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

被引：176

作者：

Natsuaki, Masahiro ^{[1
]}

Kozuma, Ken ^{[2
]}

Morimoto, Takeshi ^{[3
]}

Kadota, Kazushige ^{[4
]}

Muramatsu, Toshiya ^{[5
]}

Nakagawa, Yoshihisa ^{[6
]}

Akasaka, Takashi ^{[7
]}

Igarashi, Keiichi ^{[8
]}

Tanabe, Kengo ^{[9
]}

Morino, Yoshihiro ^{[10
]}

Ishikawa, Tetsuya ^{[11
]}

Nishikawa, Hideo ^{[12
]}

Awata, Masaki ^{[13
]}

Abe, Mitsuru ^{[14
]}

Okada, Hisayuki ^{[15
]}

Takatsu, Yoshiki ^{[16
]}

Ogata, Nobuhiko ^{[17
]}

Kimura, Kazuo ^{[18
]}

Urasawa, Kazushi ^{[19
]}

Tarutani, Yasuhiro ^{[20
]}

Shiode, Nobuo ^{[21
]}

Kimura, Takeshi ^{[1
]}

机构：

[1] Kyoto Univ, Grad Sch Med, Dept Cardiovasc Med, Kyoto 6068507, Japan

[2] Teikyo Univ Hosp, Div Cardiol, Tokyo, Japan

[3] Kinki Univ, Sch Med, Ctr Gen Internal Med & Emergency Care, Osaka 589, Japan

[4] Kurashiki Cent Hosp, Dept Cardiol, Kurashiki, Okayama, Japan

[5] Saiseikai Yokohama City Eastern Hosp, Div Cardiol, Yokohama, Kanagawa, Japan

[6] Tenri Hosp, Div Cardiol, Tenri, Nara 632, Japan

[7] Wakayama Med Univ Hosp, Dept Cardiovasc Med, Wakayama, Japan

[8] Hokkaido Social Insurance Hosp, Div Cardiol, Sapporo, Hokkaido, Japan

[9] Mitsui Mem Hosp, Div Cardiol, Tokyo 101, Japan

[10] Iwate Med Univ Hosp, Div Cardiol, Morioka, Iwate, Japan

[11] Saitama Cardiovasc & Resp Ctr, Div Cardiol, Kumagaya, Saitama, Japan

[12] Mie Heart Ctr, Div Cardiol, Tsu, Mie, Japan

[13] Kansai Rosai Hosp, Div Cardiol, Amagasaki, Hyogo, Japan

[14] Natl Hosp Org, Kyoto Med Ctr, Div Cardiol, Kyoto, Japan

[15] Seirei Hamamatsu Gen Hosp, Div Cardiol, Hamamatsu, Shizuoka, Japan

[16] Hyogo Kenritsu Amagasaki Hosp, Div Cardiol, Amagasaki, Hyogo, Japan

[17] Tokai Univ Hosp, Div Cardiol, Isehara, Kanagawa, Japan

[18] Yokohama City Univ, Med Ctr, Div Cardiol, Yokohama, Kanagawa 232, Japan

[19] Caress Sapporo Tokeidai Mem Hosp, Div Cardiol, Sapporo, Hokkaido, Japan

[20] Okamura Mem Hosp, Div Cardiol, Shizuoka, Japan

[21] Tsuchiya Gen Hosp, Div Cardiol, Hiroshima, Japan

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2013年 / 62卷 / 03期

关键词：

biolimus-eluting stent(s); everolimus-eluting stent(s); percutaneous coronary intervention; NON-INFERIORITY TRIAL; THROMBOSIS; DESIGN;

D O I：

10.1016/j.jacc.2013.04.045

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 +/- 0.39 mm vs. 0.06 +/- 0.45 mm, p for noninferiority <0.0001, and p for superiority = 0.52) at 266 +/- 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. (c) 2013 by the American College of Cardiology Foundation

引用

页码：181 / 190

页数：10

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