Abstract 8996: Efficacy and Safety of Direct Oral Anticoagulants in Those Identifying as Black or African-American: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Abstract

Introduction: Direct oral anticoagulants (DOACs) are indicated for prevention of stroke in non-valvular atrial fibrillation (AF) and for both treatment and prevention of recurrence of venous thromboembolism (VTE). Very little is known about efficacy and safety of these agents in patients identifying as Black or African-American (AA), as landmark trials demonstrating their non-inferiority to vitamin K antagonists (VKAs) are notable for discrepancies in enrollment by patient’s race. As the primary efficacy and safety outcomes for both AF and VTE are similar, we hypothesized that the cumulative efficacy and safety of DOACs in AA patients would be similar to that of the general population. Methods: A systematic review was conducted of clinical trials that investigated the comparison between DOACs and VKAs in patients for both AF and VTE. The Mantel-Haenszel Method was used to estimate pooled risk ratios (RRs) and corresponding confidence intervals (CIs) for the efficacy and safety of DOACs in AAs compared to the general population. Primary efficacy outcome was defined as stroke or systolic embolism in AF or symptomatic, recurrent VTE. Primary safety outcome was defined as major bleeding in both AF and VTE. Results: Nine studies were used for meta-analysis, with 26 eliminated due to lack of randomization or subgroup data for AAs. A total of 80,688 of patients were analyzed with 1.67% being AA. Regarding efficacy, the RR for AAs using DOACs compared to VKAs was 0.98 (95% CI 0.62,1.55; I 2 =0%; p=0.94), while the RR for the entire population was 0.90 (CI 0.78,1.04; I 2 =41%; p=0.1). Regarding safety, the RR for AAs using DOACs compared to VKAs was 0.83 (CI 0.56,1.25; I 2 =0%; p=0.92), while the RR for the entire population was 0.78 (CI 0.65,0.93; I 2 =76%; p<0.01). Conclusions: The use of DOACs versus VKAs in AF and VTE for AAs results in similar efficacy to the general population. DOACs are non-inferior to VKAs with respect to safety outcomes in AF and VTE for AAs. It is uncertain why superiority of safety outcomes seen in the general population are not seen in the AA population, and will require further studies.