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Int J Cardiol. 2017 Oct 1;244:192-195. doi: 10.1016/j.ijcard.2017.05.098. Epub 2017 Jun 2.

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

Author information

1
Department of Cardiology, University Heart Center Zurich, Switzerland.
2
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
3
National Heart and Lung Institute, Imperial College, London, United Kingdom; Royal Brompton Hospital, London, United Kingdom.
4
Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.
5
Daiichi-Sankyo Europe GmbH, Munich, Germany.
6
Daiichi-Sankyo Pharma Development, Edison, NJ, United States.
7
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: rgiugliano@partners.org.

Abstract

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 >3days (median time of interruption: 18days, interquartile range 3-30days); 86 ablations were performed with ≤10days, and 36 ablations with ≤3days study drug interruption. During the first 30days 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 ≤10days 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 30days post ablation.

KEYWORDS:

Ablation; Anticoagulation; Atrial fibrillation; DOAC; Edoxaban

PMID:
28625512
DOI:
10.1016/j.ijcard.2017.05.098
[Indexed for MEDLINE]

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