February 11, 2008 - The first patient has enrolled in the PROENCY (PROMUS, Endeavor and Cypher) European registry, Boston Scientific’s new clinical designed to observe different 'Olimus'-eluting coronary stents with the aim of helping physicians in making appropriate stent choices.
The registry 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 Cypher Sirolimus-Eluting Stent and Medtronic’s Endeavor Zotarolimus-Eluting Stent in patients in routine clinical practice.
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.
"We have previously seen efficacy data from clinical trials with the PROMUS, Cypher and Endeavor stents but data from this registry will allow us, for the first time, to comparatively assess the differences between everolimus-, sirolimus- and zotarolimus-eluting stents in patients with simple and complex lesions. This should help clinicians in making the appropriate stent choice for their patients," said Professor Christian Hamm, Principal Investigator, Kerckhoff Heart Center, Bad Nauheim, Germany.
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 U.S. with its Premarket Approval (PMA) application currently under review by FDA.
For more information: www.bostonscientific.com