Safety. First.

Transcription

Safety. First.

INSIDE THIS ISSUE
TIMING OF PCI AFTER
SURGERY IMPORTANT
PCI after noncardiac surgery a
potential MACE risk factor.
page 3
ACC, CRF ANNOUNCE
COLLABORATION
American College of Cardiology
will co-sponsor TCT beginning
in 2011.
page 8
EVEREST II RESULTS
ANNOUNCED
Trial stirs debate over effectiveness
of intervention for mitral
regurgitation.
page 12
PCI FOR LEFT MAIN
DISEASE
New guidelines suggest PCI is a
viable option in some patients with
unprotected left main disease.
page 14
Washington D.C.
PARTNER: All-Cause, CV Mortality
Lower in Patients Treated with TAVI
vs. Standard Therapy at 1 Year
LATE-BREAKING TRIAL
New randomized clinical trial data demonstrate statistically significant reductions in
all-cause and CV mortality with transcatheter aortic valve implantation compared with
standard therapy in patients who are not
candidates for surgical therapy, according
to data presented at
TCT 2010.
“Although patient
selection,
operator
skills and technology
have improved, all previous
transcatheter
Martin B. Leon, MD
aortic valve implanta-
Two late-breaking clinical trials at TCT 2010
have demonstrated that Xience V, a second-generation DES, produces superior
and sustained benefits over the standard
Taxus stent.
SPIRIT IV
For SPIRIT IV, researchers randomized
3,687 patients in a 2:1 ratio to treatment
with the everolimus-eluting Xience V stent
(Abbott Vascular) or the paclitaxel-eluting
Taxus Express stent (Boston Scientific).
Gregg W. Stone, MD, of Columbia University Medical Center, New York, N.Y., present-
8
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TCT 2010
TCT2010_2_Friday_1.indd 1
tion (TAVI) studies have been observational
registries, without standardization of endpoint
definitions,” TCT Course Director Martin B.
Leon, MD, of Columbia University Medical
Center, New York, said in his presentation.
The PARTNER investigators randomized
358 patients with severe aortic stenosis and
cardiac symptoms who were
unable to undergo surgery.
They then assessed the safety and effectiveness of TAVI
(n=179) vs. standard therapy
(n=179).
Primary, co-primary endpoints
At 30 days, all-cause mortality was
(PARTNER, continued on page 38)
SPIRIT IV: Everolimus-Eluting
Stent Sustains Advantage over
Paclitaxel-Eluting Stent at 2 Years
LATE-BREAKING TRIALS
To view additional online tables and slides
via the accompanying tags, download the
free ‘app’ at http://gettag.mobi from your
mobile device.
Tags are made possible through support
from Edwards Lifesciences.
Friday, September 24, 2010
ed data showing that, compared with the paclitaxel-eluting stent, the everolimus-eluting
stent continued to reduce the primary
composite endpoint of target lesion failure
(a composite of cardiac death, target-vessel MI or ischemia-driven target lesion revascularization) as well as its individual
components from 1 to 2 years. Academic
LEVANT I,
PERfECT Stent
Uphold Promise
The LEVANT I and PERfECT Stent studies yielded positive results for drugeluting balloons, according to findings
presented at TCT 2010.
Dierk Scheinert, MD, of Park Hospital in Leipzig, Germany, reported that the
Moxy drug-coated balloon catheter (Lutonix) outperformed standard percutaneous transluminal angioplasty for the treatment of femoropopliteal disease.
“The primary endpoints of late lumen
loss in the intention-to-treat and per protocol analyses at 6
months were met,”
Scheinert said.
Jochen Wöhrle,
MD, of the University of Ulm in
LEVANT I
Ulm,
Germany,
reported that the
combined
treatment strategy of a
paclitaxel-coated
balloon (SeQuent
PERfECT
Please, B. Braun)
(LEVANT I, PERfECT, continued on page 38)
Today’s Highlights
Plenary:
The TCT 2010 Geoffrey O. Hartzler Master Clinical
Operator Award
Main Arena, 10:45 a.m. to 11:00 a.m.
Plenary:
Late Breaking Trials II
Main Arena, 11:00 a.m. to 12:00 p.m.
Special Session:
The PARTNER Trial: In-Depth Analyses
Room 207AB, 12:00 p.m. to 2:00 p.m.
Meet the Trialists:
Exhibit Hall, 1:00 p.m. to 2:00 p.m.
COMPARE
SPIRIT IV
(SPIRIT IV, continued on page 38)
Plenary:
The “Best of the Best” TCT 2010 Abstracts
Main Arena, 2:50 p.m. to 3:30 p.m.
Safety. First.
Visit us at booth 1456
9/23/2010 11:33:56 PM
Shows a Significant
Cardiac Mortality Benefit
Cardiac Death Rate (%)
10
50%
psup= 0.033
8.8
-73.9%
8
6
4
2.3
2
10
Cardiac Death Rate (%)
74%
Significant Reduction in Cardiac
Mortality in STEMI Patients
at 2 Years1
Significant Reduction in Cardiac
Mortality in Complex Patients
at 2 Years2
Syntax Score High (>16)
psup= 0.045
9.6
8
-50.5%
6
4.7
4
2
0
0
Cypher® Select™ (n = 140)
BioMatrix Flex™ (n = 135)
LEADERS post-hoc analysis
Cypher® Select™ (n = 222)
BioMatrix Flex™ (n = 239)
LEADERS post-hoc analysis
1. Oldroyd, K., oral presentation, EuroPCR 2010
ACS defined as a composite of ACS-STEMI (ST-elevated Myocardial Infarction),
ACS-NSTEMI (Non ST-elevated Myocardial Infarction) and unstable angina.
For display purposes only.
Not approved for use in the United States.
BioMatrix Flex Drug Eluting Coronary Stent System is CE approved.
BioMatrix Flex is a trademark or registered trademark of
Biosensors International Group, Ltd. in the United States and other countries.
All cited trademarks are the property of their respective owners.
Not available for sale in the United States and certain other countries.
© 2010 Biosensors International Group, Ltd. All rights reserved.
10810-000-EN - Rev.01 + 10822+10811-000-EN - Rev.02
2. Wykrzykowska, J., oral presentation, Late Breaking Trial Session, EuroPCR 2010
Visit us at Booth 1452
TCT2010_2_Friday_2-8.indd 2
9/23/2010 10:49:51 PM
3
TCT Daily
LANCELOT: Atopaxar Inhibits PAR-1
Without Significant Increases in Bleeding
More studies needed, but blockade of
PAR-1 receptor appears to be safe and
potentially effective.
LATE-BREAKING TRIAL
Results from the LANCELOT-ACS trial
suggest that atopaxar, an orally active
reversible inhibitor of the PAR-1 receptor, does not significantly increase CURE
bleeding or TIMI bleeding in patients
with acute coronary syndromes.
Figure 1
Discussing the results during a
plenary session Thursday, Michelle
O’Donoghue, MD, MPH, of Brigham
and Women’s Hospital in Boston, said
that although the study was not powered to detect efficacy, a significant
decrease in Holter-detected ischemia
suggested favorable trends.
“This signal towards efficacy was
supported by a significant 33% relative
risk reduction in the incidence of Holterdetected ischemia following the com-
Figure 2
mon 400-mg loading dose,” she said.
For the LANCELOT-ACS study,
researchers at 187 sites in 22 countries enrolled 603 patients with ACS.
Patients were assigned to placebo
(n=142), 50 mg daily atopaxar (n=156),
100 mg (n=157) or 200 mg (n=148). All
patients in the atopaxar group received
a 400-mg loading dose.
For the primary endpoint of incidence
of any CURE-defined major bleeding at
12 weeks, O’Donoghue said patients
did not experience a significant increase
in CURE bleeding when assigned to
atopaxar (see Figure 1). Additionally,
incidence of TIMI bleeding was similar
between the two groups (see Figure 2).
Although there was no significant
difference in incidence of cardiovascular death,
MI, stroke or recurrent ischemia,
when data were
combined for all
atopaxar dosing
groups and compared with placebo (RR=1.04;
95% CI, 0.551.97), those assigned to 50 mg
daily
atopaxar
had a decrease in
the incidence of these combined secondary endpoints from 7.8% to 3.8%
(RR=0.50; 95% CI, 0.16-1.27). However, O’Donoghue said there was no
Measuring Platelet Function Has Merit
Functional testing, yes; genotyping, not yet.
There are at least three good reasons to
measure patients’ platelet function, said
J.M. ten Berg, PhD, of St. Antonius Hospital in Nieuwegein, The Netherlands.
There is a marked interindividual variability in baseline reactivity, ten Berg
said. Patients who have high spontaneous aggregation do significantly worse
than those who have normal aggregation. There also is wide interindividual
variability in response to antiplatelet drugs.
Most
important, a “one size
fits all” approach
does not provide
adequate protection in all patients.
However,
it
J.M. ten Berg, PhD
is important not
to simply measure response or “resistance,” which does not take into account baseline reactivity, ten Berg said.
Instead, clinicians should measure ontreatment platelet reactivity in patients
undergoing PCI, he recommended.
On-treatment reactivity correlation
The POPULAR trial was able to
identify four platelet function tests that
reliably predict clinical outcome: light
transmittance aggregometry, VerifyNow
P2Y12 assay, Plateletworks and the
LGA-20 system. According to ten Berg,
one immediate motivation to use these
tests is that PCI patients with high onclopidogrel platelet reactivity face an
increased risk of periprocedural MI, but
adding a glycoprotein IIb/IIIa inhibitor
reduces the risk.
The positive predictive value of the
functional tests is low, but their negative predictive value is high, he added.
About 75% of patients undergoing PCI
fall into the category of normal reactivity.
Testing can reassure that these patients
probably will not have to be switched to
a more potent and costly therapy.
Genotyping an unreliable predictor
Dirk Sibbing, MD, of the Deutsches
Herzzentrum München in Munich, Germany, underlined the limitations of genetic testing.
The wide variability in response
to clopidogrel is primarily due to its
bioactivation, which depends on two
steps, with CYP2C19 as a key isoenzyme for both. Two polymorphisms
of CYP2C19 — *2 and *17 — are the
focus of most research because they
Clinicians should
measure on-treatment
platelet reactivity in
patients undergoing
PCI.
dose-dependent trend.
There also was a non-significant
decrease in incidence of cardiovascular death, MI or stroke in the combined
atopaxar groups compared with placebo (5.6% vs. 3.3%; RR=0.58; 95%
CI, 0.25-1.41). The greatest reduction
again was observed in the 50-mg daily group (1.9%;
RR=0.34; 95% CI,
0.10-1.18) which
also did not reach
statistical significance.
Incidence
of
Holter-detected
ischemia at 48 Michelle O’Donoghue,
hours
following MD, MPH
a 400-mg loading dose of atopaxar
was 28.1% in the placebo group and
18.7% in the combined atopaxar group
(RR=0.67; 95% CI, 0.48-0.94; P=.02).
“Atopaxar achieves potent and rapid
platelet inhibition via the PAR-1 receptor
without a clear increase in bleeding in
patients with ACS,” O’Donoghue said.
“Future studies will be required to fully
establish the safety
and efficacy of atopaxar. However, the PAR-1
receptor appears to be
a promising target.”
Disclosures:
●
Dr. O’Donoghue reports receiving
grant funding from Eisai and
GlaxoSmithKline
and
receiving
honoraria from Daiichi Sankyo, Eli
Lilly and GlaxoSmithKline.
Carrying either a *2 or *17 allele affects platelet aggregation. But, Sibbing
pointed out, even patients who are
homozygous for these alleles still can
be stratified into low, normal and high
responders. The lesson is that there is
a wide spread of aggregation values
across genotypes, and genotype does
not reliably predict responder phenotype.
As a result, genotyping for CYP2C19
cannot substitute for platelet function
testing, which is likely to be a better tool
for assessing response, Sibbing said.
However, genotyping may have added
value in combination with platelet function testing, he added.
Disclosures:
Dr. ten Berg reports receiving
speaker’s fees from Bristol-Myers
Squibb, Eli Lilly, Merck Sharpe
Dome and Sanofi-Aventis and
serving as a consultant to Eli Lilly,
GlaxoSmithKline, Sanofi-Aventis and
Schering-Plough.
●
Dr. Sibbing reports receiving grant
support from Cordis, Dynabyte, Eli
Lilly, Medtronic and PGXHealth and
consulting fees from AstraZeneca,
Dynabyte, Eli Lilly and The Medicines
Company.
●
have an impact on response and because they are fairly common, he said.
CYP2C19*2 is a loss-of-function allele that attenuates clopidogrel response and has been associated with
an increased risk of stent thrombosis.
Moreover, there appears to be a genedose effect in carriers of two *2 alleles.
CYP2C19*17, on the other hand, enhances response; carriers of this allele
are at increased risk of bleeding.
9/23/2010 10:49:58 PM
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5
TCT Daily
Strategies Outlined for Overcoming
Platelet Reactivity in Resistant Patients
Two trials presented at TCT 2010 investigated strategies for overcoming
genetic resistance to conventional antiplatelet therapy.
Jean-Philippe Collet, MD, of Pitié
Salpêtrière Hospital in Paris, France, cited
recent studies showing a higher risk of
stent thrombosis among carriers of the
CYP2C19*2 loss-of-function allele.
These results are fascinating for geneticists, but there is a lack of guidance on
how to implement
this information in
clinical practice,
Collet said.
In the first phase
of the crossover
trial, 106 young
(⬍45 years), postMI patients, most
Jean-Philippe Collet, MD
on dual antiplatelet
therapy, were randomized to a 300-mg or
900-mg loading dose of clopidogrel. After
a 4-week washout period, the patients
were switched to the opposite regimen.
Of the 106 participants, 51 were carriers of the CYP2C19*2 loss-of-function
allele (43 heterozygotes [normal/*2]; 8
homozygotes [*2/*2]); the balance of patients were age- and gender-matched
noncarriers (normal/normal).
The main endpoints were the relative
reduction in residual platelet aggregation
(RPA) and the formation of active metabolites between baseline and 6 hours.
There was a stepwise reduction of RPA
with decreasing numbers of *2 alleles at
the 300-mg dose. At the 900-mg dose, the
difference between normal homozygotes
and heterozygous *2 carriers was attenuated, but there was little effect on homozyotes (see Figure).
Collet concluded that homozygotes require alternate therapy.
“We need to define a clinical strategy
to exploit this pharmacogenetic informa-
Figure
tion to optimize outcomes in patients who
are eligible for clopidogrel,” he said.
Dimitrios Alexopoulos, MD, of Patras
University Hospital, Patras, Greece, reported results of the PRO-GR trial, which
investigated the antiplatelet effects of
the potent P2Y12 inhibitor prasugrel
compared with high-dose maintenance
clopidogrel in clopidogrel-resistant patients following PCI.
At the time of PCI, a 600-mg loading
dose was given to clopidogrel-naïve patients or to those on 75-mg clopidogrel for
⬍7 days without initial loading. No additional loading dose was given to patients
who were on clopidogrel
for ⬎7 days or those who
were on clopidogrel for
⬍7 days but who had
received an initial loading
dose of 300 mg.
Following PCI, platelet
reactivity was assessed
in 210 patients (about
75% with acute coronary
syndromes) using the
VerifyNow point-of-care
assay (Accumetrics). Of
those patients, 71 had
high on-treatment reactivity based on a cutpoint
of ⭓235 platelet reactivity units. This
study group also was genotyped for CYP2C19*2 allele status.
These patients then were randomized
to receive 150 mg of clopidogrel (n=35) or
10 mg of prasugrel (n=36) daily, crossing
over therapy after 30 days.
In combined pre- and post-crossover
data, platelet reactivity at 60 days, the primary endpoint, was significantly lower in the
prasugrel group compared with the clopidogrel group (129.4 PRU vs. 201.7 PRU,
P⬍.001). The incidence of high platelet reactivity was lower in patients on prasugrel
compared with those on clopidogrel (7.5%
vs. 35.8%, P⬍.01), with almost no patients
on prasugrel remaining “resistant.”
In patients who have high platelet reactivity after PCI, prasugrel is more effective
than high-dose clopidogrel in inhibiting
platelet reactivity, and the effect is more
prominent in patients who carry at least
one loss-of-function allele, Alexopoulos
said.
Disclosures:
• Dr. Alexopoulos reports no relevant
conflicts of interest.
• Dr. Collet reports receiving research
grants from Bristol-Myers Squibb,
Cordis Corporation, Eli Lilly, Johnson
& Johnson, Medtronic and SanofiAventis; consulting and lecture fees
from
AstraZeneca,
Bristol-Myers
Squibb, Daiichi Sankyo, Eli Lilly and
Sanofi-Aventis.
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9/23/2010 10:50:05 PM
Why Should You
Treat Veins?
Join us for the TCT Workshop:
“How Treating Veins
Changed My Practice”
Ask a panel of experts about their
experiences and learn about clinical
opportunities in endovenous laser ablation.
TCT Presentation Theater
Friday, September 24, 2010, 2 p.m.
• Learn how to easily incorporate vein treatment into your current practice
• More than 50% of people over the age of 50 suffer from superficial venous disease
• Nationally reimbursed by Medicare more than $1,000 for qualified patients for a
procedure that takes less than one hour
Space is limited, register today at
AngioDynamics’ booth #1117
9/23/2010 10:50:10 PM
7
TCT Daily
Noncardiac Surgery After Stent
Placement Ups Risk for Complications
Patients who undergo an elective noncardiac surgical procedure shortly after
PCI with stent placement may be at increased risk for complications, including
stent thrombosis. During his presentation on Thursday, Charanjit S. Rihal, MD,
highlighted some management strategies
to reduce these risks.
Rihal, of the
Mayo Clinic in
Rochester, Minn.,
reviewed
2008
data on the incidence of MACE
after PCI. One
study assessed
the optimal duraCharanjit S. Rihal, MD
tion of time that
elective noncardiac surgery should
be delayed after PCI with BMS. The
incidence of MACE was lowest when
noncardiac surgery was performed at
least 90 days after PCI with BMS (see
Figure).
In another study looking at MACE in
patients who received DES and were
scheduled for noncardiac surgery within
2 years, postoperative stent thrombosis
risk factors included emergency surgery,
older age, prior stenting for MI, prior
stent thrombosis or not adhering to physician recommendations.
Some of the best management approaches for the DES patient requiring
surgery, Rihal suggested, are to:
●
Postpone the surgery, if possible.
●
Operate on the patient while using
dual antiplatelet therapy.
●
Operate on the patient while using
aspirin.
●
Use BMS if the surgery is planned.
●
Seek alternatives to surgery altogether.
low bleeding risk and some antiplatelet
therapy is recommended. However, if
the risk for bleeding is high, clinicians
must still negotiate to minimize [time
without antiplatelet therapy].”
Disclosures:
Dr. Rihal reports no relevant conflicts
of interest.
●
Dr. Dauerman reports receiving
●
research
support
and consulting fees/
honoraria from Abbott
Vascular, Medtronic
and MDS Scientific
and has received
consulting
fees/
honoraria from The
Medicines Company
and St. Jude Medical.
Figure
Stent thrombosis and antiplatelet
therapy
In a separate presentation, Harold L.
Dauerman, MD, of the University of Vermont in Burlington, cautioned against
discontinuing antiplatelet therapy after a
nonsurgical procedure.
As an example, he cautioned that
cessation of dual antiplatelet therapy
after a gastrointestinal procedure may
lead to increased stent thrombosis.
