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).

• Publikační typ
• časopisecké články MeSH

AIMS: Heart failure (HF) is a risk factor for major adverse events in atrial fibrillation (AF). Whether this risk persists on non-vitamin K antagonist oral anticoagulants (NOACs) and varies according to left ventricular ejection fraction (LVEF) is debated. METHODS AND RESULTS: We investigated the relation of HF in the ETNA-AF-Europe registry, a prospective, multicentre, observational study with an overall 4-year follow-up of edoxaban-treated AF patients. We report 2-year follow-up for ischaemic stroke/transient ischaemic attack (TIA)/systemic embolic events (SEE), major bleeding, and mortality. Of the 13 133 patients, 1854 (14.1%) had HF. Left ventricular ejection fraction was available for 82.4% of HF patients and was <40% in 671 (43.9%) and ≥40% in 857 (56.1%). Patients with HF were older, more often men, and had more comorbidities. Annualized event rates (AnERs) of any stroke/SEE were 0.86%/year and 0.67%/year in patients with and without HF. Compared with patients without HF, those with HF also had higher AnERs for major bleeding (1.73%/year vs. 0.86%/year) and all-cause death (8.30%/year vs. 3.17%/year). Multivariate Cox proportional models confirmed HF as a significant predictor of major bleeding [hazard ratio (HR) 1.65, 95% confidence interval (CI): 1.20-2.26] and all-cause death [HF with LVEF <40% (HR 2.42, 95% CI: 1.95-3.00) and HF with LVEF ≥40% (HR 1.80, 95% CI: 1.45-2.23)] but not of ischaemic stroke/TIA/SEE. CONCLUSION: Anticoagulated patients with HF at baseline featured higher rates of major bleeding and all-cause death, requiring optimized management and novel preventive strategies. NOAC treatment was similarly effective in reducing risk of ischaemic events in patients with or without concomitant HF.

• MeSH
• antikoagulancia škodlivé účinky   MeSH
• aplikace orální MeSH
• cévní mozková příhoda * diagnóza   epidemiologie   etiologie   MeSH
• embolie * MeSH
• fibrilace síní * komplikace   diagnóza   farmakoterapie   MeSH
• funkce levé komory srdeční MeSH
• ischemická cévní mozková příhoda * MeSH
• ischemie mozku * MeSH
• krvácení chemicky indukované   MeSH
• lidé MeSH
• prospektivní studie MeSH
• registrace MeSH
• srdeční selhání * diagnóza   epidemiologie   MeSH
• tepový objem fyziologie   MeSH
• tranzitorní ischemická ataka * diagnóza   epidemiologie   prevence a kontrola   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH

• MeSH
• cévní endotel patofyziologie   MeSH
• krev MeSH
• nemoci cév MeSH
• Publikační typ
• monografie MeSH

• Konspekt
• Patologie. Klinická medicína
• NLK Obory
• angiologie
• kardiologie
• fyziologie

• MeSH
• farmakoterapie MeSH
• fibrinolytika MeSH
• léčivé přípravky MeSH
• trombóza terapie   MeSH

• Konspekt
• Patologie. Klinická medicína
• NLK Obory
• hematologie a transfuzní lékařství
• angiologie
• NLK Publikační typ
• kolektivní monografie