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

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. :在中国行冠脉介入治疗的急性冠脉综合征患者中，观察基础出血风险对替格瑞洛和氯吡格雷疗效与安全性对比结果的影响摘要背景： ACS患者中，替格瑞洛对比氯吡格雷在抗血栓方面的优势仍存在争议。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：本研究连续纳入我中心2011年10月至2014年8月期间接受经皮冠状动脉介入治疗（PCI）的20816例患者。根据CRUSADE评分，将接受替格瑞洛或氯吡格雷治疗的患者进一步细分为低和中至高等出血风险组。主要研究终点定义为1年随访期内的净临床不良事件（NACE），由主要心脑血管不良事件（MACCE，包括全因死亡，心肌梗死，缺血驱动的靶血管血运重建或脑卒中组成）和全部出血组成。替格瑞洛与氯吡格雷之间的比较通过倾向评分匹配（PSM）按照1:2的比例进行匹配校正。结果：本研究共纳入20,816例PCI患者，经PSM校正后，氯吡格雷组和替格瑞洛组分别有1578例和779例患者被纳入分析，临床基线指标匹配良好。接受替格瑞洛治疗的患者与氯吡格雷治疗组相比NACE风险相当（5.3% 比 5.1%，P = 0.842），MACCE发生率数值上有所降低（3.1%比4.0%，P = 0.246），全部出血显著增加（2.3%vs 1.0%，P = 0.015）。在不同出血风险人群的分析中，发现对于基础出血风险低的患者，替格瑞洛可以明显降低MACCE风险，但在出血中-高危的患者中，替格瑞洛组MACCE发生率反而有所增加（替格瑞洛与氯吡格雷，低危：2.5% 比 4.9%，P = 0.022; 中-高危：4.8% 比 3.0%，P = 0.225; 相互作用P = 0.021），全部出血的比较结果在两类人群中也有较大差异（替格瑞洛与氯吡格雷，低危：1.5%比0.8%，P = 0.210;中-高危：4.8%比3.0%，P = 0.002; 相互作用P = 0.296）。结论：在中国的ACS患者中，与氯吡格雷相比，替格瑞洛仅在出血风险较低的患者中表现出显著的抗栓优势，而在出血中-高危患者中却并不优于氯吡格雷。.

journal_name

Chin Med J (Engl)

journal_title

Chinese medical journal

authors

Wang HY,Li Y,Xu XM,Li J,Han YL

doi

10.4103/0366-6999.239306

subject

Has Abstract

pub_date

2018-09-05 00:00:00

pages

2017-2024

issue

eissn

0366-6999

issn

2542-5641

pii

ChinMedJ_2018_131_17_2017_239306

journal_volume

131

pub_type

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