Long-term effectiveness and safety of edoxaban in patients with atrial fibrillation: 4-year data from the ETNA-AF-Europe study.
| Autor: | Kirchhof P; Institute of Cardiovascular Sciences, University of Birmingham, IBR 136, Wolfson Drive, Birmingham B15 2TT, UK; Department of Cardiology, University Heart and Vascular Centre Hamburg, University Medical Centre Hamburg Eppendorf, Martinistraße 52, Hamburg 20246, Germany; German Center for Cardiovascular Sciences (DZHK), Partner Site Hamburg/Kiel/Lübeck, Germany., Bakhai A; Department of Cardiology, Royal Free London NHS Foundation Trust, Pond Street, London NW3 2QG, UK., de Asmundis C; Heart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Belgium., de Groot JR; Amsterdam UMC location University of Amsterdam, Cardiology, Meibergdreef 9, Amsterdam 1105 AZ, the Netherlands; Amsterdam Cardiovascular Sciences, Heart Failure and Arrhythmias, Amsterdam 1105 AZ, the Netherlands., Deharo JC; AP-HM, Aix Marseille University, Hospital Timone, Cardiologie, Rythmologie, 264 rue Saint-Pierre, Marseille 13005, France., Kelly P; Department of Neurology, HRB Stroke Clinical Trials Network Ireland, University College Dublin/Mater Misericordiae University Hospital, Eccles St, Northside, Dublin, Ireland., Lopez-de-Sa E; Cardiology Department, Hospital Universitario La Paz, IDIPAZ, Madrid 28046, Spain., Monteiro P; Department of Cardiology, Centro Hospitalar e Universitario de Coimbra, Praceta Mota Pinto 3000-075, Coimbra, Portugal., Fronk EM; Daiichi Sankyo Europe GmbH, Zielstattstr. 48, Munich 81379, Germany., Lamparter M; Daiichi Sankyo Europe GmbH, Zielstattstr. 48, Munich 81379, Germany., Laeis P; Daiichi Sankyo Europe GmbH, Zielstattstr. 48, Munich 81379, Germany., Smolnik R; Daiichi Sankyo Europe GmbH, Zielstattstr. 48, Munich 81379, Germany., Steffel J; University of Zurich, Zurich, Switzerland., Waltenberger J; Chair of Cardiology and Vascular Medicine, University of Münster, Schlossplatz 2, Münster 48149, Germany; Diagnostic and Therapeutic Heart Center, Kappelistr. 35, Zurich 8002, Switzerland., Weiss TW; Institute for Cardiometabolic Diseases, Karl Landsteiner Society, St. Polten, Austria., De Caterina R; Chair of Cardiology, University of Pisa, and Cardiology Division, Pisa University Hospital, 56124 Pisa, Italy; and Fondazione VillaSerena per la Ricerca, Città Sant'Angelo, Pescara, Italy. Electronic address: raffaele.decaterina@unipi.it. |
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| Jazyk: | angličtina |
| Zdroj: | International journal of cardiology [Int J Cardiol] 2024 Aug 01; Vol. 408, pp. 132118. Date of Electronic Publication: 2024 Apr 30. |
| DOI: | 10.1016/j.ijcard.2024.132118 |
| Abstrakt: | Background: To assess long-term effectiveness and safety of edoxaban in Europe. Methods and Results: ETNA-AF-Europe, a prospective, multinational, multi-centre, post-authorisation, observational study was conducted in agreement with the European Medicines Agency. The primary and secondary objectives assessed real-world safety (including bleeding and deaths) and effectiveness (including stroke, systemic embolic events and clinical edoxaban use), respectively. Median (interquartile range) age of the 13,164 patients was 75.0 (68.0-80.0) years; CHA Conclusions: In European patients with AF, long-term therapy with edoxaban is associated with low and relatively constant annualised rates of stroke and major bleeding. Differences in outcomes between the two approved doses are attributable to differences in clinical characteristics. Competing Interests: Declaration of competing interest P.K. receives research support for basic, translational, and clinical research projects from European Union Big- Data@Heart (grant agreement EU IMI 116074) CATCH ME (grant agreement ID: 633196) AFFECT-EU (grant agreement ID: 847770); Leducq foundation, Medical Research Council (UK); German Centre for Cardiovascular Research supported by the German