All-Comers Trial Studies Medtronic's Resolute DES

May 25, 201—Medtronic, Inc. (Minneapolis, MN) announced that the first results of the RESOLUTE All- Comers (AC) study were presented at the EuroPCR 2010 conference in Paris. The study is directly comparing the company's Resolute drug-eluting stent (DES) to the current market-leading platform. The design of the RESOLUTE AC study includes patients who are not typically enrolled in comparative clinical studies, so that the results are representative of real-world clinical practice.

According to the company, the 2,292-patient, randomized trial found the Resolute zotarolimus-eluting stent to be as safe and effective as the Xience V everolimus-eluting stent (Abbott Vascular, Santa Clara, CA). At 1 year, the Resolute DES was shown to be as effective as the Xience V DES in reducing the need for repeat procedures, and both secondgeneration secondgeneration stents were associated with low and similar rates of death from cardiac causes and myocardial infarctions attributed to the treated vessel. In the primary endpoint of the study, target lesion failure, the Resolute DES demonstrated a rate of 8.2% versus 8.3% for the Xience V DES (noninferiority, P ≤ .001).

The Resolute DES is indicated for improving coronary luminal diameter and reducing restenosis in patients with symptomatic ischemic heart disease in de novo coronary artery lesions in native coronary arteries with a reference vessel diameter of 2.25 to 4 mm. Medtronic advised that the device is available in many countries outside the United States and Japan. In the United States, the Resolute DES is limited to investigational use only.

Medtronic stated that the RESOLUTE AC trial is one part of the comprehensive Resolute clinical program that will enroll a total of more than 6,000 patients worldwide across a series of single-arm, randomized controlled trials including RESOLUTE, RESOLUTE US, RESOLUTE International, and RESOLUTE Japan. 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.