Efficacy and Safety of Uninterrupted Periprocedural Edoxaban in Patients Undergoing Catheter Ablation for Atrial Fibrillation　― The Prospective KYU-RABLE Study ―

Abstract

Background: The KYU-RABLE study, a prospective, multicenter, single-arm interventional study, evaluated the efficacy and safety of uninterrupted oral edoxaban in patients undergoing catheter ablation (CA) for atrial fibrillation (AF). Methods and Results: We enrolled patients with AF from 23 centers in Japan. Edoxaban 60 mg (30 mg in patients indicated for dose adjustment) was administered uninterrupted, once daily in the morning for ≥4 weeks before CA and 4 weeks ±7 days after CA with one dose delayed on the procedural day. The primary endpoint was a composite of thromboembolism and major bleeding during 4 weeks from the procedural day. Among the 513 eligible patients who underwent CA, 63.5% received edoxaban 60 mg/day and 36.1% received 30 mg/day. For the primary endpoint, no thromboembolism and 1 major bleeding event (0.2%, cardiac tamponade) were observed. The plasma edoxaban concentration decreased depending on the time from the last administration to the CA procedure. However, plasma levels of coagulative biomarkers were within appropriate ranges regardless of the interval from the last administration of edoxaban. Conclusions: The present study provided evidence of the efficacy and safety of uninterrupted edoxaban administered once daily in the morning, with one dose delayed on procedural day, in patients with AF undergoing CA. Edoxaban was associated with a low risk of periprocedural thromboembolic and bleeding complications.

Safety and efficacy of uninterrupted treatment with edoxaban or warfarin during the peri‐procedural period of catheter ablation for atrial fibrillation

“…In a single‐arm observational study of patients with AF, Takahashi et al showed the efficacy and safety of uninterrupted EDX administered once in the morning, with one dose delayed on the procedural day. The results showed a low composite incidence of thromboembolism and major bleeding (0.2%) 21 . Hirao et al reported that administration of rivaroxaban within 8 hours prior to the CA procedure was associated with a higher incidence of major bleeding than administration 8‐28 hours prior to the CA procedure (18% vs 0%, respectively, P = .026) 22 .…”

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

“…The calculation of the target sample size was previously reported. 14 Between-group differences in baseline variables were calculated the anticipated last dose ablation duration was 30 hours, and this was subsequently refined to the four stated categories based on the number of patients and the information collected. All statistical analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, NC, USA).…”

“…Subsequently, edoxaban was administered in the morning for 4 weeks ± 7 days. 14 The study was approved by the ethics committee of Oita…”

“…As previously described, 14 solid-phase extraction using a liquid chromatography-tandem mass spectrometry system (SCIEX;…”

Editorial to “Safety and Efficacy of Uninterrupted Treatment with Edoxaban or Warfarin During the Peri‐Procedural Period of Catheter Ablation for Atrial Fibrillation”

“…Regarding the safety of edoxaban in this issue, Takahashi, et al previously performed an excellent, relatively large, prospective edoxaban single‐arm study, that is, the KYU‐RABLE study 5 . In this study, only one major bleeding complication (cardiac tamponade during the procedure: 0.2%), clinically relevant non‐major bleeding events in 1.4%, and minor bleeding events in 1.9% were observed in the 537 enrolled patients.…”