Medtronic has received expanded clearance for a bunch of new indications for its flagship Resolute Integrity drug eluting coronary stent in countries using the CE Mark. It was previously labeled for use in patients with diabetes and multi-vessel disease, but is now also approved for acute coronary syndromes, acute myocardial infarction, unstable angina, bifurcations, in-stent restenosis, total occlusions and chronic total occlusions.
Recent clinical study results, according to the latest company’s announcement:
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).
Two-year results from RESOLUTE All Comers and RESOLUTE International in patients with bifurcation lesions and in-stent restenosis will also be presented at EuroPCR. These two subsets are common in standard clinical practice, together accounting for approximately 20–25 percent of patients who receive stents.
The pooled data set on bifurcation lesions, which remain a therapeutic challenge for the interventional community, will be presented on Thursday by Dr. Ran Kornowski from Rabin Medical Center and Tel Aviv University in Israel.
As the only DES on the market with an indication for treating bifurcated lesions, the Resolute DES performed extremely well in this patient subset. Of the 702 patients with bifurcated lesions, the use of the Resolute DES and its excellent side branch access resulted in a low TLF rate of 12.6 percent at two years (and 10.4 percent at one year).
The pooled data set on in-stent restenosis (ISR) will be presented on Friday by Dr. Gert Richardt from the Segeberger Clinic’s Heart Center in Germany. Patients presenting with ISR have been associated with worse outcomes and a higher rate of repeat procedures than patients who are treated for de novo lesions. At two years, the 281 ISR patients treated with a Resolute DES had a TLF rate of 17.5 percent, which is considered low for patients with this challenging lesion type. The TLF rate at one year was 10.8 percent.
Press release: Medtronic Nets New Indications for Resolute Integrity Drug-Eluting Stent in Europe…
Product page: Resolute Integrity…
Flashbacks: Medtronic Resolute Integrity DES Cleared in the U.S.; Medtronic’s Resolute Integrity Now Available in Europe; Medtronic Integrity Stent Gets US Clearance
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