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ABRIDGE-J: Dabigatran lowers bleeding risk in ablation for nonvalvular AF
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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.
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
Reference:
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.
Disclosures: 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.
Perspective
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Jagmeet P. Singh, MD, DPhil, FACC, FHRS
ABRIDGE-J showed that minimally interrupted dabigatran reduced the number of bleeding complications procedurally as compared to uninterrupted warfarin. The VENTURE-AF study of rivaroxaban (Xarelto, Janssen) and the RE-CIRCUIT study of dabigatran already showed that they’re fairly safe uninterrupted in patients preparing for surgery with AF ablation.
The interesting thing was that this study showed that a minimal reduction of dabigatran with heparin bridging was better than uninterrupted warfarin. What surprised me was the higher percentage of complications in the warfarin arm, which is around 5%.
The study moves the needle a little bit, in that patients who may be at high risk for vascular complications or bleeding complications, one could potentially cut back on the dabigatran and still not have any periprocedural bleeding or strokes.
Perspective
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Mary Norine Walsh, MD, FACC
ABRIDGE-J, which is a comparison between dabigatran, which is direct oral anticoagulant, vs. heparin in patients undergoing atrial fibrillation ablation, is one of the most interesting late-breakers, along with the BRUISE CONTROL-2 study, which is a study of direct oral anticoagulants vs. warfarin for patients who are undergoing device implantation.
The importance of these two studies presented in the same session are helping us answer the clinical question whether or not these new direct oral anticoagulants can be continued around the time of procedures. We know from long experience over the last decade or so that continuing warfarin at the time of device implant, for example, has become the standard of care because the decreased risk of thromboembolic complications. Over time, our electrophysiology community has proven that there is not an increased risk of hematoma in the device generator pocket, but the big question is what about the patients who are now on direct oral anticoagulants, which is a growing population of patients.
The fact that both these studies are presented here and show favorable results for those uninterrupted therapy on these new agents is favorable for patients and also a game-changer, allowing us to understand that going forward, we will feel safer to continue these therapies in these patients when they have either ablation or a device implantation.
As always, we need larger studies in more diverse patient populations. In ABRIDGE, dabigatran was the direct oral anticoagulant, so that was the first one available on the market, and so replicating that those results with some of the newer agents will be important.
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