Resolute Integrity drug-eluting stent gets CE mark approval for new indications in Europe

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Medtronic has 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.

The RESOLUTE All Comers and the RESOLUTE International studies contributed to the European regulatory authority’s approval of these indications. Results from these two studies are being presented at EuroPCR.


Stephan Windecker, Bern University Hospital, Switzerland, presented the three-years results of RESOLUTE ALL Comers on Tuesday 15 May. The results showed that the rates of TLF at three years in RESOLUTE All Comers remain equivalent for the two devices studied: 13.1% for Resolute; 12.4% for Xience V (Abbott) (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).


“RESOLUTE All Comers has amassed an invaluable data set to guide stent selection for patients with coronary artery disease, regardless of its complexity,” said Windecker, co-principal investigator of RESOLUTE ALL Comers. “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: Bifurcation lesions and in-stent restenosis at two years


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% 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, 17 May by Ran Kornowski, 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% at two years (and 10.4% at one year).


The pooled data set on in-stent restenosis (ISR) will be presented on Friday, 18 May by Gert Richardt, 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%, which is considered low for patients with this challenging lesion type. The TLF rate at one year was 10.8%.