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Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.pdf (766.82 kB)

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.

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posted on 2019-07-05, 14:14 authored by P Kirchhof, KG Haeusler, B Blank, J De Bono, D Callans, A Elvan, T Fetsch, IC Van Gelder, P Gentlesk, M Grimaldi, J Hansen, G Hindricks, HR Al-Khalidi, T Massaro, L Mont, JC Nielsen, G Nölker, JP Piccini, T De Potter, D Scherr, U Schotten, S Themistoclakis, D Todd, J Vijgen, L Di Biase
Aims: It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested. Methods and results: We compared continuous apixaban (5 mg b.i.d.) to vitamin K antagonists (VKA, international normalized ratio 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-centre study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (Bleeding Academic Research Consortium 2-5). A high-resolution brain magnetic resonance imaging (MRI) sub-study quantified acute brain lesions. Cognitive function was assessed by Montreal Cognitive Assessment (MoCA) at baseline and at end of follow-up. Overall, 674 patients (median age 64 years, 33% female, 42% non-paroxysmal atrial fibrillation, 49 sites) were randomized; 633 received study drug and underwent ablation; 335 undertook MRI (25 sites, 323 analysable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA {difference -0.38% [90% confidence interval (CI) -4.0%, 3.3%], non-inferiority P = 0.0002 at the pre-specified absolute margin of 0.075}, including 2 (0.3%) deaths, 2 (0.3%) strokes, and 24 (3.8%) ISTH major bleeds. Acute small brain lesions were found in a similar number of patients in each arm [apixaban 44/162 (27.2%); VKA 40/161 (24.8%); P = 0.64]. Cognitive function increased at the end of follow-up (median 1 MoCA unit; P = 0.005) without differences between study groups. Conclusions: Continuous apixaban is safe and effective in patients undergoing atrial fibrillation ablation at risk of stroke with respect to bleeding, stroke, and cognitive function. Further research is needed to reduce ablation-related acute brain lesions.

Funding

AXAFA – AFNET 5 is an investigator-initiated trial. Sponsor of the trial is AFNET. AXAFA – AFNET 5 was partially funded by BMS/Pfizer, the DZHK (German Centre for Cardiovascular Research) and by the BMBF (German Ministry of Education and Research) to AFNET. Further support came from European Union [Grant Agreement No. 633196 (CATCH ME) to B.B., P.K., L.M., U.S., AFNET], British Heart Foundation (FS/13/43/30324 to P.K.), Leducq Foundation to P.K., and the Netherlands Heart Foundation (RACE V) to U.S. and I.v.G. AFNET, DZHK, BMS/Pfizer; AXAFA – AFNET 5; NCT02227550.

History

Citation

European Heart Journal, 2018, 39 (32), pp. 2942-2955

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Cardiovascular Sciences

Version

  • VoR (Version of Record)

Published in

European Heart Journal

Publisher

Oxford University Press

eissn

1522-9645

Acceptance date

2018-03-14

Copyright date

2018

Available date

2019-07-05

Notes

Supplementary data is available on the publisher's website https://doi.org/10.1093/eurheartj/ehy176

Language

en

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