Mattia Galli, Renzo Laborante, Giovanni Occhipinti, Andea Zito, Luigi Spadafora, Giuseppe Biondi-Zoccai, Roberto Nerla, Fausto Castriota, Domenico D'Amario, Davide Capodanno, Young-Hoon Jeong, Takeshi Kimura, Roxana Mehran, Dominick J Angiolillo
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The primary efficacy endpoint was major adverse cardiovascular events (MACE) as defined in each trial and the primary safety endpoint was minor or major bleeding. Twenty-six RCTs testing seven different BRATs were included. The only strategy associated with a trade-off in MACE was 'upfront unguided de-escalation' in the subgroup of non-EAs (risk ratio 1.16, 95% confidence interval 1.09-1.24). All but aspirin monotherapy-based strategies (i.e. 'short and very short DAPT followed by aspirin') were associated with reduced bleeding compared with standard DAPT in both EA and non-EA patients. There were no significant differences between subgroups, but the lack of RCTs in some of the included strategies and the difference in the certainty of evidence between EA and non-EA patients revealed that the evidence in support of different BRATs in ACS undergoing PCI is influenced by ethnicity. 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引用次数: 0
摘要
目的:随机对照试验(RCTs)在急性冠状动脉综合征(ACS)中使用抗血小板治疗方案(BRATs)减少出血的策略已经显示出有希望的结果，但是这些结果的广泛性可能受到入组患者种族的显著影响，因为东亚(EA)患者与非EA患者相比表现出不同的缺血-出血风险特征。方法和结果:选择了比较BRATs和标准12个月双重抗血小板治疗(DAPT)对ACS经皮冠状动脉介入治疗(PCI)患者的影响的随机对照试验。主要疗效终点是每个试验中定义的主要不良心血管事件(MACE)，主要安全性终点是轻微或严重出血。共纳入26项随机对照试验，测试7种不同的brat。与MACE权衡相关的唯一策略是在非ea亚组中“预先无指导降级”(RR 1.16, 95% CI 1.09-1.24)。与标准DAPT相比，EA和非EA患者除阿司匹林单药治疗外的所有策略(即“短时间和极短时间DAPT后服用阿司匹林”)均与出血减少相关。亚组间无显著差异，但部分纳入策略缺乏随机对照试验，EA和非EA患者之间证据确定性的差异表明，支持ACS行PCI的不同brat的证据受种族影响。此外，绝对风险降低估计显示，根据种族，一些brat可能比其他brat在减少出血方面更有效。结论:大多数brat与出血减少有关，在硬缺血终点没有任何权衡，而与种族无关。然而，不同brat的支持证据和相对安全性可能会受到种族的显著影响，这在临床实践中应予以考虑。本研究在PROSPERO注册(CRD42023416710)。
Impact of ethnicity on antiplatelet treatment regimens for bleeding reduction in acute coronary syndromes: a systematic review and pre-specified subgroup meta-analysis.
Aims: Randomized controlled trials (RCTs) testing bleeding reduction strategies using antiplatelet treatment regimens (BRATs) in acute coronary syndromes (ACS) have shown promising results, but the generalizability of these findings may be significantly influenced by the ethnicity of the patients enrolled, given that East Asian (EA) patients show different ischaemic-bleeding risk profile compared to non-EA patients.
Methods and results: RCTs comparing a BRAT vs. standard 12-month dual antiplatelet therapy (DAPT) in patients with ACS undergoing percutaneous coronary intervention (PCI) were selected. The primary efficacy endpoint was major adverse cardiovascular events (MACE) as defined in each trial and the primary safety endpoint was minor or major bleeding. Twenty-six RCTs testing seven different BRATs were included. The only strategy associated with a trade-off in MACE was 'upfront unguided de-escalation' in the subgroup of non-EAs (risk ratio 1.16, 95% confidence interval 1.09-1.24). All but aspirin monotherapy-based strategies (i.e. 'short and very short DAPT followed by aspirin') were associated with reduced bleeding compared with standard DAPT in both EA and non-EA patients. There were no significant differences between subgroups, but the lack of RCTs in some of the included strategies and the difference in the certainty of evidence between EA and non-EA patients revealed that the evidence in support of different BRATs in ACS undergoing PCI is influenced by ethnicity. Moreover, absolute risk reduction estimation revealed that some BRATs might be more effective than others in reducing bleeding according to ethnicity.
Conclusion: The majority of BRATs are associated with reduced bleeding without any trade-off in hard ischaemic endpoints regardless of ethnicity. However, the supporting evidence and relative safety profiles of different BRATs might be significantly affected by ethnicity, which should be taken into account in clinical practice.
Study registration: This study is registered in PROSPERO (CRD42023416710).
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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