Department of Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs, CT, USA; Evidence-Based Practice Center, Hartford Hospital, Hartford, CT, USA.
TeamHealth LifePoint Group, Southaven, MS, USA.
J Natl Med Assoc. 2020 Aug;112(4):395-401. doi: 10.1016/j.jnma.2020.04.014. Epub 2020 May 31.
Black patients are under-represented in randomized trials evaluating oral anticoagulants in non-valvular atrial fibrillation (NVAF). We sought to evaluate the effectiveness and safety of rivaroxaban versus warfarin in African Americans with NVAF.
We performed an analysis using Optum® De-Identified Electronic Health Record (EHR) data from 1/1/2012-9/30/2018. We included adult African American patients with a diagnosis of NVAF who were anticoagulant-naïve during the 12-months prior to initiation of rivaroxaban or warfarin. Patients receiving rivaroxaban were 1:1 propensity score matched to warfarin patients. Our primary effectiveness and safety outcomes were the 2-year incidence rates (%/year) of stroke or systemic embolism (SSE) and major bleeding using an intention-to-treat approach. Cohorts were compared using doubly-robust Cox regression and reported as hazard ratios (HRs) with 95% confidence intervals (CIs).
We matched 4102 rivaroxaban and 4102 warfarin users with a median (interquartile range) available follow-up of 2.0 (0.9, 2.0) years. Median CHA2DS2-VASc and HASBLED scores were 3 (2, 4) and 2 (1, 3). Rivaroxaban use was associated with a lower risk of SSE (1.99 versus 2.48, HR = 0.77, 95%CI = 0.60-0.99), ischemic stroke (1.84 versus 2.37, HR = 0.76, 95%CI = 0.59-0.98) and major bleeding (4.22 versus 4.98, HR = 0.84, 95%CI = 0.70-0.99). No differences in intracranial hemorrhage or gastrointestinal bleeding were observed. Neither sensitivity analyses utilizing an on-treatment methodology nor inverse probability-of-treatment weighting showed significant differences in SSE or major bleeding between rivaroxaban and warfarin users.
Rivaroxaban appeared at least as effective and safe as warfarin when used to manage African American patients with NVAF in routine practice.
在非瓣膜性心房颤动（NVAF）中评估口服抗凝剂的随机试验中，黑种人患者代表性不足。我们旨在评估利伐沙班与华法林在非瓣膜性心房颤动的非裔美国人中的有效性和安全性。
我们使用来自 2012 年 1 月 1 日至 2018 年 9 月 30 日的 Optum®去识别电子健康记录（EHR）数据进行分析。我们纳入了 NVAF 的成年非裔美国患者，在开始使用利伐沙班或华法林之前的 12 个月内为抗凝剂初治患者。接受利伐沙班的患者与华法林患者按 1:1 倾向评分匹配。我们的主要有效性和安全性结局是使用意向治疗方法的 2 年中风或全身性栓塞（SSE）和大出血发生率（%/年）。使用双重稳健 Cox 回归比较队列，并报告风险比（HR）及其 95%置信区间（CI）。
我们匹配了 4102 名利伐沙班和 4102 名华法林使用者，中位（四分位距）可随访时间为 2.0（0.9，2.0）年。中位 CHA2DS2-VASc 和 HASBLED 评分分别为 3（2，4）和 2（1，3）。与华法林相比，利伐沙班的 SSE 风险较低（1.99 比 2.48，HR=0.77，95%CI=0.60-0.99），缺血性中风（1.84 比 2.37，HR=0.76，95%CI=0.59-0.98）和大出血（4.22 比 4.98，HR=0.84，95%CI=0.70-0.99）的风险较低。颅内出血或胃肠道出血无差异。采用治疗方法的敏感性分析或治疗倾向逆概率加权均未显示利伐沙班与华法林使用者在 SSE 或大出血方面有显著差异。
在常规实践中，利伐沙班治疗非瓣膜性心房颤动的非裔美国人患者的有效性和安全性与华法林至少相当。
