Edoxaban Safety and Effectiveness in Real-Life Patients with Heart Failure and Atrial Fibrillation: EMAYIC Study

Background/Objectives: Real-world data about clinical characteristics and edoxaban performance in patients with heart failure (HF) and atrial fibrillation (AF) are lacking. The EMAYIC study aimed to assess and compare the profile and cardiovascular outcomes in those patients according to HF subtypes based on left ventricular ejection fraction (LVEF). Methods: Multicentre, prospective (follow-up: 12 months), observational study. Consecutive adult patients were included at cardiology and internal medicine clinics across Spain with HF (NT-proBNP > 600 pg/mL) and AF, receiving edoxaban as per routine clinical practice. Incidence of major or clinically relevant non-major (CRNM) bleeding and composite of incidence of stroke or systemic embolism (SE) were assessed according to HF subtypes: reduced (HFrEF, LVEF < 40%), mildly reduced (HFmrEF, LVEF40-49%), and preserved (HFpEF, LVEF ≥ 50%) left ventricular ejection fraction. Results: Between March 2021 and January 2022, 497 patients were enrolled (HFrEF: 30.4%, HFmrEF: 17.3%, HFpEF: 52.3%). The median age was 76.3 years, 57.9% were male, and the mean CHA2DS2-VASc score was 4. A 60 mg edoxaban dose was prescribed in 70% of patients. The observed rate of bleeding was 6.6% (95% CI: 4.5-9.3%), without differences across HF subtypes (HFrEF: 7.5%, HFmrEF: 3.6%, HFpEF: 7.1%; p = 0.474). Intracranial bleeding occurred in one patient (HFrEF). Stroke occurred in seven patients (1.5%) (HFrEF: 3, HFmrEF: 1, HFpEF: 3), two cases of which were fatal (HFrEF: 1, HFpEF: 1). No SE events were reported. Cardiovascular death occurred in 19 patients (4.1%) (HFrEF: 4.8%, HFmrEF: 3.6%, HFpEF: 3.8%; p = 0.871). Conclusions: This study evidences a low incidence of major or CRNM bleeding in patients with HF and AF treated with edoxaban, regardless of HF subtype. Low rates of stroke (1.5%) and SE events (0%) were assessed.