Endeavor® Stent Reduced
Risk of Heart Attack/Cardiac Death by 48% at Three Years Compared
to Taxus® Stent in Large Study
Latest Findings from ENDEAVOR
IV Clinical Trial Also Showed 91 Percent Reduction in Risk of Very
Late Stent-Related Blood Clots for Endeavor Patients
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Medtronic
Endeavor
Stent |
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September
21, 2009 -- San Francisco -- Anticipating a change in
the practice of interventional cardiology, Medtronic, Inc. (NYSE:
MDT), announced today that the latest findings from the ENDEAVOR
IV clinical trial – a large study comparing two drug-eluting coronary
stents head-to-head – demonstrate statistically and clinically
significant differences in measures of safety between Medtronic’s
Endeavor zotarolimus-eluting stent and Boston Scientific’s Taxus
paclitaxel-eluting stent at three years of patient follow-up.
The
new data, which also show no difference in efficacy between the
two devices at three years, will be presented at Transcatheter
Cardiovascular Therapeutics (TCT) 2009 at approximately 5:28 p.m.
Pacific time during The Drug-Eluting Stent Summit Part 1 in Room
104 at San Francisco’s Moscone Center. |
"The three-year results
from ENDEAVOR IV conclusively demonstrate that choice of stent
really
does matter for patients with coronary artery disease,” said
principal investigator Dr. Martin B. Leon of New York-Presbyterian
Hospital/Columbia University Medical Center and the Cardiovascular
Research Foundation. “As interventionalists, we now have long-term
outcomes data that should be critically evaluated when making
treatment choices for our patients." Dr. Leon added: “For several
years we have seen a trend toward outstanding safety with the Endeavor
stent throughout the clinical program and in pooled analyses. |
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Martin B.
Leon, MD |
These latest randomized data are
the first to show statistically significant differences on hard clinical
endpoints that clearly favor one drug-eluting stent over another
at three years. Specifically, they show comparable efficacy between
the Endeavor and Taxus stents in long-term follow-up, with significant
safety advantages for Endeavor patients with regard to a reduction
in large myocardial infarctions that are directly attributable to
the significantly higher rate of very late stent thrombosis observed
with the Taxus stent.”
Concerns about the consequences of the higher
observed rate of very late (>1 year) stent clotting in drug
eluting versus bare metal stents have loomed since 2006 but have
been allayed by large, population-based
registry data that have not shown an increase in death or myocardial
infarction . Endeavor IV represents the first long-term large, head-to-head
drug eluting vs. drug eluting stent comparison to demonstrate a statistically
significant increase in very late stent clotting and a corresponding
significant increase in cardiac death and myocardial infarction.
The Endeavor IV data definitively show that at three years of follow-up,
patients treated with an Endeavor stent have a statistically and
clinically significant 48 percent (p=0.004) lower risk of heart attack
or cardiac death than patients treated with a Taxus stent and a 91
percent (p=0.004) reduction in the risk of very late stent thrombosis.
David Kandzari,
MD |
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"These are practice-changing
data, demonstrating that we can only truly evaluate the safety
and efficacy of drug-eluting stents over the long term. In clinical
trials, as in clinical practice, events may continue to occur,
and the story does not end at the timing of a study’s initial
endpoint,” said the trial’s other principal investigator, Dr.
David Kandzari of the Scripps Clinic in La Jolla, Calif.
“At
three years of follow-up, the Endeavor stent demonstrated comparable
efficacy and impressive safety in this study versus the Taxus
stent – a finding that was consistent across all patient populations
in this study and across the entire Endeavor clinical trial program.” |
ENDEAVOR IV enrolled 1,548 patients, equally
randomized to receive an Endeavor or Taxus drug-eluting stent.
The primary endpoint in
the study was non-inferiority on the measure of target vessel failure
(TVF) – a composite of cardiac death, myocardial infarction
and target vessel revascularization – at nine months.
“Medtronic understands that clinical outcomes are what matter
to patients, and we are committed to ongoing evidence-based research
to develop products that improve people’s lives,” said
interventional cardiologist Dr. Richard Kuntz, senior vice president
of strategy, clinical and regulatory affairs at Medtronic. “These
new data from ENDEAVOR IV clearly and compellingly demonstrate that
the Endeavor stent should play a much larger role in the care of
patients with coronary artery disease.”
Medtronic CardioVascular is committed to advancing
the treatment of coronary, peripheral, aortic and structural heart
disease through
collaboration with leading clinicians, researchers and scientists
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.
Any forward-looking statements are subject
to risks and uncertainties such as those described in Medtronic’s
Annual Report on Form 10-K for the year ended April 24, 2009. Actual
results may differ
materially from anticipated results.
Source: Medtronic,
Inc.
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