Biolimus-eluting versus everolimus-eluting stents in coronary artery disease: a pooled analysis from the NEXT (NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent) and COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) randomised trials

AIMS: This study sought to investigate the safety and efficacy of a biolimus-eluting stent with biodegradable polymer (BP-BES) (Nobori; Terumo Corp.) compared to an everolimus-eluting stent with durable polymer (DP-EES) (XIENCE V or Prime; Abbott Vascular, or PROMUS; Boston Scientific).

METHODS AND RESULTS: The all-comers NEXT and COMPARE II clinical trials randomly assigned 5,942 patients to BP-BES (N=3,412) or DP-EES (N=2,530). We conducted a patient level pooled analysis at three-year follow-up with specified study endpoints: definite stent thrombosis (ST), the combined safety endpoint cardiac death or target vessel myocardial infarction (TV-MI), and the efficacy endpoint target lesion revascularisation (TLR). At three-year follow-up, all endpoints, namely definite stent thrombosis (BP-BES 0.8% vs. 0.4%, p=0.20), death or TV-MI (BP-BES 7.8% vs. 6.7%, p=0.07), as well as TLR (BP-BES 6.4% vs. 6.4%, p=0.78) were similar between groups. Interestingly, unadjusted (BP-BES 5.6% vs. 4.5%, p=0.02) and adjusted (HR 1.36; 1.01-1.82, p=0.04) TV-MI rates were higher in the BP-BES group than in the DP-EES group.

CONCLUSIONS: In this large-scale patient level pooled analysis of the NEXT and COMPARE II randomised trials, the use of BP-BES compared with DP-EES resulted in similar outcomes, but with an observed higher rate of TV-MI in the BP-BES group.