As EuroPCR 2012 gets under way today, Medtronic, Inc. (NYSE: MDT) announced that the Resolute Integrity Coronary Stent System has received European regulatory approval for several new indications, making it the drug-eluting stent (DES) with the broadest range of approved indications in Europe.
The Resolute Integrity DES is now explicitly indicated in countries outside the United States that accept the CE mark for the following patient and lesion types: acute coronary syndromes, acute myocardial infarction, unstable angina; diabetes mellitus; bifurcations; multi-vessel disease; total occlusions and chronic total occlusions; and in-stent restenosis. All but the indications for diabetes and multi-vessel disease are new.
Two of the studies that contributed to the European regulatory authority’s approval of these indications, RESOLUTE All Comers and RESOLUTE International, are the subject of several new data presentations at EuroPCR, which attracts thousands of physicians from around the world who specialize in cardiovascular interventions.
RESOLUTE All Comers: Three-Year Results
Three-year results from RESOLUTE All Comers, a randomized controlled trial comparing the Resolute DES to the Xience V DES from Abbott Laboratories, showed that the Medtronic device continues to match its chief competitor on important measures of safety and efficacy in long-term follow-up.
RESOLUTE All Comers enrolled nearly 2,300 patients, with very few exclusion criteria, at 17 centers in Europe and Israel. As a result, 66 percent of the “real-world” patients in the study were considered complex, which is representative of standard clinical practice.
RESOLUTE All Comers used the primary endpoint preferred by the U.S. Food and Drug Administration (FDA) for studies of drug-eluting stents: target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularization, at one year of follow-up.
Presented today by Prof. Stephan Windecker of Bern University Hospital in Switzerland, a co-principal investigator of the study, the rates of TLF at three years in RESOLUTE All Comers remain equivalent for the two devices: 13.1% for Resolute; 12.4% for Xience V (p=0.614). Additionally, the rates of definite/probable stent thrombosis at three years were low, with no statistically significant difference. Rates of definite/probable very late stent thrombosis (VLST) were the same for the two devices (0.5% vs. 0.5%, p=1.00).