SAN FRANCISCO–(BUSINESS
WIRE)–New research findings released at TCT 2011 show that the Endeavor®
zotarolimus-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT) outperformed
Boston Scientific Corp.s Taxus® paclitaxel-eluting stent on standard measures
of safety and efficacy through five years of clinical follow-up.
The findings come from ENDEAVOR IV, a randomized trial
involving nearly 1,550 patients with coronary artery disease that compared the
two drug-eluting stents head-to-head.
A separate analysis released at the same meeting of
interventional cardiovascular specialists also affirmed the strong, long-term
safety profile of Medtronics Endeavor DES, which elutes the drug zotarolimus
from a highly biocompatible polymer that mimics the surface of a red blood
cell.
The final five-year results of ENDEAVOR IV, presented today
by co-principal investigator Dr. David Kandzari of Piedmont Heart Institute in
Atlanta during the Cardiovascular Research Foundations annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium, show statistically
significant differences favoring the Endeavor DES on cardiac death/myocardial
infarction (CD/MI) and very late stent thrombosis (VLST). The data also show a
trend toward lower rates of target vessel failure (TVF) with the Endeavor DES
in long-term follow-up.
“The five-year results from ENDEAVOR IV confirm that
long-term clinical outcomes should be an essential consideration when making
decisions related to stent selection,” said Dr. Kandzari. “Interventionalists
treating patients with coronary artery disease now have ample data to
distinguish the important differences between the performance of these two
drug-eluting stents.”
|
5-YEAR RESULTS |
||||||
|
ENDEAVOR IV |
||||||
|
N=1,548 |
||||||
|
Endeavor vs. Taxus |
||||||
|
Endpoint* |
|
Endeavor n=773 |
|
Taxus n=775 |
|
p Value |
|
TVF |
|
17.2% |
|
21.1% |
|
p=0.061 |
|
TLR |
|
7.7% |
|
8.6% |
|
p=0.70 |
|
CD/MI |
|
6.4% |
|
9.1% |
|
p=0.048 |
|
Def/Prob ST |
|
1.3% |
|
2.0% |
|
p=0.42 |
|
VLST |
|
0.4% |
|
1.8% |
|
p=0.012 |
|
* |
|
Endpoint Key |
|
TVF = target vessel failure (a composite of TVR, |
||
|
TLR = target lesion revascularization |
||
|
CD = cardiac death |
||
|
MI = myocardial infarction |
||
|
Def/Prob ST |
||
|
VLST = very late stent thrombosis |
ENDEAVOR Pooled Safety
Dr. Kandzari also presented a five-year update to a pooled analysis of safety
data from the Endeavor clinical program at TCT 2011. The analysis, called
ENDEAVOR Pooled Safety, involved 2,132 patients who received an Endeavor DES as
participants in one of six studies, including ENDEAVOR IV.
ENDEAVOR Pooled Safety shows that at five years of
follow-up, treatment with the Endeavor DES resulted in a significant reduction
in TLR and CD/MI, and was associated with no increased risk of stent thrombosis
in comparison to a bare-metal stent (BMS) control group including 596 patients
from ENDEAVOR II.
|
5-YEAR RESULTS |
||||||
|
ENDEAVOR Pooled Safety |
||||||
|
Endeavor DES vs. Driver BMS |
||||||
|
Endpoint* |
|
Endeavor n=1,879 |
|
Driver n=538 |
|
p Value |
|
TLR |
|
7.4% |
|
16.5% |
|
p<0.001 |
|
CD/MI |
|
5.7% |
|
8.4% |
|
p=0.016 |
|
Def/Prob ST |
|
0.9% |
|
1.7% |
|
p=0.10 |
|
VLST |
|
0.3% |
|
0.4% |
|
p=0.85 |
NOTE: Data in this table are from post-hoc analysis; event
rates are unadjusted.
“These findings are even more relevant because most patients
in both groups were off dual-antiplatelet therapy by one year after stent
implantation,” explained Dr. Kandzari, whose paper titled “Dual antiplatelet
therapy duration and clinical outcomes following treatment with
zotarolimus-eluting stents” appeared in the October 2011 edition of JACC:
Cardiovascular Intervention. “The Endeavor DES exhibits a safety profile that
not only is durable through late-term follow-up but that also distinguishes it
from comparative devices.”
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias.
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.
