years
Octogenarian Non-Octogen p
Procedures
Major Stroke n/(%)
Minor Stroke n/(%)
TIA (%)
Related Death (%)
Non-Related Death n(%) #
Any Stroke & Related Death (%)
83
3 (3.6)
1 (1.2)
3 (3.6)
1 (1.2)
1 (1.2)
5 (6)
663
8 (1.2)
13 (2)
8 (1.2)
3 (0.5)
21 (3.2)
0.1
1
0.1
0.1
0.3
0.2
# 4 ptes. died during the 30-day evolution due to
and emergent CABG or cardiac valve surgery
Up-dated, Mendiz O, et al. ESC 2005
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Post-procedural phase: the dark side of stents
Modified from, A. Cremonesi et al. – EuroIntervention, December 2005
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Carotid Angioplasty – Fundación Favaloro Experience
October 1995 – May 2011
CAS + CV Surgery: In-Hospital Evolution.
Procedures
Procedure Success n/(%)
TIA (%)
Minor Stroke (%)
Major Stroke (%)
Death (%) (non-related to carotid stenting)
Any Stroke or Death (%)
Mendiz O, et al. Cath Cardiovasc Interv 2006 (Up-dated & Modified)
53
49 (92.4)
1 (1.9)
4 (7.5)
4 (7.5)
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Carotid Angioplasty in Diabetic Patients: March 2010
In-Hospital Evolution
Ptes with Distal Protection
N°
DBT
118
Non-DBT
431
Related Death (%)
Non-related Death (%)
Major Stroke (%)
Minor Stroke (%)
TIA (%)
1 (0.8)
1 (0.8)
4 (3.4)
3 (2.5)
5 (1.2)
4 (0.9)
4 (0.9)
7 (1.6)
ns
ns
ns
ns
Stroke + TIA (%)
8 (6.8)
15 (3.5)
ns
Mendiz O; et al. TCT 2005, ESC 2006, (Up-dated & Modified)
p
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Carotid Artery Stenosis: revascularization
CEA
CAS
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CREST Trial: Stenting vs. Carotid Endarterectomy for
Treatment of Carotid Artery Stenosis
p=0.005
p=0.03
p=ns
p=0.03
Brott TG, et al. N Engl J Med 2010;363:11-23
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CAS vs. CEA: Metanalysis and Diversity-Adjusted Trial
Sequential Analysis of Randomized
Periprocedural death, MI or Stroke
CAVEATS:
1-Some of these Trails were done by not well-trained operators for
CAS.
2-New Trials, like ACST-2, will repit the same error and bring new
wrong conclusions.
Banagalore S, et al. Arch Neurol. 2011, Feb;68(2): 172-84
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CAS vs. CEA: A Comprehensive Meta-Analysis of Short-Term
and Long-Term Outcomes
Short term Outcomes for Cranial Nerve Injury
Economopoulus KP, et al. Stroke. 2011 Mar;42(3):687-92.
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Carotid Disease: classical clinical presentation
Carotid Stenosis
“Symptomatic”: ~25%
“Asymptomatic”: ~75%
There are no considerations regarding
“functional” status
Normal Risk
~15%
High Risk
~10%
Modified from M Jaff, 2007
Normal Risk
~50%
High Risk
~25%
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Asymptomatic???
Cerebral perfusion have been shown to be impaired in
asymptomatic Ptes with severe carotid stenosis 1.
Many Asymptomatic Ptes have ischemic defect at CT Scan (~20%)
CT scan defect presents in asymptomatic Ptes can predict new
events at follow-up when obstruction between 60-99%2.
But; what be the impact on neurocognitive functions?
No definitive answers…….
1 Van der Heyden, t al. EuroIntervention. 2011 Apr;6(9):1091-7. .CT measurement of changes in cerebral perfusion in patients with asymptomatic
carotid artery stenosis undergoing carotid stenting prior to cardiac surgery: "proof of principle”
2Kakkos SK, et al, J Vasc Surg. 2009 Apr;49(4):902-9. Epub 2009 Feb 15.Silent embolic infarcts on computed tomography brain scans and risk of ipsilateral
hemispheric events in patients with asymptomatic internal carotid artery stenosis.
