Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation

Paulus Kirchhof, Karl Georg Haeusler, Benjamin Blank, Joseph De Bono, David Callans, Arif Elvan, Thomas Fetsch, Isabelle C. Van Gelder, Philip Gentlesk, Massimo Grimaldi, Jim Hansen, Gerhard Hindricks, Hussein R. Al-Khalidi, Tyler Massaro, Lluis Mont, Jens Cosedis Nielsen, Georg Nölker, Jonathan P. Piccini, Tom De Potter, Daniel Scherr & 5 others Ulrich Schotten, Sakis Themistoclakis, Derick Todd, Johan Vijgen, Luigi Di Biase

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Aim: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.

Original languageEnglish (US)
Pages (from-to)2942-2955
Number of pages14
JournalEuropean Heart Journal
Volume39
Issue number32
DOIs
StatePublished - Aug 1 2018

Fingerprint

Atrial Fibrillation
Stroke
Cognition
Brain
Hemorrhage
Magnetic Resonance Imaging
International Normalized Ratio
Vitamin K
Research
Outcome Assessment (Health Care)
apixaban
Confidence Intervals
Pharmaceutical Preparations

Keywords

  • Ablation
  • Anticoagulation
  • Atrial fibrillation
  • Bleeding
  • Brain MRI
  • Stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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. European Heart Journal, 39(32), 2942-2955. https://doi.org/10.1093/eurheartj/ehy176

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation. / Kirchhof, Paulus; Haeusler, Karl Georg; Blank, Benjamin; De Bono, Joseph; Callans, David; Elvan, Arif; Fetsch, Thomas; Van Gelder, Isabelle C.; Gentlesk, Philip; Grimaldi, Massimo; Hansen, Jim; Hindricks, Gerhard; Al-Khalidi, Hussein R.; Massaro, Tyler; Mont, Lluis; Nielsen, Jens Cosedis; Nölker, Georg; Piccini, Jonathan P.; De Potter, Tom; Scherr, Daniel; Schotten, Ulrich; Themistoclakis, Sakis; Todd, Derick; Vijgen, Johan; Di Biase, Luigi.

In: European Heart Journal, Vol. 39, No. 32, 01.08.2018, p. 2942-2955.

Research output: Contribution to journalArticle

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 2018, 'Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation', European Heart Journal, vol. 39, no. 32, pp. 2942-2955. 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. European Heart Journal. 2018 Aug 1;39(32):2942-2955. https://doi.org/10.1093/eurheartj/ehy176
Kirchhof, Paulus ; Haeusler, Karl Georg ; Blank, Benjamin ; De Bono, Joseph ; Callans, David ; Elvan, Arif ; Fetsch, Thomas ; Van Gelder, Isabelle C. ; Gentlesk, Philip ; Grimaldi, Massimo ; Hansen, Jim ; Hindricks, Gerhard ; Al-Khalidi, Hussein R. ; Massaro, Tyler ; Mont, Lluis ; Nielsen, Jens Cosedis ; Nölker, Georg ; Piccini, Jonathan P. ; De Potter, Tom ; Scherr, Daniel ; Schotten, Ulrich ; Themistoclakis, Sakis ; Todd, Derick ; Vijgen, Johan ; Di Biase, Luigi. / Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation. In: European Heart Journal. 2018 ; Vol. 39, No. 32. pp. 2942-2955.
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T1 - Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation

AU - Kirchhof, Paulus

AU - Haeusler, Karl Georg

AU - Blank, Benjamin

AU - De Bono, Joseph

AU - Callans, David

AU - Elvan, Arif

AU - Fetsch, Thomas

AU - Van Gelder, Isabelle C.

AU - Gentlesk, Philip

AU - Grimaldi, Massimo

AU - Hansen, Jim

AU - Hindricks, Gerhard

AU - Al-Khalidi, Hussein R.

AU - Massaro, Tyler

AU - Mont, Lluis

AU - Nielsen, Jens Cosedis

AU - Nölker, Georg

AU - Piccini, Jonathan P.

AU - De Potter, Tom

AU - Scherr, Daniel

AU - Schotten, Ulrich

AU - Themistoclakis, Sakis

AU - Todd, Derick

AU - Vijgen, Johan

AU - Di Biase, Luigi

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N2 - Aim: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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KW - Ablation

KW - Anticoagulation

KW - Atrial fibrillation

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KW - Brain MRI

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