A Prospective, Randomized, Open-Label, Blinded Endpoint Evaluation Parallel Group Study Comparing Edoxaban vs. VKA in Subjects Undergoing Catheter Ablation of Non-valvular Atrial Fibrillation - ELIMINATE-AF

May 29, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Daiichi Sankyo Europe GmbH
Date Published:
04/11/2019
Date Updated:
05/29/2019
Original Posted Date:
05/29/2019
References

Contribution To Literature:

The ELIMINATE-AF trial showed that adverse events are similar with continuing edoxaban or VKA uninterrupted among patients undergoing catheter ablation of AF.


Description:

The goal of the trial was to assess the safety of performing atrial fibrillation (AF) ablations without interrupting edoxaban use. 

Study Design

Patients were randomized in a 2:1 fashion to either continuing uninterrupted edoxaban 60 mg (n = 411) or vitamin K antagonist (VKA) (n = 203) during the periprocedural period.

  • Total number of enrollees: 614
  • Duration of follow-up: 90 days
  • Mean patient age: 60.5 years
  • Percentage female: 28%

Inclusion criteria:

  • Male or female ≥18 years of age with documented history of paroxysmal, persistent, or long-standing persistent (>12 months) nonvalvular AF
  • Eligible and scheduled for either radiofrequency or cryoballoon catheter ablation

Exclusion criteria:

  • AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia, etc.)
  • Prior stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization
  • Thrombus in the left atrial appendage, left atrium, left ventricle, or aorta, or an intracardial mass
  • Myocardial infarction within the 2 months prior to randomization or coronary artery bypass graft surgery within 3 months prior to the randomization
  • Signs of bleeding, history of clinically-relevant bleeding according to International Society on Thrombosis and Haemostasis (ISTH), or conditions associated with high risk of bleeding
  • Any contraindication for anticoagulant agents

Other salient features:

  • Prior stroke/transient ischemic attack: 4.9%
  • CHA2DS2-VASc score ≥2: 50.2%
  • Baseline medications: VKA 39.4%, aspirin 3.2%, clopidogrel 1.7%

Principal Findings:

The primary outcome, death, stroke, or ISTH-defined major bleeding during the post-ablation period, for continued edoxaban vs. VKA, was 0.3% vs. 2.0% (p > 0.05).

Secondary outcomes for edoxaban vs. VKA:

  • Primary endpoint including peri- and post-ablation period: 2.7% vs. 1.7% (p > 0.05)
  • Acute cerebral microembolism ≤10 mm size: 13.8% vs. 9.6% (p = 0.62)

Interpretation:

The results of this trial indicate that adverse events are similar with continuing edoxaban or VKA uninterrupted among patients undergoing catheter ablation of AF. While post-ablation events were lower with edoxaban, periprocedural events (bleeding) were numerically higher. Similar low periprocedural rates with both direct oral anticoagulants and warfarin have been observed in other trials such as BRUISE CONTROL-1 and -2.

References:

Hohnloser SH, Camm J, Cappato R, et al. Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial. Eur Heart J 2019;40:3013-21.

Keywords: Anticoagulants, Arrhythmias, Cardiac, Aspirin, Atrial Fibrillation, Catheter Ablation, Contusions, Embolism, Hemorrhage, Ischemic Attack, Transient, Secondary Prevention, Stroke, Vitamin K, Warfarin, Vascular Diseases


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