心房颤动合并急性冠脉综合征或经皮冠状动脉介入治疗术后双联或三联抗栓治疗的对照研究  

Efficacy and safety of dual vs.triple antithrombotic therapy in atrial fibrillation patients with acute coronary syndrome or percutaneous coronary intervention

作　　者：张晗[1] 邵兴慧[1] 王娟[1] 吴双[1] 索妮 莫然 吕思奇 王景阳 杨艳敏[1] Zhang Han;Shao Xinghui;Wang Juan;Wu Shuang;Suo Ni;Mo Ran;Lyu Siqi;Wang Jingyang;Yang Yanmin(Emergency and Intensive Care Center,Fuwai Hospital,State Key Laboratory of Cardiovascular Disease,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100037,China)

机构地区：[1]中国医学科学院,北京协和医学院,国家心血管病中心,心血管疾病国家重点实验室阜外医院急重症中心,北京100037

出　　处：《中华心律失常学杂志》2022年第2期165-170,共6页Chinese Journal of Cardiac Arrhythmias

基　　金：国家重点研发计划(2017YFC0908800);首都临床特色应用研究与成果推广项目(Z171100001017193)。

摘　　要：目的观察心房颤动(房颤)合并急性冠脉综合征(ACS)或行经皮冠状动脉介入治疗(PCI)患者,接受非维生素K拮抗剂口服抗凝药物(NOAC)联合一种抗血小板药物(双联抗栓治疗,DAT)或两种抗血小板药物(三联抗栓治疗,TAT)治疗方案的安全性与有效性。方法本研究是一项单中心、前瞻性、真实世界的观察性研究。纳入2017年1月至2019年12月就诊中国医学科学院阜外医院的房颤合并ACS/PCI,且出院时接受NOAC联合抗血小板治疗的患者,根据抗栓药物种类分为DAT组及TAT组。对所有患者进行1年随访,分析并比较两组患者主要及次要终点事件的发生情况。主要终点为出血事件,次要终点为死亡或栓塞事件的复合终点事件(包括全因死亡、脑卒中、体循环栓塞、心肌梗死、支架内血栓、支架再狭窄和非计划的血运重建)。结果①共553例患者完成1年随访,其中男397例,年龄为(67.9±9.0)岁。使用DAT方案(DAT组)254例,使用TAT方案(TAT组)299例。DAT组患者年龄较大[(69.5±9.8)岁对(66.6±8.0)分,P<0.001)、男患者较少(66.5%对76.3%,P=0.011),而CHA2DS2-VASc评分[(3.9±1.8)分对(3.3±1.5)分,P=0.001]、HAS-BLED评分更高[(2.4±0.9)分对(2.2±0.8)分,P=0.013]则较高。②随访期间,DAT组患者心肌梗死溶栓治疗(TIMI)大出血、小出血及轻微出血的发生率分别为0.4%、1.2%、10.6%;TAT组患者TIMI大出血、小出血和轻微出血的发生率分别为1.0%、1.3%、16.1%。Log-rank检验提示DAT组出血风险较低(P=0.040)。③DAT组与TAT组死亡或栓塞事件的复合终点事件发生率差异无统计学意义(11.0%对10.8%,P=0.645;全因死亡,3.5%对3.3%;脑卒中,2.0%对2.3%;体循环栓塞,4.7%对4.3%;心肌梗死,0.4%对0.3%;支架内血栓,0.4%对0;支架再狭窄和非计划的血运重建事件,1.6%对2.3%)。结论在房颤合并ACS/PCI患者中,NOAC为基础的DAT与TAT相比,能够降低出血事件发生率,且不增加死亡或栓塞事件的复合终点事件发生Objective To compare the safety and efficacy of dual antithrombotic therapy[DAT,non-vitamin K antagonist oral anticoagulant(NOAC)plus single antiplatelet]with triple antithrombotic therapy(TAT:NOAC plus dual antiplatelets)in patients with atrial fibrillation(AF)concomitant with acute coronary syndrome(ACS)or undergoing percutaneous coronary intervention(PCI).Methods A prospective,observational study was conducted in Fuwai Hospital between January,2017 and December 2019.AF patients presenting with ACS or undergoing PCI,and receiving DAT or TAT with NOAC at discharge,were enrolled.The patients were followed up for 1 year.The secondary endpoint was a bleeding defined by thrombolysis in myocardial infarction(TIMI)bleeding classification.The primary efficacy endpoint was composite end point of death or embolism events.Results Overall,553 patients were included,397 were male,and the mean age was(67.9±9.0)years old.At discharge,254 received DAT and 299 received TAT.Compared to the patients receiving TAT,those receiving DAT were more elderly[(69.5±9.8)years old vs.(66.6±8.0)years old,P<0.001],less male(66.5%vs.76.3%,P=0.011),higher CHA2DS2-VASc score(3.9±1.8 vs.3.3±1.5,P=0.001)and HAS-BLED score(2.4±0.9 vs.2.2±0.8,P=0.013).During 1 year follow-up,incidence of TIMI major bleeding.minor bleeding and minimal bleeding were 0.4%,1.2%,and 10.6%in DAT group,which was lower than that in TAT group(1.0%,1.3%,and 16.1%,respectively,P=0.040).Whereas,the occurrence rates of 1-year all-cause mortality,stroke,systemic embolism,myocardial infarction,in-stent thrombosis,in-stent restenosis and unplanned revascularization were 3.5%,2.0%,4.7%,0.4%,0.4%,and 1.6%in DAT group,which were similar in TAT group(3.3%,2.3%,4.3%,0.3%,0.0%and 2.3%,respectively,P=0.645).Conclusion In this real-world study,patients with AF concomitant with ACS or undergoing PCI treated on NOAC-based DAT showed lower bleeding rates than those with TAT,while composite end point of death or embolism events were similar between groups.

关 键 词：心房颤动 急性冠脉综合征 经皮冠状动脉介入治疗 非维生素K拮抗剂口服抗凝药物 抗栓治疗 

分 类 号：R541.4[医药卫生—心血管疾病] R541.75[医药卫生—内科学]