经皮冠状动脉介入治疗后双联抗血小板治疗短期疗程后 P2Y 抑制剂单药治疗的疗效和安全性的荟萃分析。

Meta-Analysis of the Efficacy and Safety of P2Y Inhibitor Monotherapy After Short Course of Dual-Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention.

机构信息

Department of Internal Medicine, University of Toledo Medical Center, Toledo, OH, USA.

Departement of Cardiology, University of Toledo Medical Center, Toledo, OH, USA.

出版信息

Cardiovasc Revasc Med. 2020 Dec;21(12):1500-1506. doi: 10.1016/j.carrev.2020.05.012. Epub 2020 May 16.

DOI:10.1016/j.carrev.2020.05.012

PMID:32457020

Abstract

BACKGROUND

Guidelines recommend dual antiplatelet therapy (DAPT) following drug-eluting stent (DES) placement for ≥12 months in acute coronary syndrome or 6 months in stable coronary artery disease. However, with the advent of newer-generation stents, the optimal duration of DAPT to balance bleeding and thrombotic risks has been debated.

OBJECTIVES

We aimed to perform a meta-analysis of randomized controlled trials (RCT) comparing P2Y monotherapy in short-duration group (SDG) vs. standard treatment group (STG) course of DAPT in patients undergoing PCI.

METHODS

Electronic databases were searched for RCTs of patients undergoing percutaneous coronary intervention (PCI) with DES placement who received short (≤ 3 months) vs. standard DAPT course (≥12 months) and were followed for ≥12-months. Rates of major adverse cardiovascular events (a composite of cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke) were the primary outcome. Study-specific odds ratios (OR) and corresponding 95% confidence intervals were calculated using random-effects model.

RESULTS

A total of 20,706 patients (10,344 in the SDG and 10,362 in the STG) were analysed from four studies. There was no significant difference observed for MACE (OR = 0.95, 95% CI: 0.81-1.08, P = .92, I = 0%) myocardial infarction or stent thrombosis. However, lower rates of major bleeding were noted in the SDG (1.20 vs. 1.80%; OR: 0.61; 95% CI: 0.37-0.99; P = .04; I = 71%) albeit with increased heterogeneity.

CONCLUSION

A short duration of DAPT followed by P2Y inhibitor monotherapy was comparable to 12 months of DAPT with respect to MACE and thrombotic events, with lower rates of major bleeding events in select group of patients undergoing PCI. More data is needed to assess efficacy in patients with complex lesions and high risk ACS population including those with STEMI presentation.

摘要

背景

指南建议，在急性冠状动脉综合征患者中，药物洗脱支架（DES）置入后应进行至少 12 个月的双联抗血小板治疗（DAPT），而在稳定性冠状动脉疾病患者中则应进行 6 个月的 DAPT。然而，随着新一代支架的出现，平衡出血和血栓形成风险的最佳 DAPT 持续时间一直存在争议。

目的

我们旨在对比较经皮冠状动脉介入治疗（PCI）患者中 P2Y 单药治疗短期组（SDG）与标准治疗组（STG）DAPT 疗程的随机对照试验（RCT）进行荟萃分析。

方法

电子数据库检索了接受 DES 置入的 PCI 患者的 RCT 研究，这些患者接受了短（≤3 个月）与标准 DAPT 疗程（≥12 个月）的治疗，并随访了≥12 个月。主要心血管不良事件（心血管死亡率、非致死性心肌梗死和非致死性卒中等复合事件）的发生率为主要结局。使用随机效应模型计算研究特异性比值比（OR）和相应的 95%置信区间。

结果

四项研究共纳入了 20706 例患者（SDG 组 10344 例，STG 组 10362 例）。在 MACE（OR=0.95，95%CI：0.81-1.08，P=0.92，I²=0%）或心肌梗死或支架血栓形成方面，两组间无显著差异。然而，SDG 组的大出血发生率较低（1.20%比 1.80%；OR：0.61；95%CI：0.37-0.99；P=0.04；I²=71%），但存在更高的异质性。