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American College of
Cardiology 2011 Preview: Stents, Valves and Wrists
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Ernest N.
Morial Convention
Center, New Orleans |
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April 2,
2011 -- New studies on stents, angioplasty and
interventional treatments for heart disease will be taking
center stage in New Orleans over the next four days, as the
American College of Cardiology holds its 60th Annual Scientific
Session and Innovation in Intervention: i2 Summit 2011. Attended
by almost 30,000 cardiologists and
other healthcare professionals, the ACC.11 meeting will be
offering a platform for some of the most important findings
affecting millions of patients who suffer from coronary and
structural heart disease.
Angioplasty.Org
will be covering these studies in detail, as they are presented.
Here's a quick overview of what will be the "big stories" over
the new few days: |
Sunday, April 3, 2011
Transcatheter Aortic Valve Implantation versus Surgical Aortic
Valve Replacement in High Risk Patients with Aortic Stenosis: The
Randomized PARTNER Trial
At last fall's TCT meeting, the first results of the PARTNER Trial were presented,
and subsequently published in the New England Journal of Medicine. These
were
results from "Cohort B" of the trial, specifically patients who were ineligible
for open surgery. These patients were randomized to standard therapy, which
was medical management, or to a new non-surgical procedure, the percutaneous
transcatheter aortic-valve implantation (TAVI) in which an aortic valve is threaded
through the arterial system, similar to coronary angioplasty, and deployed
-- without the need for open heart surgery. The results were striking.
The transcatheter Sapien valve, manufactured by Edwards, showed a 46% relative
risk reduction in
mortality
over
standard medical
therapy
in patients who were too sick to have open surgery. Today's presentation will
be of "Cohort A", patients who are well enough to have the choice between open
surgery and percutaneous interventional procedures. Surgeon Craig
R.
Smith will be presenting the results which, if the percutaneously implanted valve
shows equivalence or even superiority, could radically change the treatment of
aortic valve disease.
Lifetime Cost Effectiveness of Transcatheter
Aortic Valve Implantation Compared with Standard Care among Inoperable
Patients
with Severe Aortic Stenosis:
Results from the
Randomized PARTNER Trial (Cohort B)
A follow-up to the Fall presentation of the initial PARTNER results will discuss
the cost-effectiveness component of transcatheter aortic valve implantation in
patients too sick for surgery.
Two-Year Outcomes from the Randomized RESOLUTE All-Comers Trial
Dr. Patrick W. Serruys will present the two year data, comparing
Medtronic's Resolute zotarolimus-eluting stent with Abbott's XIENCE
V everolimus-eluting
stent in this European trial -- the largest comparative trial between
two second generation drug-eluting stents (although, since the
Resolute is an improved version of the Endeavor, it might be considered
a third-generation stent). The one-year
outcomes,
presented at last year's EuroPCR, showed equivalence between the
two devices. The two-year outcomes, along with the US trial results,
will figure strongly in the FDA's approval process for the Resolute.
The ABSORB Trial: An Evaluation of the BVS Bioresorbable
Everolimus-Eluting Scaffold in the Treatment of Patients with de
Novo Native Coronary Artery Lesions: First Report of the 1 Year Clinical
and Imaging Results of Cohort B
Dr. Serruys (again) will present the one-year data on 101 patients
from the second phase of the ABSORB trial, evaluating Abbott's ABSORB
BVS, which restores blood flow by opening
a clogged vessel and then is slowly metabolized and resorbed by the
body. In January 2011, Abbott announced that it received CE Mark
approval in Europe for ABSORB, the world's first drug eluting BVS
for the treatment of coronary artery disease. ABSORB is not currently
available for sale in the U.S.
Monday, April 4, 2011
EVEREST II Randomized Clinical Trial: Two Year Outcomes
Last year's ACC saw the
one-year results of mitral valve repair with the MitraClip,
which were very favorable. There was much praise, but also concern
that the benefits might not be as durable as open
surgical
repair.
So this
year's
presentation of the two-year results are being closely watched. Abbott,
which acquired the MitraClip when it
purchased eValve at the end of 2009, is hoping for FDA
approval in the near future, based on these results.
RIVAL Trial: A Randomized Comparison of Radial vs. Femoral Access
for Coronary Angiography or Intervention in Patients with Acute Coronary
Syndromes
We have been evangelizing for the transradial (wrist) approach
to catheter-based procedures for four years now, because of its lower
complication rate and increased patient comfort. So the
RIVAL trial, which, in the words of Dr. Sunil V. Rao,
"...will be the largest
multicenter
randomized trial worldwide ever done in the radial approach with
hard clinical endpoints: death or MI", is of critical importance
to the growth of the transradial procedure, which Dr. Ralph Brindis,
President of the ACC, has stated is currently at a "tipping point".
One Year Clinical Outcomes from the Pivotal Multicenter RESOLUTE
US Study
Presented by Dr. Martin Leon, this study represents the final submission
to the FDA by Medtronic for its new drug-eluting stent, which has
performed
very well in European trials. If this trial is positive,
the Resolute may become the newest drug-eluting stent available to
U.S.
patients as early as next year.
A Prospective, Randomized Investigation of
a Novel Platinum Chromium Everolimus-Eluting Coronary Stent: The
PLATINUM Trial
Dr. Gregg Stone, the Global Principal
Investigator
of
the PLATINUM
clinical
program,
will
present 12-month results from the PLATINUM Workhorse trial. The randomized,
controlled trial enrolled 1,530 patients at 132 sites worldwide and
compares the PROMUS Element Everolimus-Eluting Platinum Chromium
Coronary Stent System to the PROMUS Everolimus-Eluting Coronary Stent
System. The Promus Element is manufactured by Boston Scientific
and the company is hoping for positive results as it looks to
FDA
approval, possibly by mid-2012.
Its current drug-eluting stent, the PROMUS, is licensed under an agreement
with Abbott which expires next year, so the fortunes of the company
are closely tied to success with this platform.
Stay tuned to Angioplasty.Org for in-depth reporting
of these and other studies being presented at this year's ACC.11
Scientific Session.
Reported by Burt Cohen, April 2, 2011
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