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

Publication ,  Journal Article
Kirchhof, P; Haeusler, KG; Blank, B; De Bono, J; Callans, D; Elvan, A; Fetsch, T; Van Gelder, IC; Gentlesk, P; Grimaldi, M; Hansen, J; Mont, L ...
Published in: Eur Heart J
August 21, 2018

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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Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

August 21, 2018

Volume

39

Issue

32

Start / End Page

2942 / 2955

Location

England

Related Subject Headings

  • Vitamin K
  • Treatment Outcome
  • Stroke
  • Risk Factors
  • Pyridones
  • Pyrazoles
  • Prospective Studies
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
 

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Kirchhof, P., Haeusler, K. G., Blank, B., De Bono, J., Callans, D., Elvan, A., … Di Biase, L. (2018). Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation. Eur Heart J, 39(32), 2942–2955. https://doi.org/10.1093/eurheartj/ehy176
Kirchhof, Paulus, Karl Georg Haeusler, Benjamin Blank, Joseph De Bono, David Callans, Arif Elvan, Thomas Fetsch, et al. “Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.Eur Heart J 39, no. 32 (August 21, 2018): 2942–55. https://doi.org/10.1093/eurheartj/ehy176.
Kirchhof P, Haeusler KG, Blank B, De Bono J, Callans D, Elvan A, et al. Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation. Eur Heart J. 2018 Aug 21;39(32):2942–55.
Kirchhof, Paulus, et al. “Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.Eur Heart J, vol. 39, no. 32, Aug. 2018, pp. 2942–55. Pubmed, doi:10.1093/eurheartj/ehy176.
Kirchhof P, Haeusler KG, Blank B, De Bono J, Callans D, Elvan A, Fetsch T, Van Gelder IC, Gentlesk P, Grimaldi M, Hansen J, Hindricks G, Al-Khalidi HR, Massaro T, Mont L, Nielsen JC, Nölker G, Piccini JP, De Potter T, Scherr D, Schotten U, Themistoclakis S, Todd D, Vijgen J, Di Biase L. Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation. Eur Heart J. 2018 Aug 21;39(32):2942–2955.
Journal cover image

Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

August 21, 2018

Volume

39

Issue

32

Start / End Page

2942 / 2955

Location

England

Related Subject Headings

  • Vitamin K
  • Treatment Outcome
  • Stroke
  • Risk Factors
  • Pyridones
  • Pyrazoles
  • Prospective Studies
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging