在患有心房高频发作病例的患者中使用埃多克萨班的抗凝剂
Paulus Kirchhof1, Tobias Toennis1, Andreas Goette1
1From the Atrial Fibrillation Network, Münster (P.K., A.G., U.S.), the Department of Cardiology, University Heart and Vascular Center Hamburg (P.K., T.T., N.B.), and the Institute of Medical Biometry and Epidemiology (A.-K.O., S.S., A.Z.), University Medical Center Hamburg-Eppendorf, and the German Center for Cardiovascular Research (DZHK) Partner Site Hamburg-Kiel-Lübeck (P.K., T.T., N.B.), Hamburg, the Department of Cardiology and Intensive Care Medicine, St. Vincenz Hospital Paderborn, Paderborn (A.G.), the Department of Neuroepidemiology, Institute for Medical Informatics, Biometry, and Epidemiology, University Duisburg-Essen, Essen (H.C.D.), and the Heart Center, Segeberger Kliniken, Bad Segeberg (M.B.) - all in Germany; the Institute of Cardiovascular Sciences (P.K.) and the Centre for Patient Reported Outcome Research, Institute of Applied Health Research, the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, and the NIHR Applied Research Collaboration West Midlands (M.C.), University of Birmingham, Birmingham, the Cardiovascular and Cell Sciences Research Institute, St. George's University of London, and Imperial College London, London (A.J.C.), the Cardiac Department, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford (K.R.), and Liverpool Centre for Cardiovascular Science at University of Liverpool, John Moores University, and Liverpool Heart and Chest Hospital, Liverpool (G.Y.H.L.) - all in the United Kingdom; Unità Operativa Complessa Cardiologia-Azienda Ospedale Università di Padova, Padua, Italy (E.B.); the Department of Medical Science, Uppsala University, Uppsala, and the Department of Cardiology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro - both in Sweden (C.B.L.); the Department of Cardiology, Odense University Hospital, Odense, and the Department of Cardiology, Esbjerg Hospital-University Hospital of Southern Denmark, Esbjerg (A.B.), and the Danish Center for Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg (G.Y.H.L.) - all in Denmark; the Cardiology Department, Fernando Fonseca Hospital, Amadora, Portugal (N.C.); the Biostatistics Lab, School of Medicine, University of Crete (G.C.), and the Department of Cardiology, Heraklion University Hospital (E.S.), Heraklion, and the Biomedical Research Foundation Academy of Athens and Hygeia Hospitals Group, Athens (P.V.) - all in Greece; Medicine University Carol Davila, Colentina University Hospital, Bucharest, Romania (G.-A.D.); the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (J.R.G.), and the Departments of Cardiology and Physiology, Maastricht University, Maastricht (U.S.) - both in the Netherlands; the Department of Internal Medicine III, Cardiology and Angiology, Innsbruck Medical University, Innsbruck (W.D.), and the Department of Cardiology, Medical University of Graz, Graz (D.S.) - both in Austria; the National Institute of Cardiovascular Surgery, Academy of Medical Sciences of Ukraine, Kyiv (B.K.); the Department of Cardiology and Internal Disease, Medical University of Gdansk, Gdansk (A.L.), and the Department of Electrocardiology and Heart Failure, Leszek Giec Upper Silesian Medical Center, Katowice (R.S.) - both in Poland; the Cardiology Division, European Georges Pompidou Hospital, Paris (E.M.); the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); the Hospital Clinic, Universtitat de Barcelona, Barcelona, Institut d'Investigacions Biomèdiques August Pi Sunyer, Barcelona, and Centro de Investigacion Biomedica en Red Cardiovascular, Madrid - all in Spain (L.M.); the Department of Cardiology, University Hospital Antwerp, Edegem, Belgium (A.S.); the Cardiology Clinic, St. Anna University Hospital Sofia, Sofia Medical University, Sofia, Bulgaria (V.V.); and the Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (D.W.).
埃多克萨班并没有显著降低设备检测到心房高频发作 (AHREs) 的患者中风风险. 与安慰剂相比,使用edoxaban的抗凝血药物增加了死亡或严重出血的风险.
科学领域:
- 心脏病学 心脏病学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 设备检测到的高频率心房发作 (AHREs) 是由起器或除器检测到的短暂心律不整.
- AHREs的临床意义和在没有记录的心房的患者中需要抗凝药的需要仍然不清楚.
研究的目的:
- 调查EDOXABAN抗凝药是否有效和安全在患有AHREs和至少一个额外的中风风险因素的患者.
- 为了比较EDOXABAN和安慰剂组之间的心血管事件和出血的发生率.
主要方法:
- 一个随机,双盲,双模拟试验,涉及2536名65岁或以上的AHREs患者.
- 患者接受了埃多克萨班或安慰剂,主要疗效通过心血管死亡,中风或全身栓塞的复合评估.
- 安全结果包括全因死亡或严重出血.
主要成果:
- 由于安全问题和徒劳性评估,试验被提前终止.
- 埃多克萨班并没有显著降低初级疗效结局 (HR,0.81;P=0.15).
- 埃多克萨班显著增加了死亡或严重出血的风险 (HR,1.31;P=0.03),两组中风发病率都很低.
结论:
- 在患有AHREs的患者中,使用edoxaban的抗凝固药物没有提供显著的疗效益.
- 埃多克萨班的使用与严重出血和死亡的风险增加有关.
- 这些发现表明,抗凝剂可能不仅仅基于设备检测到的AHREs来证明是合理的.
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