AUTHOR=Jeong Jonghyun , Heo Kyu-Nam , Lee Suhyun , Ah Young-Mi , Min Sangil , Han Ji Min , Lee Ju-Yeun TITLE=Exploring bleeding in oral anticoagulant users: assessing incidence by indications and risk factors in the entire nationwide cohort JOURNAL=Frontiers in Pharmacology VOLUME=Volume 15 - 2024 YEAR=2024 URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1399955 DOI=10.3389/fphar.2024.1399955 ISSN=1663-9812 ABSTRACT=Background: Oral anticoagulants (OACs) are essential for the prevention and treatment of thromboembolic disorders, but bleeding, a major complication, can have a fatal impact on the patient’s treatment. Objectives: We aimed to estimate the nationwide, real-world incidence rate of bleeding in patients taking OACs and to confirm the incidence by indications and risk factors. Methods: This cross-sectional study identified OAC users from April 1 to December 31 both 2019 and 2020 in the HIRA-NPS database. The primary outcome variables were the incidence rate of major bleeding events during OAC treatment and within 30 days of treatment end. We estimated the adjusted incidence rate ratio in subpopulations. Results: Among 18,822 OAC users, the incidence rate of major bleeding was 27.9 (95% CI, 24.6-31.5) per 1000 person-years. The incidence rate of major bleeding was higher in patients with a bleeding history at aIRR 11.51, high bleeding risk (HAS-BLED score ≥3) at aIRR 1.51, high CCI scores ≥3 at aIRR 1.88, and liver disease at aIRR 1.41. For indications, compared to patients with NVAF, the aIRR of major bleeding was significantly higher at aIRR 2.35 in patients undergoing VTE treatment. Patients with ischemic stroke showed a higher incidence of major bleeding at aIRR 2.35 compared to NVAF patients. The aIRR of major bleeding in the oral anticoagulant group compared to the matched control group was 2.25 (95% CI, 1.93-2.63). Conclusion: These findings may be useful in implementing strategies to improve the evaluation and management of anticoagulation-related bleeding.