However, Dauerman added, aspirin
may be administered without significant
increase in risk for bleeding in most GI
procedures.
“Don’t stop the aspirin unless the
GI doctor convinces you the patient is
at high risk for bleeding. Avoid ‘no antiplatelet therapy’ after DES at all times
— whether it is at 3 months, 6 months, 1
year or 5 years [post PCI],” he said.
“The default reflex of clinicians should
be to reject a strategy of ‘no antiplatelet
therapy’ at any time after DES,” Dauerman said. “Most GI procedures have
9/23/2010 10:50:10 PM
8
FRIDAY • SEPTEMBER 24, 2010
ACC Named Official Co-Sponsor of TCT
Beginning in 2011
The new collaboration builds upon a preexisting partnership agreement between
the two organizations.
The American College of Cardiolbetween the two organizations initiogy and the Cardiovascular Research
ated in 2008. The initial partnership
Foundation announced an educaallowed CRF to aid in the selection of
tional collaboration between the two
interventional content for the Innovaorganizations, making ACC
an official co-sponsor of the
annual TCT meeting. Beginning in 2011, the meeting will
become: Transcatheter Cardiovascular Therapeutics in
Partnership with ACC.
“It is our hope that this
close relationship will prove
over the years to be very
meaningful to you and to
bring more value to your
practices,” TCT Course Director Gregg W. Stone, MD,
of Columbia University Medical Center, New York, N.Y., Drs. Holmes, Lewin, Leon and Stone announce the new CRF/ACC collaboration.
said during a Main Arena announcement at TCT 2010.
tions in Interventions Summit at ACC’s
The new collaboration builds upon
Annual Scientific Session. With the
a pre-existing partnership agreement
partnership, however, TCT will remain
®
The XIENCE V Everolimus Eluting Coronary Stent on the
MULTI-LINK MINI-VISION or MULTI-LINK VISION
Delivery System
®
®
INDICATIONS
The XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V
stent) is indicated for improving coronary luminal diameter in patients with
symptomatic heart disease due to de novo native coronary artery lesions
(length ≤ 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm.
CONTRAINDICATIONS
The XIENCE V stent is contraindicated for use in patients:
• Who cannot receive antiplatelet and/or anti-coagulant therapy
• With lesions that prevent complete angioplasty balloon inflation or
proper placement of the stent or stent delivery system
• With hypersensitivity or contraindication to everolimus or structurallyrelated compounds, cobalt, chromium, nickel, tungsten, acrylic and
fluoropolymers.
WARNINGS
• Ensure that the inner package sterile barrier has not been opened or
damaged prior to use.
• Judicious patient selection is necessary because device use has been
associated with stent thrombosis, vascular complications, and/or
bleeding events.
• This product should not be used in patients who are not likely to comply
with the recommended antiplatelet therapy.
PRECAUTIONS
• Stent implantation should only be performed by physicians who have
received appropriate training.
• Stent placement should be performed at hospitals where emergency
coronary artery bypass graft surgery is accessible.
• Subsequent restenosis may require repeat dilatation of the arterial
segment containing the stent. Long-term outcomes following repeat
dilatation of the stent are presently unknown.
• Risks and benefits should be considered in patients with severe
contrast agent allergies.
• Care should be taken to control the guiding catheter tip during stent
delivery, deployment and balloon withdrawal. Use fluoroscopy to avoid
arterial damage.
• Stent thrombosis is a low-frequency event that current drug-eluting stent
(DES) clinical trials are not adequately powered to fully characterize.
Stent thrombosis is frequently associated with myocardial infarction (MI)
or death.
a CRF event and the i2 Summit will remain an ACC event.
New collaborative efforts
According to Stone, the multi-year
commitment will allow the two organizations to develop and share website
content for CardioSource and TCTMD;
develop and promote national and international educational meetings; develop
young faculty and investigational programs to continue
to search out and nurture the
next generation of leaders
and practitioners; and to align
CME and RWI/COI policies
in an effort to try and take a
leadership role in the field.
A physician-led collaborative council comprising senior physician leaders from
both organizations will meet
regularly to review progress
and set the direction of the
affiliation. Further national
and international educational
program collaborations and
scientific efforts also will be explored.
“This meeting has always been a lens
to the future, and we are hoping with
• When DES are used outside the specified Indications for Use, patient
outcomes may differ from the results observed in the XIENCE V SPIRIT
family of trials.
• Compared to use within the specified Indications for Use, the use of
DES in patients and lesions outside of the labeled indications, including
more tortuous anatomy, may have an increased risk of adverse events,
including stent thrombosis, stent embolization, MI or death.
• Orally administered everolimus combined with cyclosporine is
associated with increased serum cholesterol and triglycerides levels.
• A patient’s exposure to drug and polymer is proportional to the number
of and total length of implanted stents. See Instructions for Use for
current data on multiple stent implantation.
• Safety and effectiveness of the XIENCE V stent have not been
established for subject populations with the following clinical settings:
• Patients with prior target lesion or in-stent restenosis related
brachytherapy, patients in whom mechanical atherectomy devices
or laser angioplasty devices are used simultaneously, women who
are pregnant or lactating, men intending to father children, pediatric
patients, unresolved vessel thrombus at the lesion site, coronary artery
reference vessel diameters < 2.5 mm or > 4.25 mm or lesion lengths
> 28 mm, lesions located in saphenous vein grafts, unprotected left
main coronary artery, ostial lesions, chronic total occlusions, lesions
located at a bifurcation or previously stented lesions, diffuse disease
or poor flow (TIMI < 1) distal to the identified lesions, excessive
tortuosity proximal to or within the lesion, recent acute myocardial
infarction (AMI) or evidence of thrombus in target vessel, moderate
or severe lesion calcification, multivessel disease, in-stent restenosis,
and patients with longer than 24 months follow-up.
• Everolimus has been shown to reduce the clearance of some
prescription medications when it was administered orally along with
cyclosporine (CsA). Formal drug interaction studies have not been
performed with the XIENCE V stent because of limited systemic
exposure to everolimus eluted from XIENCE V.
• Everolimus is an immunosuppressive agent. Consideration should be
given to patients taking other immunosuppressive agents or who are
at risk for immune suppression.
• Oral everolimus use in renal transplant patients was associated with
increased serum cholesterol and triglycerides that in some cases
required treatment.
• Non-clinical testing has demonstrated that the XIENCE V stent, in
single and in overlapped configurations up to 68 mm in length, is
MR Conditional. It can be scanned safely under the conditions in the
Instructions for Use.
these many other educational formats
that TCT will enrich your understanding
of interventional cardiovascular medicine, allowing you to become better
physicians, health care providers, practitioners, investigators and clinicians,”
TCT Course Director Martin B. Leon,
MD, of Columbia University Medical
Center, told attendees at the meeting.
Our message to all
of our colleagues is to
adapt and evolve.
“
- Martin B. Leon, MD
”
“Our message to all of our colleagues
is to adapt and evolve.”
President-elect of the ACC David
R. Holmes, MD, of the Mayo Clinic in
Rochester, Minn., expressed enthusiasm about the collaboration.
“Education could be deemed as
an exchange of ideas from one part to
another, and during this process of exchange each party learns about each
other’s needs, visions and expectations,” Holmes said. “The future will
be about developing enthusiasm and
opportunities and also about delivering the most optimal care around the
world. The ACC is greatly excited to
celebrate this process.”
• The XIENCE V stent should be handled, placed, implanted and
removed according to the Instructions for Use.
POTENTIAL ADVERSE EVENTS
Adverse events (in alphabetical order) which may be associated with
coronary stent use in native coronary arteries include but are not limited to:
• Abrupt closure, Access site pain, hematoma, or hemorrhage, Acute
myocardial infarction, Allergic reaction or hypersensitivity to contrast
agent or cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers;
and drug reactions to antiplatelet drugs or contrast agent, Aneurysm,
Arrhythmias, atrial and ventricular, Arterial perforation and injury to
the coronary artery, Arterial rupture, Arteriovenous fistula, Bleeding
complications, which may require transfusion, Cardiac tamponade,
Coronary artery spasm, Coronary or stent embolism, Coronary or
stent thrombosis, Death, Dissection of the coronary artery, Distal
emboli (air, tissue or thrombotic), Emergent or non-emergent coronary
artery bypass graft surgery, Fever, Hypotension and/or hypertension,
Infection and pain at insertion site, Injury to the coronary artery,
Ischemia (myocardial), Myocardial infarction (MI), Nausea and
vomiting, Palpitations, Peripheral ischemia (due to vascular injury),
Pseudoaneurysm, Renal Failure, Restenosis of the stented segment of
the artery, Shock/pulmonary edema, Stroke/cerebrovascular accident
(CVA), Total occlusion of coronary artery, Unstable or stable angina
pectoris, Vascular complications including at the entry site which may
require vessel repair, Vessel dissection.
Adverse events associated with daily oral administration of everolimus to
organ transplant patients include but are not limited to:
• Abdominal pain, Acne, Anemia, Coagulopathy, Diarrhea, Edema,
Hemolysis, Hypercholesterolemia, Hyperlipidemia, Hypertension,
Hypertriglyceridemia, Hypogonadism male, Infections: wound infection,
urinary tract infection, pneumonia, pyelonephritis, sepsis and other
viral, bacterial and fungal infections, Leukopenia, Liver function test
abnormality, Lymphocele, Myalgia, Nausea, Pain, Rash, Renal tubular
necrosis, Surgical wound complication, Thrombocytopenia, Venous
thromboembolism, Vomiting.
Prior to use, please reference the Instructions for Use at
www.abbottvascular.com/ifu for more information on indications,
contraindications, warnings, precautions and adverse events.
AP2932814 Rev. A 7/10 ©2010 Abbott Laboratories
9/23/2010 10:50:14 PM
Driving Innovation.
Delivering Solutions.
Every day, we’re redefining vascular care through:
t"SPCVTUEFWFMPQNFOUQJQFMJOFXJUIDVUUJOHFEHFUFDIOPMPHJFT
t6OJRVFJOJUJBUJWFTEFTJHOFEXJUIZPVBOEZPVSQBUJFOUTJONJOE
t$PNQSFIFOTJWFUSBJOJOHBOEFEVDBUJPOQSPHSBNT
With every innovation, we’re turning science into caring
TCT 2010
Visit us at booth 1456
For more information, visit our website at AbbottVascular.com.
© 2010 Abbott Laboratories. All rights reserved. Printed in the USA.
AP2932547 Rev. A 07/10
9/23/2010 7:32:43 PM
10
Biolimus-Eluting Stent May Be Beneficial
in Patients with STEMI
Use of a biodegradable polymer may explain
lower rates of MACE in LEADERS subgroup.
Three-year results from LEADERS suggest noninferior safety and efficacy of a
biolimus-eluting stent compared with a
sirolimus-eluting stent, although the former may be superior in reducing MACE
among patients with STEMI.
Previously, investigators have reported noninferior MACE rates at 9 months
associated with an
abluminal biodegradable biolimus
A9-eluting stent
(BioMatrix
Flex,
Biosensors) compared with a sirolimus-eluting coronary stent (Cypher
Patrick W. Serruys, MD, PhD
Select,
Cordis
Corporation). That finding also was confirmed at 12 and 24 months, Patrick W.
Serruys, MD, PhD, of Erasmus Medical
Center, Rotterdam, The Netherlands,
said at TCT 2010.
In the overall population of patients
enrolled in the prospective, randomized
trial, there was no difference in rates of
MACE (cardiac death, MI and clinically
indicated target vessel revascularization)
at 3 years. However, “the Kaplan-Meier
curves for MACE continue to diverge,
showing lower event rates for the biolimus group,” Serruys said.
Subgroup analysis among STEMI patients revealed a significantly lower rate
of MACE in patients in the biolimus group
compared with the sirolimus group: 9.6%
vs. 20.7%, respectively (Psup = .01). The
explanation for this result is unknown,
but the interaction of the biodegradable
polymer used in the manufacture of the
biolimus stent in the face of long-standing thrombogenesis may be part of the
reason, Serruys said.
“The coating is certainly an element,”
Serruys said. “On the other hand, with the
biolimus A9, you have something that disappears with water and CO2, and you are
facing again a BMS. That is at least the
theory, and that is why people believe it is
better to do such an implant in acute MI.”
Further study is ongoing among patients with STEMI implanted with the biolimus stent, Serruys said.
Three-year outcomes
At 3 years , 812 of the 857 patients initially randomized to the biolimus stent in
LEADERS were still being followed, and
the rate of cardiac death in that group
was 4.2%. In the sirolimus group, 809
of the 850 patients randomized were still
being followed, and the cardiac death
rate in that group was 5.2%.The difference was not statistically significant.
The rate of cardiac death in either
group did not change significantly from
the 2-year time point, when it was 3.2%
in the biolimus group and 4.1% in the sirolimus group.
The rate of MI at 3 years was similar
between the two groups: 7.1% in the
biolimus group and 7.2% in the sirolimus
Figure
group. Among study patients, TVR was
initiated in 11.1% of sirolimus-treated
patients by 3 years, and in 9.4% of biolimus-treated patients.
Rates of any MACE were not significantly different at any time point in the
trial. However, Serruys said, the difference between the two groups appears to
be widening (see Figure).
“I am interested to see what happens
with this result at 4 years,” he said.
Experts Debate Role of Cardiac
Subspecialists in Future of TAVI
Changes predicted for how future generations
are trained and interact in the field.
Wider implementation of transaortic valve
implantation will likely require significant
changes to how patients are selected, as
well as how future generations of cardiac
specialists are trained and interact within
the field.
Evidence suggests that there is an
increasing incidence of aortic stenosis in the aging population, particularly
aortic stenosis secondary to bicuspid
aortic valve disease. Yet, Patrick
T. O’Gara, MD, of
the Brigham and
Women’s Hospital
in Boston noted,
treatment options
remain scant.
“It is unfortuPatrick T. O’Gara, MD
nate that there are
no treatments for retarding the progression of aortic stenosis, especially in the
wake of our several-year improvement in
the understanding of the pathobiology of
senile calcific disease,” O’Gara said.
Registry data indicate a 28% mortality rate at 1 year after TAVI and 30% at 2
years among patients considered at high
risk for surgery, he added. If those data
are considered against surgical options,
“long-term outcomes of patients who
are considered high risk for surgery and
treated with TAVI are quite reasonable,”
O’Gara explained.
Patient selection
The success of TAVI intervention is
likely to improve as the technique and the
devices used are refined. Moreover, creation of viable risk stratification criteria will
help with improved patient selection, said
Martyn R. Thomas, MD, of St. Thomas’
Hospital, London.
EuroScore ⬎20 and Society of Thorac-
ic Surgeons’ mortality risk measurements
⬎10, currently used to indicate appropriate TAVI intervention, may be inappropriate, Thomas said. However, EuroScore is
somewhat predictive of outcome. Survival
rates at 1 year from the SOURCE trial,
which involved surgical intervention, did
show a correlation between a lower EuroScore and survival.
These measures, he said, consider risk
at 30 days, because surgical risk is more
likely related to procedural risk, whereas a
1-year outcome may be more appropriate
for a percutaneous intervention.
Attempts at patient selection criteria
have been unsuccessful, Thomas said,
because death after TAVI may be more
commonly related to noncardiac events;
thus, consideration of “frailty” in selecting
appropriate patients may be required.
Future training involves collaboration
Despite the difficulties in identifying an ideal patient population for TAVI,
Thomas and others expect a rapid increase in the use of the technique, per-
Safety, efficacy
In an analysis of safety and efficacy
markers based on the total randomized
population, there was no statistically
significant difference between the two
groups in rates of death, cardiac death,
MI, non-Q-wave MI, Q-wave MI or combined cardiac death or MI.
However, Serruys said, the data indicate a trend towards benefit in the biolimus group, with higher reported rates
of death, cardiac death, Q-wave MI and
combined cardiac death or MI, among
patients treated with the
sirolimus-eluting stent.
Stent thrombosis was
rare among both groups,
with a rate in the first 30
days of 1.6% and 1.7% in
the biolimus and sirolimus
groups, respectively. The
rates between 30 days
and 1 year were 0.4%
and 0.5% in the biolimus
and sirolimus groups,
respectively. There was
a higher rate of very late
stent thrombosis (after 1
year) among sirolimustreated patients (0.9%)
compared with biolimus-treated patients
(0.2%), but the difference was not statistically significant.
There was no very late stent thrombosis – between years 2 and 3 – among
patients in the biolimus stent group,
Serruys said.
Disclosures:
Dr. Serruys reports no relevant conflicts
of interest.
●
haps by as much as 30% to 40% within
the next 5 years. Exactly who will be
performing TAVI in the future, though, is
another question facing the field.
Because surgical aortic valve replacement is a highly effective treatment in the
correct patient, Thomas said, discretion
for initiating TAVI may best be left to surgeons, who can serve as “gatekeepers”
for the technology.
But, Thomas and others said, the “heart
team” collaboration between interventional, surgical and general cardiologists
that was so instrumental in bringing TAVI
to realization must continue in practice.
The need for integrated teams required to
perform TAVI also may necessitate the future development of training programs to
turn out specialists with expertise in both
surgical and interventional techniques. Already, 10 such training programs are currently operating in the United States.
Disclosures:
Dr. O’Gara reports no relevant conflicts
of interest.
●
Dr. Thomas reports receiving grant/
research support from Edwards
Lifesciences, as well as consulting
fees/honoraria from Boston Scientific
Corporation and Cordis Corporation.
●
9/23/2010 7:32:56 PM
9/23/2010 7:33:03 PM
12
EVEREST II: Safety of Mitral Valve Repair
Device Evident, but Effectiveness Debated
Data clearly show that the major adverse
event rate is higher in the control group.
Results from the EVEREST II randomized clinical trial indicate that the MitraClip system is safer than surgical
options for mitral valve repair, but effectiveness measures depended on
how data were analyzed.
In an intent-to-treat analysis of major adverse events in patients with mitral
regurgitation randomized to intervention
with MitraClip (Abbott Vascular) (n=184
enrolled, 178 treated) or a control group
Figure 1
of patients who underwent surgical intervention (n=95 enrolled, 80 treated), the
rate of major adverse events was much
lower in the MitraClip group compared
with the control group (see Figure 1).
According to Saibal Kar, MD, of
Cedars-Sinai Medical Center, Los Angeles, a modified analysis of safety
outcomes that considered bleeding
events revealed an even greater disparity between the two groups. Under
Figure 2
the modified definition, the rate was
8.3% in the device group and 42.6%
in the control group.
“No matter how you look at [the data],
it clearly shows that the major adverse
event rate is higher in the control group,”
Kar said.
The effectiveness of the devicebased intervention was less clear from
the data. Because EVEREST II was a
strategy trial – device vs. surgery – investigators performed an intent-to-treat
analysis to determine effectiveness.
However, because it was known
from baseline that a certain number of
patients would require subsequent surgery after devicebased intervention (i.e., device
failure), a per protocol analysis also
was performed to
eliminate bias introduced by patients
requiring
surgery.
According to
Ted
Feldman,
MD, of Evanston
Hospital in Evanston, Ill., in the
intent-to-treat analysis, “effectiveness”
could be defined in several different
fashions, and the resulting measure
varied accordingly. For instance, in a
classic intent-to-treat analysis, 72.3%
of patients in the device group and
74.2% of patients in the control group
were free from death and ⬎2+ mitral
regurgitation at 12 months. However,
when an intent-to-treat analysis of the
initial strategy was performed – that is,
an analysis considering freedom from
death and ⬎2+ mitral regurgitation, as
well as no need for reoperation – the
rate was 55.2% in the device group and
73% in the control group.
