ANAHEIM, Calif. — Patients with nonvalvular atrial fibrillation who underwent ablation and were treated with minimally disrupted dabigatran with and without heparin had a decreased risk for bleeding complications and no increase in thromboembolic events compared with those treated with warfarin, according to data presented at the American Heart Association Scientific Sessions.
Akihiko Nogami, MD, PhD, of the University of Tsukuba in Japan, and colleagues assessed data from 500 patients with persistent or paroxysmal nonvalvular AF who were scheduled for initial catheter ablation. Patients were assigned to minimally interrupted dabigatran (Pradaxa, Boehringer Ingelheim) or uninterrupted warfarin. Minimally interrupted treatment involved skipping one or two doses of dabigatran before ablation. Patients were treated with heparin during the period they were undergoing ablation. Follow-up was conducted for up to 12 months.
The primary endpoint was incidence of major bleeding events during ablation and up to 3 months after the procedure. Secondary endpoints were defined as a composite of systemic embolism, stroke and transient ischemic attack, minor bleeding events and a composite of thromboembolic events and major bleeding events.
After randomization, 220 patients from the dabigatran group (mean age, 64 years; 78% men) and 251 patients from the warfarin group (mean age, 64 years; 72% men) underwent ablation in 28 Japanese sites between May 2014 and December 2016.
Dabigatran was interrupted for 12 to 24 hours in 132 patients, and longer than 24 hours in 83 patients. Treatment was not interrupted for five patients.
At 3 months, total major bleeding events occurred in 1.4% of patients assigned dabigatran and 5% of those assigned warfarin. Patients in the dabigatran group had a significantly lower incidence of major bleeding event within 3 months after the procedure than the warfarin group (P = .032).
Composite incidence of major bleeding and thromboembolic events was higher in the warfarin group vs. the dabigatran group (P = .01). This was also seen in composite incidence for all bleeding and thromboembolic events, although it was not significant.
Jonathan P. Piccini
A subgroup analysis showed that a significant reduction in major bleeding risk was seen more in patients in the dabigatran group who were men aged 65 to 75 years, had a CHA2DS2-VASc score of 1 and had radiofrequency ablation.
“The results of this trial do help further inform our current consensus recommendations for periprocedural anticoagulation surrounding atrial fibrillation,” Jonathan P. Piccini, MD, MHS, FAHA, FHRS, director of Duke Center for Atrial Fibrillation and associate professor of medicine at Duke University Medical Center, said in the presentation. “When taken in combination with apixaban AEIOU study, the results from ABRIDGE-J provide further evidence that minimally interrupted strategy of holding one to two doses of [non-vitamin K antagonist oral anticoagulants] before ablation with reinitiation after is a very reasonable alternative to uninterrupted oral anticoagulation.” – by Darlene Dobkowski
Nogami A, et al. LBS.01. CABG and EP Peri-procedural Dilemmas. Presented at: American Heart Association Scientific Sessions; Nov. 11-15, 2017; Anaheim, Calif.
Nogami reports he receives research grants from Johnson & Johnson and Medtronic and honoraria from Daiichi Sankyo, Japan Life Line and St. Jude Medical. Piccini reports he receives research grants from ARCA biopharma, Boston Scientific, Gilead, Johnson & Johnson, ResMed and St. Jude Medical; and consults for Bayer Healthcare, Bristol-Myers Squibb/Pfizer, Janssen Pharmaceuticals and Medtronic.