心肌梗死后-受体阻滞剂治疗的丹麦-挪威随机试验:设计、基本原理和基线特征。

IF 5.3 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Anna Meta Dyrvig Kristensen, John Munkhaugen, Sigrun Halvorsen, Michael Hecht Olsen, Arnhild Bakken, Thomas Steen Gyldenstierne Sehested, Vidar Ruddox, Theis Lange, Morten Wang Fagerland, Christian Torp-Pedersen, Eva Prescott, Dan Atar
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引用次数: 0

摘要

目的:心肌梗死(MI)后β受体阻滞剂治疗的证据是30多年前进行的随机试验,其持续疗效受到质疑。设计和方法:结合正在进行的丹麦(DANBLOCK)和挪威(BETAMI)随机β受体阻滞剂试验,评估心肌梗死后长期β受体阻滞剂治疗的有效性和风险。左心室射血分数正常或轻度降低(LVEF≥40%)的患者将随机接受β受体阻滞剂开放标签治疗或不接受β受体阻滞剂治疗。这项事件驱动的试验将随机分配约5700名患者,并持续到950个主要终点发生。截至2023年7月,5228名患者被随机分配。在首批随机分配的4000名患者中,中位年龄为62岁,79%为男性,48%为STEMI, 84%为正常LVEF。主要终点是确定复发性心肌梗死、偶发性心力衰竭、冠状动脉血运重建、缺血性中风、全因死亡率、恶性室性心律失常或复苏性心脏骤停的综合结果。主要安全终点包括复发性心肌梗死、心力衰竭、全因死亡率、恶性室性心律失常或随机分组后30天复苏的心脏骤停。次要终点包括主要终点的每个组成部分,患者报告的结果,以及与受体阻滞剂治疗相关的其他临床结果。根据意向治疗原则,采用Cox比例风险回归模型进行初步分析。预计随访将于2024年12月结束。结论:联合BETAMI-DANBLOCK试验将有可能影响目前对心肌梗死后LVEF正常或轻度降低的患者进行β受体阻滞剂治疗的临床实践。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Danish-Norwegian randomized trial on beta-blocker therapy after myocardial infarction: Design, rationale, and baseline characteristics.

Background and aims: The evidence for beta-blocker therapy after myocardial infarction (MI) is randomized trials conducted more than 30 years ago, and the continued efficacy has been questioned.

Design and methods: The ongoing Danish (DANBLOCK) and Norwegian (BETAMI) randomized beta-blocker trials are joined to evaluate the effectiveness and risks of long-term beta-blocker therapy after MI. Patients with normal or mildly reduced left ventricular ejection fraction (LVEF ≥ 40%) will be randomized to open-label treatment with beta-blockers or no such therapy. The event-driven trial will randomize ∼5700 patients and continue until 950 primary endpoints have occurred. As of July 2023, 5228 patients have been randomized. Of the first 4000 patients randomized, median age was 62 years, 79% were men, 48% had a ST-segment elevation myocardial infarction (STEMI), and 84% had a normal LVEF. The primary endpoint is a composite of adjudicated recurrent MI, incident heart failure (HF), coronary revascularization, ischaemic stroke, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest. The primary safety endpoint includes a composite of recurrent MI, HF, all-cause mortality, malignant ventricular arrhythmia, or resuscitated cardiac arrest 30 days after randomization. Secondary endpoints include each of the components of the primary endpoint, patient-reported outcomes, and other clinical outcomes linked to beta-blocker therapy. The primary analysis will be conducted according to the intention-to-treat principle using a Cox proportional hazards regression model. End of follow-up is expected in December 2024.

Conclusion: The combined BETAMI-DANBLOCK trial will have the potential to affect current clinical practice for beta-blocker therapy in patients with normal or mildly reduced LVEF after MI.

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来源期刊
European Heart Journal - Cardiovascular Pharmacotherapy
European Heart Journal - Cardiovascular Pharmacotherapy Medicine-Cardiology and Cardiovascular Medicine
CiteScore
10.10
自引率
14.10%
发文量
65
期刊介绍: The European Heart Journal - Cardiovascular Pharmacotherapy (EHJ-CVP) is an international, peer-reviewed journal published in English, specifically dedicated to clinical cardiovascular pharmacology. EHJ-CVP publishes original articles focusing on clinical research involving both new and established drugs and methods, along with meta-analyses and topical reviews. The journal's primary aim is to enhance the pharmacological treatment of patients with cardiovascular disease by interpreting and integrating new scientific developments in this field. While the emphasis is on clinical topics, EHJ-CVP also considers basic research articles from fields such as physiology and molecular biology that contribute to the understanding of cardiovascular drug therapy. These may include articles related to new drug development and evaluation, the physiological and pharmacological basis of drug action, metabolism, drug interactions, and side effects.
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