Key findings on new-generation stent

May 11 2007

New data reported at the 30th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI), offered 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.