论文部分内容阅读
目的:基于“采用抗凝策略人群中的心血管结局（COMPASS）”的中国亚组数据，分析利伐沙班与阿司匹林联用对稳定性心血管疾病患者心血管事件二级预防的疗效与安全性。方法:COMPASS研究是一项前瞻性、国际多中心、随机、平行组设计的临床试验。本研究选取其中2014年9月至2017年2月中国31家医学中心的稳定性心血管病患者（诊断为稳定性冠心病、外周动脉疾病或两者同时存在）进行亚组分析，采用随机数表法分为利伐沙班与阿司匹林联用组、利伐沙班单用组及阿司匹林单用组。收集3组的年龄、性别等基线临床资料。患者于随机分配后第1、6个月以及此后每隔6个月于门诊或电话中接受随访。观察的主要疗效终点是心血管病死亡、心肌梗死及卒中的复合事件，主要安全性终点为修改的国际血栓与止血协会标准大出血，评价临床净获益及其他不良事件发生情况。采用Kaplan-Meier生存曲线估算终点事件的年化发生率，并采用分层Cox比例风险回归模型分析比较3组终点事件及临床净获益事件风险的差异。结果:COMPASS研究中国亚组共纳入1 086例稳定性心血管疾病患者，其中利伐沙班与阿司匹林联用组366例，年龄（64.2±8.3）岁，男性293例（80.1%）；利伐沙班单用组365例，年龄（63.8±9.0）岁，男性301例（82.5%）；阿司匹林单用组355例，年龄（63.6±8.8）岁，男性282例（79.4%）。最终共1 081例患者完成随访，随访率为99.5%，中位随访时间为575（413，673）d。利伐沙班与阿司匹林联用组主要疗效终点事件发生9次（1.5%/年），利伐沙班单用组发生21次（3.7%/年），阿司匹林单用组发生14次（2.5%/年）；主要安全性终点3组分别为6次（1.0%/年）、9次（1.6%/年）及7次（1.2%/年）；临床净获益事件3组分别为10次（1.7%/年）、22次（3.9%/年）、15次（2.7%/年），差异均无统计学意义（n P>0.05）。其他不良事件在中国亚组中发生较少。n 结论:利伐沙班与阿司匹林联用以可安全有效地用于中国稳定性冠心病和外周动脉疾病患者的心血管事件二级预防。“,”Objective:This analysis was performed to evaluate the efficacy and the safety of rivaroxaban-aspirin combination therapy in secondary prevention of major adverse cardiovascular events in Chinese patients enrolled in the COMPASS trial.Methods:COMPASS was a prospective, international multi-center and randomized controlled trial. From September 2014 to February 2017, 1 086 patients with stable coronary artery disease and peripheral artery diseases were recruited from 31 centers in China. Patients were randomly assigned to separately receive the therapy of rivaroxaban (2.5 mg twice a day) plus aspirin (100 mg once a day,) group (n n=366), rivaroxaban (5 mg twice a day) alone group (n n=365), and aspirin (100 mg once a day) alone group (n n=355). Baseline information such as age, sex, etc. of all three groups was collected. Finally, 1 081 patients were followed up successfully, with the follow-up rate 99.5% and the average follow-up time was 19 months. The primary efficacy endpoint was the composite of cardiovascular death, myocardial infarction and stroke. The primary safety endpoint was major bleeding evaluated by modified International Society on Thrombosis and Haemostasis criteria.n Results:Age of patients was (64.2±8.3) years and there were 293 male in rivaroxaban plus aspirin group. Age of patients was (63.8±9.0) years, and there were 301 male patients in rivaroxaban alone group. Age of patients was (63.6±8.8) years, and there were 282 male patients in the aspirin alone group. The incidences of primary efficacy endpoint occurred in 9 cases (1.5%) in rivaroxaban with aspirin group, 21 cases (3.7%) in rivaroxaban alone group and 14 cases (2.5%) in aspirin alone group. Meanwhile, the incidences of primary safety endpoint occurred in 6 cases (1.0%) in rivaroxaban with aspirin group, 9 cases (1.6%) in rivaroxaban alone group and 7 cases (1.2%) in aspirin alone group. The net clinical benefit events were 10 cases (1.7%) in rivaroxaban with aspirin group, 22 cases (3.9%) in rivaroxaban alone group and 15 cases (2.7%) in aspirin alone group (n P>0.5%).n Conclusions:The combination of rivaroxaban with aspirin can be safe and effectively used for the secondary prevention in Chinese patients with stable coronary artery disease and peripheral artery diseases.