Comparative safety and effectiveness of direct oral anticoagulants in patients with atrial fibrillation in clinical practice in Scotland

Comparative safety and effectiveness of direct oral anticoagulants in patients with atrial fibrillation in clinical practice in Scotland
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DOI:
10.1111/bcp.13814
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发表时间:
2019-02-01
影响因子:
3.4
通讯作者:
Bennie, Marion
Bennie, Marion
中科院分区:
医学3区
文献类型:
--
作者:
Mueller, Tanja;Alvarez-Madrazo, Samantha;Bennie, Marion

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目的 本研究的目的是比较常规临床实践中直接口服抗凝剂 (DOAC) 对心房颤动 (AF) 患者的临床有效性和安全性。方法 这项回顾性队列研究使用了关联的管理数据。研究人群 (n = 14 577) 包括 2011 年 8 月至 2015 年 12 月期间在苏格兰开始接受 DOAC 治疗的 AF 诊断患者(在医院确诊)。使用多变量 Cox 比例风险模型来估计血栓栓塞事件、死亡率和出血事件的风险比。结果 DOAC 之间在中风、全身性栓塞或心血管死亡风险方面没有观察到差异。相比之下,与服用利伐沙班的患者相比,服用阿哌沙班的患者发生心肌梗死的风险更高(HR 1.67,95% CI 1.02-2.71),与阿哌沙班(1.22 [1.01-1.47])和达比加群(1.55)相比,利伐沙班患者的全因死亡率更高。 [1.16-2.05])患者;利伐沙班患者发生肺栓塞的风险也高于阿哌沙班患者(5.27 [1.79-15.53])。与阿哌沙班 (1.50 [1.10-2.03]) 和达比加群 (1.58 [1.01-2.48]) 患者相比,利伐沙班患者发生其他大出血的风险较高;利伐沙班患者的胃肠道出血和总体出血风险高于阿哌沙班患者(分别为 1.48 [1.01-2.16] 和 1.52 [1.21-1.92])。结论 所有 DOAC 在预防中风和全身性栓塞方面的效果相似,而接受利伐沙班治疗的患者表现出最高的出血风险。观察到的全因死亡、心肌梗死和肺栓塞风险的差异值得进一步研究。
Aims The aim of this study was to compare the clinical effectiveness and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) in routine clinical practice. Methods This retrospective cohort study used linked administrative data. The study population (n = 14 577) included patients with a diagnosis of AF (confirmed in hospital) who initiated DOAC treatment in Scotland between August 2011 and December 2015. Multivariate Cox proportional hazard models were used to estimate hazard ratios of thromboembolic events, mortality and bleeding events. Results No differences between the DOACs were observed with regard to the risk of stroke, systemic embolism or cardiovascular death. In contrast, the risk of myocardial infarction was higher among patients prescribed apixaban in comparison to those on rivaroxaban (HR 1.67, 95% CI 1.02-2.71), and all-cause mortality was higher among rivaroxaban patients in contrast to both apixaban (1.22 [1.01-1.47]) and dabigatran (1.55 [1.16-2.05]) patients; rivaroxaban patients also had a higher risk of pulmonary embolism than apixaban patients (5.27 [1.79-15.53]). The risk of other major bleeds was higher among rivaroxaban patients compared to apixaban (1.50 [1.10-2.03]) and dabigatran (1.58 [1.01-2.48]) patients; the risks of gastrointestinal bleeds and overall bleeding were higher among rivaroxaban patients than among apixaban patients (1.48 [1.01-2.16] and 1.52 [1.21-1.92], respectively). Conclusions All DOACs were similarly effective in preventing strokes and systemic embolisms, while patients being treated with rivaroxaban exhibited the highest bleeding risks. Observed differences in the risks of all-cause mortality, myocardial infarction and pulmonary embolism warrant further research.