In Asian patients with atrial fibrillation (AFib), edoxaban might be associated with reduced risk of ischemic stroke, major bleeding, and all-cause death compared with warfarin, according to research published Aug. 13 in the Journal of the American College of Cardiology.

So-Ryoung Lee, MD, et al., used data from the national health claims database established by the National Health Insurance Service of Korea. They included new users of edoxaban and warfarin in patients with AFib from January to December 2014, and analyzed the risk of ischemic stroke, intracranial hemorrhage (ICH), hospitalization for gastrointestinal (GI) bleeding, hospitalization for major bleeding, and all-cause death.

Results showed that 16,244 patients were included in the final analysis, with 4,061 taking edoxaban and 12,183 taking warfarin. During follow-up, the incidence of ischemic stroke was 3.22 per 100 person-years and 3.89 per 100 person-years for edoxaban and warfarin, respectively. Patients using edoxaban had a significantly lower risk of ischemic stroke than those using warfarin (hazard ratio [HR]: 0.693; 95 percent confidence interval [CI]: 0.487 to 0.959; p = 0.033). Edoxaban was associated with a 60 percent lower risk of ICH, a 40 percent risk reduction in hospitalization for GI bleeding and a 47 percent risk reduction in hospitalization for major bleeding compared with warfarin. Edoxaban was associated also with a 28 percent lower risk of all-cause death than warfarin. Patients receiving edoxaban 60 and 30 mg showed trends toward better outcomes for most clinical events compared with warfarin.

According to the authors, this is the first study to examine the effectiveness and safety of edoxaban compared with those of warfarin in a population-based cohort.

In an accompanying editorial comment, Shinya Goto, MD, PhD, FACC, and Shinichi Goto, MD, PhD, note that "this type of regional validation of global trials in East Asia is important due to the perception that East Asian patients differ from other patient populations with regard to the use of anticoagulants." They add that "regional validation of global trial results with observatory data, as conducted by Lee et al., is one way to overcome potential heterogeneity within the worldwide population."

Keywords: Warfarin, Anticoagulants, Atrial Fibrillation, Incidence, Confidence Intervals, Stroke, Follow-Up Studies, Brain Ischemia, Thiazoles, Pyridines, Hemorrhage, Intracranial Hemorrhages, Risk Reduction Behavior, Hospitalization, National Health Programs, Asia, Republic of Korea

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