Abstract
Introduction: Oral anticoagulants reduce the risk of ischemic stroke but may increase the risk of bleeding in atrial fibrillation (AF) patients. However, the clinical outcomes of patients after major or non-major bleeding are unknown. Methods: In the Fushimi AF Registry, follow-up data were available in 4,470 patients by the end of September 2020. Major bleeding was defined according to the criteria of the International Society on Thrombosis and Haemostasis. We investigated the demographics and outcomes of AF patients who experienced major bleeding and clinically relevant non-major bleeding (CRNM) during follow-up period. Results: During the median follow-up period of 1,459 days, major bleeding and CRNM occurred in 350 (7.8%) and 719 patients (16.1%) as first bleeding event, respectively. Patients with major bleeding were older (major vs CRNM vs no-bleeding; 75.6 vs 73.9 vs 73.3, p=0.001), and more likely to have chronic kidney disease (44.6% vs 35.2% vs 35.1%, p=0.002), previous major bleeding (8.0% vs 3.5% vs 4.4%, p=0.006). Patients with major bleeding had higher CHADS 2 score (2.3 vs 2.0 vs 2.0, p<0.001), higher CHA 2 DS 2 -VASC score (3.7 vs 3.4 vs 3.3, p=0.001), and higher HAS-BLED score (2.0 vs 1.8 vs 1.7, p<0.001). On landmark analysis, all-cause mortality occurred in 137 patients after major bleeding (15.8 /100 person-years), 134 patients after CRNM (5.3 /100 person-years), and 803 patients without bleeding during follow-up period (5.2 /100 person-years) (hazard ratio [HR] 2.68, 95% confidence interval [CI] 2.24-3.22, p<0.0001 [major bleeding vs. no-bleeding]; HR 0.97, 95%CI 0.81-1.17, p=0.761 [CRNM vs. no-bleeding]). (Figure) Conclusion: AF patients after major bleeding had significantly higher incidence of all-cause mortality, but those after CRNM did not have significant incidence of all-cause mortality in a community-based AF cohort.
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