期刊
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
卷 68, 期 11, 页码 1169-1178出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2016.06.034
关键词
anticoagulation; atrial fibrillation; edoxaban; falls; frailty; NOACs
资金
- Daiichi-Sankyo Pharma Development
- Amgen
- AstraZeneca
- Atricure
- Bayer
- Biotronik
- Biosense Webster
- Boehringer-Ingelheim
- Boston Scientific
- Bristol-Myers Squibb
- Daiichi-Sankyo
- Cook Medical
- Medtronic
- Novartis
- Pfizer
- Roche
- Sanofi
- Sorin
- St. Jude Medical
- Zoll
- Bayer Healthcare
- American College of Cardiology
- Janssen
- Merck
- Portola
- Johnson Johnson
- The Medicines Company
- Theravance
- Menarini
- Medscape
- Merck Co.
- GlaxoSmithKline
- Eli Lilly and Company
- National Institutes of Health
- Merck Sharpe Dohme
- George Institute
- Omthera Pharmaceuticals
- Pfizer New Zealand
- Intarcia Therapeutics Inc.
- Elsai Inc.
- DalGen Products and Services
- Boehringer Ingelheim
- Eisai
- Intarcia
BACKGROUND Anticoagulation is often avoided in patients with atrial fibrillation who are at an increased risk of falling. OBJECTIVES This study assessed the relative efficacy and safety of edoxaban versus warfarin in the ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction 48) trial in patients with atrial fibrillation judged to be at increased risk of falling. METHODS We performed a pre-specified analysis of the ENGAGE AF-TIMI 48, comparing patients with versus without increased risk of falling. RESULTS Nine hundred patients (4.3%) were judged to be at increased risk of falling. These patients were older (median, 77 vs. 72 years; p < 0.001), and had a higher prevalence of comorbidities including prior stroke/transient ischemic attack, diabetes, and coronary artery disease. After multivariable adjustment, patients at increased risk of falling experienced more bone fractures caused by falling (adjusted hazard ratio [HRadj]: 1.88; 95% confidence interval [CI]: 1.49 to 2.38; p < 0.001), major bleeding (HRadj: 1.30; 95% CI: 1.04 to 1.64; p = 0.023), life-threatening bleeding (HRadj: 1.67; 95% CI: 1.11 to 2.50; p = 0.013), and all-cause death (HRadj: 1.45; 95% CI: 1.23 to 1.70; p < 0.001), but not ischemic events including stroke/systemic embolic event (HRadj: 1.16; 95% CI: 0.89 to 1.51; p = 0.27). No treatment interaction was observed between either dosing regimens of edoxaban and warfarin for the efficacy and safety outcomes. Treatment with edoxaban resulted in a greater absolute risk reduction in severe bleeding events and all-cause mortality compared with warfarin. CONCLUSIONS Edoxaban is an attractive alternative to warfarin in patients at increased risk of falling, because it is associated with an even greater absolute reduction in severe bleeding events and mortality. (C) 2016 by the American College of Cardiology Foundation.
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