1. Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation
- Author
-
Lluís Mont, Georg Nölker, Hussein R. Al-Khalidi, David J. Callans, Paulus Kirchhof, Philip J. Gentlesk, Arif Elvan, Thomas Fetsch, Joseph de Bono, Benjamin F. Blank, Jens Cosedis Nielsen, Massimo Grimaldi, Daniel Scherr, Derick Todd, Ulrich Schotten, Tom De Potter, Isabelle C. Van Gelder, Karl Georg Haeusler, Gerhard Hindricks, Jim Hansen, Tyler Massaro, Luigi Di Biase, Jonathan P. Piccini, Sakis Themistoclakis, Johan Vijgen, Cardiovascular Centre (CVC), Fysiologie, and RS: CARIM - R2.11 - Experimental atrial fibrillation
- Subjects
Male ,Vitamin K ,Radiofrequency ablation ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Ablation ,THERAPY ,law.invention ,Cognition ,0302 clinical medicine ,Risk Factors ,law ,Prospective Studies ,030212 general & internal medicine ,Prospective cohort study ,Stroke ,CATHETER ABLATION ,Arrhythmia/Electrophysiology ,Brain ,Montreal Cognitive Assessment ,Atrial fibrillation ,Cerebral Infarction ,Middle Aged ,Magnetic Resonance Imaging ,3. Good health ,Treatment Outcome ,CRYOBALLOON ,Cardiology ,Female ,Apixaban ,TRIAL ,Cardiology and Cardiovascular Medicine ,medicine.drug ,medicine.medical_specialty ,Pyridones ,ANTICOAGULATION MANAGEMENT ,Fast Track Clinical Research ,Catheter ablation ,TERM ,WARFARIN ,03 medical and health sciences ,Anticoagulation ,VITAMIN-K ANTAGONISTS ,Internal medicine ,medicine ,Humans ,RADIOFREQUENCY ABLATION ,Aged ,LESIONS ,business.industry ,HEART RHYTHM ASSOCIATION ,Bleeding ,Warfarin ,medicine.disease ,Editor's Choice ,Brain MRI ,Pyrazoles ,business - 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.
- Published
- 2018
- Full Text
- View/download PDF