As EuroPCR 2012 gets under way today, Medtronic, Inc.
announced that the Resolute Integrity Coronary Stent System has received
European regulatory approval for several new indications, making it the
drug-eluting stent (DES) with the broadest range of approved indications in Europe.
The Resolute Integrity DES is now explicitly indicated in
countries outside the United States that accept the CE mark for the following
patient and lesion types: acute coronary syndromes, acute myocardial
infarction, unstable angina; diabetes mellitus; bifurcations; multi-vessel
disease; total occlusions and chronic total occlusions; and in-stent
restenosis. All but the indications for diabetes and multi-vessel disease are
new.
Two of the studies that contributed to the European
regulatory authority’s approval of these indications, RESOLUTE All Comers and
RESOLUTE International, are the subject of several new data presentations at
EuroPCR, which attracts thousands of physicians from around the world who
specialize in cardiovascular interventions.
RESOLUTE All Comers: Three-Year Results
Three-year results from RESOLUTE All Comers, a randomized controlled trial
comparing the Resolute DES to the Xience V DES from Abbott Laboratories, showed
that the Medtronic device continues to match its chief competitor on important
measures of safety and efficacy in long-term follow-up.
RESOLUTE All Comers enrolled nearly 2,300 patients, with
very few exclusion criteria, at 17 centers in Europe and Israel. As a
result, 66 percent of the “real-world” patients in the study were considered
complex, which is representative of standard clinical practice.
RESOLUTE All Comers used the primary endpoint preferred by
the U.S. Food and Drug Administration (FDA) for studies of drug-eluting stents:
target lesion failure (TLF), a composite of cardiac death, target vessel
myocardial infarction and clinically-driven target lesion revascularization, at
one year of follow-up.
Presented today by Prof. Stephan Windecker of Bern
University Hospital in Switzerland, a co-principal investigator of the study,
the rates of TLF at three years in RESOLUTE All Comers remain equivalent for
the two devices: 13.1% for Resolute; 12.4% for Xience V (p=0.614).
Additionally, the rates of definite/probable stent thrombosis at three years
were low, with no statistically significant difference. Rates of
definite/probable very late stent thrombosis (VLST) were the same for the two devices
(0.5% vs. 0.5%, p=1.00).
“RESOLUTE All Comers has amassed an invaluable data set to
guide stent selection for patients with coronary artery disease, regardless of
its complexity,” said Prof. Windecker. “The rigorous design and conduct of the
study, which enrolled a majority of complex patients and has lost less than two
percent of patients to follow-up, makes the results highly relevant to the
contemporary clinical practice of interventional cardiology worldwide.”
Prof. Windecker’s co-PIs for RESOLUTE All Comers are Prof.
Patrick Serruys, M.D., Ph.D., of the Thoraxcenter at Erasmus
University in Rotterdam,
the Netherlands, and Prof.
Sigmund Silber, M.D., of the Heart Catheterization Centre in Munich, Germany.
Pooled Analyses: Bifurcation Lesions and In-Stent Restenosis
at Two Years
Two-year results from RESOLUTE All Comers and RESOLUTE International in
patients with bifurcation lesions and in-stent restenosis will also be
presented at EuroPCR. These two subsets are common in standard clinical
practice, together accounting for approximately 20–25 percent of patients who
receive stents.
The pooled data set on bifurcation lesions, which remain a
therapeutic challenge for the interventional community, will be presented on
Thursday by Dr. Ran Kornowski from Rabin
Medical Center
and Tel Aviv
University in Israel.
As the only DES on the market with an indication for
treating bifurcated lesions, the Resolute DES performed extremely well in this
patient subset. Of the 702 patients with bifurcated lesions, the use of the
Resolute DES and its excellent side branch access resulted in a low TLF rate of
12.6 percent at two years (and 10.4 percent at one year).
The pooled data set on in-stent restenosis (ISR) will be
presented on Friday by Dr. Gert Richardt from the Segeberger Clinic’s Heart Center
in Germany.
Patients presenting with ISR have been associated with worse outcomes and a
higher rate of repeat procedures than patients who are treated for de novo
lesions. At two years, the 281 ISR patients treated with a Resolute DES had a
TLF rate of 17.5 percent, which is considered low for patients with this
challenging lesion type. The TLF rate at one year was 10.8 percent.
In collaboration with leading clinicians, researchers and
scientists, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias. The company strives to offer products and
services that deliver clinical and economic value to healthcare consumers and
providers worldwide.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the
global leader in medical technology – alleviating pain, restoring health and
extending life for millions of people around the world.
