Association Between Direct Oral Anticoagulant Score and Bleeding Events in Patients With Atrial Fibrillation Following Transcatheter Aortic Valve Replacement: A Retrospective Multicenter Cohort Study

Background The Direct Oral Anticoagulant (DOAC) Score can predict bleeding risk in patients with atrial fibrillation taking DOACs; however, it lacks external validation. Therefore, this study aimed to assess the association between the DOAC Score and bleeding events in patients with atrial fibrillation who underwent transcatheter aortic valve replacement. Methods and Results This retrospective multicenter cohort study included patients with atrial fibrillation who underwent transcatheter aortic valve replacement, as registered in a Japanese multicenter registry. The primary end point was the incidence of bleeding. Patients were categorized based on their DOAC Score: low and moderate‐ (≤7 points), high‐ (8–9 points), and very high‐risk (≥10 points) groups. Among 1230 patients (mean age 84.6±5.1 years; 457 men), 465 (37.8%) received a vitamin K antagonist, and the remaining patients received DOACs. The low and moderate‐, high‐, and very high‐risk groups included 380 (30.1%), 497 (40.4%), and 353 patients (28.7%), respectively. The 3‐year cumulative incidence of all bleeding events was significantly different among the 3 groups (low and moderate risk: 6.6%, high risk: 6.9%, and very high risk: 14.0%; P <0.01). Multivariable Cox regression analysis revealed that significant increments in the DOAC Score were associated with a risk of all bleeding events at 3 years in the overall cohort (hazard ratio [HR], 1.22 [95% CI, 1.08–1.38]; P <0.01), in the DOAC cohort (HR, 1.20 [95% CI, 1.01–1.42]; P =0.04), and in the vitamin K antagonist cohort (HR, 1.25 [95% CI, 1.04–1.50]; P =0.02). Conclusions The DOAC Score was significantly associated with bleeding events in patients with atrial fibrillation after transcatheter aortic valve replacement, aiding in clinical decision‐making for anticoagulant management. Registration URL: https://center6.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000023585 ; Unique identifier: UMIN000020423.