Abstract
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 CHA(2)DS(2)-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).