Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation

Paulus Kirchhof; Karl Georg Haeusler; Benjamin F  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 Nolker; Jonathan  Piccini; Tom De Potter; Daniel Scherr; Ulrich Schotten; Sakis  Themistoclakis; Derick M Todd; Johan Vijgen; Luigi  Di Biase

doi:10.1093/eurheartj/ehy176

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation

Paulus Kirchhof, Karl Georg Haeusler, Benjamin F 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 Nolker, Jonathan Piccini, Tom De Potter, Daniel ScherrUlrich Schotten, Sakis Themistoclakis, Derick M Todd, Johan Vijgen, Luigi Di Biase

Cardiovascular Sciences

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Abstract

Background: It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested.

Methods: We compared continuous apixaban (5 mg BD) to vitamin K antagonists (VKA, INR 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-center study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (BARC 2-5). A highresolution 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.

Results: 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 analyzable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA (difference -0.38% [90% 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 language	English
Pages (from-to)	2942–2955
Number of pages	14
Journal	European Heart Journal
Volume	39
Issue number	32
Early online date	20 Mar 2018
DOIs	https://doi.org/10.1093/eurheartj/ehy176
Publication status	Published - 21 Aug 2018

Keywords

Atrial fibrillation
Ablation
Anticoagulation
Bleeding
Stroke
Brain MRI

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Kirchhof, P., Haeusler, K. G., Blank, B. F., De Bono, J., Callans, D., Elvan, A., Fetsch, T., Van Gelder, I. C., Gentlesk, P., Grimaldi, M., Hansen, J., Hindricks, G., Al-Khalidi, H. R., Massaro, T., Mont, L., Nielsen, J. C., Nolker, G., Piccini, J., De Potter, T., ... 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

@article{655c4f339a0549c89fe4574237e7661d,

title = "Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation",

abstract = "Background: It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested.Methods: We compared continuous apixaban (5 mg BD) to vitamin K antagonists (VKA, INR 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-center study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (BARC 2-5). A highresolution 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.Results: 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 analyzable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA (difference -0.38% [90% 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.",

keywords = "Atrial fibrillation, Ablation, Anticoagulation, Bleeding, Stroke, Brain MRI",

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

year = "2018",

month = aug,

day = "21",

doi = "10.1093/eurheartj/ehy176",

language = "English",

volume = "39",

pages = "2942–2955",

journal = "European Heart Journal",

issn = "0195-668X",

publisher = "Oxford University Press",

number = "32",

}

Kirchhof, P, Haeusler, KG, Blank, BF, 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, Nolker, G, Piccini, J, De Potter, T, Scherr, D, Schotten, U, Themistoclakis, S, Todd, DM, 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

TY - JOUR

T1 - Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation

AU - Kirchhof, Paulus

AU - Haeusler, Karl Georg

AU - Blank, Benjamin F

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 - Nolker, Georg

AU - Piccini, Jonathan

AU - De Potter, Tom

AU - Scherr, Daniel

AU - Schotten, Ulrich

AU - Themistoclakis, Sakis

AU - Todd, Derick M

AU - Vijgen, Johan

AU - Di Biase, Luigi

PY - 2018/8/21

Y1 - 2018/8/21

N2 - Background: It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested.Methods: We compared continuous apixaban (5 mg BD) to vitamin K antagonists (VKA, INR 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-center study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (BARC 2-5). A highresolution 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.Results: 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 analyzable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA (difference -0.38% [90% 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.

AB - Background: It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested.Methods: We compared continuous apixaban (5 mg BD) to vitamin K antagonists (VKA, INR 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-center study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (BARC 2-5). A highresolution 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.Results: 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 analyzable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA (difference -0.38% [90% 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.

KW - Atrial fibrillation

KW - Ablation

KW - Anticoagulation

KW - Bleeding

KW - Stroke

KW - Brain MRI

U2 - 10.1093/eurheartj/ehy176

DO - 10.1093/eurheartj/ehy176

M3 - Article

SN - 0195-668X

VL - 39

SP - 2942

EP - 2955

JO - European Heart Journal

JF - European Heart Journal

IS - 32

ER -

Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation

Abstract

Keywords

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