Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial.

Abstract

There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10years. We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES. The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1year and the primary safety endpoint of death or myocardial infarction (MI) at 3years. In this extended follow-up study, clinical outcomes were compared from 1year after stent implantation up to 10years between patients with BP-BES and DP-EES. From May to October 2011, NEXT enrolled atotal of 3,241patients from 98 centres in Japan. The current study population consisted of 2,417patients (1,204patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In alandmark analysis at 1year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups. The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1year and up to 10years after stent implantation.