The study objective was to evaluate the safety and effectiveness of dabigatran and other direct oral anticoagulants (DOACs) compared with warfarin among patients with nonvalvular atrial fibrillation using a prospective monitoring program. We implemented a cohort design with propensity score matching to compare initiators of DOACs and warfarin between 2010 and 2015 in two US healthcare databases. Proportional hazards regression was used to estimate hazard ratios (HRs) for stroke and major bleeding. The final analyses included 29,448 dabigatran, 35,520 rivaroxaban, and 19,588 apixaban initiators, matched to warfarin initiators. The pooled HR for stroke was 0.75 (95% confidence interval (CI) 0.58-0.98) for dabigatran, 0.77 (95% CI 0.61-0.98) for rivaroxaban, and 0.69 (95% CI 0.50-0.96) for apixaban, consistent with findings from randomized trials. For major hemorrhage, the HRs were 0.72 (95% CI 0.65-0.80), 1.02 (95% CI 0.94-1.12), and 0.56 (95% CI 0.49-0.64), respectively, showing a decreased risk of major bleeding for both dabigatran and apixaban, as compared with trial evidence.

中文翻译：

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与华法林相比，达比加群和其他直接口服抗凝剂在房颤患者中的安全性和有效性。

研究目的是使用前瞻性监测程序评估达比加群和其他直接口服抗凝剂（DOAC）与华法林相比在非瓣膜性房颤患者中的安全性和有效性。我们实施了具有倾向得分匹配的队列设计，以比较两个美国医疗保健数据库中2010年至2015年之间DOAC和华法林的发起者。使用比例风险回归来估计中风和大出血的风险比（HRs）。最终分析包括与华法林引发剂匹配的29,448达比加群，35,520利伐沙班和19,588阿哌沙班引发剂。达比加群的卒中合并HR为0.75（95％置信区间（CI）0.58-0.98），利伐沙班为0.77（95％CI 0.61-0.98）和阿哌沙班为0.69（95％CI 0.50-0.96），与研究结果一致来自随机试验。