Effectiveness and safety of rivaroxaban versus warfarin in obese nonvalvular atrial fibrillation patients: analysis of electronic health record data
Effectiveness and safety of rivaroxaban versus warfarin in obese nonvalvular atrial fibrillation patients: analysis of electronic health record data
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DOI：
10.1080/03007995.2020.1762554
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发表时间：
2020-05-08
影响因子：
2.3
通讯作者：
Coleman, Craig, I
中科院分区：
文献类型：
--
作者：
Costa, Olivia S.;Beyer-Westendorf, Jan;Coleman, Craig, I
背景资料：尽管利伐沙班在正常体重和肥胖患者中的药物水平一致，但目前缺乏同等临床有效性和安全性的充分证实。目的：评价利伐沙班与华法林预防肥胖非瓣膜性房颤（NVAF）患者卒中和全身性栓塞（SSE）的有效性和安全性。研究方法：使用Optum去识别化电子健康记录（EHR）数据，从2011年11月至2018年9月，我们评估了体重指数（BMI）>= 30 kg/m2的NVAF患者，这些患者新开始使用利伐沙班或华法林（索引日期），EHR活动>= 12个月，索引日期前>= 1次。我们排除了患有瓣膜疾病或基线时有口服抗凝剂（OAC）使用证据的患者。接受利伐沙班处方的患者与接受华法林处方的患者进行1：1的倾向评分匹配（标准差= 40 kg/m2）。进行考克斯回归，并报告为风险比（HR）和95%置信区间（CI）。结果：我们纳入了35，613名利伐沙班和35，613名华法林使用者。患者的中位随访时间为2.6年（25%-75%范围= 1.2 - 4.1）。与华法林相比，利伐沙班与SSE（HR = 0.83，95%CI = 0.73 - 0.94）和大出血（HR = 0.82，95%CI = 0.75 - 0.89）风险降低相关。亚组分析未显示SSE（p-相互作用= 0.58）或大出血（p-相互作用= 0.44）结局的BMI类别之间存在统计学显著性相互作用。结论：在肥胖NVAF患者中，与华法林相比，利伐沙班处方与SSE和大出血风险降低相关，这在BMI类别中保持一致。
Background: Although rivaroxaban has demonstrated consistent drug levels in normal weight and obese patients, sufficient confirmation of equal clinical effectiveness and safety is currently lacking. Purpose: To evaluate the effectiveness and safety of rivaroxaban versus warfarin for prevention of stroke and systemic embolism (SSE) in obese nonvalvular atrial fibrillation (NVAF) patients. Methods: Using Optum de-identified Electronic Health Record (EHR) data from November 2011 to September 2018,we evaluated NVAF patients with a body mass index (BMI)>= 30 kg/m(2) newly initiated on rivaroxaban or warfarin (index date), with >= 12-months of EHR activity and >= 1 encounter before the index date. We excluded patients with valvular disease or evidence of oral anticoagulant (OAC) use at baseline. Patients who were prescribed rivaroxaban were 1:1 propensity-score matched to patients who were prescribed warfarin (standard differences = 40 kg/m(2)) were performed. Cox regression was performed and reported as hazard ratios (HRs) and 95% confidence intervals (CIs). Results: We included 35,613 rivaroxaban and 35,613 warfarin users with NVAF. Patients were followed for a median of 2.6 years (25%-75% range = 1.2-4.1). Rivaroxaban was associated with a reduced risk of SSE (HR = 0.83, 95%CI = 0.73-0.94) and major bleeding (HR = 0.82, 95%CI = 0.75-0.89) compared to warfarin. Subanalysis did not show a statistically significant interaction across BMI categories for SSE (p-interaction = .58) or major bleeding (p-interaction = .44) outcomes. Conclusions: Among obese NVAF patients, prescription of rivaroxaban was associated with a reduced risk of SSE and major bleeding compared to warfarin, which remained consistent across BMI classes.