News | October 14, 2008

Data Indicates Medtronic’s ENDEAVOR Stent Patients Are At Lower Risks for Heart Attack at Two Years

October 15, 2008 – Two-year results from the ENDEAVOR-IV clinical trial show that the Endeavor drug-eluting stent (DES) from Medtronic Inc. is associated with statistically fewer heart attacks than Boston Scientific’s Taxus DES.

Martin B. Leon, M.D., founder and chairman emeritus of the Cardiovascular Research Foundation and principal investigator of ENDEAVOR-IV, presented the results at TCT 2008.

“Through two years of follow up in the ENDEAVOR-IV clinical trial, the Endeavor drug-eluting stent has proven to be statistically safer than Taxus on the important measure of myocardial infarction, and no different in terms of efficacy as measured by the need for repeat procedures,” said Dr. Leon. “The latest data clarify the comparative safety and efficacy of these two drug-eluting stents beyond one year. As importantly, the data also show that Endeavor is associated with numerically fewer instances of very late stent thrombosis.”

In ENDEAVOR-IV, only one of the Endeavor patients (n=742) experienced a very late stent thrombosis (ARC definite/probable), compared to six of the Taxus patients (n=739): 0.1 percent vs. 0.8 percent (p=0.069). Very late stent thrombosis (VLST) is a rare but potentially fatal complication in which a blood clot forms around the stent a year or more after implant. VLST usually causes death or myocardial infarction (MI).

Differences in duration of dual-antiplatelet therapy (DAPT) between the two groups underscore the safety benefits of the Endeavor stent. While a significantly greater proportion of patients randomized to the Taxus stent received DAPT to two years of follow-up (p=0.02), the Taxus patients experienced a 50 percent increased incidence of MI (p=0.02) and a seven-to-one higher ratio of VLST (p=0.06).

Similarly to the VLST rates, the two-year follow-up on the primary endpoint of target vessel failure (TVF) – a composite of death, MI and target lesion revascularization (TLR) – favored Endeavor patients numerically compared to Taxus patients: 11.1 percent (82/742) vs. 13.1 percent (97/739) (p=0.232), driven by a 34 percent reduction in cardiac death and MI to two years.

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