Endeavor Stent Showed Lower Death, MI Rates in ZEST Study Over Taxus Liberte
April 16, 2009 -Twelve-month data from the ZEST trial presented at ACC 2009 showed the Endeavor Drug-Eluting Stent (DES) from Medtronic Inc. was associated with a statistically significant 29 percent reduction in a composite primary endpoint of death, myocardial infarction (MI) and in ischemia-driven target vessel revascularization (TVR), when compared to the Taxus Liberte DES.
The study also found Endeavor was non-inferior to the Cypher Sirolimus-eluting stent on the same primary endpoint.
The Taxus Liberte was shown in this randomized, controlled trial to be associated with a 25 percent increase in death and MI, and a 32 percent increase in the need for repeat revascularization when compared to the Endeavor, Medtronic pointed out in trial data.
The multi-center, Korean study also reported 12-month data on the rate of stent thrombosis (ST) for the three stents. ST is a rare, but frequently fatal event for which no randomized, controlled study to date has been powered to analyze. The first trial to make such a stent thrombosis comparison will be Medtronic's PROTECT study of 8,800 patients in which the Endeavor stent will be compared to the Cypher at three years. Medtronic initiated this study in October 2006 following analysis of data pooled from the clinical programs of both Endeavor and Cypher, in which the rate of ST with Endeavor virtually halts at one-year post implant, whereas the rate with Cypher, and other DES for which data are available, shows a consistent 0.3-0.6 percent annual increase, Medtronic said.
The ST rate appears broadly consistent for all stents in the first year, but the rarity of the event has led to considerable inter-trial variation in rates reported at 12-months. After one year, available data suggest a marked long-term advantage for Endeavor. The rates of stent thrombosis observed in the ZEST study were low, consistent with those observed in other studies and similarly inconclusive.
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