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RE-CIRCUIT: Uninterrupted dabiagtran confers less bleeding risk vs. warfarin during AF catheter ablation
WASHINGTON — In patients undergoing catheter ablation for paroxysmal or persistent atrial fibrillation, uninterrupted dabigatran was associated with fewer bleeding complications compared with uninterrupted warfarin.
Catheter ablation for patients with AF is usually performed without interruption in anticoagulation if the patient is taking warfarin, but with interruption if the patient is taking a non-vitamin K oral anticoagulant such as dabigatran (Pradaxa, Boehringer Ingelheim). However, data on strategies with an uninterrupted non-vitamin K oral anticoagulant are sparse, Hugh Calkins, MD, professor of cardiology at Johns Hopkins Medicine, said during a presentation at the American College of Cardiology Scientific Session.
“Prior studies have shown that performance of AF ablation on uninterrupted anticoagulation with a vitamin K antagonist helps to minimize the risk of [thromboembolic] complications, and is now a well-established anticoagulation strategy at the time of AF ablation,” he said. “This approach is cumbersome, as most patients are anticoagulated with a non-vitamin K anticoagulant prior to AF ablation. It requires transition to a [vitamin K antagonist] therapy prior to ablation. If the patient presents on the day of ablation with an [international normalized ratio] that is too high — 4 for example — the procedure is cancelled. If they present with an INR that’s too low, if the procedure is carried out, it is done so with an increased stroke risk.”
The RE-CIRCUIT study enrolled 704 patients with paroxysmal or persistent AF (mean age, 59 years) across 104 sites, 635 of whom underwent catheter ablation. Patients were randomly assigned to receive dabigatran 150 mg twice daily or warfarin with an international normalized ratio target of 2 to 3.
Ablation was performed after 4 to 8 weeks of uninterrupted anticoagulation; patients in the dabigatran group took their morning dose at their usual scheduled time on the day of the procedure. Anticoagulation continued during and for 8 weeks after ablation.
The primary endpoint was ISTH major bleeding events at 8 weeks. Secondary endpoints included various thromboembolic and other bleeding events.
Major bleeding events at 8 weeks were observed in 1.6% of patients in the dabigatran group and 6.9% of patients in the warfarin group (absolute risk difference, –5.3 percentage points; 95% CI, –8.4 to –2.2; P < .001; absolute risk reduction, 5.3%; relative risk reduction, 77%).
Most bleeding events occurred within 1 or 2 days of the procedure, according to Calkins.
Minor bleeding events were similar between the groups (dabigatran, 18.6%; warfarin, 17%), and there was one thromboembolic event (a transient ischemic attack) in the warfarin group and none in the dabigatran group, Calkins said.
The rates of adverse events leading to study drug continuation were 5.6% in the dabigatran group and 2.4% in the warfarin group. The dabigatran group had fewer periprocedural pericardial tamponades and groin hematomas compared with the warfarin group.
There were no deaths and no one in the dabigatran group required the use of the reversal agent idarucizumab (Praxbind, Boehringer Ingelheim), Calkins said.
“The results of RE-CIRCUIT demonstrate that the performance of AF ablation on uninterrupted dabigatran is a better anticoagulation strategy as compared to performance of AF ablation on uninterrupted warfarin,” Calkins said during the presentation. “The availability of the specific reversal agent idarucizumab, while not needed in any patient in this trial, further motivates the adoption of uninterrupted dabigatran as the preferred anticoagulation strategy in patients undergoing AF ablation.” – by Erik Swain
Reference:
Calkins H, et al. Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Calkins H, et al. N Engl J Med. 2017;doi:10.1056/NEJMoa1701005.
Disclosure: The study was funded by Boehringer Ingelheim. Calkins reports receiving personal fees from Abbott, AtriCure, Boehringer Ingelheim and Medtronic.
Editor’s Note: This story was modified on March 21, 2017 to make minor changes to data.
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It was important to see that uninterrupted administration of a direct oral anticoagulant was done safely. We have come a long way in our comfort zone to avoid bridging during AF ablation. Initially, when we started doing AF ablation, we disrupted anticoagulation with vitamin K-dependent anticoagulants with enoxaparin (Lovenox, Sanofi) during the periprocedural period.
We later found out that this method increased both bleeding and thromboembolic events. This led to continuation of anticoagulation during the time the procedure with therapeutic INRs. Over the last several years, with the introduction of direct oral anticoagulants, we have varied our practice, looking at small studies that have supported uninterrupted anticoagulation during ablation.
The RE-CIRCUIT trial looked at uninterrupted dabigatran periprocedural AF ablation. Dabigatran was administered the morning of the procedure and continued postprocedure. No significant bleeding risk or thromboembolic risk was noted in comparison to uninterrupted warfarin. This may lead to clinicians feeling more comfortable giving the direct oral anticoagulants without interruption.