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新一代药物洗脱支架植入后,基于P2Y抑制剂的单药抗血小板治疗与传统双联抗血小板治疗用于慢性和急性冠状动脉综合征的比较:一项随机临床试验的系统评价和荟萃分析

P2Y Inhibitor-Based Single Antiplatelet Therapy Versus Conventional Dual Antiplatelet Therapy After Newer-Generation Drug-Eluting Stent Implantation in Chronic and Acute Coronary Syndromes: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

作者信息

Iglesias Juan F, Assouline Benjamin, Chatelain Quentin, Musayeb Yazan, Degrauwe Sophie, Roffi Marco

机构信息

Department of Cardiology Geneva University Hospitals Geneva Switzerland.

Intensive Care Unit Geneva University Hospitals Geneva Switzerland.

出版信息

J Am Heart Assoc. 2025 Mar 18;14(6):e036642. doi: 10.1161/JAHA.124.036642. Epub 2025 Mar 13.

DOI:10.1161/JAHA.124.036642
PMID:40079326
Abstract

BACKGROUND

P2Y inhibitor-based single antiplatelet therapy (SAPT) after drug-eluting stent implantation reduces major bleeding without increasing the risk of major adverse cardiovascular and cerebral events compared with 12-month dual antiplatelet therapy (DAPT). The differential effects of P2Y inhibitor monotherapy compared with conventional DAPT in patients with chronic coronary syndromes versus acute coronary syndromes (ACS) remain uncertain.

METHODS AND RESULTS

PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched for randomized controlled trials comparing oral P2Y inhibitor-based SAPT after ≤3 months DAPT versus 12-month DAPT after newer-generation drug-eluting stent implantation. Patients were categorized based on baseline presentation (chronic coronary syndromes versus ACS). The co-primary end points were major bleeding and major adverse cardiovascular and cerebral events, a composite of all-cause death, myocardial infarction, or ischemic stroke. A total of 43 945 (ACS, 28 360, 65%) patients from 7 randomized controlled trials were included. At a median follow-up of 12 months, P2Y inhibitor-based SAPT was associated with a lower risk of major bleeding (risk ratio [RR], 0.63 [95% CI, 0.48-0.82]; <0.001) compared with 12-month DAPT. The risk of major bleeding was significantly lower among patients with ACS (RR, 0.55 [95% CI, 0.40-0.75]; <0.001). Compared with standard DAPT, P2Y inhibitor-based SAPT was associated with a similar risk of major adverse cardiovascular and cerebral events (RR, 0.98 [95%CI, 0.87-1.11]; =0.74) among patients with chronic coronary syndromes and ACS. There was no significant interaction between treatment effect and baseline presentation.

CONCLUSIONS

Compared with 12-month DAPT, P2Y inhibitor-based SAPT after newer-generation drug-eluting stent implantation is associated with a lower risk of major bleeding without increasing the risk of major adverse cardiovascular and cerebral events, a difference primarily driven by patients with ACS.

REGISTRATION

URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42023239341.

摘要

背景

与12个月的双联抗血小板治疗(DAPT)相比,药物洗脱支架植入术后基于P2Y抑制剂的单药抗血小板治疗(SAPT)可减少大出血,且不增加主要不良心血管和脑血管事件的风险。在慢性冠状动脉综合征与急性冠状动脉综合征(ACS)患者中,P2Y抑制剂单药治疗与传统DAPT相比的差异效应仍不确定。

方法和结果

检索了PubMed、Embase和Cochrane对照试验中央注册库,以查找比较新一代药物洗脱支架植入术后≤3个月DAPT后基于口服P2Y抑制剂的SAPT与12个月DAPT的随机对照试验。根据基线表现(慢性冠状动脉综合征与ACS)对患者进行分类。共同主要终点是大出血和主要不良心血管和脑血管事件,这是全因死亡、心肌梗死或缺血性中风的综合指标。纳入了来自7项随机对照试验的总共43945名患者(ACS患者28360名,占65%)。在中位随访12个月时,与12个月的DAPT相比,基于P2Y抑制剂的SAPT大出血风险较低(风险比[RR],0.63[95%CI,0.48-0.82];<0.001)。ACS患者的大出血风险显著较低(RR,0.55[95%CI,0.40-0.75];<0.001)。与标准DAPT相比,在慢性冠状动脉综合征和ACS患者中,基于P2Y抑制剂的SAPT主要不良心血管和脑血管事件风险相似(RR,0.98[95%CI,0.87-1.11];=0.74)。治疗效果与基线表现之间无显著交互作用。

结论

与12个月的DAPT相比,新一代药物洗脱支架植入术后基于P2Y抑制剂的SAPT大出血风险较低,且不增加主要不良心血管和脑血管事件的风险,这一差异主要由ACS患者驱动。

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