Ministry of Education and Research; from several drug and device companies active in atrial fibrillation and has received honoraria from several such companies in the past, but not in the last three years. P.K. is listed as inventor on two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). P.K. is employed as Director of the Department of Cardiology, University Heart and Vascular Centre UKE Hamburg and Professor of Cardiovascular Medicine (part-time), University of Birmingham, UK. He is Speaker of the board of AFNET, Germany, and Board member of the ESC. A.B. is founder and clinical trial design advisor of Amore Health Ltd., reports support from Daiichi Sankyo for attending meetings and advisory boards; receives honorarium from Daiichi Sankyo, Pfizer, BMS, Bayer, Novartis, Roche, Napp, Boehringer Ingelheim for lecturing and scientific advice outside the submitted work. C.d.A. has received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Atricure, Biosense Webster, Boston Scientific, Acutus Medical and research grants on behalf of the centre from Biotronik, Medtronic Abbott, Microport, Boston Scientific, Biosense Webster, Acutus Medical. J.R.d.G. reports personal fees from Daiichi Sankyo during the conduct of the study; grants from Abbott, Atricure, Bayer, Boston Scientific, Daiichi Sankyo, Johnson & Johnson and Medtronic; personal fees from Atricure, Bayer, Berlin Chemie, Daiichi Sankyo, Johnson & Johnson, Menarini, Medtronic, Novartis, and Servier; and other from RhythmCARE outside the submitted work. J.C.D. has received honoraria for lectures from Bayer, Boehringer Ingelheim, and Bristol Myers Squibb. J.C.D. has also received research grants from Boston Scientific, Sorin Group, Biotronik, and Abbott. P.K. has received speaker's and committee membership from Daiichi Sankyo, and received consulting fee (<€5000) from Alexion and Novo Nordisk. He is the Lead Investigator of the HRB Stroke Clinical Trials Network Ireland, which has received grant funding from the Irish government, Irish Heart Foundation, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Pfizer, Bristol Myers Squibb, Amgen, and A Menarini. E.L.-d.-S. reports personal fees from Daiichi Sankyo; grants and personal fees from Servier, ZOLL Medical, and Becton Dickinson; grants from AstraZeneca, MedImmune LLC and Novartis, during the conduct of the study. P.M. is an ETNA-AF investigator and has received lecture and research fees from Daiichi Sankyo, Bayer, Boehringer Ingelheim, and Pfizer/BMS. E.-M.F., M.L., P.L., and R.S. are employees of Daiichi Sankyo Europe GmbH, Munich, Germany. J.S. has received consultant and/or speaker fees from Abbott, Alexion, Astra-Zeneca, Bayer, Berlin-Chemie, Biosense Webster, Biotronik, Boehringer-Ingelheim, Boston Scientific, BMS, Daiichi Sankyo, Medscape, Medtronic, Menarini, Merck/MSD, Organon, Pfizer, Saja, Servier, and WebMD. He reports ownership of Swiss EP and CorXL. J.W. reports personal fees and non-financial support from Biotronik, Boehringer Ingelheim, and Daiichi Sankyo; personal fees from Akzea, Bayer Vital, MSD, Berlin-Chemie and Siemens Healthineers, outside the submitted work. T.W.W. has received fees, honoraria and research funding from AstraZeneca, Boehringer Ingelheim, Bayer, Bristol Myers Squibb/Pfizer, Daiichi Sankyo, Medtronic, Menarini Pharma, Novartis, and Sanofi Aventis. R.D.C. reports grants, personal fees and non-financial support from Daiichi Sankyo, during the conduct of the study; and reports consulting fees, honoraria and other financial or non-financial interests: Amgen, Boehringer Ingelheim, Bayer, BMS/Pfizer, Daiichi Sankyo, Janssen, Milestone, Novartis, Sanofi, Menarini, Guidotti, and Roche, outside the submitted work. Consultancy fees from Daiichi Sankyo Europe for the Chairing of the ETNA-AF Europe registry. (Copyright © 2023. Published by Elsevier B.V.) |
| Databáze: | MEDLINE |
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