ABlation peRIoperative DabiGatran in use Envisioning in Japan - ABRIDGE-J

Apr 23, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
11/12/2017
Date Published:
04/19/2019
Date Updated:
04/23/2019
Original Posted Date:
11/12/2017
References

Contribution To Literature:

The ABRIDGE-J trial showed that a strategy of brief interruption of dabigatran (1-2 doses) results in lower bleeding events compared with uninterrupted warfarin use among patients undergoing catheter ablation for nonvalvular AF.

Description:

The goal of the trial was to assess the safety of minimally interrupted dabigatran versus continued warfarin uninterrupted for performing catheter ablation for nonvalvular atrial fibrillation (AF).

Study Design

Patients scheduled for catheter ablation for nonvalvular AF were randomized in a 1:1 fashion to either minimally interrupted dabigatran (n = 220) or uninterrupted warfarin (n = 222). In the dabigatran arm, 1-2 doses were held prior to the procedure, whereas in the warfarin arm, international normalized ratio (INR) was maintained between 2 and 3 if age <70 years and between 1.6 and 2.6 if age ≥70 years. If the interval between stopping dabigatran and procedure was ≥24 hours, then heparin bridging was recommended (used in 31%).  

Inclusion criteria:

  • Undergoing catheter ablation for paroxysmal or persistent nonvalvular AF
  • Treated with dabigatran or warfarin for at least 4 weeks prior to procedure
  • Age 20-85 years
  • Total number of enrollees: 500
  • Duration of follow-up: 1 year
  • Mean patient age: 64 years
  • Percentage female: 25%

Other salient features:

  • Prior stroke: 6%
  • Mean CHA2DS2-VASc score: 1.9
  • Other medications: aspirin: 6%, clopidogrel: 1.4%
  • Mean left ventricular ejection fraction: 65%

Principal Findings:

The primary outcome, major bleeding at 3 months, for minimally interrupted dabigatran vs. warfarin, was 1.4% vs. 5.0%, p = 0.032. Groin bleeding/hematoma was 0% vs. 1.4%, respectively.

Secondary outcomes for minimally interrupted dabigatran vs. warfarin:

  • Cerebrovascular accident: 0% vs. 0.5%
  • Composite of major bleeding + thromboembolic events at 1 year lower in dabigatran arm (p = 0.01)

Interpretation:

The results of this trial indicate that a strategy of brief interruption of dabigatran (1-2 doses) results in lower bleeding events compared with uninterrupted warfarin use among patients undergoing catheter ablation for nonvalvular AF. This is despite the use of bridging heparin in nearly one-third of patients in the dabigatran arm. The majority of bleeding events were related to access site bleeding.

In general, dabigatran results in lower bleeding than warfarin for patients with nonvalvular AF (e.g., ROCKET-AF trial), and thus, these results are perhaps not totally surprising. They do demonstrate the safety of doing ablations with dabigatran. It is unclear if minimally interrupted dabigatran would be better than uninterrupted dabigatran in this clinical scenario. In the RE-CIRCUIT trial, the bleeding event rate with uninterrupted dabigatran use was 1.6%. 

References:

Nogami A, Harada T, Sekiguchi Y, et al. Safety and Efficacy of Minimally Interrupted Dabigatran vs. Uninterrupted Warfarin Therapy in Adults Undergoing Atrial Fibrillation Catheter Ablation: A Randomized Clinical Trial. JAMA Netw Open 2019;Apr 19:[Epub ahead of print].

Presented by Dr. Akihiko Nogami at the American Heart Association Annual Scientific Sessions (AHA 2017), Anaheim, CA, November 12, 2017.

Keywords: AHA17, AHA Annual Scientific Sessions, Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Cardiac Surgical Procedures, Catheter Ablation, Hematoma, Hemorrhage, Heparin, International Normalized Ratio, Stroke, Thromboembolism, Warfarin


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