Five-year outcomes of a drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent

Abstract

Background: The biolimus A9-coated polymer-free stent was not non-inferior for target lesion failure (TLF) when compared with an ultrathin-strut biodegradable-polymer sirolimus-eluting stent within 1 year in the Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention (SORT OUT IX) trial.

Aims: We aimed to assess the 5-year outcomes of the drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent.

Methods: The SORT OUT IX trial was a registry-based, randomised, all-comer population trial. The primary endpoint, TLF, was defined as the composite of cardiac death, myocardial infarction (MI) not related to any segment other than the target lesion, or target lesion revascularisation (TLR) within 1 year. Follow-up was extended to 5 years.

Results: A total of 3,151 patients were randomly assigned to receive either the polymer-free biolimus-coated stent (1,572 patients [1,966 lesions]) or the ultrathin-strut biodegradable-polymer sirolimus-eluting stent (1,579 patients [1,985 lesions]). Only 0.3% of participants were lost to follow-up, and all of those were due to emigration. At 5 years, TLF was 14.1% in the polymer-free biolimus-coated stent group and 12.0% in the ultrathin-strut biodegradable-polymer sirolimus-eluting stent group (rate ratio [RR] 1.19, 95% confidence interval [CI]: 0.97-1.44). Cardiac death, MI and definite stent thrombosis did not differ between the two groups. Clinically driven TLR was 7.6% versus 5.0% (RR 1.56, 95% CI: 1.17-2.07) and was higher in the polymer-free biolimus-coated stent group at 5 years, attributable to a higher risk of TLR within the first year.

Conclusions: Five-year TLF did not differ significantly between the drug-coated biolimus-eluting stent group and the ultrathin-strut biodegradable-polymer stent group, but the risk of TLR was higher in the drug-coated biolimus-eluting stent group.