延长双联抗血小板治疗急性冠脉综合征患者临床有效性及安全性分析

Efficacy and safety of prolonged dual antiplatelet therapy on the progonosis of patients with acute coronary syndrome

目的探讨12个月以上的双联抗血小板治疗(DAPT)对急性冠脉综合征(ACS)患者的有效性及安全性。方法选取中国冠心病患者抗血小板治疗现状调查研究(OPT-CAD)中接受12个月DAPT且随访时无临床不良事件的6 314例ACS患者为研究对象。根据患者出院12个月后是否继续应用DAPT分为12个月后DAPT组(n=4 771)与未超过12个月DAPT的单抗血小板药物(SAPT)组(n=1 543)。比较接受和未接受延长DAPT患者的临床疗效及安全性,主要观察终点为12～24个月缺血事件(包括心源性死亡、心肌梗死、卒中),次要终点为全部出血事件。结果 SAPT组患者既往行冠状动脉介入治疗(PCI)、既往卒中史及高血压病史比例明显高于DAPT组,两组比较,差异均有统计学意义(P<0.05)。DAPT组患者吸烟比例高于SAPT组,两组比较,差异有统计学意义(P<0.05)。SAPT组左室射血分数高于SAPT组,两组比较,差异有统计学意义(P<0.05)。DAPT组12～24个月MACCE事件发生率为1.55%(74/4 771),低于SAPT组的2.33%(36/1 543),两组比较,差异有统计学意义(P<0.05)。两组患者全部出血发生率比较,差异无统计学意义(P>0.05)。结论延长DAPT可以降低ACS患者12～24个月缺血事件的发生率,其主要得益于降低心源性死亡和卒中事件发生率,同时未增加出血风险。

Objective To investigate the efficacy and safety of dual antiplatelet therapy(DAPT)for patients with acute coronary syndrome(ACS)over 12 months.Methods All 6 314 ACS patients who received DAPT for 12 months and had no clinical adverse events during follow-up were selected as subjects in the current investigation of antiplatelet therapy in Chinese patients with coronary heart disease(OPT-CAD).According to whether patients continued to apply DAPT after 12 months of discharge,they were divided into the DAPT group at 12 months(n=4 771)and monoclonal antiplatelet drugs(SAPT)group at no more than 12 months(n=1 543).The clinical efficacy and safety of patients receiving and not receiving extended DAPT were compared.The main endpoint was 12 to 24 months of ischemic events(including cardiogenic death,myocardial infarction and stroke),and the secondary endpoints were all bleeding events.Results The proportion of patients in the SAPT group receiving previous percutaneous coronary intervention(PCI)treatment,previous history of stroke and history of hypertension was significantly higher than that in the DAPT group,and the difference between the two groups was statistically significant(P<0.05).The smoking rate in DAPT group was higher than that in SAPT group(P<0.05).The left ventricular ejection fraction of SAPT group was higher than that of SAPT group(P<0.05).The incidence of MACCE events in 12-24 months in DAPT group was 1.55%(74/4 771),which was lower than 2.33%(36/1 543)in SAPT group(P<0.05).There was no significant difference in the incidence of total bleeding between the two groups(P>0.05).Conclusion Prolonging DAPT can reduce the incidence of ischemic events in ACS patients for 12-24 months,which mainly benefits from reducing the incidence of cardiac death and stroke events without increasing the risk of bleeding.