Using criteria established prior to patient enrollment, the MitraClip device did
meet the study primary effectiveness
endpoint: MitraClip device effectiveness
was 72% and mitral valve surgery effectiveness was 88%.
The per protocol analysis of effectiveness appeared to suggest greater
benefit of the device-based intervention,
in that there was a steady increase of
mortality in the control group over time,
Feldman said (see Figure 2).
Disclosures:
●
Dr. Feldman is a consultant for and
has received research grants from
Abbott Vascular.
●
Dr. Kar is a consultant for and has
received research grants from Abbott
Vascular.
9/23/2010 7:33:04 PM
Greater Versatility.
Proven Results.
For the lower extremities and beyond.
The AngioSculpt® PTA Scoring Balloon Catheter has been cleared
for dilation of lesions in the renal arteries, bringing its unique advantages
to a whole new patient population. But that’s just part of the story:
s NEW longer-length (40 mm) devices for infrapopliteal procedures
s Recent SFA data from the MASCOT study demonstrated 74.1%
overall primary patency at 12 months*
78.9% primary patency in patients treated with AngioSculpt alone
66.7% primary patency in patients treated with AngioSculpt plus
adjunctive stenting
For more information:
E-mail us at [email protected] or visit us at
www.angioscore.com. To set up a meeting with a sales
consultant, call 1-877-264-4692.
*Poster Presentation #518, Cardiovascular Research Technologies (CRT 2010),
Washington, DC; February 2010.
PERIPHERAL (Reference PN-3134-0001)
CE Mark Granted for Peripheral Applications
CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician.
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Not for use in the coronary or neuro-vasculature.
FOR A FULL SUMMARY OF SAFETY AND EFFECTIVENESS REFER TO THE INSTRUCTIONS FOR USE.
WARNINGS: The AngioSculpt is intended for single use only. Balloon pressure should not exceed the RBP. Never use air or any gaseous medium to inflate the balloon. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.
Proceed cautiously when using the AngioSculpt in a freshly deployed bare metal or drug-eluting stent. The AngioSculpt has not been tested for post-dilation of stents or in lesions distal to freshly deployed stents in clinical studies. If resistance is met
during manipulation, determine the cause of the resistance before proceeding.
PRECAUTIONS: Prior to angioplasty, the AngioSculpt should be examined to verify functionality, device integrity and to ensure that its size and length are suitable for the specific procedure for which it is to be used.
POSSIBLE ADVERSE EFFECTS: Total occlusion of the treated artery, arterial dissection or perforation, arterial spasm, pseudo-aneurysm, restenosis of the dilated artery, embolism, thrombus, retained device components, hemorrhage or hematoma,
arteriovenous fistula.
AR-1062 Rev A 8/10
9/23/2010 5:09:53 PM
14
Percutaneous Mitral Valve Therapy: Looking Ahead
‘Truly nonsurgical’ device leads the way,
with new technologies in the wings.
In a wide-ranging presentation, Ted Feldman, MD, of Evanston Hospital in Evanston, Ill., surveyed the present and future
of the emerging field of percutanteous mitral valve therapy.
The MitraClip system (Abbott Vascular)
is the first device that is “truly nonsurgical”
and the one that is farthest along in terms
of testing and clinical
application,
Feldman said. It
recapitulates the
surgical procedure
by fixing the two
free mitral edges
together to create
a double orifice.
Ted Feldman, MD
Surgery has provided proof of principle that this strategy
yields durable results.
Current experience
Thus far, about 2,000 patients world-
wide have been treated with the MitraClip
in both registries and randomized trials,
Feldman said.
In EVEREST, 279 patients with moderate to severe mitral regurgitation (3+ to 4+)
were randomized in a 2-to-1 ratio to treatment with the clip device or surgical repair
or replacement. For the safety endpoint of
major adverse events at 30 days, the clip
group was superior with a rate of 8.3% vs.
42.6% for surgery. For efficacy at 1 year,
the MitraClip proved noninferior to surgery
(66.9% vs. 74.2%).
A point of contention regarding the
safety results, Feldman said, is that a large
proportion of the events were related to
transfusion, originally defined as the need
for two or more units of blood (44.7% in the
surgical group vs. 13.3% in the clip group).
But even when the definition is made more
stringent, the difference remains significant, Feldman said. Moreover, transfusion
has been shown to have both an early and
a late adverse effect on survival.
Long-term data from EVEREST show
high rates of survival out to 3 years that are
comparable for the clip and surgery.
New mitral devices on the horizon
There is some clinical experience with
other mitral technologies, such as coronary
sinus annuloplasty devices, Feldman said.
They have been slow to come into clinical
use because of technical issues of deliver-
The steps we have
taken in mitral valve
therapy are really giant
steps because it is a
new field.
“
”
- Ted Feldman, MD
ing a device to the coronary sinus as well
as concerns about mechanical integrity.
Recently, however, encouraging data have
emerged from the TITAN trial showing a
reduction in mitral regurgitation severity
and improvements in left ventricular func-
tion and exercise capacity out to 1 year
with the Carillon Mitral Contour System
(Cardiac Dimensions). The main limitation
of this approach is that the sinus crosses
the circumflex in a significant proportion of
patients, Feldman said.
Also on the horizon are a number of
novel approaches. For example, one device anchors a balloon-like catheter in
the left ventricular apex, filling the space
of the regurgitant orifice. This has the
attraction of being procedurally simple,
Feldman said. Also in preclinical development are replacement technologies.
However, these devices face formidable
challenges, including large size and the
difficulty of anchoring them in the mitral
orifice, Feldman noted.
“The steps we have taken in mitral valve
therapy are really giant steps because it is
a new field,” Feldman concluded.
Disclosures:
●
Dr. Feldman reports receiving research
grants from and serving as a consultant
for Abbott Vascular and Edwards
Lifesciences.
Role of PCI for Left Main Disease Reconsidered
in 2010 and Beyond
Data suggest safety of PCI for unprotected
disease is improving.
A variety of factors, including improvements in safety, are leading cardiologists to re-evaluate the role of PCI for
treatment of left main disease, David J.
Cohen, MD, MSc, said.
Unprotected left main PCI has
gained support in recent years, particularly in Asia
and Europe, but
the United States
lags behind in
using it, said
Cohen, director
of cardiovascular research at
Saint Luke’s MidDavid J. Cohen, MD, MSc
America Heart Institute in Kansas City, Mo. Currently, it
accounts for just 2% to 3% of all PCI
procedures in the U.S.
However, newer guidelines may
have some impact on enthusiasm, he
said. In the past, CABG was designated a class 1A recommendation for
all patients with significant left main
disease and, until recently, PCI was at
the lowest level of recommendation.
But as of 2009, PCI holds a class 2B
recommendation for left main disease,
and may be considered in patients with
anatomic conditions associated with a
low risk for PCI complications and clinical conditions that predict an increased
risk for adverse surgical outcomes.
“We have a long way to go in the
United States to move PCI for left main
disease up the ladder,” Cohen said.
Factors for reconsideration
Most bypass surgery for left main
disease is performed in patients who
do not derive a survival benefit, according to Cohen. He shared data
from the CASS registry of patients with
⭓50% left main coronary artery stenosis initially treated with either surgical
or nonsurgical therapy. According to
Cohen, only 24% of patients who underwent CABG for left main disease
had one or more conditions for which
surgery has been shown to improve
long-term survival. Additionally, recent
observational studies and randomized
trials demonstrated comparable intermediate mortality with PCI vs. CABG,
at least in patients without complex
three-vessel disease.
A second factor for reconsideration
is improvements in safety of PCI for left
main disease.
“Although often considered a highrisk procedure, today, in experienced
hands, unprotected left main PCI can
be performed safely in good surgical
candidates,” Cohen said.
Specifically, for patients in 2001 who
have isolated ostial or shaft disease of
the left main coronary artery and normal
We have a long way
to go in the United
States to move PCI for
left main disease up
the ladder.
“
”
- David J. Cohen, MD, MSc
LV function, unprotected left main PCI
can be performed very safely, Cohen
said. For patients with distal or bifurcation disease — the majority of patients
with left main disease — the short- and
intermediate-term outcomes are less
favorable with PCI, but these mainly reflect an increased rate of target vessel
revascularization, he said.
Finally, a consistent theme has
emerged from virtually all studies of
PCI in left main disease: Stroke rates
appear to be consistently lower compared with CABG.
Exclusions apply
On the other hand, certain groups of
patients should not undergo left main
PCI in 2010, including:
●
Patients with lesions that are not
technically feasible.
●
Patients with left main disease plus
an occluded right coronary artery
who are surgical candidates.
●
Patients with diffuse multivessel
disease and SYNTAX scores ⬎33.
●
Patients who will not or cannot be
compliant with dual antiplatelet
therapy or aggressive secondary
coronary prevention.
●
Patients with specific risk factors
associated with high rates of disease
progression and DES restenosis,
such as those with diabetes or renal
insufficiency.
“In the absence of any of these
characteristics, everything else is fair
game,” Cohen said.
Disclosures:
Dr. Cohen reports grant support for
pharmaceutical research from Eisai
Pharmaceuticals, Eli Lilly/DaiichiSankyo and Merck/Schering Plough;
grant support for device research
from Abbott Vascular, Boston
Scientific, Edwards Lifesciences,
Medtronic and MedRad; and
consulting/advisory appointments
for Boehringer-Ingelheim, Cordis
Corporation, Eli Lilly/Daiichi-Sankyo
and Medtronic.
●
9/23/2010 5:10:11 PM
Transradial is TERUMO Territory.™
America,
Transradial is Here.
Please visit Terumo booth 2066 at TCT for more information about our
Friday dinner symposium, Clinical and Economical Considerations of Transradial,
and our Terumo Training Pavilion Programs being held Thursday through Saturday.
For more information, call 800.862.4143 to speak to an Inside Sales Specialist, or visit www.terumois.com
Terumo Interventional Systems • 2101 Cottontail Lane • Somerset, NJ 08873 • Fax: 800.411.5870
©2010 Terumo Medical Corporation. All rights reserved. All brand names are trademarks or registered trademarks of Terumo.
TERUMO INTERVENTIONAL SYSTEMS
9/23/2010 5:10:15 PM
Cordis Carotid System
Conformability
like no other.
Design matters.
Cordis PRECISE® PRO RX® Carotid Stent System
and ANGIOGUARD® RX Emboli Capture
Guidewire System
PRODUCTS SERVICES OUTCOMES
Cordis Corporation
© Cordis Corporation 2010 155-7221-2 21726 08/10
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. For more information on indications,
contraindications, warnings, precautions, and adverse events, see Essential Prescribing Information on adjacent page.
9/23/2010 5:10:16 PM
Cordis PRECISE® PRO RX® Carotid Stent System
Cordis ANGIOGUARD® RX Emboli Capture Guidewire System
Essential Prescribing Information
Essential Prescribing Information
INDICATIONS
The Cordis PRECISE® PRO RX® Carotid Stent System, used in conjunction with the Cordis ANGIOGUARD® RX Emboli Capture
Guidewire System, is indicated for treatment of patients at high risk for adverse events from carotid endarterectomy who require
carotid revascularization and meet the following criteria:
• Patients with neurological symptoms and > 50% stenosis of the common or internal carotid artery by ultrasound or angiogram
OR patients without neurological symptoms and > 80% stenosis of the common or internal carotid artery by ultrasound or
angiogram.
• Patients must have a vessel diameter of 4-9mm at the target lesion. The vessel distal to the target lesion must be within the range
of 3mm and 7.5mm to allow for placement of the ANGIOGUARD® RX Guidewire System.
CONTRAINDICATIONS
• Patients in whom antiplatelet and or anticoagulation therapy is contraindicated.
• Patients in whom the guide catheter is unable to be placed.
• Patients with uncorrected bleeding disorders.
• Patients with known allergies to nitinol.
• Lesions in the ostium of the common carotid artery.
WARNINGS
• Only physicians who have received appropriate training for carotid stenting and who are familiar with the principles,
clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures
should use this device.
• The safety and efficacy of the PRECISE® Stent System have not been demonstrated with embolic protection systems
other than the ANGIOGUARD® RX Guidewire System.
• The long-term performance (>3 years) of carotid stents has not yet been established.
• As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis, pseudoaneurysm
or rupture.
• The stent may cause a thrombus, distal embolization or may migrate from the site of implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration. In the event of thrombosis of the
expanded stent, thrombolysis and PTA should be attempted.
• Overstretching of the artery may result in rupture and life-threatening bleeding.
• In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption of
antiplatelet agents (e.g. aspirin) may be adversely affected.
• Appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure.
• In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent may be required.
• Safety and effectiveness of the Cordis PRECISE® PRO RX® Carotid Stent System has NOT yet been established in patients with
the characteristics noted below:
Lesion Characteristics:
• Patients with evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
• Patients whose lesion(s) may require more than two stents.
• Patients with total occlusion of the target vessel.
• Patients with lesions of the ostium of the common carotid.
• Patients with highly calcified lesions resistant to PTA.
• Concurrent treatment of bilateral lesions.
Patient Characteristics:
• Patients at low-to-moderate risk for adverse events from carotid endarterectomy.
• Patients experiencing acute ischemic neurologic stroke or who experienced a stroke within 48 hours.
• Patients with an intracranial mass lesion (i.e., abscess, tumor, or infection) or aneurysm (>9mm).
• Patients with arterio-venous malformations in the territory of the target carotid artery.
• Patients with coagulopathies.
• Patients with poor renal function, who, in the physician’s opinion, may be at high risk for a reaction to contrast medium.
• Patients with perforated vessels evidenced by extravasation of contrast media.
• Patients with aneurysmal dilation immediately proximal or distal to the lesion.
• Pregnant patients or patients under the age of 18.
Access Characteristics:
• Patients with known peripheral vascular, supra-aortic or internal carotid artery tortuosity that would preclude the use of catheterbased techniques.
• Patients in whom femoral or brachial access is not possible.
• Risk of distal embolization may be higher if the Cordis PRECISE® PRO RX® Carotid Stent System device cannot be used in
conjunction with the ANGIOGUARD® RX Guidewire System during the carotid stenting procedure.
• The black dotted pattern on the gray temperature exposure indicator found on the pouch must be clearly visible. Do not use
if entire circle is completely black as the preprogrammed stent diameter may have been compromised.
• Do not use the device if there are abnormalities in the sterile barrier (e.g. broken seal, torn or breached barrier) or product.
• Do not reuse.
• Do not use with Ethiodol or Lipiodol* contrast media, which may adversely affect the stent delivery system.
• Do not expose the delivery system to organic solvents (e.g. alcohol) as structural integrity and/or function of the device may
be impaired.
• The stent is not designed for dragging or repositioning.
• Once the stent is partially deployed, it cannot be recaptured using the stent delivery system.
• As with any type of vascular implant, infection secondary to contamination of the stent may lead to thrombosis,
pseudoaneurysm or rupture.
PRECAUTIONS
• Venous access should be available during carotid stenting in order to manage bradycardia and/or hypotension by pharmaceutical intervention or placement of a temporary pacemaker.
• Catheters in the body should be manipulated only under fluoroscopy. Radiographic equipment that provides high quality
images is needed.
• The delivery system is not designed for the use of power injection. Use of power injection may adversely affect device
performance.
• If resistance is met during delivery system introduction, the system should be withdrawn and another system used.
• Prior to stent deployment, remove all slack from the catheter delivery system.
• When treating multiple lesions, the distal lesion should be initially stented, followed by the proximal lesion. Stenting in this
order obviates the need to cross the proximal stent in placement of the distal stent, reducing the chance for dislodging stents
that have already been placed.
• Overlap of sequential stents is necessary, but the amount of overlap should be kept to a minimum (approximately 5mm). In no
instance should more than 2 stents overlap.
• Recrossing a deployed stent with adjunct devices must be performed with caution.
• In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
• Fractures of this stent may occur. Fractures may also occur with the use of multiple overlapping stents. In the PRECISE Stent,
they have been reported most often in clinical uses for which the safety and effectiveness have not been established. The
causes and clinical implications of stent fractures are not well characterized. Care should also be taken when deploying the stent
as excessive force could, in rare instances, lead to stent deformation and/or fracture.
• The Cordis PRECISE Stent was evaluated through bench testing and has been shown to be MR safe at field strengths of 1.5
Tesla or less, with a maximum spatial gradient of 3 T/m, gradient magnetic fields of 33 mT/m or less, a temporal magnetic field
gradient (dB/dt) of 80 T/m/s, and a maximum whole body averaged specific absorption rate (SAR) of 1.33 W/kg for 16:40:00
min of MR imaging. MR imaging quality may be compromised if the area of interest is in the exact same area or relatively close
to the position of the PRECISE Stent. The PRECISE Stent has not been evaluated to determine if it is safe in MRI systems with
field strengths greater than 1.5 Tesla.
Possible adverse events include, but are not limited to:
INDICATIONS
The Cordis ANGIOGUARD® RX Emboli Capture Guidewire System is indicated for use as a guidewire and embolic protection system
to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in
carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5mm (see Instructions for
Use for basket/vessel sizing).
CONTRAINDICATIONS
• Patients in whom antiplatelet and or anticoagulation therapy is contraindicated.
• Patients in whom the guide catheter is unable to be placed.
• Patients with uncorrected bleeding disorders.
• Patients with known allergies to nitinol.
• Lesions in the ostium of the common carotid artery.
WARNINGS
• Only physicians who have received appropriate training for carotid stenting and who are familiar with the principles, clinical
applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use
this device.
• The safety and effectiveness of this device as an emboli protection system has not been established in the coronary, cerebral, or
peripheral vasculature, other than carotid arteries.
• The safety and efficacy of the ANGIOGUARD® RX Guidewire System have not been demonstrated with stent systems other than
the PRECISE® Stent System.
• Overstretching of the artery may result in rupture and life-threatening bleeding.
• Patient ACT of >300 seconds needs to be maintained during ANGIOGUARD® RX Guidewire System deployment.
• Safety and effectiveness of the angioplasty and carotid stenting procedure has NOT yet been established in patients with the
characteristics noted below:
Lesion Characteristics:
• Patients with evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
• Patients whose lesion(s) may require more than two stents.
• Patients with total occlusion of the target vessel.
• Patients with lesions of the ostium of the common carotid.
• Patients with highly calcified lesions resistant to PTA.
• Concurrent treatment of bilateral lesions
Patient Characteristics:
• Patients at low-to-moderate risk for adverse events from carotid endarterectomy.
• Patients experiencing acute ischemic neurologic stroke or who experienced a stroke within 48 hours.
• Patients with an intracranial mass lesion (i.e., abscess, tumor, or infection) or aneurysm (>9mm).
• Patients with arterio-venous malformations in the territory of the target carotid artery.
• Patients with coagulopathies.
• Patients with poor renal function, who, in the physician's opinion, may be at high risk for a reaction to contrast medium.
• Patients with perforated vessels evidenced by extravasation of contrast media.
• Patients with aneurysmal dilation immediately proximal or distal to the lesion.
• Pregnant patients or patients under the age of 18.
Access Characteristics:
• Patients with known peripheral vascular, supra-aortic or internal carotid artery tortuosity that would preclude the use of
catheter-based techniques.
• Patients in whom femoral or brachial access is not possible.
• Risk of distal embolization may be higher if the ANGIOGUARD® RX Guidewire System is not used during carotid stenting procedures.
