Author + information
- Jan Steffel,
- Christian Ruff,
- Rose Hammershock,
- Sabina Murphy,
- Hans Lanz,
- Michele Mercuri,
- Elliott Antman,
- Eugene Braunwald and
- Robert Giugliano
Background: Atrial fibrillation (AF) ablation procedures are increasingly performed in patients receiving novel anticoagulants (NOACs). Experience regarding the safety of edoxaban in this context is limited. In an exploratory analysis we therefore investigated the outcome of patients included in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial undergoing AF ablation.
Methods and Results: During the course of the study 197 AF ablation procedures were performed. Patients undergoing ablation were younger (64.0 (57.0 – 71.0) vs. 72.0 (64.0 – 78.0); p<.001), more likely to be paroxysmal (60.7% vs. 25.1%, p<0.001), more frequently had a CHADS2 score ≤ 3 (87.9% vs. 77.3%, p=0.001), and most frequently were from North America (52.0% vs. 21.9%; p<0.001). Following most ablations (72%), study drug was interrupted (median time of study drug interruption: 21 days, interquartile range 2 – 30 days); 88 patients had ≤ 10 days, and 55 patients had ≤ 3 days study drug interruption. During the first 30 days after the ablation procedure, one ischemic stroke was observed in the warfarin group and none in the high-dose edoxaban regimen (HDER) or low-dose edoxaban regimen (LDER). Three clinically relevant non-major bleeding events were observed in the warfarin group, whereas one major bleed was seen in the HDER and one minor bleeding as well as one cardiovascular death 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: This pilot evaluation of patients in the ENGAGE-AF TIMI 48 trial undergoing AF ablation revealed a low risk of ischemic or bleeding events during the first 30 days post ablation, independent of the allocated treatment arm. These findings indicate for the first time that the use of edoxaban may be safe in the context of AF ablation. Further dedicated studies are necessary to substantiate these observations in larger patient populations.
Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:45 a.m.
Session Title: Fibrillatory Arrhythmias: Outcomes With Contemporary Practice
Abstract Category: 8. Arrhythmias and Clinical EP: Supraventricular/Ventricular Arrhythmias
Presentation Number: 1110-100
- 2017 American College of Cardiology Foundation