Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF–TIMI 48 Trial
Eri Toda Kato,Robert P. Giugliano,Christian T. Ruff,Yukihiro Koretsune,Takeshi Yamashita,Róbert Gábor Kiss,Francesco Nordio,Sabina A. Murphy,Tetsuya Kimura,James Jin,Hans Lanz,Michele Mercuri,Eugene Braunwald,Elliott M. Antman +13 more
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TLDR
Age has a greater influence on major bleeding than thromboembolic risk in patients with atrial fibrillation, and treatment of elderly patients with edoxaban provides an even greater absolute reduction in safety events over warfarin, compared to treatment with Edoxaban versus warFarin in younger patients.Abstract:
Background Elderly patients with atrial fibrillation are at higher risk of both ischemic and bleeding events compared to younger patients. In a prespecified analysis from the ENGAGE AF‐TIMI 48 trial, we evaluate clinical outcomes with edoxaban versus warfarin according to age.
Methods and Results Twenty‐one thousand one‐hundred and five patients enrolled in the ENGAGE AF‐TIMI 48 trial were stratified into 3 prespecified age groups: <65 (n=5497), 65 to 74 (n=7134), and ≥75 (n=8474) years. Older patients were more likely to be female, with lower body weight and reduced creatinine clearance, leading to higher rates of edoxaban dose reduction (10%, 18%, and 41% for the 3 age groups, P <0.001). Stroke or systemic embolic event (1.1%, 1.8%, and 2.3%) and major bleeding (1.8%, 3.3%, and 4.8%) rates with warfarin increased across age groups ( P trend<0.001 for both). There were no interactions between age group and randomized treatment in the primary efficacy and safety outcomes. In the elderly (≥75 years), the rates of stroke/systemic embolic event were similar with edoxaban versus warfarin (hazard ratio 0.83 [0.66–1.04]), while major bleeding was significantly reduced with edoxaban (hazard ratio 0.83 [0.70–0.99]). The absolute risk difference in major bleeding (−82 events/10 000 pt‐yrs) and in intracranial hemorrhage (−73 events/10 000 pt‐yrs) both favored edoxaban over warfarin in older patients.
Conclusions Age has a greater influence on major bleeding than thromboembolic risk in patients with atrial fibrillation. Given the higher rates of bleeding and death with increasing age, treatment of elderly patients with edoxaban provides an even greater absolute reduction in safety events over warfarin, compared to treatment with edoxaban versus warfarin in younger patients.
Clinical Trial Registration URL: . Unique identifier: NCT00781391.read more
Citations
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2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).
Gerhard Hindricks,Tatjana S. Potpara,Nikolaos Dagres,Elena Arbelo,Jeroen J. Bax,Carina Blomström-Lundqvist,Giuseppe Boriani,Manuel Castellá,Gheorghe Andrei Dan,Polychronis Dilaveris,Laurent Fauchier,Gerasimos Filippatos,Jonathan M. Kalman,Jonathan M. Kalman,Mark La Meir,Deirdre A. Lane,Jean-Pierre Lebeau,Maddalena Lettino,G. Y. H. Lip,Fausto J. Pinto,G. Neil Thomas,Marco Valgimigli,Isabelle C. Van Gelder,Isabelle C. Van Gelder,Bart P. Van Putte,Caroline L Watkins +25 more
TL;DR: The content of these European Society of Cardiology (ESC) Guidelines has been published for personal and educational use only and no commercial use is authorized.
Journal ArticleDOI
The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation.
Jan Steffel,Peter Verhamme,Tatjana S. Potpara,Pierre Albaladejo,M Antz,Lien Desteghe,Karl Georg Haeusler,Jonas Oldgren,Holger Reinecke,Roldan-Schilling,Nigel Rowell,Peter Sinnaeve,Ronan Collins,Alan John Camm,Hein Heidbuchel +14 more
TL;DR: Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF) and have emerged as the preferred choice, particularly in patients newly started on antICOagulation.
Journal ArticleDOI
The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation
Jason G. Andrade,Jason G. Andrade,Martin Aguilar,Clare L. Atzema,Alan Bell,John A. Cairns,Christopher C. Cheung,Jafna L. Cox,Paul Dorian,David J. Gladstone,Jeff S. Healey,Paul Khairy,Kori Leblanc,M. Sean McMurtry,L. Brent Mitchell,Girish M. Nair,Stanley Nattel,Ratika Parkash,Louise Pilote,Roopinder K. Sandhu,Jean-François Sarrazin,Mukul Sharma,Allan C. Skanes,Mario Talajic,Teresa S.M. Tsang,Atul Verma,Subodh Verma,Richard P. Whitlock,D. George Wyse,Laurent Macle +29 more
TL;DR: The 2020 iteration of the CCS AF guidelines represents a comprehensive renewal that integrates, updates, and replaces the past decade of guidelines, recommendations, and practical tips.
Journal ArticleDOI
The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: executive summary
Jan Steffel,Peter Verhamme,Tatjana S. Potpara,Pierre Albaladejo,Matthias Antz,Lien Desteghe,Karl Georg Haeusler,Jonas Oldgren,Holger Reinecke,Vanessa Roldan-Schilling,Nigel Rowell,Peter Sinnaeve,Ronan Collins,A. John Camm,Hein Heidbuchel +14 more
TL;DR: The European Heart Rhythm Association (EHRA) set out to co-ordinate a unified way of informing physicians on the use of different NOACs, and formulated 20 practical answers for which practical answers were formulated, based on available evidence as discussed by the authors.
Journal ArticleDOI
Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation
Ken Okumura,Masaharu Akao,Tetsuro Yoshida,Masahito Kawata,Osamu Okazaki,Shintaro Akashi,Kenichi Eshima,Kimihiko Tanizawa,Masayuki Fukuzawa,Takuya Hayashi,Masahiro Akishita,Gregory Y.H. Lip,Takeshi Yamashita +12 more
TL;DR: In very elderly Japanese patients with nonvalvular atrial fibrillation who were not appropriate candidates for standard doses of oral anticoagulants, a once-daily 15-mg dose of edoxaban was superior to placebo in preventing stroke or systemic embolism and did not result in a significantly higher incidence of major bleeding than placebo.
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