AIMS: The 2020 European Society of Cardiology (ESC)-atrial fibrillation (AF) guidelines recommend a risk-based approach to oral anticoagulation (OAC) therapy in patients with AF; however, it is unknown if current practice aligns with these recommendations. This study assessed the associated effectiveness and safety of edoxaban in patients with AF according to the 2020 ESC-AF guidelines and the approved label in routine clinical care. METHODS AND RESULTS: The Global ETNA-AF programme is a large prospective, noninterventional programme evaluating safety and effectiveness of edoxaban. Baseline characteristics and 2-year clinical event data were analysed in subgroups, defined by ESC-AF guidelines indication of OAC therapy according to CHA2DS2-VASc score [no OAC to be considered, OAC should be considered (2 for females/1 for males), and OAC recommended (≥3 for females/≥2 for males)] and modified HAS-BLED score [(≥3 (bleeding risk high) vs. <3 (bleeding risk low)]. Of 19 960 patients included, 16 912 (84.7%) were categorized as OAC recommended and 2501 (12.5%) as OAC should be considered; 547 (2.7%) were in the no OAC to be considered group. In the OAC recommended group, 12 006 (71.0%) had high bleeding risk. Clinical event rates were <5%/year across all risk groups, even in the OAC recommended and high bleeding risk groups. In the OAC recommended and high bleeding risk groups, patients had low ischaemic stroke and bleeding event rates, regardless of receiving the 30 or 60 mg dose. CONCLUSION: This study demonstrated that edoxaban use in patients with AF largely aligns with 2020 ESC-AF guidelines, while maintaining low clinical event rates. REGISTRATION: Europe (NCT02944019), Japan (UMIN000017011), and Korea/Taiwan (NCT02951039).

Center for Cardiovascular Research University of Birmingham and SWBH and UHB NHS Trusts Birmingham B15 2TT UK

Chair of Cardiology University of Pisa and Cardiology 1 Division Pisa University Hospital Via Paradisa 2 Pisa 56125 Italy

Daiichi Sankyo Europe GmbH Zielstattstraße 48 Munich 81379 Germany

Daiichi Sankyo Inc 211 Mt Airy Rd Basking Ridge NJ 07920 USA

Department of Cardiology University Heart and Vascular Center Hamburg Martinistraße 52 Hamburg 20246 Germany

Department of Cardiovascular Medicine The Cardiovascular Institute 3 2 19 Nishiazabu Minato ku Tokyo 106 0031 Japan

Department of Surgery Medical Molecular and Critical Area Pathology University of Pisa Via Paradisa 2 Pisa 50124 Italy

Division of Cardiology Department of Internal Medicine Chang Gung University and Chang Gung Memorial Hospital No 5 Fuxing St Guishan District Taoyuan 333 Taiwan

Fondazione VillaSerena per la Ricerca Via Leonardo Petruzzi 42 Città Sant'Angelo Pescara 65013 Italy

German Center for Cardiovascular Research Partner Site Hamburg Kiel Lübeck Lübeck Germany

Institute of Computer Science of the Academy of Sciences of the Czech Republic Pod Vodárenskou věží 2 Prague 18200 Czech Republic

National Hospital Organization Osaka National Hospital 2 Chome 1 14 Hoenzaka Chuo Ward Osaka 540 0006 Japan

Universitäres Herzzentrum Hamburg Eppendorf Martinistraße 52 Hamburg 20246 Germany

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ClinicalTrials.gov
NCT02951039