Edoxaban veilig en effectief bij atriumfibrilleren met nierfunctiestoornis — ETNA-AF-Europe

BACKGROUND: Non-vitamin K oral anticoagulants, like edoxaban, are essential in managing atrial fibrillation (AF). The impact of renal function on edoxaban dosages in real-world settings remains unclear. This 4-year ETNA-AF-Europe study follow-up analysis investigated how chronic kidney disease (CKD) stages affect the safety and effectiveness of usual edoxaban doses. METHODS: ETNA-AF-Europe (NCT02944019) was an observational study conducted from 2016 to 2022 across 776 centres in 10 European countries. Hazard ratios (HR) and annualized event rates were calculated for all-cause death, cardiovascular (CV) death, stroke and bleeding events for the overall population and participants stratified by dose (30/60 mg) and CKD stages at baseline. RESULTS: Of the 13,164 participants in the full analysis set, 9114 participants with CKD (Stage 1, n = 2064; Stage 2, n = 4855; Stage 3, n = 1985; Stage 4, n = 135; missing, n = 75) received label-recommended edoxaban doses. Compared with CKD Stage 1, higher CKD stages were associated with increased risks for stroke (Stage 3: HR [95% CI]: 1.889 [1.240-2.878], p = 0.003) and CV death (HR [95% CI]; Stage 4: 14.450 [8.270-25.247], Stage 3: 4.672 [3.312-6.969], Stage 2: 2.066 [1.394-3.062], all p < 0.001). All-cause death followed a similar trend. After adjusting for age, sex, body weight, CHA2DS2-VASc and modified HAS-BLED scores, most bleeding and effectiveness outcomes showed no nominally significant differences across CKD stages. CONCLUSIONS: Edoxaban in patients with AF is effective and well tolerated across CKD stages and appropriate label dosing can offset the risk from renal impairment.