The Duration of Anticoagulant Treatment and Its Association with HRQoL and Treatment Satisfaction in Patients with AF after TAVR: Results from ENVISAGE- TAVI AF

Introduction: The ENVISAGE-TAVI AF (NCT02943785) trial compared edoxaban vs vitamin K antagonists in patients with atrial fibrillation (AF) after successful transcatheter aortic valve replacement (TAVR). The association between anticoagulation treatment duration and patient-reported outcomes (PROs) and treatment satisfaction is unclear. Hypothesis : Longer duration of anticoagulation treatment may be positively associated with PROs and treatment satisfaction in patients from ENVISAGE-TAVI AF. Methods: HRQoL and treatment satisfaction were assessed by EQ-5D-3L, EQ-5D visual analogue scale (EQ-VAS), and the Perception Anticoagulant Treatment Questionnaire (PACT-Q). Patients were grouped by treatment duration: <6 months, 6 month-1 year (yr), 1-1.5 yrs, 1.5-2 yrs, and >2 yrs. A mixed-effect model for repeated measures assessed least square (LS) mean differences between treatment durations while controlling for relevant covariates. Results: Of 1426 patients enrolled in ENVISAGE-TAVI AF, 1147 (80.4%) and 1107 (77.4%) were included in the EQ-5D-5L and PACT-Q analysis sets. Baseline characteristics were similar across the treatment durations ( Table ). In patients receiving treatment >1.5 years, LS mean scores for EQ-5D-5L utility index ( P = 0.012) and EQ-VAS ( P = 0.002) at month 3 were significantly higher than those treated for <6 months. Prolonged treatment duration was associated with improved HRQoL and treatment satisfaction ( Figure ). Conclusions: Patients with AF and longer treatment duration after TAVR reported significantly higher HRQoL and treatment satisfaction vs shorter treatment duration. Further research is needed to determine causal effects.