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PCI术后高危出血患者进行1个月双重抗血小板治疗的预后不劣于两个月治疗
作者:小柯机器人 发布时间:2021/8/31 14:46:32

瑞士意大利语区大学Marco Valgimigli团队研究了PCI术后高危出血患者的不同方案双重抗血小板治疗的效果。这一研究成果于2021年8月28日发表在《新英格兰医学杂志》上。

对于药物洗脱冠状动脉支架植入术后出血风险高的患者,双重抗血小板治疗的适当持续时间尚不清楚。

在植入生物可降解聚合物西罗莫司洗脱冠状动脉支架一个月后,研究组随机将出血风险高的患者分配到立即停止双抗血小板治疗(简化治疗)或至少继续治疗2个月治疗(标准治疗)。三项主要结局为净不良临床事件(全因死亡、心肌梗死、中风或大出血)、重大不良心脏或脑事件(全因死亡、心肌梗死或中风)和大出血或临床相关非重大出血;在335天时评估累积发病率。前两个结局在按方案人群中评估非劣效性,第三个结局是评估意向治疗人群的优越性。

在按方案进行的4434名患者中,简化治疗组有165名(7.5%)患者发生净不良临床事件,标准治疗组有172名(7.7%)。简化治疗组共有133例(6.1%)患者发生严重的心脏或大脑不良事件,标准治疗组有132例(5.9%)。在意向治疗的4579名患者中,简化治疗组有148名(6.5%)患者发生大出血或临床相关非重大出血,标准治疗组有211名(9.4%)。

研究结果表明,就净不良临床事件和主要不良心脏或脑事件的发生率而言,采取1个月的双重抗血小板治疗不劣于至少2个月的标准继续治疗,简化治疗还降低了大出血或临床相关非重大出血的发生率。

附:英文原文

Title: Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk | NEJM

Author: Marco Valgimigli, M.D., Ph.D.,, Enrico Frigoli, M.D.,, Dik Heg, Ph.D.,, Jan Tijssen, Ph.D.,, Peter Jüni, M.D.,, Pascal Vranckx, M.D., Ph.D.,, Yukio Ozaki, M.D., Ph.D.,, Marie-Claude Morice, M.D.,, Bernard Chevalier, M.D.,, Yoshinobu Onuma, M.D., Ph.D.,, Stephan Windecker, M.D.,, Pim A.L. Tonino, M.D.,, Marco Roffi, M.D.,, Maciej Lesiak, M.D.,, Felix Mahfoud, M.D.,, Jozef Bartunek, M.D., Ph.D.,, David Hildick-Smith, M.D.,, Antonio Colombo, M.D.,, Goran Stankovi, M.D., Ph.D.,, Andrés Iiguez, M.D., Ph.D.,, Carl Schultz, M.D., Ph.D.,, Ran Kornowski, M.D.,, Paul J.L. Ong, M.D., Ph.D.,, Mirvat Alasnag, M.D., Ph.D.,, Alfredo E. Rodriguez, M.D., Ph.D.,, Aris Moschovitis, M.D.,, Peep Laanmets, M.D.,, Michael Donahue, M.D.,, Sergio Leonardi, M.D.,, and Pieter C. Smits, M.D., Ph.D.

Issue&Volume: 2021-08-28

Abstract:

Background

The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear.

Methods

One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population.

Results

Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, 0.23 percentage points; 95% confidence interval [CI], 1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, 1.29 to 1.51; P=0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, 2.82 percentage points; 95% CI, 4.40 to 1.24; P<0.001 for superiority).

Conclusions

One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding.

DOI: 10.1056/NEJMoa2108749

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2108749

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home