Medtronic has initiated the first investigational sites in the U.S. to participate in PROTECT, the company’s international study comparing the Endeavor and Cypher drug-eluting stents on safety metrics, including stent thrombosis.
Carlos Mego, MD, and his team at Doctors Hospital at Renaissance in Edinburg, Texas, enrolled the first U.S. patient in PROTECT last week, according to the Minneapolis-based company.
Initiated in May 2007 in Europe, Medtronic said that PROTECT will enroll a total of 8,800 patients, equally randomized to its Endeavor zotarolimus-eluting coronary stent or the Cordis’ Cypher sirolimus-eluting coronary stent, at more than 200 medical centers globally. Enrollment through July stands at nearly 5,500 patients.
Collectively, the company said that data from PROTECT augments the ENDEAVOR clinical program, which involves more than 21,000 patients—more than 15,000 of whom will have received an Endeavor stent.
PROTECT sites in the U.S. will serve to provide the FDA with U.S.-specific data on the post-market experience with the Endeavor stent, which received FDA approval Feb. 1, according to the company. The U.S. sites will enroll a minimum of 1,000 patients who receive Endeavor stents through PROTECT or, if necessary, through a nonrandomized continued-access arm.