News | October 14, 2008

Endeavor Drug-Eluting Stent Has Superior Safety Profile vs. Bare-Metal Stents, Analysis Shows

October 15, 2008 – The latest update to an independently conducted pooled data analysis shows that Medtronic’s Endeavor drug-eluting stent (DES) 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. The results, released at TCT 2008, also include a comparison of stent thrombosis in Endeavor patients receiving six and 12 months of dual antiplatelet therapy.

Laura Mauri, M.D., 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 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)].”

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