A real-world evaluation of the safety of edoxaban in frail older adults with non-valvular atrial fibrillation

BACKGROUND: Despite available observational data and post hoc analyses, the underprescription of DOACs in frail older adults and their underrepresentation in randomized trials have resulted in a still limited evidence base. OBJECTIVE: To evaluate the safety of edoxaban in frail older patients in routine clinical practice in Spain. MATERIALS AND METHODS: EDO-FRAG-001 was a multicenter, prospective, observational, real-world, single-cohort study with 12 months of follow-up. Patients aged ≥75 years with non-valvular atrial fibrillation (NVAF), a FRAIL scale score between 3 and 5, and those who initiated edoxaban within the previous 6 months were enrolled. RESULTS: A total of 411 patients (63% women) were included, with a median age of 87 years. Fifty-five percent had previously received vitamin K antagonists. Edoxaban was prescribed according to the drug label in 89.1% of patients. During follow-up, 31 patients experienced major bleeding events [annualized rate: 8.7% (95% CI: 5.8-11.6)], and 5 individuals developed an ischemic stroke or systemic embolism [1.1% (95% CI: 0.1-2.2)]. One-year all-cause mortality was 18.8% (95% CI: 15.1-22.5), and cardiovascular mortality accounted for 8.7% (95% CI: 6.2-11.2). The incidence of bleeding-related death was 2.0% (95% CI: 0.5-3.5). CONCLUSION: This real-world study supports that the use of edoxaban in frail older adults with NVAF is associated with an acceptable rate of bleeding and stroke. Age and frailty alone should not preclude anticoagulation when treatment is carefully individualized.