New Data from ENDEAVOR-II Challenges Conventional Wisdom on Drug-Eluting Stents
Five-Year Results Confirm Durability of Endeavor Stent's Long-Term Clinical Efficacy
In ENDEAVOR-II (n=1,197), a randomized controlled trial comparing Medtronic's (NYSE:MDT) Endeavor drug-eluting stent (DES) to its Driver bare-metal stent (BMS), patients treated with the Endeavor DES required fewer repeat procedures at five years post-implant than many observers and analysts would have expected based on the results of other trials with comparable designs.
With clinical data from ENDEAVOR-II now through five years of follow-up, 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 late-breaking 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 long-term performance of the Endeavor stent is really remarkable,” said Dr. Kandzari. “There is an especially unique consistency and durability in late-term 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 long-term safety is complemented by long-term 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 positive long-term outcomes for patients.”
This long-term data also will be submitted in a pre-market approval (PMA) application for review by the U.S. Food and Drug Administration.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.
Contact: Medtronic, Inc.
Joe McGrath, 707-591-7367
Jeff Warren, 763-505-2696
Posted: May 2009