PCI术后双联抗血小板治疗1年急性冠状动脉综合征患者应用不同抗血小板方案治疗的疗效和安全性比较

Comparison of efficacy and safety between two antiplatelet therapies in patients with acute coronary syndromes after percutaneous coronary intervention and 1 year′s dual antiplatelet therapy

目的 比较经皮冠状动脉介入治疗（PCI）术后双联抗血小板疗法（DAPT）治疗满1年冠状动脉综合征（ACS）患者应用不同抗血小板方案治疗的疗效和安全性. 方法 收集2015年1月1日至12月31日在江苏省苏北人民医院行PCI且术后接受DAPT治疗满1年患者的病历资料,记录性别、年龄、原发心血管疾病、合并疾病、既往PCI史、是否吸烟以及联用质子泵抑制剂和他汀类药物情况.根据后续抗血小板方案的不同将患者分为DAPT组（口服阿司匹林100 mg、1次/d＋氯吡格雷75 mg、1次/d或替格瑞洛90 mg、2次/d）和阿司匹林组（仅口服阿司匹林100 mg、1次/d）,治疗均持续6个月.通过电话和门诊复诊对患者进行随访,采用Log-rank检验分析比较2组患者心血管事件和出血事件发生情况. 结果 DAPT组纳入患者75例,阿司匹林组71例,2组患者性别、年龄、ACS类型分布和既往有PCI史者、吸烟者、联用质子泵抑制剂和他汀类药物者占比差异均无统计学意义（均P〉0.05）,DAPT组合并糖尿病和高血压病者占比均高于阿司匹林组（均 P〈0.05）.DAPT组1例停用氯吡格雷,2例失访,随访率96.0%（72/75）;阿司匹林组2例失访,随访率97.2%（69/71）.随访期满时,DAPT组心血管事件和严重心血管事件累积发生率分别为27.8%（20/72）和9.7%（7/72）,阿司匹林组分别为27.5%（19/69）和13.0%（9/69）;DAPT组出血事件和严重出血事件累积发生率分别为22.2%（16/72）和11.1%（8/72）,阿司匹林组分别为26.1%（18/69）和4.3%（3/69）,差异均无统计学意义（均P〉0.05）. 结论 PCI术后接受DAPT治疗1年内未出现严重心血管事件和出血事件的ACS患者延长DAPT疗程未明显降低心血管事件发生率,也未明显增加出血风险,可以考虑单用阿司匹林进行后续抗血小板治疗.

Objective To compare the efficacy and safety between two antiplatelet therapies in patients with acute coronary syndromes（ACS）after percutaneous coronary intervention（PCI）and 1 year dual antiplatelet therapy（DAPT）. Methods The medical records of patient with ACS who underwent PCI and received DAPT for 1 year in Northern Jiangsu People′s Hospital from January 1,2015 to December 31,2015 were collected. The patients′sex,age,primary cardiovascular disease,coexisting diseases,past PCI history,smoking status,and the status of combination of proton pump inhibitors and statins were recorded. The patients were divided into DAPT group（aspirin 100 mg once daily plus clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily,orally）and aspirin group（aspirin 100 mg once daily,orally） according to the different subsequent antiplatelet therapies. The two therapies were persisted for 6 months. The patients were followed up by telephone or subsequent visit. The occurrences of cardiovascular events and the bleeding events in 2 groups were compared by log-rank test. Results The number of patients in DAPT group and Aspirin group were 75 and 71,respectively. There were no significant differences in gender,age,ACS type distribution,past PCI histories,proportions of smoker and combined use of proton pump inhibitors and statins between the 2 groups（all P〉0.05）. The proportions of patients complicated with diabetes and hypertension in the DAPT group were higher than those in the aspirin group（all P〈0.05）. There was 1 patient who stopped clopidogrel and 2 patients lost to follow up in the DAPT group,the follow-up rate was 96.0%（72/75）. Two patients in in the aspirin group were lost to follow up,the follow-up rate was 97.2%（69/71）. At the end of follow-up,the cumulative incidence rates of cardiovascular events and severe cardiovascular events in the DAPT group were 27.8%（20/72）and 9.7%（7/72）,and 27.5%（19/69） and 13.0%（9/69）in the aspirin group,respectively. The cumulative incidence rates of bleeding events and severe bleeding events in the DAPT group were 22.2%（16/72）and 11.1%（8/72）,and 26.1%（18/69）and 4. 3%（3/69）in the aspirin group,respectively. None of the differences were statistically significant（all P〉0.05）. Conclusions The results of prolonging DAPT course in patients with ACS who underwent PCI and had no severe cardiovascular events and bleeding events during the period of 1 year′s DAPT showed that there were no significant decrease in incidence rate of cardiovascular event,and no increase in risk of bleeding. Aspirin may be recommended to be used for the continuous antiplatelet therapy.