Edoxaban treatment in routine clinical care for atrial fibrillation resulted in low 2-year event rates, with stroke or systemic embolism occurring in 0.70% and major bleeding in 0.97% of patients.
Observational (n=13,133)
Yes
What are the 2-year clinical outcomes and predictors of stroke, bleeding, and death in patients with atrial fibrillation treated with edoxaban in routine care?
Real-world data from the ETNA-AF Europe registry demonstrate low 2-year rates of stroke and major bleeding in unselected atrial fibrillation patients treated with edoxaban.
AIMS: Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. METHODS AND RESULTS: The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P < 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P < 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P < 0.0001) and cardiovascular death (Wald χ2: 100.38; P < 0.0001). CONCLUSION: Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively.
Kirchhof et al. (2022) conducted an observational in Non-Valvular Atrial Fibrillation (n=13,133). Edoxaban was evaluated on stroke or systemic embolic events (SEE). Edoxaban treatment in routine clinical care for atrial fibrillation resulted in low 2-year event rates, with stroke or systemic embolism occurring in 0.70% and major bleeding in 0.97% of patients.