Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent: A Randomized, Controlled, Noninferiority Trial

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• 作者：Masahiro Natsuaki ; Ken Kozuma ; Takeshi Morimoto ; Kazushige Kadota ; Toshiya Muramatsu ; Yoshihisa Nakagawa ; Takashi Akasaka ; Keiichi Igarashi ; Kengo Tanabe ; Yoshihiro Morino ; Tetsuya Ishikawa ; Hideo Nishikawa ; Masaki Awata ; Mitsuru Abe ; Hisayuki Okada ; Yoshiki Takatsu ; Nobuhiko Ogata ; Kazuo Kimura ; Kazushi Urasawa ; Yasuhiro Tarutani ; et al.
• 关键词：biolimus-eluting stent(s) ; everolimus-eluting stent(s) ; percutaneous coronary intervention
• 刊名：Journal of the American College of Cardiology
• 出版年：2013
• 出版时间：16 July, 2013
• 年：2013
• 卷：62
• 期：3
• 页码：181-190
• 全文大小：1566 K

文摘

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Objectives

NEXT (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial) was designed for evaluating the noninferiority of a biolimus-eluting stent (BES) relative to an 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

The NEXT trial is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BES with EES. Between May and October 2011, 3,235 patients were randomly assigned to receive either BES (n?=?1,617) or EES (n?=?1,618).

Results

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 noninferiority of BES relative to EES (p for noninferiority?<0.0001, and p for superiority?= 0.93). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.25 % vs. 0.06 % , p?= 0.18). An angiographic substudy enrolling 528 patients (BES: n?=?263, and EES: n?=?265) demonstrated noninferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03 ¡À 0.39 mm vs. 0.06 ¡À 0.45 mm, p for noninferiority?<0.0001, and p for superiority?= 0.52) at 266 ¡À 43 days after stent implantation.

Conclusions

One-year clinical and angiographic outcome after BES implantation was noninferior 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 a low rate of TLR and extremely low rate of stent thrombosis.

(NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial [NEXT]; )