Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, and Sinai Health System and University of Toronto, Toronto, Ontario, Canada (M.F.).
Sinai Health System and University of Toronto, Toronto, Ontario, Canada (M.C.).
Ann Intern Med. 2020 Apr 7;172(7):463-473. doi: 10.7326/M19-2522. Epub 2020 Mar 10.
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.
To compare the safety and effectiveness of apixaban versus rivaroxaban for patients with nonvalvular atrial fibrillation.
New-user, active-comparator, retrospective cohort study.
A U.S. nationwide commercial health care claims database from 28 December 2012 to 1 January 2019.
Adults newly prescribed apixaban (n = 59 172) or rivaroxaban (n = 40 706).
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.
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).
Unmeasured confounding, incomplete laboratory data.
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.
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital.
阿哌沙班和利伐沙班是成人非瓣膜性心房颤动最常开的直接口服抗凝药,但缺乏比较两者安全性和有效性的头对头数据。
比较非瓣膜性心房颤动患者应用阿哌沙班和利伐沙班的安全性和有效性。
新用户、活性对照、回顾性队列研究。
2012 年 12 月 28 日至 2019 年 1 月 1 日期间,美国全国商业健康保险索赔数据库。
新处方阿哌沙班(n=59172)或利伐沙班(n=40706)的成年人。
主要有效性结局是缺血性卒中和全身性栓塞的复合结局。主要安全性结局是颅内出血或胃肠道出血的复合结局。
39351 例新处方阿哌沙班的患者经倾向评分匹配,与 39351 例新处方利伐沙班的患者相匹配。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。应用阿哌沙班的成年人缺血性卒中和全身性栓塞的发生率为每 1000 人年 6.6 例,而应用利伐沙班的成年人发生率为每 1000 人年 8.0 例(风险比[HR],0.82[95%CI,0.68 至 0.98];率差,每 1000 人年减少 1.4 例[CI,0.0 至 2.7])。与应用利伐沙班相比,应用阿哌沙班的成年人胃肠道出血或颅内出血的发生率也较低(每 1000 人年 12.9 例与每 1000 人年 21.9 例),相应的 HR 为 0.58(CI,0.52 至 0.66),率差为每 1000 人年减少 9.0 例(CI,6.9 至 11.1)。
存在未测量的混杂因素,实验室数据不完整。
在常规治疗中,与应用利伐沙班相比,应用阿哌沙班的心房颤动成年人缺血性卒中和全身性栓塞及出血的发生率较低。
布莱根妇女医院的药物流行病学和药物经济学部。