Abstract
BACKGROUND: There are sparse data to guide resumption of direct oral anticoagulants (DOACs) versus warfarin in patients with atrial fibrillation (AF) who survive a major gastrointestinal bleeding (GIB) event. OBJECTIVE: To compare the risk-benefit profile of restarting DOACs versus warfarin among patients with AF following hospitalization for major GIB. METHODS: Using claims submitted to a commercial health insurance database from January 2010 to December 2017, we identified adult patients with AF hospitalized for a major GIB while receiving oral anticoagulants. Eligible patients were required to have survived and restarted oral anticoagulation with DOACs or warfarin within 90 days following hospital discharge for major GIB. The outcomes of interest were subsequent hospitalization for major bleeding, hospitalization for ischemic stroke/systemic embolism (SE), all-cause mortality, and net adverse clinical effect (NACE), which was a composite of all-cause mortality, hospitalization for ischemic stroke/SE, and hospitalization for major bleeding. Stabilized inverse probability of treatment weighting was used to balance measured covariates. RESULTS: Overall, 4,389 patients resumed oral anticoagulation, with 3016 (68.7%) on warfarin and 1373 (31.3%) on DOACs, within 90 days of hospital discharge for major GIB. The median (interquartile range) time from hospital discharge for major GIB to resumption of oral anticoagulant was 24 (10, 47) days. The weighted hazards ratio (HR) among individuals that resumed DOACs versus warfarin after major GIB was 0.76 (95% confidence interval, CI: 0.60, 0.96) for subsequent hospitalization for major bleeding, 0.91 (95% CI: 0.53, 1.55) for subsequent hospitalization for ischemic stroke/SE, and 0.83 (95% CI: 0.72, 0.97) for NACE. CONCLUSIONS: Among patients with AF who survived and resumed oral anticoagulation within the first 90 days after hospitalization for a major GIB event, restarting oral anticoagulation treatment with DOACs was associated with a lower risk of subsequent hospitalization for major bleeding and the composite outcome of ischemic stroke, SE, all-cause mortality, and recurrent or incident major bleeding.