Background Apixaban and rivaroxaban are the most commonly prescribed direct oral anticoagulants for adults with atrial fibrillation, but head-to-head data comparing their safety and effectiveness are lacking. Objective To compare the safety and effectiveness of apixaban versus rivaroxaban for patients with nonvalvular atrial fibrillation. Design New-user, active-comparator, retrospective cohort study. Setting A U.S. nationwide commercial health care claims database from 28 December 2012 to 1 January 2019. Patients Adults newly prescribed apixaban (n = 59 172) or rivaroxaban (n = 40 706). Measurements The primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of intracranial hemorrhage or gastrointestinal bleeding. Results 39 351 patients newly prescribed apixaban were propensity score matched to 39 351 patients newly prescribed rivaroxaban. Mean age was 69 years, 40% of patients were women, and mean follow-up was 288 days for new apixaban users and 291 days for new rivaroxaban users. The incidence rate of ischemic stroke or systemic embolism was 6.6 per 1000 person-years for adults prescribed apixaban compared with 8.0 per 1000 person-years for those prescribed rivaroxaban (hazard ratio [HR], 0.82 [95% CI, 0.68 to 0.98]; rate difference, 1.4 fewer events per 1000 person-years [CI, 0.0 to 2.7]). Adults prescribed apixaban also had a lower rate of gastrointestinal bleeding or intracranial hemorrhage (12.9 per 1000 person-years) compared with those prescribed rivaroxaban (21.9 per 1000 person-years), corresponding to an HR of 0.58 (CI, 0.52 to 0.66) and a rate difference of 9.0 fewer events per 1000 person-years (CI, 6.9 to 11.1). Limitation Unmeasured confounding, incomplete laboratory data. Conclusion In routine care, adults with atrial fibrillation prescribed apixaban had a lower rate of both ischemic stroke or systemic embolism and bleeding compared with those prescribed rivaroxaban. Primary Funding Source Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital.

中文翻译：

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与利伐沙班相比，阿哌沙班在常规治疗中对心房颤动患者的有效性和安全性：一项队列研究。


背景 阿哌沙班和利伐沙班是成人心房颤动最常用的直接口服抗凝药，但缺乏比较其安全性和有效性的头对头数据。目的 比较阿哌沙班与利伐沙班治疗非瓣膜性心房颤动的安全性和有效性。设计新用户、主动比较、回顾性队列研究。设置2012年12月28日至2019年1月1日美国全国商业医疗保健索赔数据库。患者成人新开阿哌沙班（n = 59 172）或利伐沙班（n = 40 706）。测量 主要有效性结果是缺血性中风或全身性栓塞的复合结果。主要安全性结局是颅内出血或胃肠道出血的复合结局。结果 39 351 名新开阿哌沙班的患者与 39 351 名新开利伐沙班的患者进行倾向评分匹配。平均年龄为 69 岁，40% 的患者为女性，新阿哌沙班使用者的平均随访时间为 288 天，新利伐沙班使用者的平均随访时间为 291 天。服用阿哌沙班的成人中，缺血性卒中或全身性栓塞的发生率为每 1000 人年 6.6 例，而服用利伐沙班的成人为每 1000 人年 8.0 例（风险比 [HR]，0.82 [95% CI，0.68 至 0.98]；率差异，每 1000 人年事件减少 1.4 次 [CI，0.0 至 2.7]）。与服用利伐沙班的成人（每 1000 人年 21.9 例）相比，服用阿哌沙班的成人的胃肠道出血或颅内出血发生率也较低（每 1000 人年 12.9 例），相应的 HR 为 0.58（CI，0.52 至 0.66）。每 1000 人年事件发生率差异为 9.0 次（CI，6.9 至 11.1）。局限性 未测量的混杂因素、不完整的实验室数据。 结论 在常规护理中，与服用利伐沙班的患者相比，服用阿哌沙班的房颤成人患者缺血性卒中或全身性栓塞和出血的发生率较低。主要资金来源布莱根妇女医院药物流行病学和药物经济学部门。