• This device is intended for one-time use only. Do not re-sterilize and/or reuse. Structural integrity and/or function may be impaired
through reuse or cleaning.
• Observe all guidewire movement in the vessels using fluoroscopic guidance
• DO NOT TORQUE THE GUIDEWIRE.
— Do not torque a guidewire without observing corresponding movement of the tip; otherwise, vessel trauma could occur.
— Torquing a guidewire against resistance may cause guidewire damage and/or guidewire tip separation. Always advance or withdraw the guidewire slowly. Never push, auger, withdraw or torque a guidewire that meets resistance. Resistance may be felt
and/ or observed using fluoroscopy by noting any buckling of the guidewire tip. Determine the cause of resistance under fluoroscopy and take the necessary remedial action.
• Before the guidewire is moved, tip movement should be examined using fluoroscopy.
• Perform all exchanges slowly to prevent air from entering the catheter system.
• When introducing the guidewire, confirm that the guiding catheter or interventional sheath introducer tip is free within the vessel
lumen and not against the vessel wall. Failure to do so may result in vessel trauma upon guidewire exit from the tip. Use the
radiopaque marker of the interventional device to confirm position.
PRECAUTIONS
• Confirm the compatibility of the ANGIOGUARD® RX Guidewire System with the interventional device before actual use.
• If distal perfusion of dye is significantly reduced or no dye is perfusing past the distal marker band of the filter basket, the ANGIOGUARD®
RX Guidewire System may have reached its maximum capacity to contain emboli. Remove and replace with a new ANGIOGUARD®
RX Guidewire System (per Instructions for use).
• Do not attempt to close the filter basket with the Deployment Sheath. The ANGIOGUARD® RX Guidewire System should only be removed
using the Capture Sheath.
• Care during diagnostic or interventional device exchanges must be practiced to minimize movement of the guidewire/filter basket.
• Use caution when withdrawing the ANGIOGUARD® RX Guidewire System device through the deployed stent.
Possible adverse events include, but are not limited to:
Air embolism
Fever
Renal failure
Allergic/anaphylactoid reaction
GI bleeding
Restenosis of vessel
( 50% obstructional)
Aneurysm
Hematoma bleed (puncture or remote site)
Seizure
Angina/coronary ischemia
Hemorrhage
Severe unilateral headache
Arrhythmia (including bradycardia,
possibly requiring need for a temporary
or permanent pacemaker)
Hyperperfusion syndrome
Stent migration
Arterial occlusion/vessel restenosis
Hypotension/hypertension
Stent thrombosis
Arterial occlusion/thrombus at
and remote from puncture site
Infection
Stroke
Transient Ischemic Attack
Air embolism
Fever
Renal failure
Allergic/anaphylactoid reaction
GI bleeding
Restenosis of vessel
( 50% obstructional)
Arteriovenous fistula
Intimal injury/dissection
Bacteremia or septicemia
Ischemia/infarction of tissue/organ
Vasospasm
Seizure
Cerebral edema
Local infection/pain at insertion site
at and remote from puncture site
Venous occlusion/thrombosis
Damage to emboli capture device
Malposition (failure to deliver stent
to intended site)
Vessel rupture, dissection,
perforation
Death
Myocardial infarction
Aneurysm
Hematoma bleed (puncture or remote site)
Angina/coronary ischemia
Hemorrhage
Severe unilateral headache
Arrhythmia (including bradycardia
possibly requiring need for a temporary or
permanent pacemaker)
Hyperperfusion syndrome
Stent migration
Arterial occlusion/vessel restenosis
Hypotension/hypertension
Stent thrombosis
Embolization (stent or arterial)
Pain
Arterial occlusion/thrombus at and
remote from puncture site
Infection
Stroke
Emergent repeat hospital intervention
Pseudoaneurysm
Arteriovenous fistula
Intimal injury/dissection
Transient Ischemic Attack
Bacteremia or septicemia
Ischemia/infarction of tissue/organ
Vasospasm
Cerebral edema
Local infection/pain at insertion site
Venous occlusion/thrombosis at
and remote from puncture site
Damage to emboli capture device
Malposition (failure to deliver stent
to intended site)
Vessel rupture, dissection,
perforation
Death
Myocardial infarction
Embolization (stent or arterial)
Pain
Emergent repeat hospital intervention
Pseudoaneurysm
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
See package insert for full product information and complete list of warnings and precautions.
The third-party trademarks used herein are trademarks of their respective owners.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
See package insert for full product information and complete list of warnings and precautions.
*The third-party trademarks used herein are trademarks of their respective owners.
Cordis Corporation
© Cordis Corporation 2010 155-7221-2 21726 08/10
9/23/2010 10:56:00 AM
18
STEMI Patients Benefit from Direct Transfer
for Primary PCI
Reduced symptom-to-balloon times affect
MACE rate.
TOP 25 POSTER
ABSTRACT
Sending STEMI patients directly to PCI
centers for intervention is associated
with long-term reductions in major adverse cardiac events, according to the
results from a retrospective analysis.
Researchers analyzed data from a
prospective database of 1,364 STEMI
patients who underwent PCI at a London hospital between October 2004
and February 2009. Of those, 863 were
directly transferred to the PCI center
and 501 were transferred via local hospitals. The co-primary study endpoints
were major adverse cardiac events,
including death, MI, stroke and target
vessel revascularization.
During a period of 1,500 days, investigators found equivalent all-cause
mortality regardless of transfer strategy
(P=.07). However, patients transferred
from local hospitals had higher rates
of MACE (15%) than did direct trans-
searchers, the results reinforce the importance of time when it comes to saving myocardium.
“Even though there was not a significant mortality benefit between the
two groups, there was still a difference in MACE, which we feel is due
The shorter the symptom-to-balloon time, the
better the outcome for the patient.
“
”
- Krishnaraj Rathod, MD
fer patients (11%, P=.0024). This difference was driven primarily by higher
rates of MI (2% vs. 0.5%, P=.05), with
no significant variation between the two
groups for stroke, TVR or mortality.
Interhospital transfer also resulted in
longer symptom-to-balloon times (190
minutes vs. 160 minutes with direct
transfer, P=.05). According to the re-
to the reduction in symptom-to-balloon time,” Krishnaraj Rathod, MD, of
the London Chest Hospital Barts and
the London National Health Service
Trust in Hornchurch, United Kingdom,
told TCT Daily. “This study provides
information that is not yet explored
thoroughly, and we probably need a
randomized, controlled trial to confirm
these findings before we can establish
any changes in our practice. However,
we can so far conclude that the shorter
the symptom-to-balloon time, the better the outcome for the patient.”
Study details
At baseline, average age and the
incidence of cardiogenic shock were
similar between the study groups, although interhospital transfer patients
had higher rates of diabetes (22% vs.
16%, P=.004), previous MI (18.2% vs.
13%, P=.001) and multivessel disease
(50.7% vs. 43.9%, P=.0223).
Patient information was recorded at
the time of the procedure, and mortality
data were provided by the Office of National Statistics by way of the British Cardiovascular Intervention Society/Central
Cardiac Audit Database national audit.
Disclosures:
●
Dr. Rathod reports
no
relevant
Spotlight on TCT Live Case Transmission Sites
Live case transmission sites span 19 locations around the globe and broadcast in high definition
to the Main Arena and “How to Treat” Theaters at TCT. In a continuing series, TCT Daily talks with
Jorge A. Belardi, MD, director of Cardiology at Instituto Cardiovascular de Buenos Aires.
Instituto Cardiovascular de Buenos Aires
Buenos Aires, Argentina
TCT Daily: What types of procedures do
you focus on? How does your team approach unique and/or complex cases?
ing into the area of cardiac structural interventions such as closure of the left atrial
appendage, patent foramen ovale, ASD
LIVE CASE SITE
TCT Daily: Please tell us about your
institution, and any interesting location
facts.
Dr. Belardi: Instituto Cardiovascular de
Buenos Aires is a cardiovascular center
with 100 beds, located in downtown
Buenos Aires. Approximately 1,000
coronary angioplasties, 300 peripheral
interventions, 300 electrophysiological
interventions and 800 CABG surgeries are performed
there each year. It
is a tertiary institution with highlevel technology,
sophisticated imaging
modalities, angiographic
equipment, a 64Jorge A. Belardi, MD
multislice CT, a
cardiac MRI, insight technology for electrophysiological interventions, 3-D ultrasound and a
Plus Full Ring C-PET.
Dr. Belardi: Our institution focuses on
several specific areas of research and
development such as: acute coronary
syndromes, complex PCI, endovascular
treatment of valvular disease, electrophysiology and mini-invasive cardiac
surgeries.
We approach complex PCI according
to decisions made by the cardiac team,
which includes not only surgeons and
interventionalists, but also a clinical cardiologist in charge of coronary patients.
Technically, PCI cases use all the imaging
technology facilities: 3-D coronary and
peripheral vascular evaluation, stent boost
and intravascular ultrasound assessment.
TCT Daily: What types of research does
your group focus on?
Dr. Belardi: Our research is focused on the
interventional treatment of acute MI evaluating different types of thrombectomy and
distal protection devices, as well as various new devices. At present, we are look-
The future of
interventional
cardiology heads
toward working
together as a
multidisciplinary
team with the cardiac
surgeons and the
imaging experts.
“
- Jorge A. Belardi, MD
”
and VSD. We also work together with our
vascular surgery team in the endovascular
treatment of aortic aneurysms and aortic
dissections.
TCT Daily: Where do you see the future
of interventional cardiology headed?
How do you see the next 5 years of
your institution?
Dr. Belardi: The future of interventional
cardiology heads toward working together as a multidisciplinary team with
the cardiac surgeons and the imaging
experts to approach the broad spectrum of structural cardiac and valvular
diseases. Within the coronary area, the
PCI approach will keep growing to encompass the left main trunk and multiple complex diseases like chronic total
occlusions, bifurcations and the use of
bioabsorbable DES.
Regarding ACS, we are currently
working with Emergency Medical
Systems to develop a better strategy for STEMI patients to reduce the
time to primary PCI using electronic
transmission of EKG results (telediagnosis) and to improve the effectiveness of myocardial reperfusion.
TCT Daily: What are you most looking
forward to at TCT 2010?
Dr. Belardi: TCT has always been a
superb academic meeting where attendees improve and update their
knowledge and experience in medical
practice, based on live-case review and
interaction. It has always been an invaluable opportunity to share the latest
research and innovative practices from
all over the world. We are sure TCT 2010
will again exceed our expectations.
9/23/2010 10:56:23 AM
19
TCT Daily
Three-Year Results from HORIZONS-AMI: DES Most
Beneficial to STEMI Patients at High Risk for TLR
TOP 25 POSTER
ABSTRACT
New data from the HORIZONS-AMI
trial suggest that DES may be of greatest benefit in STEMI patients who are at
high risk for target lesion revascularization with BMS.
Investigators were able to identify several independent predictors of ischemiadriven TLR, which they said will allow physicians to select those patients at highest
risk in whom treatment with paclitaxel-
tein IIb/IIIa inhibitor (GPI), bivalirudin plus
a GPI or bivalirudin alone. In a second
randomization, a stent cohort of 3,006
eligible patients were randomly assigned
a paclitaxel-eluting stent (n=2,257) or an
otherwise identical BMS (n=749). All patients underwent PCI within 12 hours of
symptom onset.
All events were assessed at 12 months,
with a subset of patients undergoing routine angiographic follow-up at 13 months.
Researchers then identified independent
Table. TLR Rates in STEMI Patients by Risk Category
Risk Category
BMS
DES
HR (95% CI)
Low
3.3%
3.7%
1.14 (0.52-2.52)
Intermediate
5.7%
2.3%
0.58 (0.36-0.92)
High
16.9%
6.6%
0.36 (0.19-0.69)
eluting stents (Taxus, Boston Scientific)
will be more beneficial than using BMS.
The HORIZONS-AMI investigators,
led by Gregg W. Stone, MD, of Columbia
University Medical Center in New York,
N.Y., randomized a pharmacological therapy cohort of 3,602 STEMI patients from
123 centers to heparin plus a glycopro-
predictors for 12-month ischemia-driven
TLR and used these characteristics to
group patients according to risk.
Significant reductions in TLR
Compared with BMS, treatment with
DES reduced TLR at 12 months from
7.4% to 4.5% (P=.003). In addition, al-
though paclitaxel-eluting stents significantly reduced the rate of TLR in all STEMI patients, the reduction was greatest in
those identified as high risk for TLR after
treatment with BMS (see Table).
“We have seen that the use of paclitaxel-eluting stents compared with
BMS are safe and effective in reducing
recurring ischemia requiring repeat revascularization as well as angiographic restenosis out to 12 and 13 months,
respectively,” Stone said.
Independent predictors noted
Among the 40 different candidate
variables, data indicated that diabetes,
vessel diameter, lesion length, ulceration and Killip class all were independent predictors of TLR with BMS. High
risk was defined as the presence of two
or more of these factors.
When the data were isolated to include only patients at high risk for TLR,
paclitaxel-eluting stents significantly
reduced the rate of TLR at 12 months
(P⬍.0001). High-risk patients treated
with paclitaxel-eluting stents also had
improved rates of stent thrombosis
(4% vs. 10.2%, P=.01) and reinfarction (5.2% vs. 10.3%, P=.01) compared
with those treated with BMS.
Conversely, the researchers found
that among STEMI patients at low risk
for TLR, the rates of TLR, mortality, reinfarction and stent thrombosis were
not significantly different between the
two stent types.
In patients at intermediate risk (defined as having one risk factor for TLR),
paclitaxel-eluting stents conferred a
modest but significant reduction in TLR
at 12 months, with similar rates of mortality, reinfarction and stent thrombosis.
“The optimal treatment for patients
with evolving heart attack is primary angioplasty,” Stone said. “However, there
is still a lot of debate as far as the best
pharmacologic regimen to use and the
best type of stent, whether it is a DES
or a BMS. These early choices that are
made in the cath lab can affect the longterm outcome for patients.”
Disclosures:
Dr. Stone reports serving on the
scientific advisory board for and
receiving honoraria from Abbott
Vascular and Boston Scientific
and consulting for The Medicines
Company.
●
Interventional Cardiology
Principles and Practice
Edited by
Carlo Di Mario, MD, PhD
National Heart and Lung Institute, Imperial
College and Department of Invasive Cardiology
Royal Brompton Hospital London, UK
SAVE 20%
at the Wiley-Blackwell
Booth at TCT, #2255
George Dangas, MD, PhD
Center for Interventional Vascular Therapy
Division of Cardiology Columbia University
Medical Center, USA
Peter Barlis, MBBS, MPH, FRACP
Department of Invasive Cardiology Royal
Brompton Hospital London, UK
This book provides a balanced and current
perspective on the core principles and
practice of Interventional Cardiology.
The editors and their team of first-rate,
globally recognized contributors provide
practical information gained from years of
experience. They emphasize the basics of
material selection and optimal angiographic
setup for purposes of the interventional
procedure. Comprehensive chapters
address in detail the different techniques for
t)"3%$07&3t1"(&4t*--6453"5&%
3&(6-"3-:
AFTER CONFERENCE DISCOUNT: $209.95
approaching complex coronary lesions such as chronic occlusions, bifurcations, and
unprotected left main lesions. The book mirrors the topics covered in the American
Board of Internal Medicine (ABIM) Exam in Interventional Cardiology and will prove
a comprehensive resource for those preparing for this exam. An accompanying DVD
www.wiley.com/go/cardiology
1 0 - 2 1 8 1 7 demonstrates the procedures.
9/23/2010 10:56:24 AM
Endeavor Sprint
®
ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Rapid Healing, Reassuring
Long-Term Performance
t TUFOUTUSVUDPWFSBHFCZNPOUITJODMJOJDBM0$5TUVEJFT1
t -PX45BUZFBSTEFTQJUFPOMZPO%"15BUZFBS2
t -PX5-3BUZFBST2
t .PSFUIBOQBUJFOUTTUVEJFE3
It’s reassuring to know that while dual antiplatelet therapy
compliance might be just for the short term, the safety
profile of Endeavor DES is for the long term.
1
Kim et al. J Am Coll Cardiol Intv, 2009; 2:1240-1247.
ENDEAVOR Pooled Analysis: E I (5 yr), E II (5 yr), E II CA (5 yr), E III (4 yr), E IV (3 yr) and E pK (2 yr). At 1800 days, Endeavor DES n = 1199, Driver BMS n = 538. DAPT usage based on case report forms.
The optimal duration of dual antiplatelet therapy, specifically clopidogrel, is unknown and DES thrombosis may still occur despite continued therapy.
3
Patients enrolled in the ENDEAVOR Clinical program
2
9/23/2010 10:56:28 AM
9/23/2010 10:56:57 AM
22
Oral Steroids Make Clopidogrel Discontinuation
Unnecessary in Hypersensitive Patients
TOP 25 POSTER
ABSTRACT
Results of a new study suggest that patients with negative skin reactions to clopidogrel may be treated by a short-term
course of oral steroids, without the need
to discontinue the antiplatelet drug.
Seventy-two patients with hypersensitivity to clopidogrel after coronary stenting
were enrolled between February 2007 and
April 2010. The majority of patients (92%)
presented with a pruritic, erythematous
cutaneous eruption affecting the torso
and proximal extremities starting about
5 days after clopidogrel initiation. All pa-
tients were referred to a designated clopidogrel allergy clinic for management and
received a 2-week tapering course of oral
prednisone that began with 30 mg twice
daily for 5 days.
Complete resolution of clopidogrel
sensitivity was reported in all patients;
there were no recurrences following the
termination of oral steroids. Re-exposure
to clopidogrel after discontinuation led to
recurrence of reaction in four patients.
In a subgroup of 12 patients, investigators performed punch biopsy of the
affected area at initial presentation. The
test showed epidermal spongiosis and
perivascular and interstitial infiltrates consisting of lymphocytes, histiocytes and
neutrophils. At 48 hours, patch testing
produced the adverse reaction; histology
was consistent with delayed hypersensitivity and similar to that assessed at initial
presentation.
Asim Cheema, MD, of Saint Michael’s
Hospital in Toronto, Canada, said that
some of the documented patient reactions were previously mischaracterized as
a type 1 hypersensitivity reaction similar to
penicillin allergy. However, histologic characterization of skin lesions showed that
clopidogrel hypersensitivity is a rare type
GI Bleeding Dramatically Increases Post-PCI Mortality
TOP 25 POSTER
ABSTRACT
Gastrointestinal bleeding following PCI
increases short-term mortality eightfold,
according to a study presented here.
Among higher-risk patients, meanwhile,
use of bivalirudin may be preferred, as
it reduces the chances of GI bleeding
compared with other anticoagulants.
From a cohort of 20,621 patients
who underwent PCI from January 2000
to January 2010, Michael A. Gaglia Jr,
MD, and colleagues from the Cardiovascular Research Institute in Washington, D.C., identified 147 patients
(0.72%) who experienced in-hospital
GI bleeding.
GI bleeding yielded a 30-day mortality incidence of 20.5% vs. 2.4% in
those without GI bleeding. After multivariate adjustment, GI bleeding and
shock (and their interaction) were the
most important predictors of 30-day
mortality.
Indications
The Endeavor® Sprint Zotarolimus-Eluting Coronary Stent Delivery System is indicated for
improving coronary luminal diameter in patients with ischemic heart disease due to de novo
lesions of length ≤27 mm in native coronary arteries with reference vessel diameters of ≥2.5
mm to ≤3.5 mm.
