Costa Olivia S, Thompson Stanley, Ashton Veronica, Palladino Michael, Bunz Thomas J, Coleman Craig I
1Department of Pharmacy Practice, University of Connecticut School of Pharmacy, 69 North Eagleville Road, Unit 3092, Storrs, CT 06269 USA.
2Evidence-Based Practice Center, Hartford Hospital, Hartford, CT USA.
Thromb J. 2020 Apr 8;18:6. doi: 10.1186/s12959-020-00219-w. eCollection 2020.
African Americans are under-represented in trials evaluating oral anticoagulants for the treatment of acute venous thromboembolism (VTE). The aim of this study was to evaluate the effectiveness and safety of rivaroxaban versus warfarin for the treatment of VTE in African Americans.
We utilized Optum® De-Identified Electronic Health Record data from 11/1/2012-9/30/2018. We included African Americans experiencing an acute VTE during a hospital or emergency department visit, who received rivaroxaban or warfarin as their first oral anticoagulant within 7-days of the acute VTE event and had ≥1 provider visit in the prior 12-months. Differences in baseline characteristics between cohorts were adjusted using inverse probability-of-treatment weighting based on propensity scores (standard differences < 0.10 were achieved for all covariates). Our primary endpoint was the composite of recurrent VTE or major bleeding at 6-months. Three- and 12-month timepoints were also assessed. Secondary endpoints included recurrent VTE and major bleeding as individual endpoints. Cohort risk was compared using Cox regression and reported as hazard ratios (HRs) with 95% confidence intervals (CIs).
We identified 2097 rivaroxaban and 2842 warfarin users with incident VTE. At 6-months, no significant differences in the composite endpoint (HR = 0.96, 95%CI = 0.75-1.24), recurrent VTE (HR = 1.02, 95%CI = 0.76-1.36) or major bleeding alone (HR = 0.93, 95%CI = 0.59-1.47) were observed between cohorts. Analysis at 3- and 12-months provided consistent findings for these endpoints.
In African Americans experiencing an acute VTE, no significant difference in the incidence of recurrent VTE or major bleeding was observed between patients receiving rivaroxaban or warfarin.
在评估口服抗凝剂治疗急性静脉血栓栓塞症(VTE)的试验中,非裔美国人的参与率较低。本研究的目的是评估利伐沙班与华法林治疗非裔美国人VTE的有效性和安全性。
我们使用了2012年11月1日至2018年9月30日Optum®去识别化电子健康记录数据。我们纳入了在医院或急诊科就诊时发生急性VTE的非裔美国人,他们在急性VTE事件发生后7天内接受利伐沙班或华法林作为首次口服抗凝剂,且在过去12个月内有≥1次医疗服务提供者就诊。根据倾向评分使用治疗逆概率加权法调整队列之间的基线特征差异(所有协变量的标准化差异<0.10)。我们的主要终点是6个月时复发性VTE或大出血的复合终点。还评估了3个月和12个月的时间点。次要终点包括复发性VTE和大出血作为单独终点。使用Cox回归比较队列风险,并报告为风险比(HRs)及95%置信区间(CIs)。
我们确定了2097名利伐沙班使用者和2842名华法林使用者发生VTE。在6个月时,队列之间在复合终点(HR = 0.96,95%CI = 0.75 - 1.24)、复发性VTE(HR = 1.02,95%CI = 0.76 - 1.36)或单独大出血(HR = 0.93,95%CI = 0.59 - 1.47)方面未观察到显著差异。在3个月和12个月时的分析为这些终点提供了一致的结果。
在发生急性VTE 的非裔美国人中,接受利伐沙班或华法林治疗的患者在复发性VTE或大出血发生率方面未观察到显著差异。