Comparative effectiveness and safety of apixaban versus warfarin in patients with venous thromboembolism
Comparative effectiveness and safety of apixaban versus warfarin in patients with venous thromboembolism
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DOI：
10.1093/ajhp/zxz307
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发表时间：
2020-02-01
影响因子：
2.7
通讯作者：
Park, Haesuk
中科院分区：
文献类型：
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作者：
Dawwas, Ghadeer K.;Smith, Steven M.;Park, Haesuk
目的.与常规治疗（依诺肝素后华法林）相比，直接作用的口服抗凝剂阿哌沙班被认为对复发性静脉血栓栓塞（VTE）具有相似的保护作用，出血风险较低。然而，缺乏来自真实世界数据的关于治疗效果异质性的证据。本研究旨在比较阿哌沙班与华法林治疗VTE患者的有效性和安全性。我们对商业和医疗保险补充数据库（数据覆盖期，2014-2017年）进行了回顾性队列分析，诊断为VTE的患者是阿哌沙班或华法林的新用户。我们使用倾向评分[PS] 1：4匹配控制混杂因素。使用考克斯比例风险模型获得风险比（HR）和95%置信区间（CI）。评估诱发性VTE与非诱发性VTE患者治疗效果的异质性。PS匹配后，共36，907例患者纳入队列（n = 8，094例阿哌沙班使用者和n = 28，813例华法林使用者）。在考克斯回归模型中，与华法林相比，阿哌沙班的使用与VTE复发（HR，0.54; 95%CI，0.45-0.65）和大出血事件（HR，0.67; 95%CI，0.54-0.84）的风险较低相关;这些结果在诱发性VTE患者和非诱发性VTE患者中保持一致。这项基于人群的VTE患者分析扩展了随机临床试验的结果，表明在现实环境中使用阿哌沙班与华法林相比，发生复发性VTE和大出血事件的风险较低。观察到的阿哌沙班获益扩展至VTE人群的选定亚组，包括诱发性VTE患者。
Purpose. Compared with conventional therapy (enoxaparin followed by warfarin), the direct-acting oral anticoagulant apixaban is thought to offer similar protection against recurrent venous thromboembolism (VTE) with lower bleeding risk. However, evidence regarding the heterogeneity of treatment effect from real-world data is lacking. The study described here aimed to compare the effectiveness and safety of use of apixaban versus warfarin in patients with VTE.Methods. We conducted a retrospective cohort analysis of commercial and Medicare supplemental databases (data coverage period, 2014-2017) among patients with a diagnosis of VTE who were new users of apixaban or warfarin. We controlled for confounding using propensity score [PS] 1:4 matching. Cox proportional hazard models were used to obtain hazard ratios (HRs) and 95% confidence intervals (CIs). Heterogeneity of treatment effect was assessed among patients with provoked VTE versus unprovoked VTE.Results. After PS matching, a total of 36,907 patients were included in the cohort (n = 8,094 apixaban users and n = 28,813 warfarin users). In Cox regression models, the use of apixaban versus warfarin was associated with lower risks of recurrent VTE (HR, 0.54; 95% CI, 0.45-0.65) and major bleeding events (HR, 0.67; 95% CI, 0.54-0.84); these results remained consistent in patients with provoked VTE and those with unprovoked VTE.Conclusion. This population-based analysis of patients with VTE extends results of randomized clinical trials indicating lower risks of development of recurrent VTE and major bleeding events with use of apixaban versus warfarin in real-world settings. The observed benefits of apixaban extended to selected subgroups of the VTE population, including patients with provoked VTE.