抗血小板药物治疗在动脉粥样硬化性疾病患者中的应用：一项随机临床试验的荟萃分析。

Ticagrelor-based antiplatelet regimens in patients with atherosclerotic artery disease-A meta-analysis of randomized clinical trials.

机构信息

Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

出版信息

Am Heart J. 2020 Jan;219:109-116. doi: 10.1016/j.ahj.2019.08.020. Epub 2019 Aug 31.

DOI:10.1016/j.ahj.2019.08.020

PMID:31756624

Abstract

BACKGROUND

Randomized trials did not consistently support superiority of ticagrelor, as monotherapy or in combination with aspirin, in terms of efficacy or safety, in patients with atherosclerotic artery disease.

METHODS

Medline, EMBASE, the Cochrane Central Register of Controlled Trials, and scientific session abstracts were searched for trials of patients with coronary or peripheral artery disease (with >1,000 participants and a follow-up ≥3 months) randomly assigned to ticagrelor-based or conventional antiplatelet therapies. Trial-level hazard ratios (HRs) were pooled using a fixed- or random-effect model (in case of significant heterogeneity) with the inverse variance weighting. The primary outcome was all-cause mortality. Other outcomes were myocardial infarction (MI), stroke, and major bleeding.

RESULTS

Overall 77,489 patients received either ticagrelor-based (n = 38,721) or conventional antiplatelet regimens (n = 38,768) in 6 trials. The primary outcome occurred in 4.5% of patients treated with experimental therapy and 4.9% of patients treated with control therapy (HR = 0.91, 95% CI 0.81-1.01; P = .07). Overall, patients treated with ticagrelor-based versus conventional antiplatelet regimens showed no significant difference in terms of all-cause death, MI, stroke, or major bleeding after 20 months. However, in trials of patients with coronary artery disease as primary diagnosis, the risk for all-cause death (HR = 0.84 [0.77-0.91], P < .001) and MI (HR = 0.87 [0.80-0.94], P = .007) was significantly reduced by experimental therapy.

CONCLUSIONS

In patients with atherosclerotic artery disease, the benefit of ticagrelor-based therapies was confined to patients treated for coronary artery disease. The drug significantly reduced the risk for all-cause death and MI without excess risk of bleeding in these patients. In consideration of limitations of subgroup analyses, these results need further validation.

摘要

背景

随机试验并未一致支持替格瑞洛作为单药治疗或与阿司匹林联合用于治疗动脉粥样硬化性血管疾病患者在疗效或安全性方面的优越性。

方法

检索了 Medline、EMBASE、Cochrane 中心对照试验注册库和科学会议摘要，以查找纳入了冠状动脉或外周动脉疾病患者（≥1000 名参与者，随访时间≥3 个月）的试验，这些患者被随机分配至替格瑞洛为基础或常规抗血小板治疗组。使用固定效应或随机效应模型（如果存在显著异质性）对试验水平的风险比（HR）进行汇总，采用倒数方差加权法。主要结局为全因死亡率。其他结局为心肌梗死（MI）、卒中和大出血。

结果

共有 77489 例患者在 6 项试验中分别接受了替格瑞洛为基础或常规抗血小板治疗（实验组 38721 例，对照组 38768 例）。实验组患者的主要结局发生率为 4.5%，对照组为 4.9%（HR=0.91，95%CI 0.81-1.01；P=0.07）。总体而言，接受替格瑞洛为基础与常规抗血小板治疗的患者在 20 个月后，在全因死亡、MI、卒中和大出血方面无显著差异。然而，在以冠状动脉疾病为主要诊断的试验中，实验组全因死亡（HR=0.84[0.77-0.91]，P<0.001）和 MI（HR=0.87[0.80-0.94]，P=0.007）的风险显著降低。