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Published on 31 March 2008

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Positive results for drug-eluting stent trial

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Two-year results from the Medtronic ENDEAVOR III trial confirm the positive clinical profile of the Endeavor drug-eluting coronary stent.

The trial results bring the number of Endeavor patients who have at least two years of follow-up to nearly 1,300. Significantly, among that number there have been no reported cases of late stent thrombosis using the independent, pre-specified clinical trial protocol definitions for thrombosis. The results were presented at the 56th Annual Scientific Session of the American College of Cardiology (ACC) in New Orleans.

The 436 patients in the ENDEAVOR III trial are being followed for five years. The clinical data reported at ACC as part of the study design indicate that the Endeavor stent continues to exhibit an excellent safety profile while delivering sustained efficacy and a low need for repeat procedures that is consistent with the overall Endeavor clinical program. At two years, the rate of Major Adverse Cardiac Events – a composite safety measure of death, repeat procedures and myocardial infarction (MI) – was reported to be 9.3% for Endeavor and 11.6% for the Cypher stent also studied in the ENDEAVOR III trial. There was no statistically significant difference in the need for repeat procedures, or Target Lesion Revascularization (7% and 4.5% for Endeavor and Cypher, respectively), or all-cause mortality (1.6% for Endeavor and 4.5% for Cypher). However, fewer patients experienced heart attacks (MI) when treated with the Endeavor stent (0.6% vs. 3.6% for Cypher) and the combined rate of heart attack and death also was statistically   significantly lower among patients randomized to the Endeavor stent (2.2% vs. 7.1% for Cypher).

Worldwide, Medtronic has approximately 2,100 Endeavor patients enrolled in its multiple clinical trials, and the growing volume of positive data and number of patients with long-term follow-up continues to reinforce the stent’s favourable safety and efficacy profile.

Martin Leon, MD, principal investigator of the ENDEAVOR III clinical trial, said: “With two years of follow-up in nearly 1,300 patients and the volume of positive clinical data we’ve seen to date, we can continue to have confidence in Endeavor’s clinical performance. As the Endeavor clinical program has matured, it has provided evidence that consistent and predictable patient outcomes are being sustained through time.”

Medtronic will present additional long-term data on Endeavor in the coming months. At the EuroPCR meeting in May, Medtronic will provide updated four-year and three-year results from the ENDEAVOR I and ENDEAVOR II trials respectively, as well as new data on the next-generation Endeavor Resolute drug-eluting stent.  Results from the ongoing ENDEAVOR IV trial, another large randomized trial (1,548 patients) evaluating Endeavor against the Taxus stent made by Boston Scientific, are expected to be presented in Autumn.

The Endeavor stent is made of a cobalt alloy and has a unique modular architecture designed to enhance deliverability over standard bare metal stents. In addition to the proprietary drug compound Zotarolimus, the Endeavor stent is coated with phosphorylcholine (PC), a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane.

Medtronic

EuroPCR



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