Edoxaban for stroke prevention in atrial fibrillation and age-adjusted predictors of clinical outcomes in routine clinical care

Author:

Kirchhof Paulus123ORCID,Pecen Ladislav4ORCID,Bakhai Ameet5,de Asmundis Carlo6,de Groot Joris R78,Deharo Jean Claude9,Kelly Peter10,Levy Pierre11,Lopez-de-Sa Esteban12,Monteiro Pedro13,Steffel Jan14ORCID,Waltenberger Johannes1516ORCID,Weiss Thomas W17,Laeis Petra18,Manu Marius Constantin18,Souza José18,De Caterina Raffaele19ORCID

Affiliation:

1. Institute of Cardiovascular Sciences, University of Birmingham , IBR 136, Wolfson Drive, Birmingham B15 2TT , UK

2. Department of Cardiology, University Heart and Vascular Centre Hamburg, University Medical Centre Hamburg Eppendorf , Martinistraße 52, 20246 Hamburg , Germany

3. German Center for Cardiovascular Sciences (DZHK) , partner site Hamburg/Kiel/Lübeck, Germany

4. Department of Statistical Modelling, Institute of Computer Science of the Czech Academy of Sciences , Pod Vodarenskou vezi 271/2, 182 07 Prague , Czech Republic

5. Department of Cardiology, Royal Free London NHS Foundation Trust , Pond Street, London NW3 2QG , UK

6. Heart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel , Laarbeeklaan 101, 1090 Jette, Brussels , Belgium

7. Amsterdam UMC location University of Amsterdam , Cardiology, Meibergrdreef 9, 1105 AZ Amsterdam , the Netherlands

8. Amsterdam Cardiovascular Sciences, Heart Failure and Arrhythmias , 1105 AZ Amsterdam , the Netherlands

9. AP-HM, Aix Marseille University, Hospital Timone, Cardiologie, Rythmologie , 264 rue Saint-Pierre, 13005, Marseille , France

10. Department of Neurology, HRB Stroke Clinical Trials Network Ireland, University College Dublin/Mater Misericordiae University Hospital , Eccles St, Northside, D07 R2WY Dublin , Ireland

11. Department of Economics, Universite Paris-Dauphine, PSL Research University , LEDa-LEGOS, 75775 Paris , France

12. Cardiological Intensive Care Unit, Cardiology Service, Hospital Universitario La Paz , IDIPAZ, CIBERCV, 28046 Madrid , Spain

13. Department of Cardiology, Centro Hospitalar e Universitario de Coimbra , Praceta Mota Pinto 3000-075 Coimbra , Portugal

14. Department of Cardiology and Invasive Electrophysiology, Heart Clinic Hirslanden , Witellikerstrasse 40, 8032 Zürich , Switzerland

15. Chair of Cardiology and Vascular Medicine, University of Munster , Schlossplatz 2, 48149 Munster , Germany

16. Diagnostic and Therapeutic Heart Center , Kappelistr. 35, 8002 Zurich , Switzerland

17. Institute for Cardiometabolic Diseases , Karl Landsteiner Society, 3100 St. Polten, Austria

18. Daiichi Sankyo Europe GmbH , Zielstattstr. 48, 81379 Munich , Germany

19. Department of Surgical, Medical, Molecular Pathology and Critical Care Medicine, University of Pisa, First Division of Cardiology, Pisa University Hospital, 56124 Pisa, Italy; and Fondazione VillaSerena per la Ricerca , Città Sant'Angelo, Pescara , Italy

Abstract

Abstract Aims Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes. Methods and results The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P < 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P < 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P < 0.0001) and cardiovascular death (Wald χ2: 100.38; P < 0.0001). Conclusion Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively.

Funder

Daiichi Sankyo Company

GmbH

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Cardiology and Cardiovascular Medicine

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