Boston Scientific has enrolled the first patient in its PROENCY (PROmus, ENdeavor and CYpher) European registry, the first to observe different -olimus-eluting coronary stents.
The Natick, Mass.-based company said it will collect real-life clinical outcome data for Boston Scientific's Promus everolimus-eluting coronary stent and compare them with data from Johnson & Johnson's Cordis’ Cypher sirolimus-Eluting Stent and Medtronic's Endeavor zotarolimus-eluting stent in patients in routine clinical practice.
The Promus stent is a private-labeled Xience V everolimus-eluting coronary stent system manufactured by Abbott and distributed by Boston Scientific. The Promus stent is an investigational device in the United States with its premarket approval (PMA) application currently under review by the FDA.
Boston Scientific said the registry will enroll up to 2,500 patients with simple and complex lesions at multiple sites in several European countries. Of the patients at each site, half will receive the Promus stent and half will receive either the Cypher or the Endeavor stent to attain a 2:1:1 ratio of PROMUS, Cypher, and Endeavor stents respectively. The primary endpoint of the registry will be the rate of major cardiac events (cardiac death, all myocardial infarction and target vessel revascularization) at 12 months, the company said.