Contraindications
The Endeavor Zotarolimus-Eluting Coronary Stent System is contraindicated for use in:
r1BUJFOUTXJUIBLOPXOIZQFSTFOTJUJWJUZUP[PUBSPMJNVTPSTUSVDUVSBMMZSFMBUFEDPNQPVOET
r1BUJFOUTXJUIBLOPXOIZQFSTFOTJUJWJUZUPUIFDPCBMUCBTFEBMMPZDPCBMUOJDLFMDISPNJVN
BOENPMZCEFOVN
r1BUJFOUTXJUIBLOPXOIZQFSTFOTJUJWJUZUP1IPTQIPSZMDIPMJOFQPMZNFSPS
its individual components.
Coronary artery stenting is contraindicated for use in:
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Warnings
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with the recommended antiplatelet therapy.
Precautions
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TUFOUUISPNCPTJTTUFOUFNCPMJ[BUJPO.*PSEFBUI
In a landmark analysis of patients surviving to discharge, however, GI bleeding was not associated with increased
mortality or MACE at 1 year.
In regression analysis, older age,
shock, acute MI, chronic renal insufficiency and use of a glycoprotein IIb/
IIIa inhibitor predicted higher risk for GI
bleeding, while baseline hematocrit and
bivalirudin (Angiomax, The Medicines
Co.) use lowered GI bleeding risk.
GI bleeding was reduced in patients
of allergic reaction classified as systemic
contact type dermatitis.
“We were able to reproduce this skin reaction after patch testing with various concentrations of clopidogrel,” Cheema said.
“Patients and physicians do not need
to discontinue or substitute clopidogrel after development of an allergic reaction after initial exposure,” he said. “This can be
successfully treated with a 3-week course
of tapering oral prednisone.”
Disclosures:
●
Dr. Cheema reports no relevant
who received bivalirudin (OR=0.58; 95%
CI, 0.36-0.94; P=.03) vs. those who received heparin (OR=0.79; 95% CI, 0.501.25; P=.32) or thrombolytics (OR=0.74;
95% CI, 0.36-1.55; P=.43). “At least
in our population, the patients who received bivalirudin, as opposed to other
anticoagulant strategies, had less GI
bleeding,” Gaglia said.
Disclosures:
●
Dr. Gaglia reports no relevant conflicts
of interest.
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CSBDIZUIFSBQZPGUIFUBSHFUMFTJPOPSUIFVTFPGCSBDIZUIFSBQZUPUSFBUJOTUFOUSFTUFOPTJTJO
an Endeavor stent.
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DBSPUJEPSQFSJQIFSBMWBTDVMBUVSF
Potential Adverse Events
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1MFBTFSFGFSFODFBQQSPQSJBUFQSPEVDUInstructions for Use for more information regarding
JOEJDBUJPOTXBSOJOHTQSFDBVUJPOTBOEQPUFOUJBMBEWFSTFFWFOUT
CAUTION:'FEFSBM64"
MBXSFTUSJDUTUIJTEFWJDFUPTBMFCZPSPOUIFPSEFSPGBQIZTJDJBO
www.medtronic.com
www.medtronicstents.com
Medtronic CardioVascular
6OPDBM1MBDF
4BOUB3PTB$"
64"
5FM
CardioVascular LifeLine
Customer Support
5FM
5FM
Product Services
Tel: 888.283.7868
'BY
'PSEJTUSJCVUJPOJOUIF64"POMZ¥.FEUSPOJD*OD"MMSJHIUTSFTFSWFE
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9/23/2010 10:57:19 AM
23
TCT Daily
Alain G. Cribier, MD, Honored for Innovation-Filled Career
Transcatheter aortic valve implantation is
his best-known contribution.
The Cardiovascular Research Foundation presented Alain G. Cribier, MD, with
the TCT Career Achievement Award
Thursday in recognition of his lifelong
pursuit of innovation in the field of interventional cardiology.
“Receiving this prestigious award is an
honor and a privilege,” said Cribier, head of
the department of cardiology at University
Hospital Charles Nicolle in Rouen, France.
“It is certainly a very kind recognition by
the interventional cardiologist community
of my efforts to bring breakthrough technologies to the field.”
Among the technologies that Cribier
helped to introduce, transcatheter aortic valve implantation is the most widely
known and used.
A true pioneer
“In every sense of the term ‘pioneer,’
Dr. Cribier is a deserving individual, in
that during the course of his morethan-20-year career, he has committed
himself to improving therapies for patients with valvular heart disease,” said
TCT Course Director Martin B. Leon,
MD, of Columbia University Medical
Center, New York, N.Y. “He is both an
educator, teaching other physicians
how to perform these cases, and an
academic, describing the results accurately and rigorously. He has retained
a strong commitment to patient care,
never lost his sense of humility nor his
commitment to mentoring young physicians,” Leon added.
TCT Course Director Gregg W. Stone,
MD, also of Columbia University Medical
Center, described Cribier as a founding
father of transcatheter valve therapies,
whose work and career are “almost
legendary. His pioneering efforts and
inspirational activities are one of the
leading reasons why transcatheter valve
therapies are emerging as the next major thrust of interventional cardiology,”
Stone observed.
Multilayer Stent Shows
Success in Peripheral,
Visceral Aneurysms
Lifelong pursuit
Cribier’s dedication to innovative technologies for interventional cardiology began in 1985 with his pioneering work on
balloon valvuloplasty and has not stopped
since, Stone said. At the time, valvular
disease was not an important concern for
the interventional cardiology community.
Soon, however, many of Cribier’s innovations changed that.
Among these innovations are the development and first-in-man use of three
technologies: balloon valvuloplasty of
acquired calcific aortic stenosis in 1985,
metallic commissurotomy of mitral valve
stenosis in 1992 and percutaneous aortic
valve replacement in 2002.
“Balloon valvuloplasty of calcific aortic
valve stenosis was a great milestone in
my career, since it instantaneously generated an immense interest in the cardiology community worldwide,” Cribier said.
“It provided a therapeutic solution for a
very large number of elderly patients with
aortic stenosis who were denied valve replacement at a time when age was a contraindication to surgery.”
However, Cribier says his greatest
adventure began in 2002 when he performed the first-in-man implantation of
a transcatheter aortic valve. Since then,
the technology has been tested in trials
in hundreds of patients and its feasibility
has been fully demonstrated.
“To date, more than 20,000 high-risk
surgical patients have been treated worldwide,” Cribier said.
He acknowledged that his career
has been marked by both failures and
successes. “But eventually, I was able
to significantly enlarge the field of invasive cardiology to include the treatment
of valvular disease, and today, after 25
years, I think I can draw a positive balance sheet,” he said.
Acknowledging the past and looking
toward the future, Cribier said that his
battle to establish transcatheter aortic
valve implantation has been long and
difficult, and it could not have succeeded without the support of many
people. This includes his collaborators
in Rouen, Hélène Eltchaninoff, MD (who
Cribier says has been closely involved
throughout) and Christophe Tron, MD,
with whom he has developed a superb
partnership, and a number of other colleagues and engineers worldwide.
“The future of this procedure looks
bright, with the increasing number of
patients in an aging population, and indications that might expand to include
other subsets of patients in the near
future,” Cribier said. “After 15 years of
development, this is definitely a success story.”
Tridimensional mesh makes up layers of
self-expandable device.
TOP 25 POSTER
ABSTRACT
A unique multilayer stent appears efficacious in endovascular exclusion
of peripheral and visceral aneurysms
with collateral branches, according to
preliminary research presented at TCT
2010. If confirmed in larger studies, the
findings could broaden eligibility for endovascular repair.
Maria Antonella Ruffino, MD, from
the San Giovanni Battista Hospital in
Turin, Italy, and colleagues from the Italian Registry Group of Endovascular Procedures with Cardiatis Multilayer Stents
(CMPS), followed 54 patients with peripheral (n=35) and visceral (n=19) aneurysms who were treated with this flow
diverter at centers throughout Italy between May 2009 and June 2010.
The self-expandable device has a
tridimensional mesh made of metallic cobalt alloy wires interconnected in
multiple layers.
The researchers analyzed 30-day,
3-month and 6-month technical and
clinical success. Rates of aneurysm
thrombosis and stent and branch patency were recorded in the Italian Reg-
istry of Cardiatis Procedures along
with sac shrinkage at 6 months.
High technical and clinical
success rates
Intraoperative immediate technical
success was achieved in 48 of 52 cases (92.3%). CT angiography evaluation
found clinical success to be 88.9% at 30
days, 93.3% at 3 months and 100% at
6 months. In addition, there was a 100%
success rate for side branch patency
and 93.3% success rate for stent patency at the latest follow-up visit.
The researchers noted that although
initial sac shrinkage at 1 month was observed in 22 of 42 patients (52.4%), by
6 months, shrinkage was present in almost all cases (93.7%).
“This significant shrinkage of the sac
would allow a broader group of patients
to be treated with endovascular repair,“
Ruffino noted.
Further studies are needed to evaluate long-term results, he said.
Disclosures:
●
Dr. Ruffino reports
no
relevant
9/23/2010 10:57:20 AM
24
Robotically Assisted PCI Up to Manual Operation,
Radically Reduces Operator Radiation Exposure
Operators manipulate the device using joy
sticks at a radiation-shielded control console.
TOP 25 POSTER
ABSTRACT
Robotically assisted PCI appears safe,
performing as well as manual PCI,
according to a first-in-human study.
Moreover, the technology significantly
reduces radiation exposure for operators while lowering contrast volume in
patients.
“Interventional procedures have become so complex that now more than
ever there is concern about radiation
exposure, contrast exposure and control of interventional hardware,” said
lead author Juan F. Granada, MD, of
the Cardiovascular Research Foundation’s Jack H. Skirball Center for Cardiovascular Research in Orangeburg,
N.Y. In this first attempt to demonstrate
that robotics may have a role in interventional cardiology, “the procedure
was as safe as it would be if you did it
with your hands,” Granada said.
How it works
PCI was performed using the CorPath 200 System (Corindus), a robotic
a heavy lead [apron] during these procedures,” Granada commented. “The
patient [benefits] because the physician
is much more rested.”
Granada and colleagues evaluated
the technique in 8 patients undergoing
PCI. The primary endpoint was technical success, defined as ⬍30% final di-
Interventional procedures have become so
complex that now more than ever there is concern
about radiation exposure, contrast exposure and
control of interventional hardware.
“
- Juan F. Granada, MD
technology that drives coronary guidewires and stent and balloon catheters.
Operators manipulate the device using
joysticks at a control console while sitting in a radiation-shielded “cockpit”
equipped with angiography monitors for
easy visualization.
“This reduces stress on the interventionalist, who normally has to wear
”
ameter stenosis without any in-hospital
MACE (cardiac death, MI or clinically
driven TVR).
Equal to manual operation
The safety and technical endpoint criteria were met in all cases. The CorPath
200 demonstrated a performance success
rate of 97.8%, completing 47 of 48 de-
fined procedural steps. No patient experienced MACE, either in-hospital or during
30-day follow-up, or any other device- or
procedure-related adverse events.
Operators rated the robotic device
performance as equal to manual operation in seven of the eight cases.
The robotic procedure reduced radiation exposure and contrast media
volume compared with conventional
manual procedures. The average contrast media used during the robotic procedure was low (159 mL vs. 250 mL for
published data). The investigators say
the difference may be related to better
visualization and increased technical
precision with the robotic system. Moreover, operator exposure to radiation
was a striking 97% lower than at the
table position during manual procedures
(1.8±1.9 μGy vs. 61.6±55 μGy, P⬍.01).
“This [technology] opens a new avenue of research for interventional procedures,” Granada commented.
Disclosures:
●
Dr. Granada reports no relevant
le!
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Pantera Lux Paclitaxel Releasing Coronary Balloon Catheter
Expand your universe
Visit our booth #1309 to find out more about our drug eluting balloon and latest clinical data.
Product not for sale in the U.S.
www.biotronik.com
9/23/2010 10:57:22 AM
If it’s critical enough to treat,
it’s critical enough to use
the CYPHER® Stent
we’ve got your back
The CYPHER® Stent has the strength of design to reduce
the risk of re-intervention in patients with critical lesions.*
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Visit us at TCT Booth 1300
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HUKSH[LZHML[`VMHaV[HYVSPT\ZLS\[PUNZ[LU[7YLZLU[LKH[,\YV7*9"4H`")HYJLSVUH:WHPU
Please see accompanying Essential Prescribing Information.
For full Instructions for Use, go to cordislabeling.com.
Sirolimus-eluting Stent is made by Cordis Corporation pursuant to a license
from Wyeth Pharmaceuticals.
© Cordis Corporation 2010
21758
155-7488
08/10
9/23/2010 5:26:54 PM
CYPHER® Sirolimus-eluting Coronary Stent - Essential Prescribing Information
Device Component Description:
The CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent) is a device/drug
combination product comprised of two regulated components: a device (a
BX VELOCITY® Coronary Stent System) and a drug product (a formulation of sirolimus
in a polymer coating). The device component consists of the BX VELOCITY® Stent
premounted onto a stent delivery system (SDS), either the RAPTOR® PTCA Dilatation
Catheter (Over-the Wire (OTW)) or the RAPTORRAIL® PTCA Dilatation Catheter (Rapid
Exchange (RX)). The range of stent diameters is made possible by varying the number of
circumferential “cells” on the stent. The 2.25, 2.50, 2.75 and 3.00 mm diameter 316L
stainless steel stents have six circumferential cells, whereas, the 3.50 mm diameter 316L
stainless steel stents have seven circumferential cells. The stent is crimped on various size
delivery catheter balloons, which are sized from 2.25 to 3.50 mm.
Drug Component Description:
The active pharmaceutical ingredient in the CYPHER® Stent is sirolimus (also known as
Rapamycin). Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus.
The chemical name of sirolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,
23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c ][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its
molecular formula is C51H79NO13 and its molecular weight is 914.2.
The inactive ingredients in the CYPHER® Stent contain parylene C and the following
two non-erodible polymers: polyethylene-co-vinyl acetate (PEVA) and poly n-butyl
methacrylate (PBMA). A combination of the two polymers mixed with sirolimus
(67%/33%) makes up the basecoat formulation which is applied to a parylene C treated stent. A drug-free topcoat solution of PBMA polymer is applied to the stent surface.
The drug/polymer coating is adhered to the entire surface (i.e., luminal and abluminal) of
the stent.
Indications:
The CYPHER® Stent is indicated for improving coronary luminal diameter in patients
with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 30 mm
in native coronary arteries with a reference vessel diameter of ≥ 2.25 to ≤ 3.50 mm.
Contraindications:
Use of the CYPHER® Stent is contraindicated in the following patient types:
• Patients with a hypersensitivity to sirolimus or its structurally related compounds.
• Patients with a known hypersensitivity to polymethacrylates or polyolefin copolymers.
Coronary artery stenting is contraindicated for use in:
• Patients who cannot receive recommended antiplatelet and/or anticoagulation
therapy.
• Patients judged to have a lesion that prevents complete inflation of an angioplasty
balloon or proper placement of the stent or delivery catheter.
Warnings:
• Please ensure that the inner package has not been opened or damaged as this may
indicate the sterile barrier has been breached.
• The use of the product carries the risks associated with coronary artery stenting,
including subacute thrombosis, vascular complications, and/or bleeding events.
• Patients with a known hypersensitivity to 316L stainless steel may suffer an allergic
reaction to this implant.
• Patients who are unlikely to comply with recommended antiplatelet therapy should not
receive this product.
Precautions - General Precautions:
• Only physicians who have received adequate training should perform implantation of
the stent.
• Stent placement should only be performed at hospitals where emergency coronary
artery bypass graft surgery can be readily performed.
• Subsequent stent blockage may require repeat dilatation of the arterial segment
containing the stent. The long-term outcome following repeat dilatation of
endothelialized stents is not well characterized.
• Do not use Ethiodol or Lipiodol contrast media.
• Do not expose the delivery system to organic solvents, such as alcohol, or detergents.
• Stent thrombosis is a low frequency event that current drug-eluting stent (DES)
clinical trials are not adequately powered to fully characterize. Stent thrombosis is
frequently associated with MI or death. Data from CYPHER® Stent randomized
clinical trials (RAVEL and SIRIUS) have been prospectively evaluated and adjudicated
using both the protocol definition of stent thrombosis and the definition developed by
the Academic Research Consortium (ARC), and demonstrate specific patterns of
stent thrombosis that vary depending on the definition used. In the CYPHER® Stent
clinical trials analyzed to date, differences in the incidence of stent thrombosis
observed with the CYPHER® Stent when compared to bare-metal stents have not
been associated with an increased risk of cardiac death, myocardial infarction, or all
cause mortality. Additional data from longer-term follow-up in the randomized clinical
trials on the CYPHER® Stent and analyses of DES-related stent thrombosis are
expected and should be considered in making treatment decisions as data
become available.
• When drug-eluting stents are used outside the specified Indications for Use, patient
outcomes may differ from the results observed in the pivotal trials.
• Compared to use within the specified Indications for Use, the use of drug-eluting
stents in patients and lesions outside the labeled indications may have an increased
risk of adverse events, including stent thrombosis, stent embolization, myocardial
infarction, or death.
Precautions - Pre- and Post-Procedure Antiplatelet Regimen:
In the pivotal clinical trial of the CYPHER® Stent, clopidogrel or ticlopidine was administered pre-procedure and for a period of three months post-procedure. Aspirin was
administered concomitantly with clopidogrel or ticlopidine and then continued indefinitely to reduce risk of thrombosis. The use of aspirin together with clopidogrel or ticlopidine
is referred to as “dual antiplatelet therapy.” The optimal duration of dual antiplatelet
therapy, specifically clopidogrel is unknown and DES thrombosis may still occur despite
continued therapy. Data from several studies suggest that a longer duration of clopidogrel than was recommended post procedurally in drug-eluting stent pivotal trials (including SIRIUS) may be beneficial. Based upon consensus opinion, practice guidelines recommend that patients receive aspirin indefinitely plus a minimum of 3 months of clopidogrel, with clopidogrel therapy extended to 12 months in patients at low risk of bleeding (ref: ACC/AHA/SCAI PCI Practice Guidelines 1,2,3).
It is very important that the patient is compliant with the post-procedural antiplatelet recommendations. Early discontinuation of prescribed antiplatelet medication could result
in a higher risk of thrombosis, myocardial infarction or death. Prior to Percutaneous
Coronary Intervention (PCI), if a surgical or dental procedure is anticipated that requires
early discontinuation of antiplatelet therapy, the interventionalist and patient should
carefully consider whether a drug-eluting stent and its associated recommended
antiplatelet therapy is the appropriate PCI treatment choice. Following PCI, should a surgical or dental procedure be recommended, the risks and benefits of the procedure
should be weighed against the possible risk associated with early discontinuation of
antiplatelet therapy.
Patients who require early discontinuation of antiplatelet therapy (e.g., secondary to
active bleeding) should be monitored carefully for cardiac events. At the discretion of the
patient’s treating physicians, the antiplatelet therapy should be restarted as soon as possible.
Precautions - Use of Multiple Stents:
The extent of the patient’s exposure to drug and polymer is directly related to the number of stents implanted. Use of more than two CYPHER® Stents has not received adequate clinical evaluation. Use of more than two CYPHER® Stents with total length
> 36 mm will result in the patient receiving larger amounts of drug and polymer than
the experience reflected in the clinical studies.
