替格瑞洛单药治疗行经皮冠状动脉介入治疗的急性冠状动脉综合征患者的安全性和疗效：TWILIGHT 和 TICO 随机试验的个体患者数据荟萃分析。

Safety and Efficacy of Ticagrelor Monotherapy in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: An Individual Patient Data Meta-Analysis of TWILIGHT and TICO Randomized Trials.

机构信息

Cardiovascular Disease Section, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City (U.B.).

Bundang CHA Medical Center, CHA University School of Medicine, Seongnam, South Korea (Y.J.).

出版信息

Circulation. 2024 Feb 20;149(8):574-584. doi: 10.1161/CIRCULATIONAHA.123.067283. Epub 2023 Oct 23.

DOI:10.1161/CIRCULATIONAHA.123.067283

PMID:37870970

Abstract

BACKGROUND

Dual antiplatelet therapy with a potent P2Y inhibitor coupled with aspirin for 1 year is the recommended treatment for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). As an alternative, monotherapy with a P2Y inhibitor after a short period of dual antiplatelet therapy has emerged as a bleeding reduction strategy.

METHODS

We pooled individual patient data from randomized trials that included patients with ACS undergoing PCI treated with an initial 3-month course of dual antiplatelet therapy followed by ticagrelor monotherapy versus continued ticagrelor plus aspirin. Patients sustaining a major ischemic or bleeding event in the first 3 months after PCI were excluded from analysis. The primary outcome was Bleeding Academic Research Consortium type 3 or 5 bleeding occurring between 3 and 12 months after index PCI. The key secondary end point was the composite of death, myocardial infarction, or stroke. Hazard ratios and 95% CIs were generated using Cox regression with a one-stage approach in the intention-to-treat population.

RESULTS

The pooled cohort (n=7529) had a mean age of 62.8 years, 23.2% were female, and 55% presented with biomarker-positive ACS. Between 3 and 12 months, ticagrelor monotherapy significantly reduced Bleeding Academic Research Consortium 3 or 5 bleeding compared with ticagrelor plus aspirin (0.8% versus 2.1%; hazard ratio, 0.37 [95% CI, 0.24-0.56]; <0.001). Rates of all-cause death, myocardial infarction, or stroke were not significantly different between groups (2.4% versus 2.7%; hazard ratio, 0.91 [95% CI, 0.68-1.21]; =0.515). Findings were unchanged among patients presenting with biomarker-positive ACS.

CONCLUSIONS

Among patients with ACS undergoing PCI who have completed a 3-month course of dual antiplatelet therapy, discontinuation of aspirin followed by ticagrelor monotherapy significantly reduced major bleeding without incremental ischemic risk compared with ticagrelor plus aspirin.

REGISTRATION

URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42023449646.

摘要

背景

对于接受经皮冠状动脉介入治疗（PCI）的急性冠脉综合征（ACS）患者，推荐使用强效 P2Y 抑制剂联合阿司匹林进行为期 1 年的双联抗血小板治疗。作为替代方案，双联抗血小板治疗短期后采用 P2Y 抑制剂单药治疗已成为一种减少出血的策略。

方法

我们汇总了包含接受初始 3 个月双联抗血小板治疗后接受替格瑞洛单药治疗与继续替格瑞洛加阿司匹林治疗的 ACS 并接受 PCI 治疗的患者的随机试验的个体患者数据。排除 PCI 后 3 个月内发生主要缺血或出血事件的患者。主要结局是在 PCI 后 3 至 12 个月内发生的出血学术研究联合会（BARC）3 或 5 型出血。关键次要终点是死亡、心肌梗死或卒中的复合终点。使用意向治疗人群的一阶 Cox 回归生成风险比（HR）和 95%置信区间（CI）。

结果

汇总队列（n=7529）的平均年龄为 62.8 岁，23.2%为女性，55%为生物标志物阳性 ACS。在 3 至 12 个月期间，替格瑞洛单药治疗与替格瑞洛加阿司匹林相比显著降低了 BARC 3 或 5 型出血（0.8%比 2.1%；HR，0.37[95%CI，0.24-0.56]；<0.001）。两组之间全因死亡率、心肌梗死或卒中等的发生率无显著差异（2.4%比 2.7%；HR，0.91[95%CI，0.68-1.21]；=0.515）。在生物标志物阳性 ACS 的患者中，结果保持不变。