替格瑞洛用于急性冠状动脉综合征患者经皮冠状动脉介入术后的出血风险观察

摘要

目的 观察替格瑞洛用于急性冠状动脉综合征(ACS)患者经皮冠状动脉介入(PCI)术后的出血风险.方法 纳入2013年1月至2015年6月在首都医科大学附属北京安贞医院住院完成PCI并接受双联抗血小板治疗(DAPT)的ACS患者,首先入选替格瑞洛组,同时按照性别、年龄(±5岁)相匹配,建立随机数字表,按照1:1比例随机抽取氯吡格雷组,2组在相应用药的基础上均联合口服阿司匹林肠溶片行DAPT.记录患者的相关临床信息.随访12个月,观察患者发生的出血事件.主要终点事件为:1年内PLATO研究定义的非冠状动脉旁路移植术(CABG)相关出血事件.通过单因素分析及Logistic回归分析探讨影响出血的因素.结果 最终本研究入选病例936例,2组各468例,男性各358例.随访1年替格瑞洛组非CABG相关总出血发生率高于氯吡格雷组[19.2％ (90/468)比4.9％(23/468)];口腔牙龈出血、消肖化道出血、鼻腔出血发生率高于氯吡格雷组[7.1％ (33/468)比0.6％ (3/468)、2.6％ (12/468)比0.4％ (2/468)、3.8％ (18/468)比0.9％(4/468)];呼吸困难发生率及因出血或其他不良事件停药率高于氯吡格雷组[11.8％ (55/468)比0.2％ (1/468)、22.6％(106/468)比1.3％(6/468)],差异均有统计学意义(均P＜0.05).Logistic回归分析结果显示,女性(比值比=2.01,95％置信区间:1.16 ～5.28,P=0.007)、低体质量(比值比=1.02,95％置信区间:1.00～1.03,P=0.033)是2组DAPT后出血的独立危险因素,与氯吡格雷组相比,替格瑞洛组出血风险明显增加(比值比=5.18,95％置信区间:3.09 ～8.67,P＜0.001).结论 在完成PCI并接受DAPT的ACS患者中,相对于氯吡格雷,应用替格瑞洛出血风险明显增加.%Objective To observe the bleeding risk of ticagrelor in treatment of acute coronary syndrome (ACS) patients after percutaneous coronary intervention (PCI).Methods ACS patients who had PCI from January 2013 to June 2015 in Beijing Anzhen Hospital,Capital Medical University were enrolled;patients who accepted dual antiplatelet therapy(DAPT) with ticagrelor were as ticagrelor group;patients who accepted DAPT with clopidogrel were matched(1:1) by sex and age as clopidogrel group.All patients took enteric-coated aspirin and ticagrelor or clopidogrel for DAPT.Bleeding events that were not related to coronary artery bypass graft (CABG) were defined as the primary endpoint according to the PLATO standard.Risk factors of bleeding in 12 months were analyzed by univariate and logistic regression analysis.Results Totally 936 cases were enrolled,with 468 cases (358 males) in each group.The 1 year non-CABG-related bleeding rate in ticagrelor group was significantly higher than that in clopidogrel group [19.2％ (90/468) vs 4.9％ (23/468)];oral gingival bleeding,gastrointestinal bleeding and nasal bleeding rates in ticagrelor group were significandy higher than those in clopidogrel group[7.1％ (33/468) vs 0.6％ (3/468),2.6％ (12/468) vs 0.4％ (2/468),3.8％ (18/468) vs 0.9％ (4/468)];dyspnea rate and drug withdrawal rate in ticagrelor group were significantly higher than those in clopidogrel group[11.8％ (55/468) vs 0.2％ (1/468),22.6％ (106/468) vs 1.3％ (6/468)] (all P ＜ 0.05).Logistic regression analysis showed that female (odds ratio =2.01,95％ confidence interval:1.16-5.28,P =0.007) and low body mass(odds ratio =1.02,95％ confidence interval:1.00-1.03,P =0.033) were independent risk factors of bleeding in patients with DAPT;the bleeding risk of ticagrelor was significantly higher than that of clopidogrel(odds ratio =5.18,95％ confidence interval:3.09-8.67,P ＜ 0.001).Conclusion Ticagrelor has a higher bleeding risk than clopidogrel in treating ACS patients with DAPT after PCI.