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替格瑞洛与普拉格雷治疗经皮冠状动脉介入术后2型糖尿病患者的系统评价与Meta分析

Ticagrelor Versus Prasugrel for the Treatment of Patients with Type 2 Diabetes Mellitus Following Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.

作者信息

Yang Hua, Tang Bing, Xu Chen Hong, Ahmed Anis

机构信息

Department of Cardiology, Jingzhou Central Hospital, The Second Clinical Medical College, Yangtze University, Jingzhou, 434020, Hubei, China.

Department of Internal Medicine, Ealing Hospital, University of Buckingham, London, UK.

出版信息

Diabetes Ther. 2019 Feb;10(1):81-93. doi: 10.1007/s13300-018-0537-7. Epub 2018 Nov 19.

Abstract

INTRODUCTION

Antiplatelet therapy is very important following percutaneous coronary intervention (PCI). New generation P2Y inhibitors (ticagrelor and prasugrel) might potentially replace clopidogrel for the treatment of post-interventional acute coronary syndrome (ACS). In this analysis, we aimed to systematically compare the post-interventional clinical outcomes and bleeding events observed with ticagrelor versus prasugrel in patients with type 2 diabetes mellitus (T2DM).

METHODS

EMBASE, MEDLINE, the Cochrane Central Register of Controlled Trials, and www.ClinicalTrials.gov were carefully searched for publications comparing the post-coronary interventional outcomes following ticagrelor versus prasugrel use in patients with T2DM. Adverse clinical outcomes and bleeding events were considered as the endpoints. Statistical analysis was carried out by the Revman software (version 5.3). Odds ratios (OR) and 95% confidence intervals (CI) were used to represent the data during subgroup analysis.

RESULTS

A total of 2004 participants with T2DM were included in this analysis. Following PCI, mortality (OR 1.00, 95% CI 0.57-1.76; P = 0.99, I = 19%), myocardial infarction (OR 0.86, 95% CI 0.42-1.75; P = 0.67, I = 0%), major adverse cardiac events (OR 0.73, 95% CI 0.42-1.27; P = 0.27, I = 0%), and stroke (OR 0.72, 95% CI 0.20-2.59; P = 0.61, I = 0%) were not significantly different between ticagrelor and prasugrel. In addition, total bleeding events (OR 0.87, 95% CI 0.55-1.40; P = 0.58, I = 6%), Thrombolysis in Myocardial Infarction (TIMI) defined minor bleeding (OR 2.39, 95% CI 0.58-9.91; P = 0.23, I = 0%), TIMI defined major bleeding (OR 1.42, 95% CI 0.27-7.45; P = 0.68, I = 0%), bleeding defined according to the Bleeding Academic Research Consortium (BARC) major bleeding (OR 0.55, 95% CI 0.22-1.36; P = 0.20, I = 0%), BARC minor bleeding (OR 1.44, 95% CI 0.52-3.99; P = 0.48, I = 0%), and total minimal bleeding (OR 3.12, 95% CI 0.55-17.59; P = 0.20, I = 0%) were also not significantly different.

CONCLUSION

Ticagrelor and prasugrel were not associated with significantly different adverse clinical outcomes and bleeding events in these patients with T2DM. Therefore, both antiplatelet agents might safely be used in patients with T2DM following coronary intervention. However, this head-to-head comparison still remains a major challenge which should be resolved in larger clinical trials.

摘要

引言

经皮冠状动脉介入治疗(PCI)后抗血小板治疗非常重要。新一代P2Y抑制剂(替格瑞洛和普拉格雷)可能会取代氯吡格雷用于治疗介入后急性冠状动脉综合征(ACS)。在本分析中,我们旨在系统比较替格瑞洛与普拉格雷在2型糖尿病(T2DM)患者介入治疗后的临床结局和出血事件。

方法

仔细检索了EMBASE、MEDLINE、Cochrane对照试验中央注册库和www.ClinicalTrials.gov,以查找比较替格瑞洛与普拉格雷用于T2DM患者冠状动脉介入治疗后结局的出版物。不良临床结局和出血事件被视为终点。使用Revman软件(5.3版)进行统计分析。在亚组分析期间,比值比(OR)和95%置信区间(CI)用于表示数据。

结果

本分析共纳入2004例T2DM患者。PCI后,替格瑞洛和普拉格雷在死亡率(OR 1.00,95%CI 0.57-1.76;P = 0.99,I = 19%)、心肌梗死(OR 0.86,95%CI 0.42-1.75;P = 0.67,I = 0%)、主要不良心脏事件(OR 0.73,95%CI 0.42-1.27;P = 0.27,I = 0%)和中风(OR 0.72,95%CI 0.20-2.59;P = 0.61,I = 0%)方面无显著差异。此外,总出血事件(OR 0.87,95%CI 0.55-1.40;P = 0.58,I = 6%)、心肌梗死溶栓(TIMI)定义的轻微出血(OR 2.39,95%CI 0.58-9.91;P = 0.23,I = 0%)、TIMI定义的严重出血(OR 1.42,95%CI 0.27-7.45;P = 0.68,I = 0%)、根据出血学术研究联盟(BARC)定义的严重出血(OR 0.55,95%CI 0.22-1.36;P = 0.20,I = 0%)、BARC轻微出血(OR 1.44,95%CI 0.52-3.99;P = 0.48,I = 0%)和总轻微出血(OR 3.12,95%CI 0.55-17.59;P = 0.20,I = 0%)也无显著差异。

结论

在这些T2DM患者中,替格瑞洛和普拉格雷在不良临床结局和出血事件方面无显著差异。因此,这两种抗血小板药物在冠状动脉介入治疗后的T2DM患者中均可安全使用。然而,这种直接比较仍然是一项重大挑战,应在更大规模的临床试验中加以解决。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52f0/6349280/1f76e11dc77c/13300_2018_537_Fig1_HTML.jpg

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