A review of the real-world incidence of major bleeding after anticoagulant use in atrial fibrillation patients in the United States
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OBJECTIVE: To comprehensively review real-world database studies in the United States that assess the risk of major bleeding among direct oral anticoagulant (DOAC) therapies or warfarin in a nonvalvular atrial fibrillation (NVAF) population. BACKGROUND: NVAF patients receiving anticoagulant therapy to reduce the risk of stroke or blood clots are at a higher risk of serious bleeding complications with the use of warfarin or other anticoagulant agents. METHODS: Reviewed MEDLINE (via Pubmed) and bibliographies of identified literature for publications and conference abstracts of retrospective observational studies using U.S. data sources from the first available date to June 15th, 2018. RESULTS: A total of 26 real-world database studies were identified and fully reviewed. Most studies utilized data from administrative claims or forms of patient registries (n = 25). Patient populations assessed were generally older and male. Apixaban resulted in statistically significant reductions in bleeding risk compared to warfarin in most studies that assessed the relationship (n = 11). Dabigatran was less consistently shown to exhibit a lower bleeding risk compared to warfarin; nine studies reported lower risk, though only three studies were statistically significant. In a head-to-head comparison, however, apixaban and dabigatran generally showed no significant difference. Bleeding risk for rivaroxaban was similar to warfarin. No studies were found that evaluated the bleeding risk of edoxaban. CONCLUSIONS: Overall, DOACs exhibit a lower risk of major bleeding compared to warfarin, although with significantly different rates. Apixaban most consistently shows reduced risk of bleeding in the real-world compared to warfarin, followed by dabigatran. More evidence is needed to evaluate the recently approved agent edoxaban.