TY - JOUR
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 - Nolker, 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
PY - 2018/8/21
Y1 - 2018/8/21
N2 - 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 (5mg 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.
AB - 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 (5mg 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.
KW - Atrial fibrillation
KW - Ablation
KW - Anticoagulation
KW - Bleeding
KW - Stroke
KW - Brain MRI
KW - HEART RHYTHM ASSOCIATION
KW - VITAMIN-K ANTAGONISTS
KW - CATHETER ABLATION
KW - ANTICOAGULATION MANAGEMENT
KW - RADIOFREQUENCY ABLATION
KW - TRIAL
KW - CRYOBALLOON
KW - WARFARIN
KW - THERAPY
KW - LESIONS
U2 - 10.1093/eurheartj/ehy176
DO - 10.1093/eurheartj/ehy176
M3 - Article
C2 - 29579168
SN - 0195-668X
VL - 39
SP - 2942
EP - 2955
JO - European Heart Journal
JF - European Heart Journal
IS - 32
ER -