Abstract
BackgroundAfrican 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.MethodsWe 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).ResultsWe 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.ConclusionsIn 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.
Highlights
African Americans are under-represented in trials evaluating oral anticoagulants for the treatment of acute venous thromboembolism (VTE)
Following inverse probability-of-treatment weighting (IPTW), patients were deemed well-balanced on all independent variables entered into the propensity-score model as demonstrated by absolute standardized differences between the rivaroxaban and warfarin users < 0.1
No significant differences were observed between the cohorts for either of the components when evaluated separately at these same time points, nor were there significant differences in the incidence of intracranial hemorrhage (ICH) (HR = 0.66, 95%Confidence intervals (CI) = 0.12–3.59 at 3-months; Hazard ratio (HR) = 0.50, 95%CI = 0.10–2.50 at 6-months and HR = 0.76, 95%CI = 0.27–2.19 at 12-months), GI (HR = 1.16, 95%CI = 0.61–2.21 at 3-months; HR = 0.84, 95%CI = 0.47–1.51 at 6-months and HR = 0.80, 95%CI = 0.47–1.37 at 12-months) and GU bleeding (HR = 1.08, 95%CI = 0.30–3.93 at 3-months; HR = 0.80, 95%CI = 0.24–2.63 at 6-months and HR = 0.88, 95%CI = 0.29–2.63 at 12-months)
Summary
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. Despite race-based differences in VTE incidence and prognosis, African Americans have been under-represented in randomized controlled trials (RCTs) evaluating non-vitamin K oral anticoagulants (NOACs) for the management of VTE [6,7,8,9,10]. The objective of this study was to evaluate the effectiveness and safety of rivaroxaban versus warfarin in the treatment and prevention of recurrent VTE in African Americans managed in routine practice
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