比较使用可生物降解聚合物或耐用聚合物的第二代药物洗脱支架的随机试验的最终3年结果：NOBORI生物素洗脱支架与XIENCE/PROMUS依维莫司洗脱支架试验

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.

作者信息

Natsuaki Masahiro, Kozuma Ken, Morimoto Takeshi, Kadota Kazushige, Muramatsu Toshiya, Nakagawa Yoshihisa, Akasaka Takashi, Igarashi Keiichi, Tanabe Kengo, Morino Yoshihiro, Ishikawa Tetsuya, Nishikawa Hideo, Awata Masaki, Abe Mitsuru, Okada Hisayuki, Takatsu Yoshiki, Ogata Nobuhiko, Kimura Kazuo, Urasawa Kazushi, Tarutani Yasuhiro, Shiode Nobuo, Kimura Takeshi

机构信息

Division of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan (M.N.); Division of Cardiology, Teikyo University Hospital, Tokyo, Japan (K. Kozuma); Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T. Morimoto); Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan (K. Kadota); Division of Cardiology, Saiseikai Yokohama-city Eastern Hospital, Yokohama, Japan (T. Muramatsu); Division of Cardiology, Tenri Hospital, Tenri, Japan (Y.N.); Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan (T.A.); Division of Cardiology, Japan Community Health Care Organization Hokkaido Social Hospital, Sapporo, Japan (K.I.); Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan (K.T.); Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan (Y.M.); Division of Cardiology, Saitama Cardiovascular and Respiratory Center, Kumagaya, Japan (T.I.); Division of Cardiology, Mie Heart Center, Mie, Japan (H.N.); Division of Cardiology, Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan (M. Awata); Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan (M. Abe); Division of Cardiology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan (H.O.); Division of Cardiology, Hyogo Prefectural Amagasaki Hospital, Amagasaki, Japan (Y. Takatsu); Division of Cardiology, Jichi Medical University Hospital, Shimotsuke, Japan (N.O.); Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan (K. Kimura); Division of Cardiology, Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan (K.U.); Division of Cardiology, Okamura Memorial Hospital, Shizuoka, Japan (Y. Tarutani); Division of Cardiology, Tsuchiya General Hospital, Hiroshima, Japan (N.S.); and Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan (T.K.).

出版信息

Circ Cardiovasc Interv. 2015 Oct;8(10). doi: 10.1161/CIRCINTERVENTIONS.115.002817.

DOI:10.1161/CIRCINTERVENTIONS.115.002817

PMID:26446596

Abstract

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.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01303640.

摘要

背景

在支架植入1年后聚合物完全降解时，与耐用聚合物依维莫司洗脱支架（DP-EES）相比，关于可生物降解聚合物生物雷帕霉素洗脱支架（BP-BES）临床结局的数据较少。

方法与结果

NOBORI生物雷帕霉素洗脱支架与XIENCE/PROMUS依维莫司洗脱支架试验（NEXT）是一项前瞻性、多中心、随机、开放标签、非劣效性试验，在日本98个参与中心中，对计划接受药物洗脱支架（DES）经皮冠状动脉介入治疗且无任何排除标准的患者，比较BP-BES与DP-EES。该试验旨在评估BP-BES相对于DP-EES在1年时的任何靶病变血管重建以及3年时的死亡或心肌梗死方面的非劣效性。2011年5月至10月期间，3235例患者被随机分配接受BP-BES（1617例患者）或DP-EES（1618例患者）。97.6%的患者完成了3年随访。3年时，BP-BES组159例患者（9.9%）发生了死亡或心肌梗死这一主要安全性终点事件，DP-EES组166例患者（10.3%）发生了该事件，表明BP-BES相对于DP-EES具有非劣效性（非劣效性P<0.0001，优效性P=0.7）。两组间靶病变血管重建的累积发生率无显著差异（7.4%对7.1%；P=0.8）。通过1年时的标志性分析，两组间死亡或心肌梗死以及靶病变血管重建的累积发生率也无显著差异（分别为4.6%对5.2%；P=0.46和3.3%对2.7%；P=0.39）。