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Sustained Safety Profile
of Medtronic’s
Endeavor® Drug-Eluting Stent
Differentiates It from
Other DES
Endeavor DES at Least as Safe as a Bare-Metal Stent in Four-Year, Independent Analysis
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October 14, 2008 / Washington DC --
The latest update to an independently conducted pooled data analysis
shows once again how the Endeavor drug-eluting stent (DES) from Medtronic,
Inc. (NYSE: MDT), is distinguished by persistently strong safety
benefits for patients with coronary artery disease. Called ENDEAVOR-Safety,
the analysis now includes more than 1,100 patients followed to four
years.
Compared to a bare-metal stent (n=596), the Endeavor
DES (n=2,132) has been shown at four years to be associated with
numerically lower rates of death, cardiac death, major adverse cardiac
events (MACE), myocardial infarction (MI) and stent thrombosis, with
the differences in rates of cardiac death and MI between the two
devices reaching statistical significance in this retrospective analysis.
Endeavor
Stent |
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The results, released today
at the Transcatheter Cardiovascular Therapeutics (TCT) meeting
and
summarized below, also include a comparison of stent thrombosis
in Endeavor patients receiving six and 12 months of dual antiplatelet
therapy.
Dr. Laura Mauri, chief scientific officer of the Harvard Clinical
Research Institute, an interventional cardiologist at Brigham
and Women’s Hospital Boston and principal author of the ENDEAVOR-Safety
analysis, said: “These data are truly remarkable when you remember
that we’re not comparing Endeavor to another DES but to a bare-metal
stent. The stent thrombosis figures alone present a compelling
case. Despite more than 70 percent of Endeavor patients being
off dual-antiplatelet therapy at 12 months, the cumulative incidence
of ARC-defined (Academic Research Consortium) stent thrombosis
at four years is only 0.7%, almost half the rate observed for
the bare-metal stent [1.5 percent (p=0.071)].”
“Even more reassuringly with Endeavor,” Dr. Mauri added, “almost
all of these events occurred in the first 360 days. Such a predictable
freedom from very late events – again, numerically lower than
the bare-metal stent – inspires confidence when we can expect
our patients to live many years with the stents we implant.” |
Sean
Salmon, vice president and general manager of the Coronary
and Peripheral Vascular business at Medtronic, commented: “The latest update to this four-year safety analysis provides physicians with the reassurance that really matters to patients – long-term freedom from adverse events and long-term freedom from repeat procedures. Interestingly, Endeavor’s
safety profile appears to be unaffected by differences
in duration of dual-antiplatelet therapy.” ENDEAVOR-Safety Analysis
Cumulative Incidence (%) of Safety Endpoints to 1,440 Days Endpoint | Endeavor DES
n=2,132 | Driver BMS
n=596 | Death | 5.1 | 5.2 | Cardiac Death | 1.9 | 2.6 | MI | 2.9 | 4.4 | Cardiac Death/MI | 4.6 | 7.0 | Stent Thrombosis | | | | 0.5 | 1.2 | | 0.7 | 1.5 |
ABOUT MEDTRONIC
Medtronic, Inc.
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
25, 2008. Actual results may differ materially
from anticipated results.
Source: Medtronic, Inc.
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