November 13, 2008 - Medtronic Inc. said yesterday its enrollment in the 2,300-patient RESOLUTE All-Comers (R-AC) clinical study was completed in just six months, two months ahead of schedule.
The randomized trial compares the safety and efficacy of Medtronic's Endeavor Resolute drug-eluting stent (DES) with Abbott Laboratories' Xience DES.
"The pace at which this trial enrolled is testimony to the intense focus and collaborative spirit of an excellent team of investigators," said Professor Patrick Serruys of Erasmus Medical Center's Thoraxcenter in Rotterdam, the Netherlands, on behalf of his co-principal investigators, Professor Sigmund Silber of the Heart Catheterization Centre in Munich, Germany, and Professor Stephan Windecker of University Hospital Bern in Switzerland. "We are all committed to rigorous follow-up to ensure that our patients' participation in the study adds considerably to the deepening understanding of how the Resolute and Xience drug-eluting stents perform in real-world clinical practice."
Launched outside the U.S. in October 2007, the Endeavor Resolute DES expands Medtronic's international stent portfolio for patients with coronary artery disease. The Endeavor Resolute DES received the CE Mark in October 2007 and is commercially available in more than 100 countries worldwide. In the U.S. its use is limited to investigational clinical trials.
The Endeavor Resolute DES features the highly-biocompatible BioLinx polymer, the first polymer designed specifically for use on a DES. The BioLinx polymer is designed to extend the duration of drug exposure in the vessel - an elution profile of potential relevance to patients that physicians consider to be at high risk of needing a repeat procedure - without trading off polymer biocompatibility, the company said.
R-AC is one part of the comprehensive RESOLUTE clinical program, which will enroll a total of more than 6,000 patients worldwide across a series of single-arm and randomized controlled trials. Enrollment in both RESOLUTE U.S. (R-U.S.) and RESOLUTE International (R-Int) began in August. R-U.S. (n=1,399) is a prospective, multicenter, controlled trial; R-Int (n=2,200) is a prospective, multicenter registry.
The RESOLUTE clinical program is a collaborative effort involving hundreds of medical centers in more than 25 countries across Europe, Asia, the Pacific Rim, the Middle East, Africa, Latin America and North America.
R-AC symmetrically randomized 2,300 unselected patients to the Endeavor Resolute DES or the Xience DES stent at 17 prominent medical centers in Europe and Israel. The primary endpoint for R"‘AC is target lesion failure, a composite of cardiac death, myocardial infarction and target lesion revascularization, within 12 months.
For more information: www.medtronic.com