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Mendiz OA, Sposato LA, Fabbro N, Lev GA, Calle A, Valdivieso LR, Fava CM,
Klein FR, Torralva T, Gleichgerrcht E, Manes F.J Neurosurg. 2011 Sep 30. [Epub
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Neurocognitive Impact of CAS in Asymptomatic Ptes:
CAS 3-Month F-U: Cognitive Tests Outcomes
Cognitive Feature
Preprocedure
3 months
p
27±16
36±19
<0.001
RALVT D
4.65±3.6
6.9±3.6
<0.001
ROCF D
24.3±14.4
27.3±14.9
<0.001
TMT-B
121.6±96.2
97.1±94.9
<0.001
WCST
2.15±2.1
3.6±2.16
0.013
IST
12.8±9.1
25.3±19.1
<0.001
RALVT
Mendiz O, et al. TCT 2010, oral abstract
Mendiz O, et al. Journal of Neurosurgery. accepted September 2011
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Revascularization for Asymptomatic Carotid Stenosis
Asymptomatic are not all the same.
All treatment outcomes are improved over the
time.
Although carotid revascularization proved to be
beneficial in historical series, we can currently
identify Ptes who may benefit more using
revacularization on top of the best Mx treatment.
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Carotid Artery Stenosis
CAS is safe and effective in Symptomatic and
Asymptomatic Ptes. when done by well-trained
operators.
CAS can be applied to most of Ptes with
favorable anatomy.
CAS has more stroke risk and less MI and cranial
nerve injury risk according to current evidence.
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Pending Questions??
Can be appliyed to everybody??? …..Patient
Selection
Can be done for everybody???...............
Operators Selection
Devices selection (proximal vs. distal
protection. Open vs. closed cell stent design)
Does it improve neurocognitive function???
Is it as safe and effective as CEA?
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Gracias por su atención
[email protected]
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N Engl J Med 2008
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Carotid Endartherectomy in Women
Subgroup Analysis:
Men
Women
Rothwel PM; et al. Lancet 2004:364:1122-3
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SPACE Trial: CAS vs. CEA in Symptomatic Patients
30-day Outocomes
10
8
6.84
p=0.09
6.34
6
4
2
0
Stent (605)
CEA n(595)
Death / Ipsilateral Stroke
Non inferiority primary EP was not achieved
Lancet. 2006 Oct 7;368(9543):1239-47
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EVA-3S:
CEA vs. Stenting in Ptes with Symptomatic Severe Carotid Stenosis
Stent
CEA
p
(261 Ptes)
(259Ptes)
Death (%)
0.8
1.2
ns
Nonfatal Stroke (%)
8.8
2.7
0.004
Disabling (%)
2.7
0.4
Nondisabling (%)
6.1
2.3
Any Stroke or Death (%)
9.6
3.9
0.01
Myocardial Infarction (%)
0.4
0.8
ns
Cranial nerve injury (%)
1.1
7.7
<0.001
Any Stroke or Death: NNT 1/17
Mas Jea-Louis, et al. N Engl J Med 2006;355:1660-71
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Conclusiones desde la Evidencia y la Experiencia
en la F Favaloro
Angioplastia Carotidea es:
Altamente recomendada en Ptes Sintomáticos
con alto riesgo para cirugía.
Probablemente beneficiosa en Ptes asintomáticos
con alto riesgo TQ.
Excelente alternativa en la mayoría de los casos.
Octogenarios y otros grupos de alto riesgo deben
ser cuidadosamente evaluados de acuerdo a la
experiencia del centro y el operador.
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Pending Questions??
Can be done for everybody???...............
Patient Selection
Operators Selection
Devices selection
Does it improve neurocognitive function???
Is it as safe and effective as CEA?
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