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Eur Heart J. 2018 Aug 21;39(32):2942-2955. doi: 10.1093/eurheartj/ehy176.

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

Author information

1
Institute of Cardiovascular Sciences, University of Birmingham, and SWBH and UHB NHS Trusts, IBR 136, Wolfson Drive, Birmingham, UK.
2
SWBH NHS Trust, Birmingham, UK.
3
University Hospitals Birmingham, Birmingham, UK.
4
Atrial Fibrillation NETwork Association (AFNET), Germany, Münster.
5
Center for Stroke Research Berlin & Department of Neurology, Charité - Universitätsmedizin Berlin, Germany.
6
Hospital of the University of Pennsylvania, PA, USA.
7
Isala Heart Center Zwolle, Zwolle, The Netherlands.
8
The Clinical Research Institute, Munich, Germany.
9
University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
10
Sentara Cardiovascular Research Institute, Norfolk, VA, USA.
11
Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, Italy.
12
Gentofte Hospital, Hellerup, Denmark.
13
Abteilung für Rhythmologie, Leipzig Heart Center, Leipzig, Germany.
14
Department of Biostatistics & Bioinformatics, Duke University School of Medicine, USA.
15
Duke Clinical Research Institute (DCRI), Durham, NC, USA.
16
Hospital Clinic Barcelona, University of Barcelona, Barcelona, Spain.
17
Department of Cardiology, Aarhus University Hospital, Denmark.
18
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
19
Division of Cardiology Duke University Medical Center, Duke University, Durham, NC, USA.
20
Cardiovascular Center, OLV Aalst, Belgium.
21
Department of Cardiology, Medical University Graz, Austria.
22
Department of Physiology, University Maastricht, Maastricht, Netherlands.
23
Ospedale Dell'Angelo, Mestre, Italy.
24
Liverpool Heart and Chest Hospital, Liverpool, UK.
25
Jessa Ziekenhuis, Campus Virga Jesse, Hasselt, Belgium.
26
Albert Einstein College of Medicine, at Montefiore Hospital, New York, USA.
27
Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, TX, USA.

Abstract

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.

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