Author + information
- Received July 20, 2015
- Revision received September 14, 2015
- Accepted September 17, 2015
- Published online February 1, 2016.
- aUniversity of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom
- bDepartment of Cardiology, Maastricht University Medical Centre, Maastricht, the Netherlands
- cAalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
- ↵∗Reprint requests and correspondence:
Prof. Gregory Y.H. Lip, University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Dudley Road, Birmingham B18 7QH, United Kingdom.
Objectives The purpose of this study was to determine, in a model based on Europeans at risk of stroke by virtue of atrial fibrillation (AF), the net clinical benefit of edoxaban in the reduction of the risk of stroke, mortality, and of hemorrhage.
Background Vitamin K antagonists (e.g., warfarin) are commonly underused because of such factors as fear of hemorrhage in patients with high-risk AF. The non–vitamin K antagonist oral anticoagulants are similarly or more effective than warfarin and have lower rates of serious hemorrhage. Although outcomes of the ENGAGE AF-TIMI 48 trial that compared the non–vitamin K antagonist oral anticoagulant edoxaban with warfarin and indicated similar efficacy and better safety compared with warfarin for stroke prevention in AF, the application of trial data to the general population is unknown.
Methods This study modelled a treatment effect of edoxaban on the risks of thromboembolism, major bleeding, and death in a real-world population of patients with AF drawn from the Euro Heart Survey, and extrapolated this to the general European population.
Results In those at high risk of stroke (CHA2DS2VASc ≥2), edoxaban would need to be taken by 319 patients to prevent 1 thromboembolism, major bleeding event, or death compared with warfarin, and by 41 patients to prevent 1 thromboembolism or death compared with no treatment. These translate to demonstrating a net clinical benefit of 8.9 events saved per 1,000 patients with edoxaban 60 mg. Modeling these data to the population of Europe of 508 million, use of edoxaban 30 mg and 60 mg instead of warfarin would, respectively, prevent approximately 19,400 and 30,300 thromboembolic events, major bleeds, and deaths annually.
Conclusions Our modeling exercise suggests that the use of edoxaban for thromboprophylaxis in AF based on current guidelines could provide a profound benefit on rates of stroke, major bleeds, and deaths in European patients with AF.
This study was funded by an unrestricted educational grant from Daiichi Sankyo. Dr. Blann has received funding for research from Boehringer Ingelheim; and has been on the speaker bureaus for Bayer, BMS/Pfizer, and Boehringer Ingelheim. Dr. Pister has received fees for serving on advisory boards from Pfizer and Bristol-Myers Squibb; and has received honoraria from Bayer, Daiichi Sankyo, Pfizer, and Bristol-Myers Squibb. Prof. Lip has served as a consultant for Bayer/Jensen J&J, Astellas, Merck, AstraZeneca, Sanoﬁ, BMS/Pfizer, Biotronik, Medtronic, Portola, Boehringer Ingelheim, Microlife, and Daiichi Sankyo; performed guideline membership/reviewing for various guidelines and position statements from European Society for Cardiology, European Heart Rhythm Association, and National Institute of Health and Care Excellence; served on the steering committee for various phase II and III studies, Health Economics & Outcomes Research; was an investigator in various clinical trials in cardiovascular disease, including those on antithrombotic therapies in atrial fibrillation, acute coronary syndrome, and lipids; and was a speaker for Bayer, BMS/Pfizer, Medtronic, Boehringer Ingelheim, Microlife, Roche, and Daiichi Sankyo.
- Received July 20, 2015.
- Revision received September 14, 2015.
- Accepted September 17, 2015.
- American College of Cardiology Foundation