Abstract
BACKGROUND: The direct-acting oral anticoagulant (DOAC) score has been validated for assessing the bleeding risk in patients with atrial fibrillation (AF). However, data on DOAC scores in patients undergoing percutaneous left atrial appendage closure (LAAC) is limited. This study aimed to evaluate the predictive impact of the DOAC score on clinical events following LAAC and compare it with that of the HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio [INR], Elderly [age ≥65 years], Drugs and alcohol concomitantly) score. METHODS: In this prospective, multicenter, observational study, patients with nonvalvular AF (NVAF) undergoing LAAC were categorized by the DOAC score into higher (HBR) and lower bleeding risk groups. The primary endpoints of all-cause death, stroke, and bleeding were evaluated at 3 months and 1 year. RESULTS: Among 1464 patients (mean age 77.1 years; 67.6% male), the HBR group (923 patients) had a lower body mass index, more frequent comorbidities, and higher risk profiles for bleeding and stroke. The device, technical, and procedural success rates were high and similar between groups. At 1 year, the primary endpoint was higher in the HBR group (17.6% vs 12.4%, P = 0.01), influenced by differences in bleeding events (10.9% vs 7.6%, P = 0.045). The DOAC score showed superior predictive value for the primary endpoint compared with the HAS-BLED score. CONCLUSIONS: The DOAC score is a reliable predictor of composite outcomes, including death, stroke, and bleeding, in patients undergoing LAAC, demonstrating superior utility compared with the HAS-BLED score. This scoring system may improve risk stratification and patient management in daily clinical practice. CLINICAL TRIAL REGISTRATION: UMIN-ID: UMIN000038498 (OCEAN-LAAC registry).