背景:短期双重抗血小板治疗(DAPT)后的P2Y12抑制剂单药治疗可以平衡急性冠脉综合征(ACS)患者的缺血和出血风险。然而,不同的P2Y12抑制剂作为单一疗法对结局的影响仍不确定.
方法:纳入了在ACS中比较短期DAPT(≤3个月)和12个月DAPT后P2Y12抑制剂单药治疗的随机对照试验。主要终点是主要不良心血管事件(MACE)。所有分析包括用作单一疗法的P2Y12抑制剂的相互作用术语。进行试验顺序分析,以探索每个结果的效果估计是否会受到进一步研究的影响。
结果:包括27,284名ACS患者的7项试验。与12个月的DAPT相比,短期DAPT后P2Y12抑制剂单药治疗与MACE无差异(OR0.92,95%CI0.76-1.12)和净不良临床事件(NACE)显着减少(OR0.75;95%CI0.60-0.94),任何出血(OR0.54,95%CI0.43-0.66)和大出血(OR0.47,95%CI0.37-0.60)。替格瑞洛和氯吡格雷单药治疗MACE的亚组差异存在显著交互作用(品脱=0.016),全因死亡(品脱=0.042),NACE(品脱=0.018),和心肌梗死(品脱=0.028)。试验序贯分析显示替格瑞洛改善NACE的确凿证据,但不是氯吡格雷单一疗法,与标准DAPT相比。
结论:在ACS患者中,与标准DAPT相比,短DAPT后P2Y12抑制剂单药治疗出血减半而不增加缺血事件。替格瑞洛,但不是氯吡格雷单一疗法,减少MACE,与标准DAPT相比,NACE和死亡率,支持阿司匹林停药后使用。方案注册:本研究在PROSPERO(CRD42023494797)中注册。
BACKGROUND: P2Y12 inhibitor monotherapy after a short course of dual antiplatelet therapy (DAPT) may balance ischemic and bleeding risks in patients with acute coronary syndrome (ACS). However, it remains uncertain how different P2Y12 inhibitors used as monotherapy affect outcomes.
METHODS: Randomized controlled trials comparing P2Y12 inhibitor monotherapy after a short course of DAPT (≤3 months) versus 12-month DAPT in ACS were included. The primary endpoint was major adverse cardiovascular events (MACE). All analyses included an interaction term for the P2Y12 inhibitor used as monotherapy. Trial sequential analysis were run to explore whether the effect estimate of each outcomes may be affected by further studies.
RESULTS: Seven trials encompassing 27,284 ACS patients were included. Compared with 12-month DAPT, P2Y12 inhibitor monotherapy after a short course of DAPT was associated with no difference in MACE (OR 0.92, 95% CI 0.76-1.12) and a significant reduction in net adverse clinical events (NACE) (OR 0.75; 95% CI 0.60-0.94), any bleeding (OR 0.54, 95% CI 0.43-0.66) and major bleeding (OR 0.47, 95% CI 0.37-0.60). Significant interactions for subgroup difference between ticagrelor and clopidogrel monotherapy were found for MACE (pint=0.016), all-cause death (pint=0.042), NACE (pint=0.018), and myocardial infarction (pint=0.028). Trial sequential analysis showed conclusive evidence of improved NACE with ticagrelor, but not with clopidogrel monotherapy, compared with standard DAPT.
CONCLUSIONS: In patients with ACS, P2Y12 inhibitor monotherapy after short DAPT halves bleeding without increasing ischemic events compared with standard DAPT. Ticagrelor, but not clopidogrel monotherapy, reduced MACE, NACE and mortality compared with standard DAPT, supporting its use after aspirin discontinuation. Protocol registration: This study is registered in PROSPERO (CRD42023494797).