October 24, 2007 - Presented at the TCT 2007 meeting, a pooled analysis of safety data from Medtronic’s ENDEAVOR clinical program affirmed the superior safety of the Endeavor drug-eluting coronary stent compared to Medtronic’s bare metal stent, Driver, indicating comparable safety to a bare-metal stent.
The analysis illustrated that Endeavor (n=2,132), when compared to Driver (n=596), was associated with low rates of all evaluated safety metrics. For Endeavor the respective rates, cumulatively, at three years were: heart attack (2.7%), stent thrombosis (0.7%), death (3.2%) cardiac death (1.0%). For Driver, the rates were: heart attack (4.2%), stent thrombosis (1.5%), death, (4.5%), cardiac death (2.4%).
These results mirror those of ENDEAVOR II, a 1,200-patient randomized clinical trial which directly compared Endeavor to Driver. In ENDEAVOR II, the Endeavor stent was associated with lower absolute rates of cardiac death, heart attack and stent thrombosis in follow up to three years.
The results were not only indicative of comparable safety to a bare-metal stent, they were also consistent in more challenging patient groups. For patients with diabetes or complex lesions, for whom safety is an even greater concern, Endeavor was found to have performed at least as well as the bare-metal stent across all measured safety metrics.
Laura Mauri, M.D., MSc, chief scientific officer of the Harvard Clinical Research Institute, and interventional cardiologist at the Brigham and Women’s Hospital, the author of the analysis, said, “Many of today’s cardiologists are concerned about the safety of drug-eluting stents compared to their bare-metal precursors, which are considered a benchmark for long-term safety. We were encouraged to have concluded that the next-generation Endeavor drug-eluting stent was associated with numerically fewer adverse events than the Driver bare-metal stent, itself a stent noted for its performance and safety characteristics.”
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