Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial

被引：51

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 ^{[22
]}

机构：

[1] Saiseikai Fukuoka Gen Hosp, Div Cardiol, Fukuoka, Japan

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

[3] Hyogo Coll Med, Dept Clin Epidemiol, Nishinomiya, Hyogo, 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, Japan

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

[8] Japan Community Hlth Care Org Hokkaido Social Hos, Div Cardiol, Sapporo, Hokkaido, Japan

[9] Mitsui Mem Hosp, Div Cardiol, Tokyo, 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, Meiwa, Mie, Japan

[13] Kansai Rosai Hosp, Ctr Cardiovasc, 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] Jichi Med Univ Hosp, Div Cardiol, Shimotsuke, Japan

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

[22] Kyoto Univ, Grad Sch Med, Dept Cardiovasc Med, Kyoto, Japan

来源：

CIRCULATION-CARDIOVASCULAR INTERVENTIONS | 2015年 / 8卷 / 10期

关键词：

coronary artery disease; drug-eluting stents; percutaneous coronary intervention; stents; BARE METAL STENTS; THROMBOSIS; SAFETY; REDUCTION; EFFICACY;

D O I：

10.1161/CIRCINTERVENTIONS.115.002817

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background-There is a paucity of data reporting the clinical outcomes of biodegradable polymer biolimus-eluting stent (BP-BES) compared with durable polymer everolimus-eluting stent (DP-EES) beyond 1 year after stent implantation when the polymer is fully degraded. Methods and Results-The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT) is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BP-BES with DP-EES in patients scheduled for percutaneous coronary intervention using drug-eluting stent (DES) without any exclusion criteria among 98 participating centers in Japan. The trial was designed to evaluate noninferiority of BP-BES relative to DP-EES in terms of any target-lesion revascularization at 1 year and death or myocardial infarction at 3 years. Between May and October 2011, 3235 patients were randomly assigned to receive either BP-BES (1617 patients) or DP-EES (1618 patients). Complete 3-year follow-up was achieved in 97.6% of patients. At 3 years, the primary safety end point of death or myocardial infarction occurred in 159 patients (9.9%) in the BP-BES group and in 166 patients (10.3%) in the DP-EES group, demonstrating noninferiority of BP-BES relative to DP-EES (P noninferiority< 0.0001 and P superiority=0.7). Cumulative incidence of target-lesion revascularization was not significantly different between the 2 groups (7.4% versus 7.1%; P=0.8). By a landmark analysis at 1 year, the cumulative incidences of death or myocardial infarction and target-lesion revascularization were also not significantly different between the 2 groups (4.6% versus 5.2%; P=0.46 and 3.3% versus 2.7%; P=0.39, respectively). Conclusions-Safety and efficacy outcomes of BP-BES were non inferior to those of DP-EES 3 years after stent implantation.

引用

页数：34

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