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经皮冠状动脉介入治疗的急性冠状动脉综合征患者从普拉格雷或替格瑞洛降级为氯吡格雷治疗:随机临床试验的最新荟萃分析

De-escalation from Prasugrel or Ticagrelor to Clopidogrel in Patients with Acute Coronary Syndrome Managed with Percutaneous Coronary Intervention: An Updated Meta-analysis of Randomized Clinical Trials.

作者信息

Abdelazeem Basel, Shehata Joseph, Abbas Kirellos Said, El-Shahat Nahla Ahmed, Baral Nischit, Adhikari Govinda, Khan Hafiz, Hassan Mustafa

机构信息

Department of Internal Medicine, McLaren Health Care, Flint/Michigan State University, 401 S Ballenger Hwy, Flint, MI, 48532, USA.

Faculty of Medicine, Cairo University, Cairo, Egypt.

出版信息

Am J Cardiovasc Drugs. 2022 May;22(3):287-298. doi: 10.1007/s40256-021-00504-7. Epub 2021 Oct 15.

Abstract

INTRODUCTION

We aimed to evaluate the clinical benefits of a de-escalation strategy from prasugrel or ticagrelor to clopidogrel versus continuation of prasugrel or ticagrelor along with aspirin in both strategies for patients presenting with acute coronary syndrome (ACS) and treated with percutaneous coronary intervention (PCI), and to analyze the effect of the recently published randomized clinical trial (RCT) by Park et al., which included the largest sample size ever and the largest switched number of patients, on current guidelines and practices.

DATA SOURCES

The PubMed, EMBASE, Scopus, Web of Science, Cochrane Central, and Google Scholar databases were searched systematically from inception to May 2021 by using the search terms ('de-escalation' OR 'switching') AND ('antiplatelet' OR 'clopidogrel' OR 'ticagrelor' OR 'prasugrel') AND ('percutaneous coronary intervention' OR 'PCI'' OR 'Acute coronary syndrome' OR 'ACS').

STUDY SELECTION AND DATA EXTRACTION

We included RCTs that reported the primary outcomes, i.e. net clinical benefits and Bleeding Academic Research Consortium (BARC) type 2 or higher bleeding. A combination of both ischemic and bleeding events was defined as a net clinical benefit.

DATA SYNTHESIS

A total of four RCTs were included, with 5952 patients. A random-effects meta-analysis revealed that a de-escalation strategy was associated with lower ischemic and bleeding events (net clinical benefits; risk ratio [RR] 0.63, 95% confidence interval [CI] 0.47-0.85; p = 0.003), and lower BARC type 2 or higher bleeding (RR 0.51, 95% CI 0.29-0.91; p = 0.02) when compared with a continuation strategy.

RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE

The current guidelines recommend potent P2Y12 prasugrel or ticagrelor for 12 months despite their association with a high risk of bleeding. Our meta-analysis updates cardiologists, providing them with the best available evidence in managing patients with ACS who underwent PCI.

CONCLUSION

Among patients with ACS treated with PCI, a de-escalation strategy (prasugrel or ticagrelor to clopidogrel) is associated with lower ischemic and bleeding events (net clinical benefits) and lower BARC type 2 or higher bleeding; however, due to the limited number of included studies, further high-quality studies are needed to establish the clinical efficacy of the de-escalation strategy.

摘要

引言

我们旨在评估在急性冠状动脉综合征(ACS)患者接受经皮冠状动脉介入治疗(PCI)时,从普拉格雷或替格瑞洛降级为氯吡格雷的策略与普拉格雷或替格瑞洛联合阿司匹林持续使用的两种策略相比的临床益处,并分析Park等人最近发表的随机临床试验(RCT)(该试验纳入了有史以来最大的样本量和最多的患者转换数量)对当前指南和实践的影响。

数据来源

通过使用检索词(“降级”或“转换”)与(“抗血小板”或“氯吡格雷”或“替格瑞洛”或“普拉格雷”)与(“经皮冠状动脉介入治疗”或“PCI”或“急性冠状动脉综合征”或“ACS”),从数据库建立至2021年5月对PubMed、EMBASE、Scopus、Web of Science、Cochrane Central和谷歌学术数据库进行了系统检索。

研究选择与数据提取

我们纳入了报告主要结局的随机对照试验,即净临床益处和出血学术研究联盟(BARC)2型或更高类型出血。缺血和出血事件的组合被定义为净临床益处。

数据综合

共纳入四项随机对照试验,涉及5952例患者。随机效应荟萃分析显示,与持续治疗策略相比,降级策略与更低的缺血和出血事件(净临床益处;风险比[RR]0.63,95%置信区间[CI]0.47 - 0.85;p = 0.003)以及更低的BARC 2型或更高类型出血(RR 0.51,95% CI 0.29 - 0.91;p = 得02)相关。

与患者护理和临床实践的相关性

当前指南推荐强效P2Y12抑制剂普拉格雷或替格瑞洛使用12个月,尽管它们与高出血风险相关。我们的荟萃分析为心脏病专家提供了最新信息,为他们管理接受PCI的ACS患者提供了最佳现有证据。

结论

在接受PCI治疗的ACS患者中,降级策略(从普拉格雷或替格瑞洛转换为氯吡格雷)与更低的缺血和出血事件(净临床益处)以及更低的BARC 2型或更高类型出血相关;然而,由于纳入研究数量有限,需要进一步的高质量研究来确定降级策略的临床疗效。

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