Ingelheim Pharmaceuticals
Dabigatran (Pradaxa) Photo from Boehringer
WASHINGTON, DC—Results from the RE-CIRCUIT trial suggest that uninterrupted dabigatran poses a lower risk of major bleeding than uninterrupted warfarin in patients with non-valvular atrial fibrillation (NVAF) who are undergoing catheter ablation.
Patients who received dabigatran also had fewer serious and severe adverse events (AEs).
The incidence of minor bleeding was similar between the treatment groups, and the incidence of AEs leading to treatment discontinuation was higher with dabigatran.
These results were presented at the American College of Cardiology’s 66th Annual Scientific Session and simultaneously published in NEJM.
This study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc.
The RE-CIRCUIT trial enrolled 704 patients with paroxysmal or persistent NVAF, and 635 of them ultimately underwent catheter ablation with uninterrupted anticoagulation.
The patients were randomized to receive dabigatran at 150 mg twice daily or warfarin (with a target international normalized ratio [INR] of 2.0–3.0) in a 1:1 ratio and remained on this treatment for the duration of the trial.
The mean adherence to dabigatran was 97.6%, and patients receiving warfarin were within the guideline-defined target INR range 66% of the time. The majority of patients in both groups (86.1% in the dabigatran group and 84.3% in the warfarin group) received study treatment for at least 8 weeks after ablation.
Results
The study’s primary endpoint was the incidence of major bleeding events, as defined by the International Society on Thrombosis and Hemostasis, during the ablation procedure and up to 2 months after.
There was a significantly lower incidence of major bleeding with uninterrupted dabigatran than with uninterrupted warfarin—1.6% (n=5) and 6.9% (n=22), respectively (P<0.001).
Major bleeding events (in the dabigatran and warfarin groups, respectively) included pericardial tamponade (1 and 6), pericardial effusion (1 and 0), groin bleeds (2 in both), groin hematomas (0 and 8), gastrointestinal bleeds (1 and 2), intracranial bleeds (0 and 2), pseudoaneurysm (0 and 1), and hematomas (0 and 2).
The incidence of minor bleeding was similar between the treatment groups—18.6% (n=59) in the dabigatran group and 17.0% (n=54) in the warfarin group.
The incidence of serious AEs was 18.6% in the dabigatran group and 22.2% in the warfarin group. The most frequent serious AEs were atrial flutter (5.9% and 5.6%, respectively), atrial fibrillation (1.8% and 3.8%, respectively), and cardiac tamponade (0.3% and 1.2%, respectively).
The incidence of severe AEs was 3.3% in the dabigatran group and 6.2% in the warfarin group. The incidence of AEs leading to treatment discontinuation was 5.6% and 2.4%, respectively.
There were no cases of stroke, systemic embolism, or transient ischemic attack in the dabigatran group. However, there was a transient ischemic attack in the warfarin group.
“These results are exciting news for the medical community,” said study investigator Hugh Calkins, MD, of Johns Hopkins Hospital in Baltimore, Maryland.
“During an ablation procedure, patients are at risk of potential major complications, including stroke and bleeding. Therefore, anticoagulation management at the time of AFib ablation is critically important. In RE-CIRCUIT, we have seen that uninterrupted anticoagulation with dabigatran showed significantly lower major bleeding complications than warfarin in atrial fibrillation patients undergoing cardiac ablation.”
