Public Release: 

ENDEAVOR III Trial reports key findings on new-generation stent

2-year outcomes will clarify future role of zotarolimus-eluting device

Society for Cardiovascular Angiography and Interventions

(May 10, 2007--ORLANDO, FL) -- New data reported at the 30th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI), May 9-12, 2007, in Orlando, FL, will offer clues to the fate of a new-generation drug-eluting stent that is vying for a place in the treatment of coronary artery disease.

The Endeavor III trial randomly assigned 436 patients treated at 30 medical centers in the United States to treatment with the investigational Endeavor stent (Medtronic, Minneapolis) or the Cypher stent (Cordis Johnson & Johnson, Miami Lakes, FL). The Endeavor stent is coated with zotarolimus, a medication that, like the Cypher's sirolimus coating, reduces renarrowing of the artery by preventing the growth of scar tissue inside the stent.

Initial data showed that procedural success was higher with the new Endeavor stent, which is more flexible and is considered easier to implant than the Cypher stent. However, at 8 months, the Endeavor stent fell short in angiographic studies, showing significantly greater scar tissue growth, or late loss, in the inner diameter of the artery as compared to the Cypher stent. At 12 months, clinical outcomes were equivalent with the two stents: The combined rates of death, heart attack, and repeat procedures were 8.2 percent in both groups of patients.

At the Orlando SCAI meeting, Martin Leon, M.D., FSCAI, a professor of medicine and associate director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York City, will report 2-year clinical outcomes from the Endeavor III trial.

"Long-term follow-up will further clarify not only safety with the zotarolimus-eluting stent but also whether early angiographic disparities translate into differences in late clinical restenosis," he said.

The Endeavor III trial is 1 of 5 studies gathering the data necessary for market approval of the new stent by the Food and Drug Administration.

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About SCAI

Headquartered in Washington, DC, the Society for Cardiovascular Angiography and Interventions is a 3,700-member professional organization representing invasive and interventional cardiologists in 70 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's annual meeting has become the leading venue for education, discussion, and debate about the latest developments in this dynamic medical specialty.

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