Medtronic's Resolute Integrity DES Approved for New Indications in Europe

May 15, 2012—At the EuroPCR 2012 conference in Paris, Medtronic, Inc. (Minneapolis, MN) announced that the Resolute Integrity coronary drug-eluting stent (DES) system has received European regulatory approval for several new indications: acute coronary syndrome, acute myocardial infarction, unstable angina, total occlusions and chronic total occlusions, and in-stent restenosis. The device was previously approved in Europe for treatment in patients with diabetes mellitus and multivessel disease.

The company stated that data from two of the studies that contributed to the approval of these indications, RESOLUTE All Comers (AC) and RESOLUTE International, were presented at EuroPCR.

According to Medtronic's press release, RESOLUTE AC is a randomized controlled trial comparing the Resolute DES to the Xience V DES (Abbott Vascular, Santa Clara, CA). The study enrolled approximately 2,300 patients, with very few exclusion criteria, at 17 centers in Europe and Israel. As a result, 66% of the real-world patients in the study were considered complex, which is representative of standard clinical practice. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 1 year of follow-up.

RESOLUTE AC's Co-Principal Investigators are Prof. Stephan Windecker of Bern University Hospital in Switzerland; Prof. Patrick Serruys, MD, of the Thoraxcenter at Erasmus University in Rotterdam, the Netherlands; and Prof. Sigmund Silber, MD, of the Heart Catheterization Center in Munich, Germany.

As summarized in Medtronic's announcement, the 3-year RESOLUTE AC results presented by Prof. Windecker at EuroPCR showed that the devices are closely matched on important measures of safety and efficacy in long-term follow-up. The rates of TLF at 3 years were 13.1% for Resolute and 12.4% for Xience V (P = .614). Additionally, the rates of definite/probable stent thrombosis at 3 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).

“RESOLUTE All Comers has amassed an invaluable data set to guide stent selection for patients with coronary artery disease, regardless of its complexity,” commented Prof. Windecker in the company press release. “The rigorous design and conduct of the study, which enrolled a majority of complex patients and has lost less than 2% of patients to follow-up, makes the results highly relevant to the contemporary clinical practice of interventional cardiology worldwide.”

Pooled analyses of bifurcation lesions and in-stent restenosis at 2 years from RESOLUTE AC and RESOLUTE International will be presented later in the week at EuroPCR.

The pooled data set on bifurcation lesions will be presented on May 17 by Prof. Ran Kornowski, MD, from Rabin Medical Center and Tel Aviv University in Israel. In 702 patients with bifurcated lesions, the Resolute DES with side-branch access resulted in a TLF rate of 12.6% at 2 years and 10.4% at 1 year, stated Medtronic.

On May 18, the pooled data set on in-stent restenosis will be presented by Prof. Gert Richardt, MD, from the Segeberger Clinic's Heart Center in Bad Segeberg, Schleswig-Holstein, Germany. In the 281 patients treated with a Resolute DES, the TLF rate in this challenging lesion type—which was 10.8% at 1 year—was 17.5% at 2 years, according to the Medtronic press release.