To avoid the possibility of dissimilar metal corrosion, do not implant stents of different
materials in tandem where overlap or contact is possible. Potential interactions of the
CYPHER® Stent with other drug-eluting or coated stents have not been evaluated and
should be avoided whenever possible.
In the SIRIUS trial, 30.7% (158/515) of patients in the CYPHER® Stent arm had overlapping stents to treat lesions < 30 mm in length.
Precautions – Stent Fractures
Cases of fracture have been reported in clinical use of the CYPHER® Stent; most reports
of stent fracture document that the stent was implanted in lesions beyond the approved
indications for use. Complex lesion morphologic features (including lesion length
≥20mm, ostial location, proximal tortuosity, calcium present, total occlusion, and angulation ≥45˚) and implantation of overlapping stents) were commonly present in cases of
fracture. While the clinical implications of fracture are not fully characterized, rates of
restenosis and TLR higher than those observed when used within the approved indications have been observed.
Precautions – Brachytherapy:
The safety and effectiveness of the CYPHER® Stent in patients with prior brachytherapy of the target lesion have not been established. The safety and effectiveness of use of
brachytherapy to brachytherapy and the CYPHER® Stent alter arterial biology, and the
combined vascular responses of these two treatments have not been determined.
Precautions - Use in Conjunction with Other Procedures:
The safety and effectiveness of using mechanical atherectomy devices (directional
atherectomy catheters, rotational atherectomy catheters) or laser angioplasty catheters
in conjunction with CYPHER® Stent implantation have not been established.
Precautions - Use in Special Populations:
• Pregnancy: Pregnancy Category C. There are no adequate and well-controlled
studies in pregnant women or men intending to father children. Effective
contraception should be initiated before implanting a CYPHER® Stent and for 12
weeks after implantation. The CYPHER® Stent should be used during pregnancy only
if the potential benefit outweighs the potential risk to the embryo or fetus.
• Use during lactation: A decision should be made whether to discontinue nursing or
to implant the stent, taking into account the importance of the stent to the mother.
• Gender: Clinical studies of the CYPHER® Stent did not find any significant
differences in safety and effectiveness for male and female patients.
• Ethnicity: Clinical studies of the CYPHER® Stent did not include sufficient numbers
of patients to assess for differences in safety and effectiveness due to ethnicity, either
by individual category or when grouped by Caucasian and non-Caucasian.
• Pediatric use: The safety and efficacy of the CYPHER® Stent in pediatric patients
below the age of 18 years have not been established.
• Geriatric use: Clinical studies of the CYPHER® Stent did not find that patients age
65 years and over differed with regard to safety and efficacy compared to younger
patients.
• Non-Coronary use: The safety and effectiveness of this product has not been
established in the cerebral, carotid, or peripheral vasculature.
Precautions – Lesion/Vessel Characteristics:
The safety and effectiveness of the CYPHER® Stent have not been established in these
noted patient groups: Patients with vessel thrombus at the lesion site.
• Patients with coronary artery reference vessel diameter < 2.25 mm or > 3.5 mm.
• Patients with lesions located in the saphenous vein graft, in the unprotected left main
coronary artery, ostial lesions, or lesions located at a bifurcation.
• Patients with diffuse disease or poor overflow distal to the identified lesions.
• Patients with multi-vessel disease.
• Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.
• Patients with a recent acute myocardial infarction
• Patients with lesions longer than 30 mm and requiring more than one CYPHER® Stent.
• Patients with chronic total occlusions.
• Patients with in-stent restenotic lesions.
The safety and effectiveness of the CYPHER® Stent have not been established in the
cerebral, carotid, or peripheral vasculature.
While not observed in pivotal clinical trials (First-in-Man, RAVEL, and SIRIUS) that supported the CYPHER® Stent PMA, stent fractures are uncommon events but have been
observed in long stented segments including those in which overlapping stents have
been used. They have been observed in coronary segments that undergo significant
motion, particularly in areas with severe angulation, tortuosity, and calcification. In the
CYPHER® Stent, they have been reported most often in certain lesion subgroups in
which safety and effectiveness have not been established. The clinical implications of
stent fracture are not well characterized.
Precautions - Drug Interactions:
Several drugs are known to affect the metabolism of sirolimus, and other drug interactions may be inferred from known metabolic effects. Sirolimus is known to be a substrate
for both cytochrome P450 IIIA4 (CYP3A4) and P-glycoprotein.
Consideration should be given to the potential for drug interaction when deciding to
place a CYPHER® Stent in a patient who is taking a drug that could interact with
sirolimus, or when deciding to initiate therapy with such a drug in a patient who had
recently received a CYPHER® Stent. The effect of drug interactions on the safety or efficacy of the CYPHER® Stent has not been determined.
Precautions - Coronary Artery Surgery – Effect on Anastomoses:
There have been rare reports of bronchial anastomotic dehiscence of transplant anastomoses in lung transplant patients who were receiving oral sirolimus therapy. In a vessel
that has recently been implanted with a CYPHER® Stent, the sirolimus concentrations
are expected to be several fold higher than systemic sirolimus concentrations. Therefore,
consideration should be given to the possibility that the presence of a CYPHER® Stent
may compromise the healing of coronary artery vascular anastomoses. No such event
was observed in the very limited experience from clinical trials.
Precautions - Immune Suppression Potential:
Sirolimus, the active ingredient of the CYPHER® Stent, is an immunosuppressive agent that
is also available in oral formulations. The mean peak systemic blood concentration of
sirolimus following placement of up to two CYPHER® Stents (1.05 ng/ml) is substantially
lower than the therapeutic concentrations usually obtained when sirolimus oral formulations
are used as prophylaxis for renal transplant rejection. In clinical studies of CYPHER® Stents
when used according to its intended use, there were no reports of immune suppression.
However, for patients who receive several CYPHER® Stents simultaneously, it may be possible for systemic concentrations of sirolimus to approach immunosuppressive levels temporarily, especially in patients who also have hepatic insufficiently or who are taking drugs
that inhibit CYP3A4 or P-glycoprotein. This possibility should be considered for such patients,
particularly if they are also taking oral sirolimus (or rapamycin), other immunosuppressive
agents, or are otherwise at risk for immune suppression.
Precautions - Lipid Elevation Potential:
The use of oral sirolimus in renal transplant patients was associated with increased
serum cholesterol and triglycerides that in some cases required treatment. The effect was
seen with both low and high dose prolonged oral therapy in a dose related manner.
When used according to the indications for use, the systemic sirolimus concentrations
from the CYPHER® Stent are expected to be lower than the concentrations usually
obtained in transplant patients, but the magnitude and duration of any effect of those
concentrations on lipids is not known.
Precautions - Magnetic Resonance Imaging (MRI):
Non-clinical testing has demonstrated that single and two overlapping CYPHER®
Stents are MR-conditional. They can be scanned safely, immediately post implantation,
under the following conditions:
• Static magnetic field of 3 Tesla
• Spatial gradient field of 500 Gauss/cm
• Maximum whole-body-averaged specific absorption rate (SAR) of 4.0 W/kg for 15
minutes of scanning
In non-clinical testing, a single CYPHER® Stent up to 33 mm in length produced a temperature rise of less than 1°C and two overlapping CYPHER® Stents up to 33 mm in
length produced a net temperature rise of less than 2°C at a maximum whole body averaged SAR of 4.0 W/kg for 15 minutes of MR scanning in a 3 Tesla Siemens Whole Body
MR Scanner serial 20514, Software NUMARIS/4, version Syngo MR 2003T DHHS,
VX22A. The maximum whole body averaged SAR was determined by calorimetry
following ASTM F2182-02.
The image artifact extends approximately 1 mm from the device, both inside and outside
of the device lumen when scanned in non-clinical testing using a pulse sequence generating a whole body SAR of 4.0 W/kg in a Siemens Whole Body MR Scanner, serial 20514,
Software NUMARIS/4, version Syngo MR 2003T DHHS, VX22A with 3 Tesla coil.
Precaution – Preparation:
• AVOID manipulation of the stent during flushing of the guidewire lumen, as this may
disrupt the placement of the stent on the balloon.
• Do NOT apply negative or positive pressure to the balloon during the delivery system
preparation.
Precautions - Stent Handling:
• For single use only. Do not resterilize or reuse this product. Note the “Use By” date
on the product label.
• Do not remove the stent from the delivery balloon – removal may damage
the stent and coating and/or lead to stent embolization. The stent system is
intended to perform as a system.
• Do not induce a vacuum on the delivery system prior to reaching the
target lesion.
• Special care must be taken not to handle or in any way disrupt the stent on the
balloon. This is most important while removing the catheter from the packaging,
placing it over the guidewire, and advancing it through the large-bore rotating
hemostatic valve and guiding catheter hub.
• Stent manipulation (e.g., rolling the mounted stent with your fingers) may cause
coating damage, contamination or dislodgement of the stent from the delivery
system balloon.
• Use only the appropriate balloon inflation media. Do not use air or any gaseous
medium to inflate the balloon as this may cause uneven expansion and difficulty
indeployment of the stent.
Precautions - Stent Placement:
• The vessel should be pre-dilated with an appropriate sized balloon.
• Do not prepare or pre-inflate the balloon prior to stent deployment other
than as directed.
• Guiding catheters used must have lumen sizes that are suitable to accommodate the
stent delivery system.
• Do not induce a negative pressure on the delivery catheter prior to placement of
the stent across the lesion. This may cause premature dislodgment of the stent from
the balloon.
• Although the stent delivery balloon catheter is strong enough to expand the stent
without rupture, a circumferential tear of the carrier balloon distal to the stent and
prior to complete expansion of the stent could cause the balloon to become tethered
to the stent, requiring surgical removal. In case of rupture of the balloon, it should be
withdrawn and, if necessary, a new balloon catheter exchanged over the guidewire to
complete the expansion of the stent.
• Implanting a stent may lead to a dissection of the vessel distal and/or proximal to the
stented portion and may cause acute closure of the vessel requiring additional
intervention (CABG, further dilatation, placement of additional stents, or other intervention).
• Do not expand the stent if it is not properly positioned in the vessel.
• Placement of the stent has the potential to compromise side branch patency.
• When treating multiple lesions, the distal lesion should be initially stented, followed by
stenting of the more proximal lesion(s). Stenting in this order minimizes the need to
cross the proximal stent in the placement of the distal stent and may reduce the
chances of dislodging the proximal stent, or disrupting stent coating.
• Balloon pressures should be monitored during inflation. Do not exceed rated burst
pressure as indicated on the product label. Use of pressures higher than those
specified on the product label may result in a ruptured balloon with possible intimal
damage and dissection.
• Do not attempt to pull an unexpanded stent back through the guiding
catheter, as dislodgment of the stent from the balloon may occur.
• Stent retrieval methods (use of additional wires, snares and/or forceps) may result in
additional trauma to the coronary vasculature and/or the vascular access site.
Complications may include bleeding, hematoma, or pseudoaneurysm.
• Ensure full coverage of the entire lesion/dissection site so that there are no gaps
between stents.
Precautions - Stent/System Removal:
Should unusual resistance be felt at any time during either lesion access or removal
of the stent delivery system before stent implantation, the entire system should be
removed as a single unit.
When removing the delivery system as a single unit:
• Do not retract the delivery system into the guiding catheter.
• Advance the guidewire into the coronary anatomy as far distally as safely possible.
• Tighten the rotating hemostatic valve to secure the stent delivery system to the
guiding catheter; then remove the guiding catheter and stent delivery system as a
single unit.
Failure to follow these steps or applying excessive force to the stent delivery system can
potentially result in loss or damage to the stent or stent delivery system.
If it is necessary to retain the guidewire in position for subsequent artery/lesion access,
leave the guidewire in place and remove all other system components.
Precautions – Post-Procedure
• Great care must be exercised when crossing a newly deployed stent with an
intravascular ultrasound (IVUS) catheter, a coronary guidewire or balloon catheter to
avoid disrupting the stent placement, apposition, geometry, and/or coating.
• Through non-clinical testing, single and two overlapping CYPHER® Stents have
been shown to be MRI safe at field strengths of 3 Tesla or less. MR imaging
quality may be compromised if the area of interest is in the exact same area or
relatively close to the position of the stent.
• In the pivotal clinical trial of the CYPHER® Stent, clopidogrel or ticlopidine was
administered pre-procedure and for a period of 3 months post-procedure. Aspirin
was administered concomitantly with clopidogrel or ticlopidine and then continued
indefinitely to reduce the risk of thrombosis.
• Patients who require early discontinuation of antiplatelet therapy (e.g. secondary to
active bleeding) should be monitored carefully for cardiac events. At the discretion of
the patient’s treating physician, the antiplatelet therapy should be restarted as soon
as possible.
Drug Information
Mechanism of Action:
The mechanism (or mechanisms) by which a CYPHER® Stent affects neointima production as seen in clinical studies has not been established. Sirolimus inhibits T-lymphocyte
activation and smooth muscle and endothelial cell proliferation in response to cytokine
and growth factor stimulation. In cells, sirolimus binds to the immunophilin, FK Binding
Protein-12 (FKBP-12). The sirolimus-FKBP-12 complex binds to and inhibits the activation of the mammalian Target of Rapamycin (mTOR), leading to inhibition of cell cycle
progression from the G1 to the S phase.
Pharmacokinetics of the CYPHER® Stent:
The pharmacokinetics of sirolimus as delivered by the CYPHER® Stent has been determined in patients with coronary artery disease after implantation of one (n=10) or two
(n=9) CYPHER® Stents.
The results show that Cmax and AUC were closely dose-proportional over a 2-fold range
in doses. The blood levels after stent implantation were 10 to 20 fold lower than what
was observed after oral administration of sirolimus in either healthy volunteers or transplanted patients. The mean ± SD sirolimus terminal half-life (t1/2) after stent implantation for the combined groups (n = 19) was 213 ± 97 h. By comparison, the mean ± SD
sirolimus t1/2 values after single dose administration of sirolimus by oral solution in
healthy subjects (n = 305) and renal transplant patients (n = 81) were 72.9 ± 19.3 h
and 58.2 ± 19.2 h, respectively. The apparent discrepancy in half-lives after stent implantation and oral administration is due to the fact that the decline in terminal sirolimus concentrations reflects the release of sirolimus from the stent and not elimination of
sirolimus from the body.
For additional information regarding sirolimus, please see the CYPHER® Stent
Instructions for Use.
Potential Adverse Events:
Adverse events (in alphabetical order) which may be associated with the implantation of
a coronary stent in coronary arteries: Allergic reaction, Aneurysm, Arrhythmias, Cardiac
tamponade, Death, Dissection, Drug reactions to antiplatelet agents /anticoagulation
agents / contrast media, Emboli, distal (tissue, air, or thrombotic emboli), Embolization,
stent, Emergency CABG, Failure to deliver the stent to the intended site, Fever,
Fistulization, Hemorrhage, Hypotension/Hypertension, Incomplete stent apposition,
Infection and pain at the intended site, Myocardial infarction, Myocardial ischemia,
Occlusion, Prolonged angina, Pseudoaneurysm, Renal failure, Restenosis of stented segment (greater than 50% obstruction), Rupture of native and bypass graft, , Stent migration, Stroke, Thrombosis (acute, subacute, late, or very late), Ventricular fibrillation, Vessel
spasm, and Vessel perforations.
Potential adverse events (in alphabetical order) related to sirolimus (following oral
administration): Abnormal liver function tests, Anemia, Arthralgias, Diarrhea,
Hypercholesterolemia, Hypersensitivity, including anaphylactic/anaphylactoid type reactions, Hypertriglyceridemia, Hypokalemia, Infections, Interstitial lung disease, Leukopenia,
Lymphoma and other malignancies, Thrombocytopenia.
The third-party trademarks used herein are trademarks of their respective owners.
1 Grines
CL, Bonow RO, Casey DE, Gardner TJ, Lockhart PB, Moliterno DJ, O’Gara P,
Whitlow P. Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in
Patients with Coronary Artery Stents. Circulation. 2007; 115:1-6.
2 www.cardiosource.com/guidelines/clinicalalerts/thienopyridines.pdf
3 J. Am. Coll. Cardiology. 2006;47:216-235
© Cordis Corporation 2010 155-1787-10 04/10
9/23/2010 5:27:01 PM
27
TCT Daily
TAVI Risk Score May Be Necessary
Frailty, ‘valve in valve’ appear to be
emerging indicators of TAVI.
EuroScore may not be the most effective
means of categorizing risk for transcatheter aortic valve implantation, according
to data from two consecutive cohorts in
the SOURCE registry that reveal unanticipated changes in patient population
over time.
“The Logistic EuroScore overestimates but does categorize risk for TAVI,”
said Martyn Thomas, MD, of St. Thomas’ Hospital, London, who presented the
findings on behalf of the SOURCE investigators. Even though the value of the
score should not
be dismissed categorically, Thomas
said, “We may
need to account
for other possible
risk factors,” such
as frailty. This
would
suggest
Martyn Thomas, MD
that there is an urgent need for the development of a “TAVI
risk score” to truly assess risk, he said.
Thomas noted disparities between
predicted and observed mortality at 30
days in cohort 1 (patients enrolled in the
registry between November 2007 and
January 2009). However, 1-year data
indicated that in the same cohort, the
group with a EuroScore of 20 had a
survival rate of 78.4%, compared with a
59.2% survival rate among patients with
a score 40.
The proportion of patients with a
score 20 decreased from 66.9% in
cohort 1 to 56.2% (P .001) in cohort
2 (patients enrolled between February
2009 and December 2009).The propor-
Figure
tion of patients with a score 20 increased from 32.8% to 43.5% over the
two cohorts (P .001).
Regardless of score, 30-day survival
rates across both cohorts were similar, which raised the question of what
is different about patients with a score
of 20 who underwent TAVI. “We observed porcelain aorta, cancer, severe
pulmonary disease with an FEV1 <1
and post-thoracic radiation therapy in
this group,” Thomas said. “What we do
not collect in this registry is any assessment of frailty.”
Looking at changes in patients with
a score of 20 between the cohorts,
the researchers observed that the risk may
have actually increased.
“There have been important increases in patients
with congestive heart
failure, mitral regurgitation — which we know
is a bad sign — and a
strong trend toward renal insufficiency.”
Thomas said that
transcatheter
valve
therapy appears to be
an emerging indication for the treatment
Early Pioneers of Valve Technology
Recall Initial Challenges, Successes
This year may be “the year of the valve,”
as thousands of patients have now been
implanted with this technology, but in
the early days of the field, the pioneers
who developed transcatheter valve devices were met with resistance.
This year’s TCT Career Achievement
Award recipient, Alain G. Cribier, MD,
from Hospital Charles Nicolle in Rouen,
France, conducted the first transcatheter
aortic
valve implantation
in 2002. During
Thursday’s Pioneer’s Corner, he
recalled a story
about the early
Alain G. Cribier, MD
days of clinical
trials when he presented data from the
first 30 valvular heart disease patients
who were implanted with a percutaneous valve.
“I presented the results, including the
evolution of the patients after 6 months
or so, and at the end, almost everyone
in the audience applauded, except for
one surgeon. He approached me afterward and said, ‘I have been listening
to you, and I think what you are saying is totally wrong. I don’t trust a single
word of what you presented,’” Cribier
recalled. “This is the kind of spirit I had
to fight.”
Frederick G. St. Goar, MD, who developed the MitraClip technology, said
in an interview after the panel discussion that he understands stories like
Cribier’s, as there are always many new
questions and clinical trial hurdles to
conquer with the introduction of any
new technology. However, he said he
believed in the concept of the MitraClip, and was able to obtain backing
from his colleagues.
