Postmarketing surveillance on the clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF‐Japan): One‐year safety and effectiveness analyses

Abstract

Background:The safety and effectiveness of edoxaban in real-world clinical settingshave not yet been elucidated thoroughly among Japanese patients with nonvalvular atrial fibrillation (NVAF). We report the one-year interim results of ETNA-AF-Japan (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation: UMIN000017011), an ongoing two-year study.Methods: ETNA-AF-Japan is a prospective, real-world multicenter observational study that analyzes the long-term safety and effectiveness of edoxaban. Physicians recorded clinical characteristics, bleeding events, and clinical events of ischemic stroke and systemic embolism, among others. Results:In total, 11 569 patients with NVAF were enrolled. The demographic and clinical characteristics of the patients in the safety analysis set (n = 11 107) were a mean age of 74.2 ± 10.0 years; female sex, 40.6%; age ≥75 years, 52.4%; body weight ≤60 kg, 54.3%; creatinine clearance ≤50 mL/min, 31.2%; mean CHADS 2 score of 2.2 ± 1.3. The mean treatment period was 311.2 days (median; 366.0 days), and ~80% of patients continued edoxaban treatment. In the safety analysis, the incidence of all bleeding events was 6.32% [95% CI: 5.87, 6.79] (n = 702), and for major bleeding, it was 1.08% [0.90, 1.29] (n = 120). In the effectiveness analysis set (n = 11 059), the incidence of ischemic stroke (excluding TIA) or systemic embolism was 1.10% [0.92, 1.32] (n = 122). Conclusions:At one-year follow-up, the results showed no major concerns about the safety and effectiveness of edoxaban in Japanese patients with NVAF in a real-world clinical setting. K E Y W O R D S anticoagulants, atrial fibrillation, DOAC, edoxaban, postmarketing surveillance S U PP O RTI N G I N FO R M ATI O N Additional supporting information may be found online in the Supporting Information section. How to cite this article: Yamashita T, Koretsune Y, Nagao T, Shiosakai K. Postmarketing surveillance on the clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA-AF-Japan): One-year safety and effectiveness analyses.

Changes in plasma concentrations of edoxaban and coagulation biomarkers according to thromboembolic risk and atrial fibrillation type in patients undergoing catheter ablation: Subanalysis of KYU‐RABLE

“…Only Japanese patients were included in the study, which may potentially restrict a broader generalization of the results. Additionally, the proportion of patients receiving edoxaban 60 mg rather than 30 mg was higher in both the PPS and subgroups; this ratio is the opposite of those reported in previous studies that included AF patients without CA 32 . Furthermore, the mean age of patients in this study was 64.7 years, which is younger than that of a previous study population; 33 therefore, it is possible that our study included many patients in relatively good health who did not meet the dose reduction criteria, again precluding the wider generalizability of our data to the clinical AF population.…”

“…Additionally, the proportion of patients receiving edoxaban 60 mg rather than 30 mg was higher in both the PPS and subgroups; this ratio is the opposite of those reported in previous studies that included AF patients without CA. 32 Furthermore, the mean age of patients in this study was 64.7 years, which is younger than that of a previous study population; 33 therefore, it is possible that our study included many patients in relatively good health who did not meet the dose reduction criteria, again precluding the wider generalizability of our data to the clinical AF population. Most notably, this analysis was limited by the low number of events, which may have resulted in an underestimation of differences in risk between CHADS 2 and AF groups.…”

Safety and Effectiveness of Edoxaban in Atrial Fibrillation Patients in Routine Clinical Practice: One-Year Follow-Up from the Global Noninterventional ETNA-AF Program

“…The detailed study design of the ETNA-AF program was previously published [ 13 ]. Briefly, the Global ETNA-AF program integrates data from several prospective, observational, and noninterventional regional studies from Europe (Germany, Austria, Switzerland, Belgium, Italy, Spain, United Kingdom, Ireland, the Netherlands, and Portugal), Japan, and other Asian countries [ 13 , 15 , 16 ]. Participating sites included hospitals and outpatient clinics.…”

Editorial to the Postmarketing surveillance on the clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF Japan): One‐year safety and effectiveness analyses

“…The present issue by Yamashita et al 6 shows the 1‐year effectiveness and safety of edoxaban in Japanese patients with non‐valvular AF in the real‐world clinical setting. In that study, 11 569 Japanese outpatients (aged 74 ± 10 years; male, 59%) with a CHA 2 DS 2 ‐VASc score of 3.5 ± 1.6 (CHADS 2 score 2.2 ± 1.3) have been followed up.…”