First experience with edoxaban and atrial fibrillation ablation – Insights from the ENGAGE AF-TIMI 48 trial

Background Atrial fibrillation (AF) ablation procedures are increasingly being performed in patients receiving direct oral anticoagulants (DOACs). Experience regarding the safety of edoxaban in this context is limited. In an exploratory analysis we therefore investigated the outcome of patients undergoing transcatheter AF ablation in the ENGAGE AF-TIMI 48 trial. Methods & results During the trial, 193 transcatheter AF ablation procedures were performed in 169 patients. For the majority of ablations (n = 157, 81%), study drug was interrupted >3 days (median time of interruption: 18 days, interquartile range 3–30 days); 86 ablations were performed with ≤10 days, and 36 ablations with ≤3 days study drug interruption. During the first 30 days after the ablation, one ischemic stroke was observed in the warfarin group and none in the higher-dose edoxaban regimen (HDER) or lower-dose edoxaban regimen (LDER) group. Three clinically relevant non-major (CRNM) bleeding events were observed in the warfarin group; one major bleed was seen in the HDER group; one minor bleed occurred in the LDER group. All bleeding events occurred among the patients with ≤10 days study drug interruption; in contrast, no ischemic events or deaths were observed in these patients. Conclusions In this pilot evaluation of the ENGAGE AF-TIMI 48 trial, treatment with edoxaban was associated with a low risk of ischemic and bleeding events during the first 30 days post ablation.