Randomized Evaluation of Dabigatran Etexilate Compared to Warfarin in Pulmonary Vein Ablation: Assessment of an Uninterrupted Periprocedural Anticoagulation Strategy - RE-CIRCUIT

Apr 27, 2017
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Presenter/Author:
Hugh Calkins, MD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Boehringer Ingelheim
Date Presented:
03/19/2017
Date Published:
03/19/2017
Date Updated:
04/27/2017
Original Posted Date:
03/19/2017
References

Contribution To Literature:

The RE-CIRCUIT trial showed that uninterrupted dabigatran was superior to uninterrupted warfarin at preventing bleeding complications after atrial fibrillation ablation.

Description:

The goal of the trial was to evaluate uninterrupted dabigatran compared with uninterrupted warfarin among patients undergoing catheter ablation for atrial fibrillation.


Study Design

  • Randomized
  • Parallel

Patients with atrial fibrillation undergoing catheter ablation were randomized to uninterrupted dabigatran 150 mg twice daily (n = 339) versus uninterrupted warfarin with international normalized ratio (INR) 2-3 (n = 339).

  • Total number of enrollees: 678
  • Duration of follow-up: 8 weeks
  • Mean patient age: 59 years
  • Percentage female: 27%
  • Percentage with diabetes: 10%

Inclusion criteria:

  • Paroxysmal or persistent atrial fibrillation
  • 4-8 weeks of planned anticoagulation

Exclusion criteria:

  • Permanent atrial fibrillation
  • Atrial fibrillation secondary to an obvious reversible cause
  • Valvular atrial fibrillation

Other salient features/characteristics:

  • In the dabigatran group, the final dose of dabigatran was <4 hours in 41.3%, 4 to <8 hours in 36.6%, and ≥8 hours in 19.6%.

Principal Findings:

The primary outcome, incidence of major bleeding, occurred in 1.6% of the dabigatran group versus 6.9% of the warfarin group (p < 0.001). There were fewer pericardial effusions and groin hematomas in the dabigatran group versus warfarin group.

Secondary outcomes:

  • Stroke or transient ischemic attack (TIA): 0 with dabigatran vs. 1 (TIA) with warfarin
  • Serious adverse event: 3.3% with dabigatran vs. 6.2% with warfarin

Interpretation:

Among patients with atrial fibrillation undergoing catheter ablation, uninterrupted dabigatran was superior to uninterrupted warfarin. Uninterrupted dabigatran was associated with fewer major bleeds (pericardial effusion and groin hematoma) compared with uninterrupted warfarin. In most of the dabigatran group, the last dose of the medication was given ≥4 hours from the procedure. Only one TIA occurred, which was in the warfarin group. This trial supports the use of uninterrupted dabigatran over warfarin during catheter ablation for atrial fibrillation.

References:

Calkins H, Willems S, Gerstenfeld EP, et al., on behalf of the RE-CIRCUIT Investigators. Uninterrupted Dabigatran Versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med 2017;376:1627-36.

Presented by Dr. Hugh Calkins at the American College of Cardiology Annual Scientific Session (ACC 2017), Washington, DC, March 19, 2017.

Keywords: ACC17, ACC Annual Scientific Session, Arrhythmias, Cardiac, Anticoagulants, Atrial Fibrillation, Benzimidazoles, Catheter Ablation, Antithrombins, Echocardiography, Transesophageal, Embolism, Hemostasis, International Normalized Ratio, Ischemic Attack, Transient, Stroke, Thromboembolism, Thrombosis, Warfarin


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