Michael J. Mack, MD, from the
Medical City Dallas Hospital, Texas,
understood initial resistance to valve
technologies.
“I’ve said many
times that, as a
surgeon, I wouldn’t
have invented this
technology,” Mack
said. “Sometimes
you know too
much, and as a
surgeon, you think
Michael J. Mack, MD
you can’t do it,
because there is concern about potential complications. But the first time I
saw this, there was an immediate ‘wow’
factor. You think immediately, ‘you can
do this.’”
Eberhard Grube, MD, from the International Heart Center Rhein, in Essen,
Germany, said his early experiences with
valve implantation
taught him an important lesson.
“When we were
doing the first implants, we weren’t
very
successful because we
lacked the infraEberhard Grube, MD
structure to deal
with initial complications,” Grube
said. “I had to explain to the ethics
committee
that
the [early problems that we saw
with the implant]
weren’t the fault of
Ted Feldman, MD
the implant, it was
the fault of the infrastructure. This taught
me that if you fundamentally believe a
technology works, and we had no reason
think it couldn’t, you should proceed.”
Ted Feldman, MD, of Evanston Hospital, Evanston, Ill., recalled the chal-
of a failing surgical aortic bioprosthesis, and he noted that patients in this
“valve in valve” group are very high
risk (see Figure).
The number of
patients who had
Sapien in prior
aortic bioprosthesis
increased from 0.2%
in cohort 1 to 1.9% in
cohort 2.
“
”
- Martyn Thomas, MD
“The number of patients who had Sapian (Edwards Lifesciences) in prior aortic bioprosthesis increased from 0.2% in
cohort 1 to 1.9% in cohort 2,” Thomas
said. “This result was not anticipated at
the start of this registry.”
Further evaluation of the bioprosthetic group will be conducted in the
next SOURCE registry, according to
Thomas.
Disclosures:
Dr. Thomas reports receiving grant/
research support from Edwards
Lifesciences and consulting fees
and honoraria from Boston Scientific
and Cordis.
●
lenges in finding the first patients in
whom to use this technology.
“We had a long period where we
were working with animals,” Feldman
said. But finding the first human patient
for any “first in class is a great challenge.” He said his first patient was a
man who participated in an earlier trial,
then came back presenting with shortness of breath and
presumed coronary disease. This
man said that he
was interested in
trying a new therapy, and Feldman
said that man’s
decision “was a
Martin B. Leon, MD
great moment,”
that enabled their team to try that new
technology.
Fast-forward to 2010, which session
moderator and TCT Course Director
Martin B. Leon, MD, termed the “year
of the valve.”
Leon said that the determination
and vision of people like Cribier, Mack,
Grube, Feldman and St. Goar led to “extraordinary contributions in helping patients with valvular heart disease.”
Disclosures:
●
Drs. Cribier, Grube, Feldman, Leon,
Mack and St. Goar report conflicts
of interest with several device
manufacturers.
9/23/2010 5:27:02 PM
28
Patient Honored for Her Courage
Ninety-nine-year-old Lillian K. Feldshuh
receives the TCT Courageous Patient
Award for bravery and trust.
In an effort to honor not only the physicians who develop new therapies but
also the patients who enroll in clinical
trials, a patient’s cardiology team presented her with the TCT Courageous
Patient Award for undergoing percutaneous aortic valve replacement 5
years ago.
“As physicians, we often take the
credit for all of these new therapies but
fail to recognize the impact on patients,
their families and what it means to be
involved in a clinical trial of this nature
− dealing with a life-threatening disease
and completely new therapies,” TCT
Course Director Martin B. Leon, MD,
said during the award presentation.
Her story
In 2006, Lillian K. Feldshuh suffered
from aortic stenosis. Even though
she was told nothing could be done,
the team at NewYork-Presbyterian
Hospital/Columbia University Medi-
cal Center took on the challenge and
performed percutaneous aortic valve
replacement in the then 95-year-old
woman. Today that team presented
her with the award.
“It is with great pleasure that I present [this award] to Lily Feldshuh for
her tremendous courage, trust, persistence and humor, which is always
ever-present. I present the Courageous
Patient Award to Lillian K. Feldshuh for
helping to further the progress of medicine,” Susheel Kodali, MD, of NewYork-Presbyterian
Hospital/Columbia
University Medical Center, said during
the award ceremony.
‘The chance to live’
When the option to enroll in the REVIVAL 2 trial presented itself, Feldshuh
refused after her son informed her of the
risks associated with the procedure. After some coaxing, she put her trust in
her son, David Feldshuh, MD, an emergency room physician at
Cornell University, and the
team of doctors he dubbed
“The Resurrection Team.”
Those physicians include
Kodali, Leon, Jeffrey W.
Moses, MD, and Mathew
Williams, MD.
The procedure was a
success and Feldshuh, who
will turn 100 years in just 7
months, remains in good
health.
“In June 2006, I was given
Susheel Kodali, MD (left) presented Lillian K. Feldshuh with the TCT
Courageous Patient Award. She was joined by her daughter and son.
the choice to die or take the
PFO Closure Prevents Recurrent
Cerebrovascular Events After Stroke or TIA
Patent foramen ovale closure was associated
with better survival, fewer incidents of stroke
and transient ischemic attack.
Patients with stroke or transient ischemic attack who underwent patent foramen ovale closure had fewer recurrent cerebrovascular events at 10 years
compared with those who had medical
treatment alone, said Bernhard Meier,
MD, Wednesday at TCT 2010.
A total of 308 patients with clinically
or radiologically confirmed ischemic
Figure 1
stroke or TIA treated at the University
Hospital of Bern Stroke Center in Switzerland from January 1994 to August
2000 were enrolled in the university’s
stroke/PFO registry. They were included
in the study if they had PFO and/or atrial
septal aneurysm.
According to the results, PFO closure
was associated with superior outcomes
Figure 2
at 10 years for the combined primary
endpoint of ischemic stroke, TIA or peripheral embolism vs. medical treatment
alone in both the propensity scorematched cohort (see Figure 1) and intent-to-treat cohort (see Figure 2).
“Looking at just the propensity scorematched cohort, in terms of the combined
endpoint – stroke, TIA or peripheral embolism – at 10 years, there was a reduction
of about 50%, from 21% down to 11%,
which was significant,” said Meier, professor and chairman of cardiology at Bern
University Hospital. “More than half the
TIAs had been prevented by the device.”
chance to live. Naturally, I chose to take
the chance to live. Maybe I’m a pioneer, I
don’t know. But I accept this award with
gratitude and wonder. Who could have
predicted in 1911 that in my hundredth
year I would be receiving an award from
As physicians, we
often take the credit
for all of these new
therapies but fail to
recognize the impact
on patients, their
families and what it
means to be involved
in a clinical trial…
“
- Martin B. Leon, MD
”
the finest doctors in the world? I’ve had
a blessed life. To reach this time and
these years and be with you today, life is
wonderful. I thank you from the bottom
of my heart,” Feldshuh said.
Leon said that stories like Feldshuh’s
are meaningful and allow cardiologists
to get back to the basics of what is important: finding new ways to care for
sick patients.
One hundred fifty patients were assigned to PFO closure and 158 were
assigned to medical treatment alone,
resulting in 1,796 patient-years for those
assigned to the device arm and 1,323
patient-years in the control group.The
incidence of TIA at 10 years in the intentto-treat population was 4.7% compared
with 11.4% with medical treatment alone
(HR=0.40; 95% CI, 0.17-0.96; P=.04). In
the matched cohort, the incidence was
4.9% vs. 13.6% for medical treatment
alone (HR=0.31; 95% CI, 0.10-0.94;
P=.039).
At 10 years, all-cause mortality was
5.8% for both PFO closure and medical treatment alone in the propensity
score-matched cohort (HR=1.00; 95%
CI, 0.32-3.10; P=1.00). Percutaneous
PFO closure was associated with lower
all-cause mortality in the intent-to-treat
population, although the difference was
not significant (8.2% vs. 4.7%; HR=0.55;
95% CI, 0.22-1.38; P=.21).
“PFO closure appears to be more
effective than medical treatment for
secondary prevention of recurrent cerebrovascular events among patients
with stroke or TIA presumably related
to PFO,” Meier said. “There was less
death, less stroke and less TIA with a
PFO closure device than without. Of
course the results will require confirmation from randomized trials.”
Disclosures:
●
Dr. Meier reports receiving lecture and
consultation fees from AGA Medical.
9/23/2010 5:27:07 PM
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31
TCT Daily
Cardiac Clamp Procedure Shows Promising Results in
Patients with Significant Mitral Regurgitation
EVEREST II patients are showing improved
NYHA functional class.
The MitraClip procedure is an important
therapeutic tool that shows sustained
improvements in selected patients with
significant mitral regurgitation, according
to data from EVEREST II.
In the EVEREST II trial, 279 patients
with mitral regurgitation (grade 3 or 4)
were
randomly
assigned to the
MitraClip (Abbott
Vascular) procedure (n=184) or
to surgical repair
or
replacement
(n=95) at their surgeon’s discretion.
James B. Hermiller, Jr, MD
For the per protocol analysis that James B. Hermiller, Jr,
MD, of St. Vincent’s Hospital/The Heart
Center of Minneapolis presented, 134
(72.8%) device and 74 (77.9%) surgical
patients met the study’s primary efficacy
endpoint of freedom from the combined
outcome of death, surgery or reoperation at 1 year (see Figure).
The device patients also had significant improvements in NYHA Functional
Classification, with respect to those patients with grade 1 and 2 mitral regurgitation, while in the control group only
the grade 1 patients showed functional
improvement. Hermiller added, however, that the control group was small, so
that should be taken into account when
considering the findings.
Regarding left ventricular remodeling,
Hermiller reported that in patients with mitral regurgitation grade 1 or grade 2, both
Figure
the device and surgical control groups
achieved significant reductions in diastolic
volumes, while systolic volumes fell only
in those patients with residual grade 1
mitral regurgitation (n=74). Patients in the
device group with residual mitral regurgitation of grade 1 or grade 2 at 12 months
demonstrated clinical benefits in the form
of reverse left ventricular remodeling,
improved functional status and improvements in quality of life at 12 months.
MitraClip procedure following
surgery
Other data from EVEREST II also indicated that surgery after MitraClip had safety
and clinical success
rates similar to those
of primary surgery, with
an adverse event profile
at follow-up that was
about the same as in the
de novo surgery group.
Alfredo Trento, MD,
of Cedars-Sinai Medical Center reported on
midterm data from 37
EVEREST II patients (20
who underwent mitral
valve repair and 17 who
underwent mitral valve replacement)
suggesting that the MitraClip procedure
has demonstrated durability with similar
safety and clinical success compared
with surgery.
Although EVEREST II surgeons were
highly experienced in mitral valve repair,
surgeon experience and duration of implant did not appear to affect the repair/
replacement rate, Trento said. He added
that the repair rate in patients who had
valve injury or difficulty removing the device is not different from patients who
had no such operative difficulties.
He said the midterm results also indicate mitral valve surgery following the
MitraClip procedure can be performed
safely, and with results similar to those
of the control group at 30 days and at
12 months.
Hermiller noted some limitations of
the EVEREST II study, particularly its
retrospective design and small sample
size.
Disclosures:
• Dr. Hermiller reports receiving
research grants from and serving as
a consultant for Abbott Vascular.
• Dr. Trento reports receiving research
grants from Abbott Vascular.
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32
Diabetes Continues to Impact Revascularization Decisions
‘Unmet clinical need’ for next-generation DES
platforms should address diabetes effect.
As the prevalence of diabetes increases throughout the world, cardiologists
face important decisions about revascularization and medical management
for this high-risk group of patients.
Steven P. Marso, MD, of St. Luke’s
Hospital in Kansas City, Mo.,
urged the audience at TCT 2010
to consider a
patient’s diabetes history when
selecting
pharmacologic or reSteven P. Marso, MD
vascularization
strategies in treating their cardiovascular disease.
Diabetes in the stenting era
Patients with diabetes have a higher frequency of late-vessel occlusion
with balloon angioplasty and a higher
frequency of in-stent restenosis with
BMS, he said. Previous studies have
linked diabetes to up to 60% more
restenosis in the BMS era compared
with nondiabetics.
Quantitative coronary angiography
study data are “clear and convincing”
that the type of restenosis in patients
with diabetes is different than in patients without diabetes, Marso said.
In the DES era,
diabetes has been
linked to increased
mortality, nonfatal MI
and restenosis.
“It is not focal, it is not edge. It is
diffuse, it is proliferative — a different type of restenosis that is driven by
neointimal reformation,” he said.
In the DES era, diabetes has been
linked to increased mortality, nonfatal
MI and restenosis. Although neointima
is significantly higher in the BMS era,
first-generation DES stents, specifically the paclitaxel-eluting stent platform,
were proven to reduce neointima, with
nearly similar rates in both diabetic
and nondiabetic individuals.
“The second-generation ‘-olimus’
is superior to the first-generation DES,
with improved clinical event rates, lower stent thrombosis and improved vessel patency,” Marso said. This appears
to be driven by a benefit in the nondiabetic cohort, he said.
However,
Marso
added, it is unclear how
second-generation DES
will afford the vessel
patency in patients with
diabetes.
As the prevalence of
diabetes steadily grows
in the Unites States
(see Figure), “there remains an important unmet clinical need for the
next generation DES
platforms to address
the diabetes effect,” he Figure
said.
Diabetes in the SYNTAX trial era
In SYNTAX, diabetes was associated with a much greater need for repeat revascularization across all strata
of the Syntax score.
“There appears to be a mortality
signal most noted in the diabetic patients with a Syntax score greater than
33,” Marso said.
Several years’ follow-up of the
SYNTAX data will be important to de-
APPOSITION II: Tenfold Reduction in
Malapposition with Self-Expanding Stent
More research needed to assess clinical
impact of improved early stent apposition.
Results of the APPOSITION II study revealed a 10-fold reduction in stent strut
malapposition at 3 days with a selfexpanding nitinol stent compared with
a balloon-expanding stent, reported
Robert-Jan van Geuns, MD, of Erasmus Medical Center, Rotterdam, The
Netherlands.
The prospective, randomized,
multicenter APPOSITION II study
compared a selfexpanding nitinol
stent
(Stentys)
with a convenRobert-Jan van Geuns, MD
tional balloon-expanding stent (Vision, Abbott Vascular; Driver, Medtronic)
serving as the control in patients with
acute MI. The primary endpoint was
stent strut apposition at 3 days by optical coherence tomography.
A total of 80 patients were randomly
assigned to the self-expanding stent
(n=43) or the balloon-expanding stent
Figure
(n=37) between December 2009 and
June 2010. The researchers completed optical coherence tomography and
quantitative coronary angiography at 3
days, and clinical follow-up at 30 days
and 6 months.
On optical coherence tomography,
far fewer struts were malapposed at
3 days in patients who received the
self-expanding stent (see Figure).
Malapposition was defined as the distance
between the leading
edge of the strut and
the leading edge of the
contour bigger than
the strut thickness.
Overall, 28% of patients treated with balloon-expanding stents
displayed significant
malapposition (defined
as ⭓5% malapposed
struts) at 3 days after
acute MI. In contrast,
none of the patients
treated with the selfexpanding stent had malapposition
(P⬍.001).
Additionally, coronary angiography
termine proper care for patients with
diabetes, according to Marso.
“I expect that we will see continued
disparate findings in people with dia-
betes in the PCI cohort, especially with
Syntax scores in the second or third
tertile,” he said.
Disclosures:
●
Dr. Marso reports receiving grant/
research
support
for
Amylin
Pharmaceuticals, Terumo Medical
Corporation
The
Medicines
Company and Volcano Corporation,
and consulting fees from The
Medicines Company.
at 3 days showed an in-stent lumen
loss of –0.11 ± 0.29 mm in the selfexpanding stent group vs. 0.04 ± 0.21
mm in the control group (P=.01). The
negative lumen loss was “expected”
with the self-expanding stent technology, and shows that the stent is “indeed increasing in 3 days in size,” van
Geuns said.
Far fewer struts were
malapposed at 3
days in patients who
received the selfexpanding stent.
Clinical follow-up at 30 days revealed
no major adverse cardiac events, including cardiac death, MI, CABG and
target lesion revascularization, or stent
thrombosis in either group.
“Further studies are needed to assess the clinical impact of improved
early stent apposition,” van Geuns
concluded.
Disclosures:
●
Dr. van Geuns reports no relevant
9/23/2010 7:42:43 PM
Visit Abbott Vascular’s
Innovations Theatre
TCT 2010 | Booth #1456
Come learn how Abbott Vascular is driving innovation
by experiencing the Innovations Theatre at our booth, featuring:
Technology Talks
A series of live, interactive hands-on demonstrations given by top Abbott Vascular
scientists featuring exciting new technologies in development
Live Broadcasts from Main Arena
Relax in the comfortable setting of our Innovations Theatre to watch live cases
and listen to late-breaking trial information
Internet Cafe
Enjoy Internet access and refreshments while getting to know
the Abbott Vascular team
Technology Talks
Thursday, September 23 | Friday, September 24
10:00 – 11:00 AM: Side Branch Access Technology
12:15 – 1:15 PM: Polymer Technology
2:30 – 3:30 PM: Multi-layer Balloon Technology (Thursday only)
2:30 – 3:30 PM: Drug Coated Balloon Technology (Friday only)
Go to Abbott Vascular booth #1456
TCT 2010
For more information, visit our website at AbbottVascular.com.
©2010 Abbott Laboratories. All rights reserved. Printed in the USA.
AP2933170 Rev A (8/10)
9/23/2010 11:35:44 PM
34
Technology, Manpower Needed to Battle Stroke in U.S.
Training cardiologists in neuroanatomy
could help combat the number one cause
of disability.
Cardiologists and neurointerventionalists must join forces to take on
the increasing number of strokes that
occur in the United States, urged a
presenter at TCT 2010.
Leo Nelson Hopkins, MD, a neurointerventionalist at Millard Fillmore Gates
Hospital in Buffalo, N.Y., discussed
the need for cardiologists to play a
role in the future of
stroke care.
“[Stroke] has to
be a focus for all of
us because it is the
Leo Nelson Hopkins, MD
number one cause
of disability, one of the most expensive
diseases we face and the number three
cause of death,” Hopkins said.
Approximately 800,000 strokes will occur in the United States in the next year
and, according to Hopkins, the manpower
needed to treat those strokes must come
from interventional cardiology – a field
with experts whose goal of timely treatment is aligned with those currently treating strokes. In addition, Hopkins noted,
the infrastructure for the provision of
emergency service already exists in interventional cardiology and cardiologists are
familiar with many stroke interventions,
such as clot removal and stenting.
Current stroke treatment toolbox
When performing stroke intervention, the goal is to restore blood flow
in the occluded cerebral artery to preserve the brain territory it supplies and
return the patient to normal function,
Hopkins said. Current treatment options include both medical (eg, lytics,
antiplatelet therapy, anticoagulants,
BP regulation, electrolyte control) and
endovascular (eg, intra-arterial, injections, mechanical thrombolysis, clot
retrieval-plasty) methods.
All of the current options are ef-
fective, but they each have caveats.
Intravenous tissue type plasminogen
activator – the first approved stroke
treatment – is not approved for patients older than 80 years, those taking oral anticoagulants, those with an
NIH Stroke Scale ⬎25 or those with a
history of stroke or diabetes. In addi-
Stenting for salvage
of ischemia works.
It is a principle that
was developed by
cardiology and it
needs to be applied
to acute stroke.
