In patients with atrial fibrillation receiving edoxaban, global annualized event rates in the first and second year were 1.31% and 0.86% for major bleeding, and 1.06% and 0.65% for any stroke.
Observational (n=26,805)
Yes
Does edoxaban prevent thromboembolic events and maintain safety in patients with atrial fibrillation in routine clinical practice?
In routine clinical practice, patients with atrial fibrillation receiving edoxaban maintained low annualized rates of stroke and major bleeding through 2 years of follow-up.
BACKGROUND: Randomized clinical trials demonstrated similar efficacy and improved safety of direct oral anticoagulants versus warfarin in patients with atrial fibrillation (AF). Long-term data in routine clinical practice are needed. HYPOTHESIS: Patients with AF receiving edoxaban at baseline continue to have low annualized effectiveness and safety event rates in the second year of follow-up, with regional variations observed. METHODS: The Global ETNA-AF program is a prospective, noninterventional study of patients with AF receiving edoxaban. Patient characteristics and annualized clinical event rates were assessed overall and by region across the 2-year follow-up. Annualized event rates of bleeding and thromboembolic events were assessed within the first year and conditionally in patients who were event-free up to 12 months in the second year. RESULTS: This analysis comprised 26 805 patients from Europe (n = 13 164), Japan (n = 10 342), and non-Japanese Asian regions (n = 3299). Patients from Europe had the highest burden of comorbidities. The annualized event rates for major bleeding, any stroke, all-cause death, and cardiovascular death varied by region. The global annualized event rates in the first and second year were 1.31%/year and 0.86%/year for major bleeding, 1.06%/year and 0.65%/year for any stroke, 0.84%/year and 0.73%/year for cardiovascular death, and 3.05%/year and 3.18%/year for all-cause death. CONCLUSION: Annualized event rates for any stroke and major bleeding remained low through 2-year follow-up for patients with AF receiving edoxaban at baseline. Differences in annualized event rates for all-cause and cardiovascular mortality between Europe, Japan, and non-Japanese Asian regions may reflect variations in baseline characteristics. TRIAL REGISTRATION: Europe, NCT02944019; Japan, UMIN000017011; Korea/Taiwan, NCT02951039; Hong Kong, NCT03247582; and Thailand, NCT03247569.
Caterina et al. (Thu,) conducted a observational in Atrial fibrillation (n=26,805). Edoxaban was evaluated on Annualized event rates of bleeding and thromboembolic events. In patients with atrial fibrillation receiving edoxaban, global annualized event rates in the first and second year were 1.31% and 0.86% for major bleeding, and 1.06% and 0.65% for any stroke.