
Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The available routine care data have demonstrated the safety of different NOACs; however, such data for edoxaban are scarce. Here, we report baseline characteristics of 13,638 edoxaban-treated patients with AF enrolled between November 2016 and February 2018.ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study conducted in 825 sites in 10 European countries. Patients will be followed up for four years.Overall, 13,980 patients were enrolled of which 342 patients were excluded from the analysis. Mean patient age was 73.6 years with an average creatinine clearance of 69.4 mL/min. 56.6% were male. The calculated CHA2DS2-VASc and HAS-BLED mean scores were 3.1 and 2.6, respectively. Overall, 3.3, 14.6 and 82.0% of patients had low (CHA2DS2-VASc = 0), intermediate (CHA2DS2-VASc = 1) and high (CHA2DS2-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2DS2-VASc ≥4) comprised 38.4% of the overall population. For 75.1% of patients edoxaban was their first anticoagulant prescription, whilst 16.9% switched from a VKA and 8.0% from another NOAC. A total of 23.4% of patients in ETNA-AF-Europe received the reduced dose of edoxaban 30 mg. Overall, 83.8% of patients received an edoxaban dose in line with the criteria outlined in the label.Edoxaban was predominantly initiated in older, often anticoagulation-naïve, unselected European patients with AF, with a good overall adherence to the approved label.NCT02944019; Date of registration: October 24, 2016.
Male, Registry, Time Factors, Pyridines, Administration, Oral, 610 Medicine & health, Hemorrhage, Major bleeding, Risk Assessment, 2705 Cardiology and Cardiovascular Medicine, Risk Factors, Stroke prevention, Atrial Fibrillation, Product Surveillance, Postmarketing, Diseases of the circulatory (Cardiovascular) system, Humans, Registries, Practice Patterns, Physicians', Aged, Drug Labeling, Aged, 80 and over, Safety outcomes, Non-vitamin K antagonist oral anticoagulants, Real-world, Registry, Stroke prevention, Majorbleeding, Safety outcomes, Middle Aged, Drug Utilization, Stroke, Europe, Thiazoles, Treatment Outcome, Real-world, REGISTRY, RC666-701, Practice Guidelines as Topic, 10209 Clinic for Cardiology, Non-vitamin K antagonist oral anticoagulants, Female, stroke prevention, Guideline Adherence, Research Article, Factor Xa Inhibitors
Male, Registry, Time Factors, Pyridines, Administration, Oral, 610 Medicine & health, Hemorrhage, Major bleeding, Risk Assessment, 2705 Cardiology and Cardiovascular Medicine, Risk Factors, Stroke prevention, Atrial Fibrillation, Product Surveillance, Postmarketing, Diseases of the circulatory (Cardiovascular) system, Humans, Registries, Practice Patterns, Physicians', Aged, Drug Labeling, Aged, 80 and over, Safety outcomes, Non-vitamin K antagonist oral anticoagulants, Real-world, Registry, Stroke prevention, Majorbleeding, Safety outcomes, Middle Aged, Drug Utilization, Stroke, Europe, Thiazoles, Treatment Outcome, Real-world, REGISTRY, RC666-701, Practice Guidelines as Topic, 10209 Clinic for Cardiology, Non-vitamin K antagonist oral anticoagulants, Female, stroke prevention, Guideline Adherence, Research Article, Factor Xa Inhibitors
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