“
”
- Leo Nelson Hopkins, MD
tion, there is a limited time window and
limited benefit, Hopkins said.
Data from studies of intra-arterial
methods, such as the PROACT II, demonstrated superiority with placebo but
an increased risk for hemorrhage and
no difference in the rate of mortality, according to Hopkins.
Better technology, manpower needed
A new tool called cerebral perfusion
provides quantitative data on blood flow,
blood volume and mean transit time, a
useful guide during intervention that Hopkins and colleagues relied upon heavily
during the SARIS trial. SARIS was a small
safety study that examined the use of a
self-expanding wingspan stent for stroke
intervention. Recanalization results from
the trial were favorable (100% of patients
improved to TIMI flow ⭓2), Hopkins said.
However, data on the use of stents in stroke
intervention is lacking and this method is
not currently FDA approved.
“Stenting for salvage of ischemia
works. It is a principle that was developed
by cardiology and it needs to be applied to
acute stroke,” Hopkins said.
Lastly, there is a need for manpower
in the battle against stroke and, according to Hopkins, cardiologists are the key.
Training programs designed for cardiologists to learn neuroanatomy and neurotechniques are critical to the success of
stroke intervention, he said.
Disclosures:
●
Dr. Hopkins reports no relevant
BREAKING NEWS: STENTYS® Self-Apposing Stent
superior to VISION / Driver in STEMI patients
STENTYS® Self-Apposing Stent
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Superior Stent Apposition
with 10 times fewer malapposed
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showing perfect anatomical fit
Malapposed Conventional Stent
Results of the APPOSITION II Randomized Trial
Stent
% Malapposed struts at 3 days
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VISION / Driver Stent
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9/23/2010 11:35:48 PM
ADVANCE
Your Vascular Procedures
Whether you’re looking for the latest in aortic aneurysm
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(PAD) more effectively, we want to be your procedural
partner. At Cook Medical, we continually work to promote
best practices in the global vascular community and bring
you a broad line of proven products for many vascular
procedures, including:
© COOK 2010 PI-BM-TCTDA2-EN-201008
• Endovascular Aortic Repair
• Leg Therapies
• Pulmonary Embolism Prevention
• Embolic Therapies
Visit the Cook Medical booth to have a hands-on experience
with the latest endovascular grafts, balloons, stents, coils and filters.
Don’t forget the dinner symposium!
Emerging drug-eluting devices for the SFA.
Friday from 7:00 - 9:30 pm
in the Renaissance Ballroom at the Renaissance Washington, DC Downtown Hotel
9/23/2010 11:35:53 PM
36
Fresh Air for Drug-Coated Balloon
Device appears to limit neointimal
hyperplasia, improve angiographic outcomes.
A novel drug-coated balloon shows promise for treating both de novo coronary
lesions and in-stent restenosis, according to results from
two small studies
presented at TCT
2010.
The Moxy device (Lutonix) has
a 2 μg/mm2 paclitaxel coating with
a hydrophilic nonPatrick W. Serruys, MD, PhD
polymeric carrier.
The formulation balances drug retention
during transit with drug uptake during a
single 30-second inflation.
Same Device, Two Indications
For the de novo pilot study, researchers led by Patrick W. Serruys, MD, PhD, of
Erasmus Medical Center, Rotterdam, The
Netherlands, studied 26 patients with de
novo coronary lesions who were randomized to receive the balloon device either
before or after BMS placement (Multi-Link
Vision, Abbott). Positive results were obtained for the primary endpoint of percent
volume obstruction on optical coherence
tomography at 6 months (see Table).
Serruys pointed out that, in comparison, percent volume obstruction
typically amounts
to
more
than
35% after treatment with BMS
alone.
“Without
any doubt, there
is evidence of bioLaura Mauri, MD, MSc
logical effect. And
although it could be improved, it is clearly
demonstrated by OCT,” he said, adding
target lesion revascularization.
The PERVIDEO registry has shown
good results in a difficult population, namely patients with in-stent restenosis, vessels
that the treatment also is feasible and
with a mean reference vessel diameter of
safe. By 6 months, no deaths and one
2.4 mm, and native coronary disease in
STEMI had occurred.
other vessels, Mauri concluded.
Laura Mauri, MD, MSc, of Brigham and
“The angiographic endpoint demonWomen’s Hospital, Boston, Mass., and
strated a certain biological effect, as [incolleagues looked at another patient popdicated] by very low late lumen loss and
ulation for the PERVIDEO I registry; those
small change in
percent
diamTable. Percent Volume Obstruction
eter stenosis at
Post-Procedure
6 Months
6 months comBalloon Before BMS
2.2%
25.3%
pared to post-inBalloon After BMS
2.3%
24.9%
dex procedure.
The safety and
feasibility, as much as can be determined
experiencing in-stent restenosis after prior
in this size of trial, were demonstrated at
BMS placement. In 41 patients, whose
6 months, with no evidence of either emstenoses ranged from ⭓50% to ⬍100%,
treatment with the Moxy drug-coated balbolization or thrombosis,” she said.
loon resulted in a percent diameter stenosis (the primary endpoint) of 35.6% at
Disclosures:
●
Dr. Mauri reports receiving grant/
6 months, increasing 27.5% post-proceresearch support from Abbott and
dure. By 6-month follow-up, in-segment
Lutonix.
late lumen loss was 0.16 ± 0.40 mm. No
●
Dr. Serruys reports no relevant conflicts
deaths or MIs were observed, although
of interest.
two patients (5.1%) had ischemia-driven
Early Studies Show Promising Data for
Drug-Eluting Balloon Technology
Porcine and human trials examine efficacy
of three drug-eluting balloons.
Data on the latest technology in drug-eluting balloons, including a new drug-scoring
balloon, were presented at the Drug-Eluting Stent Summit
at TCT 2010.
“Not all drugcoated
balloon
catheters
are
equally effective,”
Bruno
Scheller,
MD, University of
Saarland,
HamBruno Scheller, MD
burg,
Germany,
said during his
presentation, pointing to a need for more
data involving different coating technologies and different indications.
Figure 1
FreePac
Scheller presented findings on the
FreePac (Invatec) drug-eluting balloon,
which features a proprietary hydrophilic coating and paclitaxel (3 ␮g/mm2
balloon surface), as well as urea as a
hydrophilic additive.
In one study of 58 consecutive
patients with 66 lesions treated with
the balloon, ankle-brachial index was
0.56 at baseline, but increased to
0.85 at 1-month follow-up, a number
that remained almost unchanged after
6 months (0.81; P⬍.001 for all three
time points), Scheller said.
“Preclinical data show a similar biological response after experimental
Figure 2
injury in the porcine model with the
FreePac and Paccocath coating, and
there are two trials showing promising
clinical experience with the FreePac
coating,” he said.
AngioSculpt
Gary Gershony, MD, John Muir Cardiovascular Institute, Walnut Creek,
Calif., provided preclinical data on
AngioSculpt (AngioScore), which features
a two-component system, including a
rapid exchange semicompliant balloon
coated with paclitaxel and a laser-cut nitinol spiral scoring element. According to
Gershony, the scoring element amplifies
and magnifies the forces exerted by the
balloon along the edges of the scoring element, providing a mechanical advantage
of treatment with balloon angioplasty.
The study included 30 porcine subjects (n=60 vessels)
treated with the
device. Thirty-day
quantitative coronary Angiography
data show positive results compared with a bare
angiosculpt device
(see Figure 1).
“Animal studies
demonstrate that
a drug-coated AngioSculpt is at least
as effective as the
clinically proven Paccocath for inhibiting
neointimal proliferation post-stenting,”
Gershony said. “There is no evidence
of local drug/carrier toxicity or adverse
myocardial effects.”
Pantera Lux
Christoph Hehrlein, MD, of the University of Frieburg, Germany, presented
results from the PEPPER-FIM trial involving 81 patients treated with Pantera Lux
paclitaxel-eluting balloon (Biotronik). The
device features a Pantera semicompliant
balloon that delivers 0.3 ␮g/mm2 paclitaxel in a butyryl-tri-hexyl citrate excipient.
Six-month results from the initial 45
patients show no cardiac death and
low rates of non-fatal MI, TLR and TVR
(see Figure 2).
“The 6-month results of the first 45
German patients from the PEPPER
trial [also] show excellent in-stent and
in-segment late lumen loss,” Hehrlein
said. “Pantera Lux clinical data show
effective reduction of neointimal hyperplasia for the treatment of in-stent
restenosis, regardless of stent type.”
Disclosures:
●
Dr. Gershony reports an affiliation with
AngioScore involving grant/research
support,
consulting
fees/salary
support, major stock shareholding,
royalty income and ownership/founder
involvement.
●
Dr. Hehrlein reports that in the past 12
months either he or his spouse has
received grant/research support from
Biotronik.
●
Dr. Scheller reports receiving speaker
honoraria from Invatec.
9/23/2010 11:35:55 PM
C A R D I O VA S C U L A R
RESEARCH
F O U N D AT I O N
Educational Activities
Save the Dates
Save the Dates for these upcoming meetings sponsored
by the Cardiovascular Research Foundation
As the breadth and complexity of
interventional medicine grows,
so does the need for expanded,
up-to-the-minute educational
opportunities for physicians,
nurses, and technologists. CRF
has responded by developing a
range of educational initiatives
that meet those needs.
The Annual Pulse
of the City Gala
November 10, 2010
New York, NY
Medical Innovation
Summit:
Responding to Today’s
Challenges
November 10, 2010
New York, NY
Sixth International
Conference on
Cell Therapy for
Cardiovascular Disease
January 20-21, 2011
New York, NY
Eighth International
Chronic
Total Occlusion Summit
February 3-4, 2011
New York, NY
Optimizing PCI
Outcomes: Evolving
Paradigms
April 2, 2011
ACC.11/i2 Summit
New Orleans, LA
Transcatheter Valve
Therapies (TVT)
June 2011
Vancouver, Canada
Transcatheter
Cardiovascular
Therapeutics (TCT) 2011
November 7-11, 2011
San Francisco, CA
17th Annual
Interventional Cardiology
Fellows Course
May 8-11, 2011
Miami Beach, FL
Visit us online at www.crf.org
9/23/2010 11:36:00 PM
38
vent the co-primary endpoint was 3.4,
while the numbers needed to treat for
CV mortality and the composite of mortality and stroke were 4.1 and 5.5, respectively. Furthermore,
the 6-minute walking
distance improved in
both arms; however,
only the improvement in
the TAVI arm (baseline,
73 m vs. 1 year, 120 m;
P=.002) was statistically
significant.
Major vascular complications were higher at 30
days for TAVI vs. standard
therapy (16.2% vs. 1.1%,
P⬍.0001), as was the frequency of major bleeding episodes (16.8% vs.
3.9%,
P⬍.0001).
The frequency of
major strokes also
Standard Therapy P Value
tended to be higher
at 30 days in the
71.6%
⬍.0001
TAVI arm vs. stan44.6%
⬍.001
dard therapy (5.0%
50.3%
.001
vs. 1.1%, P=.06).
(PARTNER, continued from page 1)
numerically higher in the TAVI group (5.0%
vs. 2.8%, P=.41), as was CV mortality
(4.5% vs. 1.7%, P=.22). At 1 year, how-
Figure
Table. 1-Year Outcomes
TAVI
All Cause Mortality and
Repeat Hospitalization
42.5%
CV Mortality
20.5%
Mortality and Stroke
33.0%
ever, patients who underwent TAVI demonstrated a significant all-cause mortality
advantage vs. those who had received
standard therapy (see Figure).
The co-primary composite endpoint of
all-cause mortality and repeat hospitalization also favored the TAVI arm, as did several other 1-year outcomes (see Table).
The number needed to treat to pre-
Clinical implications
Leon emphasized that TAVI should
be the new standard of care for patients
with aortic stenosis who are not suitable
candidates for surgery.
“Next generation devices may help to
reduce the frequency of procedure-related complications in the future,” he said.
“The ultimate value of TAVI will depend on
(SPIRIT IV, continued from page 1)
COMPARE
COMPARE, meanwhile, employed
a single-center study design “that reflects everyday clinical practice,” said
investigator Peter C. Smits, MD, PhD,
of Maastad Ziekenhuis, Rotterdam,
The Netherlands. With few exclusion
criteria, all patients eligible for PCI with
an estimated lifespan of 5 years were
randomized to receive the Xience V
stent (n=897) or Taxus Liberté (n=903).
Research Consortium (ARC)-defined
definite or probable stent thrombosis rates also were substantially lower
with the newer stent, and mortality rates were similar between groups
(see Table 1).
Because the trial design excluded left
main or ostial disease and various complex lesion subsets, Dr. Stone stressed,
“This was not an all-comers trial.”
Table 1. SPIRIT IV: 2-Year Outcomes
Xience V
(n=2,458)
Taxus Express
(n=1,229)
HR (95% CI)
P Value
TLF
6.9%
9.9%
0.70 (0.55-0.89)
.003
TLR
4.5%
6.9%
0.66 (0.50-0.88)
.004
MI
2.5%
3.9%
0.64 (0.44-0.94)
.02
Stent Thrombosis
0.42%
1.23%
0.36 (0.17-0.79)
.008
Death
2.0%
2.7%
0.79 (0.51-1.23)
.30
Table 2. COMPARE: 2-Year Outcomes
Xience V
(n=897)
Taxus Liberté
(n=903)
HR (95% CI)
Log-Rank
P Value
MACE
9.0%
13.7%
0.66 (0.50-0.86)
.0016
MI
3.9%
7.6%
0.52 (0.35-0.77)
.0009
TVR
3.1%
7.7%
0.40 (0.25-0.61)
<.0001
careful assessment of bioprosthetic valve
durability, which will mandate obligatory
long-term clinical and echocardiographic
follow-up of all TAVI patients.”
Following the presentation, Patrick T.
O’Gara, MD, of Harvard Medical School,
Boston, provided additional perspective
on what the PARTNER trial means for
clinical practice.
“Although the number of patients reported in this cohort is relatively small,
the trial itself reestablishes the importance of the randomized, controlled clinical trial and our understanding of both
the efficacy and the safety of invasive
procedures for the treatment of valvular
heart disease,” he said. “I think as most
of us would agree that the field of valvular heart disease has relied too heavily on
single-institutional observational studies
or registries that have, as a result, left us
with a level-of-evidence-C recommendations for patient management.”
O’Gara also noted that the PARTNER data represent the first randomized, controlled clinical data of their
kind, even though “more than 15,000 of
these procedures have been performed
worldwide.”
Disclosures:
●
Dr. Leon reports serving on the
scientific advisory boards for Edwards
Lifesciences, Medtronic and Symetis.
He also reports an equity relationship
with Sadra.
●
Dr. O’Gara reports no relevant
Similar to the 1-year follow-up, the
everolimus-eluting stent reduced the
primary composite endpoint of MACE
(death, nonfatal MI and ischemia-driven TVR) plus nonfatal MI and TVR at
2 years (see Table 2). As in SPIRIT IV,
both groups had comparable death
rates.
Only 13% of patients were still on
dual antiplatelet therapy at 2 years,
but very late ARC-defined definite or
probable stent thrombosis was 77%
less likely between years 1 and 2 with
the everolimus-eluting stent compared
with the paclitaxel-eluting stent (0.3%
vs. 1.5%; RR=0.23; 95% CI, 0.07-0.81;
P=.013).
In both SPIRIT IV and COMPARE, patients with diabetes failed to derive any
extra benefit from the everolimus-eluting
stent over the paclitaxel-eluting stent.
Disclosures:
●
Dr. Smits reports receiving a
speaking fee from Abbott Vascular.
The research foundation of his
department has received unrestricted
research grants from Abbott Vascular
and Boston Scientific.
●
Dr. Stone reports serving on scientific
advisory boards for and receiving
honoraria from Abbott Vascular and
Boston Scientific.
(LEVANT I, PERfECT, continued from page 1)
and endothelial progenitor cell stent (OrbusNeich) implantation demonstrated
superiority for the endpoint of less late
loss than stenting alone for the treatment
of de novo coronary artery disease.
“Significantly greater proximal, in-stent
and distal reductions of late losses were
observed at 6 months in the drug-eluting
balloon treatment group,” Wöhrle said.
LEVANT I results
The LEVANT I analysis involved 49
patients in the Moxy arm and 52 patients
in the standard treatment arm. Moxy is a
drug-eluting balloon coated with 2 μg/
mm2 paclitaxel with a hydrophilic nonpolymeric carrier.
In the ITT analysis, the Moxy catheter
yielded a 0.46-mm late lumen loss, compared with a 1.09-mm loss associated
with standard intervention (P=.016). In
the per protocol analysis, the Moxy yielded a 0.36-mm loss; standard intervention
led to a 1.08-mm loss (P=.016).
For the secondary endpoint of TLR,
ITT results indicated a rate of 13% in the
Moxy arm compared with 22% in the
angioplasty arm. Per protocol analysis
results indicated a 6% TLR rate in the
Moxy arm vs. 21% for angioplasty.
“With a relatively short dual antiplatelet regimen of 1 month in the group with
no stent and 3 months in the stent group,
there were no reported incidents of acute
or late thrombosis in the Moxy group,”
Scheinert said.
Further analysis indicated that the
Moxy group had a lower incidence of
other secondary events including TVR,
thrombosis, death and composite clinical endpoints than standard treatment in
both the ITT and per protocol analyses.
PERfECT Stent study results
The PERfECT Stent compared a paclitaxel-coated balloon plus an epithelialprogenitor-cell capture stent vs. an epithelial-progenitor-cell capture stent alone.
Six-month follow-up data indicated that
the in-segment in the drug-eluting balloon
arm of the PERfECT study was 0.16 mm,
compared with 0.61 mm in the stent arm,
according to Wöhrle (P⬍.001). In-stent late
loss was 0.34 mm in the balloon arm and
0.88 mm in the stent alone arm (P⬍.001).
A significantly lower binary in-stent restenosis rate in the combination treatment
arm, 5.1% vs. 21.4%, was observed. The
combination arm had a reduced percent
diameter stenosis, a significantly larger
MLD, and reduction in MACE from 17.2%
to 4.8%, which was driven by a reduction
in TLR of 4.8% vs. 15.5% (P=.05). There
were no occurrences of ST in either arm.
Disclosures:
●
Dr. Scheinert reports involvement with
numerous device and technology
companies.
●
Dr. Wöhrle reports grant and research
support and consulting fees from B.
Braun and OrbusNeich.
9/23/2010 11:36:01 PM
PressureWire™ Aeris™
Wireless FFR Measurement System
The first and only wireless pressure sensor technology simplifies coronary procedures while providing accurate
fractional flow reserve (FFR) measurement data.
Measuring FFR accurately identifies hemodynamically relevant stenosis1
Offers exceptional control and maneuverability in tortuous vessels
Provides enhanced cath-lab efficiency
See it at booth 1432.
1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention.
N Engl J Med. 2009;360(3):213-224.
Rx Only
Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.
PressureWire is designed, developed and manufactured by St. Jude Medical Systems, AB Patent Pending. PressureWire, Aeris, RADI, ST. JUDE MEDICAL, the nine-squares symbol, and MORE CONTROL. LESS
RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2010 St. Jude Medical, Inc. All rights reserved.
9/23/2010 11:36:03 PM
Everolimus Eluting
Coronary Stent System
Safety. First.
Consistently low stent thrombosis rates.
Trial after trial.
1
8
9/23/2010 11:36:04 PM

Safety. First.

Transcription

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