1430例中年中危血栓栓塞风险心房颤动抗凝治疗的方案

Anticoagulant therapy of non-valvular atrial fibrillation in 1,430 middle-aged patients with moderate-risk thromboembolism

目的评估CHA_(2)DS_(2)-VASc评分为中危血栓栓塞风险非瓣膜性心房颤动(房颤)中年患者是否接受抗凝治疗的疗效获益与安全风险,探讨抗凝治疗的合理性及不同新型抗凝剂效果对比。方法纳入天津市胸科医院心内科2018年9月至2020年8月诊治的符合研究标准的CHA_(2)DS_(2)-VASc评分=1分的男性和CHA_(2)DS_(2)-VASc评分=2分的女性非瓣膜性房颤中年患者1 430例,根据抗凝治疗与否及抗凝剂种类非随机分为利伐沙班组(n=476)、达比加群组(n=464)和未抗凝治疗组(n=490),回顾性分析患者临床及随访资料,比较6~30个月后终点结局指标的差异。结果 3组基线临床资料的多因素Logistic回归分析显示,排除3组已知心血管危险因素(包括性别、年龄、房颤类型、房颤病程、HAS-BLED评分、既往病史、合并抗血小板药物)成为影响抗凝治疗与否和临床复合终点事件结局之间相关性的临床混杂因素(P>0.05)。利伐沙班组和达比加群组的临床复合终点事件发生率低于未抗凝治疗组(利伐沙班组:OR=0.400,95%CI:0.103~0.717,P<0.001;达比加群组:OR=0.458,95%CI:0.094~0.841,P<0.001),而药物累计出血事件发生率高于未抗凝治疗组(利伐沙班组:OR=3.204,95%CI:1.190~5.235,P<0.001;达比加群组:OR=4.173,95%CI:1.864~6.494,P<0.001),且利伐沙班组和达比加群组的轻微出血比例高于未抗凝治疗组(利伐沙班组:OR=2.628,95%CI:1.538~3.734,P<0.001;达比加群组:OR=2.759,95%CI:2.005~3.525,P<0.001),其他出血事件严重程度分型比例均差异无统计学意义(大出血:χ^(2)=1.680,P=0.432;小出血:χ^(2)=2.888,P=0.236)。单因素Kaplan-Meier生存分析显示,组间无临床复合终点事件结局累积发生率比较差异有统计学意义(χ^(2)=19.216,P<0.001)。结论接受抗凝治疗对于CHA_(2)DS_(2)-VASc评分为中危血栓栓塞风险非瓣膜性房颤中年患者可提高临床净获益和改善近远期预后,利伐沙班和达比加群的抗凝效果相似,需谨慎选择不抗凝治疗。

Objective To explore the rationality of anticoagulant therapy and compare different oral anticoagulants by evaluating the benefits and risks of anticoagulant therapy for the middle-aged non-valvular atrial fibrillation patients with moderate-risk CHA_(2)DS_(2)-VASc score. Methods A total of 1,430 middle-aged males with CHA_(2)DS_(2)-VASc score of 1 and females with CHA_(2)DS_(2)-VASc score of 2 diagnosed and treated in the Department of Cardiology of Tianjin Chest Hospital during Sep. 2018 and Aug. 2020 were enrolled in this retrospective study. According to whether the patients received anticoagulant therapy and the type of anticoagulants they used, the patients were divided into three groups: the rivaroxaban group(n=476), dabigatran group(n=464), and non-anticoagulant therapy group(n=490). The clinical and follow-up data were analyzed to compare differences in the endpoint outcome indicators after 6-30 month followed-up. Results Multivariate Logistic regression analysis of baseline data showed that the known cardiovascular risk factors(including gender, age, type and duration of atrial fibrillation, HAS-BLED score, medical history and antiplatelet drugs) were excluded as the clinical confounding factors influencing the correlation between anticoagulant therapy and endpoint outcomes(P>0.05). The incidence of the clinical endpoint outcomes in the rivaroxaban group and dabigatran group was lower than that in the non-anticoagulant therapy group(rivaroxaban group: OR=0.400, 95%CI: 0.103-0.717, P<0.001;dabigatran group: OR=0.458, 95%CI: 0.094-0.841, P<0.001);the incidence of drug-caused accumulative bleeding events was higher(rivaroxaban group: OR=3.204, 95%CI: 1.190-5.235, P<0.001;dabigatran group: OR=4.173, 95%CI: 1.864-6.494, P<0.001);the incidence of mild bleeding was higher(rivaroxaban group: OR=2.628, 95%CI: 1.538-3.734, P<0.001;dabigatran group: OR=2.759, 95%CI: 2.005-3.525, P<0.001). There were no statistically significant differences in the incidence of other bleeding events among the three groups(major bleeding: χ^(2)=1.680, P=0.432;minor bleeding: χ^(2)=2.888, P=0.236). Univariate Kaplan-Meier survival analysis showed that there was statistical difference in the cumulative incidence of non-clinical endpoint outcomes among the three groups(χ^(2)=19.216, P<0.001). Conclusion Anticoagulant therapy can improve the net clinical benefits and short-term and long-term prognosis. Rivaroxaban and dabigatran anticoagulant therapy have similar anticoagulant effects. Therefore, non-anticoagulant therapy needs to be chosen carefully.