艾多沙班与利伐沙班在老年非瓣膜性心房颤动患者中抗凝治疗的有效性及安全性对比

Comparison of efficacy and safety of edoxaban versus rivaroxaban for anticoagulation therapy in older patients with non-valvular atrial fibrillation

中文关键词: 艾多沙班    利伐沙班    心房颤动    非瓣膜性    老年人    抗凝治疗

英文关键词: edoxabanrivaroxabanatrial fibrillationnon-valvularolder adultsanticoagulation therapy

中文摘要:

      目的 比较艾多沙班与利伐沙班在老年非瓣膜性心房颤动(NVAF)患者中预防血栓栓塞事件的真实世界有效性及安全性。方法 采用回顾性队列研究设计，连续纳入2021年1月至2022年1月在复旦大学附属华东医院心内科就诊、年龄65～85岁、初始服用艾多沙班或利伐沙班抗凝治疗的NVAF患者。根据初始用药分为艾多沙班组与利伐沙班组。收集患者基线资料，主要有效性终点为随访6个月内血栓栓塞事件(缺血性卒中、系统性栓塞、短暂性脑缺血发作)。主要安全性终点为国际血栓与止血学会(ISTH)定义的大出血事件。次要终点包括临床相关出血、全因死亡及凝血功能指标变化等在内的总不良事件。结果 纳入符合条件的患者160例(艾多沙班组80例，利伐沙班组80例)。在随访6个月期间，艾多沙班组血栓栓塞事件发生率为2.5%(2/80)，低于利伐沙班组的7.5%(6/80)。2组ISTH大出血发生率均为0。临床相关出血事件发生率(艾多沙班组18.75%比利伐沙班组31.25%)及全因死亡率差异无统计学意义。探索性分析显示，服药6个月时，艾多沙班组的活化部分凝血活酶时间和凝血酶时间较基线升高幅度大于利伐沙班组(P <0.05)。结论 在本研究人群中，艾多沙班组血栓栓塞事件发生率低于利伐沙班组，但受限于事件数较少和回顾性设计，该差异需在更大样本前瞻性研究中进一步验证。

英文摘要:

      Objective To compare the real-world efficacy and safety of edoxaban versus rivaroxaban in preventing thromboembolic events in older patients with non-valvular atrial fibrillation(NVAF).Methods A retrospective cohort study design was adopted.Consecutive patients aged 65-85 years with NVAF who visited the Department of Cardiology at Huadong Hospital Affiliated to Fudan University from January 2021 to January 2022 and who initially treated with edoxaban or rivaroxaban for anticoagulation were enrolled.Patients were divided into an edoxaban group and a rivaroxaban group according to their initial medication.Baseline data were collected.The primary efficacy endpoint was a composite of thromboembolic events(ischemic stroke,systemic embolism,and transient ischemic attack)within 6 months of follow-up.The primary safety endpoint was major bleeding events as defined by the International Society on Thrombosis and Haemostasis(ISTH).Secondary endpoints included any clinically relevant bleeding,all-cause death,and changes in coagulation parameters.Results A total of 160 eligible patients were enrolled(80 in the edoxaban group and 80 in the rivaroxaban group).After 6 months of follow-up,the incidence of thromboembolic events was 2.5%(2/80)in the edoxaban group,lower than 7.5%(6/80)in the rivaroxaban group.The incidence of ISTH major bleeding was 0 in both groups.No significant difference were observed in the incidence of any clinically relevant bleeding(18.75%in the edoxaban group vs.31.25%in the rivaroxaban group)or all-cause mortality.Exploratory analysis showed that at 6 months of treatment,the activated partial thromboplastin time and thrombin time in the edoxaban group increased more from baseline than those in the rivaroxaban group(P＜0.05).Conclusion In this study population,the incidence of thromboembolic events was lower in the edoxaban group than in the rivaroxaban group.However,given the samll number of events and retrospective design,this difference needs to be further validated in larger sample prospective studies.