Healthcare Industry News: STENT Thrombosis
News Release - March 29, 2008
Endeavor(R) Stent Safety Profile Affirmed in Long-Term Experience
More Than 1,200 Patients Now Followed to Three YearsMINNEAPOLIS--(HSMN NewsFeed)--According to new data released today at the American College of Cardiology meeting, Medtronic’s Endeavor drug-eluting stent has a safety profile more commonly associated with a bare-metal stent, long considered a benchmark for stent safety.
“This latest extension to our pooled safety analysis of data from the ENDEAVOR clinical program nearly doubles the number of Endeavor patients followed to three years and therefore strengthens our confidence in the findings we presented previously,” explained Dr. Laura Mauri, chief scientific officer of the Harvard Clinical Research Institute, an interventional cardiologist at the Brigham and Women’s Hospital (both in Boston) and the lead author of the research. “With more than 1,200 patients whose clinical follow-up now extends to three years, the Endeavor drug-eluting stent continues to be associated with low rates of STENT Thrombosis, myocardial infarction and cardiac death – three key safety metrics – compared to the Driver® bare-metal stent. Importantly, there were no new STENT Thrombosis events among patients in either group.”
Launched by Medtronic (NYSE:MDT ) in the United States in February, the Endeavor stent is designed to promote rapid, complete and functional healing of the endothelium so that late safety concerns are minimized. It features an advanced cobalt alloy in a modular architecture for excellent deliverability and conformability, the antiproliferative drug zotarolimus to moderate neointimal hyperplasia, and a highly biocompatible polymer called phosphorylcholine (PC) for rapid drug elution.
The independent analysis performed by Dr. Mauri and colleagues – “The Endeavor Zotarolimus-Eluting Stent in Patients with Native Coronary Artery Disease: Safety with 1,200 Patients Followed to Three Years” (2900-104) – included a total of 2,132 Endeavor patients and 596 Driver patients.
As summarized in the table, the rate of STENT Thrombosis (ARC definite/probable) before and after one year differed between the two groups, while adherence to dual-antiplatelet therapy was similar.
Originally presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2007, the pooled safety analysis is based on data from three of the ENDEAVOR clinical program’s single-arm studies (ENDEAVOR I, II continued access, and pharmacokinetics) and its three randomized controlled trials (ENDEAVOR II, III and IV). It now includes 2,050 Endeavor patients followed to one year, 1,287 followed to two years, and 1,217 to three.
About Medtronic
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 27, 2007. Actual results may differ materially from anticipated results.
Source: Medtronic
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