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坎格雷洛与氯吡格雷用于接受经皮冠状动脉介入治疗的2型糖尿病患者:一项随机对照试验的荟萃分析

Cangrelor or Clopidogrel in Patients with Type 2 Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials.

作者信息

Lu Hongtao, Guan Wenjun, Zhou Yanhua, Tang Zhangui, Bao Hong

机构信息

Jingzhou Central Hospital of Cardiology, The Second Clinical Medical College, Yangtze University, Jingzhou, Hubei, People's Republic of China.

Department of Hematology, Jingzhou First People's Hospital, The First Affiliated Hospital of Yangtze University, Jingzhou, People's Republic of China.

出版信息

Diabetes Ther. 2019 Jun;10(3):937-950. doi: 10.1007/s13300-019-0593-7. Epub 2019 Mar 23.

Abstract

INTRODUCTION

With recent advances in interventional cardiology where percutaneous coronary intervention (PCI) has become the most preferred invasive strategy and with advances in adjunctive pharmacotherapy, several newer oral P2Y inhibitors have reached the market. In this analysis, we aimed to compare the cardiovascular outcomes and bleeding events which were associated with the use of cangrelor versus clopidogrel in patients with type 2 diabetes mellitus (T2DM) 48 h after PCI.

METHODS

The electronic databases MEDLINE (PubMed), www.ClinicalTrials.gov , EMBASE, and Cochrane central were searched for relevant publications comparing canagrelor with clopidogrel during PCI. Patients with T2DM were extracted. Adverse cardiovascular outcomes and bleeding events at 48 h follow-up were considered as the end points. This meta-analysis was carried out with the latest RevMan software (5.30). Odds ratios (OR) and 95% confidence intervals (CI) were used to represent the data.

RESULTS

This analysis consisted of a total number of 5031 participants with T2DM (enrolled between the years 2006 and 2012). Compared to clopidgrel, use of cangrelor in these patients with T2DM was not associated with significantly different primary end point (OR 0.94, 95% CI 0.75-1.16; P = 0.55), myocardial infarction (OR 0.96, 95% CI 0.76-1.20; P = 0.71), all-cause death (OR 0.70, 95% CI 0.25-1.96; P = 0.49), ischemia-driven revascularization (OR 0.66, 95% CI 0.32-1.36; P = 0.26), and stent thrombosis (OR 0.45, 95% CI 0.17-1.17; P = 0.10). Thrombolysis in myocardial infarction (TIMI)-defined major and minor bleedings were similarly manifested: (OR 1.02, 95% CI 0.38-2.74; P = 0.96) and (OR 1.39, 95% CI 0.70-2.79; P = 0.35), respectively. Global use of strategies to open occluded arteries (GUSTO)-defined moderate and severe bleeding were also not significantly different: (OR 1.36, 95% CI 0.70-2.67; P = 0.37) and (OR 1.21, 95% CI 0.41-3.59; P = 0.74), respectively. However, GUSTO-defined mild bleeding and acute catheterization and urgent intervention triage strategy (ACUITY)-defined major and minor bleedings were significantly in favor of clopidogrel in comparison to cangrelor in these patients with T2DM: (OR 1.28, 95% CI 1.09-1.50; P = 0.003), (OR 1.43, 95% CI 1.05-1.94; P = 0.02), and (OR 1.23, 95% CI 1.04-1.46; P = 0.02), respectively. Other bleeding outcomes were not significantly different.

CONCLUSIONS

In these patients with T2DM, cangrelor was comparable to clopidogrel in terms of efficacy at 48 h following PCI. However, it was associated with significantly higher mild GUSTO bleeding and major and minor ACUITY bleeding, therefore requiring further workups on its safety side. This hypothesis should be explored further and confirmed in other forthcoming trials based strictly on patients with T2DM.

摘要

引言

随着介入心脏病学的最新进展,经皮冠状动脉介入治疗(PCI)已成为最常用的侵入性策略,并且随着辅助药物治疗的进步,几种新型口服P2Y抑制剂已投放市场。在本分析中,我们旨在比较2型糖尿病(T2DM)患者PCI术后48小时使用坎格雷洛与氯吡格雷的心血管结局和出血事件。

方法

检索电子数据库MEDLINE(PubMed)、www.ClinicalTrials.gov、EMBASE和Cochrane中心,查找在PCI期间比较坎格雷洛与氯吡格雷的相关出版物。提取T2DM患者。将48小时随访时的不良心血管结局和出血事件作为终点。使用最新的RevMan软件(5.30)进行这项荟萃分析。采用比值比(OR)和95%置信区间(CI)来表示数据。

结果

该分析共纳入5031例T2DM患者(2006年至2012年期间入组)。与氯吡格雷相比,这些T2DM患者使用坎格雷洛与主要终点(OR 0.94,95%CI 0.75 - 1.16;P = 0.55)、心肌梗死(OR 0.96,95%CI 0.76 - 1.20;P = 0.71)、全因死亡(OR 0.70,95%CI 0.25 - 1.96;P = 0.49)、缺血驱动的血运重建(OR 0.66,95%CI 0.32 - 1.36;P = 0.26)及支架血栓形成(OR 0.45,95%CI 0.17 - 1.17;P = 0.10)无显著差异。心肌梗死溶栓(TIMI)定义的主要和次要出血情况类似:分别为(OR 1.02,95%CI 0.38 - 2.74;P = 0.96)和(OR 1.39,95%CI 0.70 - 2.79;P = 0.35)。全球急性冠状动脉综合征组织(GUSTO)定义的中度和重度出血情况也无显著差异:分别为(OR 1.36,95%CI 0.70 - 2.67;P = 0.37)和(OR 1.21,95%CI 0.41 - 3.59;P = 0.74)。然而,在这些T2DM患者中,与坎格雷洛相比,GUSTO定义的轻度出血以及急性导管插入和紧急干预分诊策略(ACUITY)定义的主要和次要出血明显更倾向于氯吡格雷:分别为(OR 1.28,95%CI 1.09 - 1.50;P = 0.003)、(OR 1.43,95%CI 1.05 - 1.94;P = 0.02)和(OR 1.23,95%CI 1.04 - 1.46;P = 0.02)。其他出血结局无显著差异。

结论

在这些T2DM患者中,PCI术后48小时坎格雷洛在疗效方面与氯吡格雷相当。然而,它与GUSTO定义的轻度出血以及ACUITY定义的主要和次要出血显著增加相关,因此需要进一步评估其安全性。这一假设应在严格基于T2DM患者的其他即将开展的试验中进一步探索和证实。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a23e/6531549/703d26dfdfae/13300_2019_593_Fig1_HTML.jpg

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