CardiovascularNew Data From Endeavor-II Challenges Conventional Wisdom On Drug-Eluting Stents
New clinical data presented at a major international meeting of interventional cardiologists challenged the conventionalwisdom on the long-term efficacy of drug-eluting stents, medical devices used in the treatment of coronary artery disease.
In ENDEAVOR-II (n=1,197), a randomized controlled trial comparing Medtronic"s (NYSE: MDT) Endeavor drugeluting stent (DES) to its Driver baremetal stent (BMS), patients treated with the Endeavor DES required fewer repeat procedures at five years postimplant than many observers and analysts would have expected based on the results of other trials with comparable designs.
With clinical data from ENDEAVORII now through five years of followup, the Endeavor DES continues to show a distinctively low and durable plateau in the rate of target lesion revascularization (TLR), a standard measure of efficacy for coronary stents. As presented today at EuroPCR09 in a latebreaking clinical trials session by Dr. David Kandzari of the Scripps Clinic in La Jolla, Calif., the TLR rate in this seminal DES trial at five years is 7.5 percent, only a 0.3 percent difference from the rate at three and four years.
"The longterm performance of the Endeavor stent is really remarkable," said Dr. Kandzari. "There is an especially unique consistency and durability in lateterm TLR that is distinct from alternative DES programs."
Safety has long been the Endeavor stent"s hallmark, with exceptionally low rates of complications including very late stent thrombosis to five years across various geographies, patient subsets and trial designs. These latest results confirm that the Endeavor stent"s longterm safety is complemented by longterm efficacy.
"The Endeavor stent continues to distinguish itself with a strong record of sustained safety and clinical efficacy," said Sean Salmon, vice president and general manager of Medtronic CardioVascular"s Coronary and Peripheral business. "From preclinical research and clinical imaging studies, we believe that the Endeavor stent"s proven biocompatibility contributes to complete and functional healing early on and positve longterm outcomes for patients."
This long term data also will be submitted in a premarket approval (PMA) application for review by the U.S. Food and Drug Administration.
Medtronic