Continuous DOAC is safe and effective in patients with AF undergoing ablation

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation

Literature - Kirchhof P, Haeusler KG, Blank B, et al. - Eur Heart J 2018;published online ahead of print

Introduction and methods

Ablation in patients with atrial fibrillation (AF) is associated with a risk of stroke and major bleeding [1-3]. Continuous oral anticoagulation is recommended in these patients to reduce the risk of embolic events [1,3,4]. Continuous apixaban in this setting has not been tested. Declined cognitive function and acute brain lesions have been associated with AF ablation, but this has not been studied in controlled clinical trials.

633 Patients with at least one established stroke risk factor, who were scheduled for a first AF ablation were, were randomized to receive continuous apixaban 5 mg bid or continuous VKA therapy (warfarin, phenprocoumon, acenocoumarol) in the Anticoagulation using the direct factor Xa inhibitor apixaban during Atrial Fibrillation catheter Ablation: comparison to VKA therapy (AXAFA – AFNET 5) trial.

The primary outcome was the composite of all-cause death, stroke, or major bleeding. Major bleeding was defined according to the Bleeding Academic Research Consortium (BARC ≥2) [5]. Cognitive function was assessed in all patients by Montreal Cognitive Assessment (MoCA) [6] and the prevalence and number of brain lesions by MRI were analyzed in a sub-study.

Main results

  • Apixaban was non-inferior to VKA (a difference of -0.38%, 90%CI:-4.0% to 3.3%, non-inferiority P=0.0002) for the primary outcome.
  • There was no interaction between stoke, bleeding risk factors and treatment groups.
  • After 90 days, mild cognitive dysfunction was improved; MoCA increased by a median of 1.0 unit (90%CI: -1.0 to 2.0, P=0.005) with no differences between groups.
  • No differences in acute brain lesions were detected between groups (P=0.635) in a total of 323 analyzable MRIs. Cognitive function was not different in those with or without acute brain lesions.


In patients with increased risk of stroke undergoing AF ablation, continuous apixaban therapy was safe and effective compared to VKA treatment with respect to stroke, bleeding, cognitive function and brain lesions. More research is needed to reduce ablation-related acute brain lesions.


1. Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37:2893–2962.

2. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association. Task Force on practice guidelines and the Heart Rhythm Society. Circulation 2014;130:e199–e267.

3. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm 2017;15:e275–e444.

4. Di Biase L, Burkhardt JD, Santangeli P, et al. Periprocedural Stroke and Bleeding Complications in Patients Undergoing Catheter Ablation of Atrial Fibrillation With Different Anticoagulation Management: results From the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) Randomized Trial. Circulation 2014;129:2638–2644.

5. Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the bleeding academic research consortium. Circulation 2011;123:2736–2747.

6. Nasreddine ZS, Phillips N, Chertkow H, et al. Normative data for the Montreal Cognitive Assessment (MoCA) in a population-based sample. Neurology 2012;78:765–766.

Find this article online at Eur Heart J

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