Effectiveness and safety of edoxaban therapy in daily-care patients with atrial fibrillation. Results from the DRESDEN NOAC REGISTRY. Issue 215 (July 2022) - Köhler, Christina
Abstract: Background: Edoxaban is a non-vitamin K dependent oral anticoagulant (NOAC) licensed for stroke prevention in atrial fibrillation (SPAF). Outcome data on clinical effectiveness and safety in routine care are increasing. Patients and methods: In the prospective, non-interventional DRESDEN NOAC REGISTRY a network of 230 physicians enrolled >5000 NOAC patients who received prospective central follow. All reported outcome events (stroke/transient ischemic attack/systemic embolism; ISTH bleeding; death) were adjudicated using standard definitions. Results: Between 2016 and 2021, 1258 SPAF patients receiving edoxaban were followed for 927.1 ± 562.2 days with a mean edoxaban exposure of 790.3 ± 577.2 days. Edoxaban was discontinued by 274 patients (10.1/100 patient-years; 95% CI 8.9–11.3). The combined endpoint of stroke/TIA/systemic embolism occurred at a rate of 1.7/100 patient-years (95% CI 1.3–2.3) in the intention-to-treat analysis and at 1.3/100 patient-years (95% CI 0.9–1.9) in the on-treatment analysis (censored 3 days after last edoxaban intake). On-treatment rates of ISTH major bleeding were comparable for patients receiving edoxaban 30 mg OD (3.6/100 patient-years; 95% CI 2.2–5.5) or 60 mg OD (2.5/100 patient-years; 95% CI 1.8–3.2). A total of 151 patients (12.0%) died (4.7/100 patient-years; 95% CI 4.0–5.5), with non-stroke cardiovascular events ( n = 50), infection/sepsis ( n = 40) and terminal malignant disease ( n = 31) being the leading causes of death. Conclusion: Overall rates of effectiveness and safety outcomes were in line with latest real-world data (such as ETNA-AF registry) and confirm findings of the phase-III ENGAGE-AF trial. Non-thrombotic cardiovascular events and infectious diseases were the leading causes of death, whereas fatal stroke and fatal bleeding were rare. Highlights: Patient profiles of our edoxaban atrial fibrillation cohort are consistent with trial data. Rates of effectiveness and safety outcomes were in line with latest real-world data. During 2.5 years of follow up, fatal stroke and fatal bleeding were rare outcomes. Long-term persistence to edoxaban treatment was >80%.