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替格瑞洛与氯吡格雷在中国行经皮冠状动脉介入治疗的急性冠状动脉综合征患者中的疗效和安全性与基线出血风险的关系。

Impact of Baseline Bleeding Risk on Efficacy and Safety of Ticagrelor versus Clopidogrel in Chinese Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

机构信息

Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning 110016, China.

出版信息

Chin Med J (Engl). 2018 Sep 5;131(17):2017-2024. doi: 10.4103/0366-6999.239306.

Abstract

BACKGROUND

There was still conflict on the antithrombotic advantage of ticagrelor versus clopidogrel among East Asian population with acute coronary syndrome (ACS). We considered that the baseline bleeding risk might be an undetected key factor that significantly affected the efficacy of ticagrelor.

METHODS

A total of 20,816 serial patients who underwent percutaneous coronary intervention (PCI) from October 2011 to August 2014 in the General Hospital of Shenyang Military Region were enrolled in the present study. Patients receiving ticagrelor or clopidogrel were further subdivided according to basic bleeding risk. The primary outcome was net adverse clinical events (NACEs) defined as major adverse cardiac or cerebral events (MACCE, including all-cause death, myocardial infarction, ischemia-driven target vessel revascularization, or stroke) and any bleeding during 1-year follow-up. Comparison between ticagrelor and clopidogrel was adjusted by propensity score matching (PSM).

RESULTS

Among the 20,816 eligible PCI patients who were included in this study, there were 1578 and 779 patients in the clopidogrel and ticagrelor groups, respectively, after PSM, their clinical parameters were well matched. Patients receiving ticagrelor showed comparable NACE risk compared with those treated by clopidogrel (5.3% vs. 5.1%, P = 0.842). Furthermore, ticagrelor might reduce the MACCE risk in patients with low bleeding risk but increase MACCE in patients with moderate-to-high bleeding potential (ticagrelor vs. clopidogrel, low bleeding risk: 2.5% vs. 4.9%, P = 0.022; moderate-to-high bleeding risk: 4.8% vs. 3.0%, P = 0.225; interaction P = 0.021), with vast differences in all bleeding (low bleeding risk: 1.5% vs. 0.8%, P = 0.210; moderate-to-high bleeding risk: 4.8% vs. 3.0%, P = 0.002; interaction P = 0.296).

CONCLUSION

Among real-world Chinese patients with ACS treated by PCI, ticagrelor only showed superior efficacy in patients with low bleeding risk but lost its advantage in patients with moderate-to-high bleeding potential.

摘要

背景

东亚急性冠脉综合征(ACS)患者中,替格瑞洛与氯吡格雷的抗栓优势仍存在争议。我们认为,基线出血风险可能是一个未被发现的关键因素,显著影响替格瑞洛的疗效。

方法

本研究共纳入 20816 例行经皮冠状动脉介入治疗(PCI)的患者,这些患者均来自沈阳军区总医院,于 2011 年 10 月至 2014 年 8 月期间接受治疗。根据基本出血风险,将接受替格瑞洛或氯吡格雷治疗的患者进一步细分。主要终点为净不良临床事件(NACE),定义为主要不良心脏或脑事件(MACCE,包括全因死亡、心肌梗死、缺血驱动的靶血管血运重建或卒中)和 1 年随访期间任何出血。采用倾向评分匹配(PSM)调整替格瑞洛与氯吡格雷之间的比较。

结果

在这项研究中,纳入的 20816 例符合条件的 PCI 患者中,经 PSM 后,替格瑞洛组和氯吡格雷组分别有 1578 例和 779 例患者,其临床参数匹配良好。与氯吡格雷相比,接受替格瑞洛治疗的患者 NACE 风险相当(5.3% vs. 5.1%,P=0.842)。此外,替格瑞洛可能降低低出血风险患者的 MACCE 风险,但增加中至高出血风险患者的 MACCE(替格瑞洛 vs. 氯吡格雷,低出血风险:2.5% vs. 4.9%,P=0.022;中至高出血风险:4.8% vs. 3.0%,P=0.225;交互 P=0.021),所有出血(低出血风险:1.5% vs. 0.8%,P=0.210;中至高出血风险:4.8% vs. 3.0%,P=0.002;交互 P=0.296)差异明显。

结论

在中国 ACS 接受 PCI 治疗的真实世界患者中,替格瑞洛仅在低出血风险患者中显示出更好的疗效,但在中至高出血风险患者中失去优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f1ac/6111695/9efe1c8c781a/CMJ-131-2017-g001.jpg

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