Howard C. Herrmann, MD

Data at 1 year show promise for a biolimus-eluting stent.

Biodegradable polymers and stents represent the next development frontier of coronary stent technology. In a trial conducted at 98 hospitals in Japan, researchers randomized 3235 patients undergoing percutaneous coronary intervention (PCI) to receive either a biolimus-eluting stent (BES), made of stainless steel and a biodegradable polymer, or the most commonly used stent in the U.S., an everolimus-eluting stent (EES) made of cobalt-chromium with a durable polymer. The manufacturer of the BES (brand name Nobori) funded the study. Xience and Promus are the widely known brands of EES.

The procedural success rate was 97% in both groups, and 1-year follow-up was obtained in >99% of patients. The incidence of target-lesion revascularization at 1 year, the primary endpoint, was identical (4.2%) in both groups. The two groups were also similar in all prespecified subgroup analyses (diabetes, elderly, hemodialysis, and multivessel PCI). Definite stent thrombosis occurred in 4 BES recipients and 1 EES recipient (0.25% vs. 0.06%), a nonsignificant difference. In an angiographic substudy (528 patients), mean in-segment late loss was similar in the two groups (0.03 mm for BES, 0.06 mm for EES); the rate of stent fracture was significantly higher in the BES group (3.1% vs. 0%).

Citation(s):

Natsuaki M et al on behalf of the NEXT Investigators. Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: A randomized, controlled, noninferiority trial. J Am Coll Cardiol 2013 Jul 16; 62:181.