Major Bleeding Risk Assessment With Atrial Fibrillation Post-TAVR

BACKGROUND: Estimating the probability of major bleeding (MB) in patients with atrial fibrillation (AF) after transcatheter aortic valve replacement (TAVR) is important for decision-making regarding anticoagulation strategy. OBJECTIVES: The aim of this study was to identify independent predictors of MB to create a risk assessment score in patients with AF after successful TAVR. METHODS: In this ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and their effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation-in Atrial Fibrillation; NCT02943785) on-treatment analysis, a stepwise Cox regression model identified MB predictors from baseline patient characteristics. A simple point-based additive score was constructed using the variable β estimates from the selected model. Patients were stratified into low-, moderate-, and high-risk groups according to their risk assessment scores; the likelihood of MB was compared between groups. RESULTS: Among 1,377 patients, 139 (10.1%) experienced MB (mean ± SD on-treatment follow-up: 1.3 ± 0.8 years). The independent predictors of MB formed the HARHP (low Hemoglobin, excessive Alcohol use, severe Renal impairment, history of Hypercholesterolemia, and Percutaneous coronary intervention performed within 30 days of TAVR) score, with each parameter given a weight of 1 or 2. The likelihood of MB for high-risk patients (score ≥ 4) was 6.5 times higher than for low-risk patients (score = 0 or 1) (HR: 6.54; 95% CI: 3.61-11.85; P < 0.0001) and 2.9 times higher than moderate-risk patients (score = 2 or 3) (HR: 2.86; 95% CI: 1.62-5.04; P = 0.0003). The C statistic for the HARHP score was 0.63 at 1-year follow-up and 0.62 at 2-year follow-up. CONCLUSIONS: Five independent predictors of long-term MB were identified in patients with AF requiring oral anticoagulant agents after TAVR and formed the HARHP score to assess MB risk. Use of the HARHP score may improve patient outcomes.