Abstract

Introduction: Atrial fibrillation (Afib), a major cause of morbidity and mortality, particularly affects the elderly. Direct oral anticoagulants (DOACs), despite being the preferred stroke risk reduction treatment in Afib patients, often result in gastrointestinal bleeding. This study aims to examine the incidence of this side effect across age and racial groups. Hypothesis: The risk of gastrointestinal bleeding while on DOACs increases with age. Racial variation in GI bleeding in Afib patients taking DOACs exists due to non-modifiable and modifiable risk factors. Methods: Utilizing the 'All of Us' national database, we conducted a retrospective cohort study of 6,961 Afib patients who started DOACs from 2018 to 2023. EHR data including ICD-9/10 codes and medication history were used to conduct the analysis. Patients who developed gastrointestinal bleeding after the introduction of DOACs within this period were identified. Incidence rates were further analyzed according to age and race. Results: Out of 6,961 Afib patients on DOACs, 791 developed gastrointestinal bleeding (21.9 cases per 1000 person-year). The incidence rate was highest among patients aged under 50 years (36.8 cases per 1000 person-year) and those over 80 years (24.0 cases per 1000 person-year). Patients aged 60-70 years had the lowest incidence rate (19.7 cases per 1000 person-year). Racial analysis revealed African-Americans had the highest incidence rates (29.3 cases per 1000 person-year), followed by Asians (21.9 cases per 1000 person-year), and Whites (19.6 cases per 1000 person-year; p<0.001). Conclusions: Our study revealed a bimodal peak in GI bleeding incidence in patients on DOACs for Afib, with heightened risk in those under 50 years and above 80 years. Racial disparities were also evident, with African-Americans at the highest risk. These findings underscore the need for further research to elucidate risk factors, particularly in younger patients and specific racial groups.

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