Biodegradable Polymer Biolimus-eluting Stent versus Durable Polymer Everolimus-eluting Stent: a randomized, controlled, non-inferiority trial.

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Biodegradable Polymer Biolimus-eluting Stent versus Durable Polymer Everolimus-eluting Stent: a randomized, controlled, non-inferiority trial.

J Am Coll Cardiol. 2013 May 15;

Authors: Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T

Abstract
OBJECTIVES: The NOBORI(TM) Biolimus-Eluting versus XIENCE(TM)/PROMUS(TM) Everolimus-eluting stent Trial (NEXT) was designed for evaluating non-inferiority of biolimus-eluting stent (BES) relative to everolimus-eluting stent (EES) in terms of target-lesion revascularization (TLR) at 1-year. BACKGROUND: Efficacy and safety data comparing biodegradable polymer BES with durable polymer cobalt-chromium EES are currently limited. METHODS: NEXT trial is a prospective, multicenter, randomized, open label, non-inferiority trial comparing BES with EES. RESULTS: Between May and October 2011, 3235 patients were randomly assigned to receive either BES (1617 patients) or EES (1618 patients). At 1-year, the primary efficacy endpoint of TLR occurred in 67 patients (4.2%) in the BES group, and in 66 patients (4.2%) in the EES group, demonstrating non-inferiority of BES relative to EES (P non-inferiority<0.0001, and P superiority=0.93). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.25% versus 0.06%, P=0.18). Angiographic sub-study enrolling 528 patients (BES: 263 patients, and EES: 265 patients) demonstrated non-inferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03�0.39mm versus 0.06�0.45mm, P non-inferiority<0.0001, and P superiority=0.52) at 266�43 days after stent implantation. CONCLUSIONS: One-year clinical and angiographic outcome after BES implantation was non-inferior to and not different from that after EES implantation in a mostly stable coronary artery disease population. One-year clinical outcome after both BES- and EES-use was excellent with low rate of TLR and extremely low rate of stent thrombosis. CLINICAL TRIAL IDENTIFIER: NCT01303640.

PMID: 23684673 [PubMed - as supplied by publisher]

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