Apixaban versus Warfarin for the Prevention of Periprocedural Cerebral Thromboembolism in Atrial Fibrillation Ablation: Multicenter Prospective Randomized Study
Male
Anticoagulants
Hemorrhage
Middle Aged
3. Good health
Brain Ischemia
03 medical and health sciences
Diffusion Magnetic Resonance Imaging
0302 clinical medicine
Intracranial Embolism
Japan
Atrial Fibrillation
Catheter Ablation
Humans
Pyrazoles
Female
International Normalized Ratio
Prospective Studies
Drug Monitoring
Intracranial Thrombosis
Blood Coagulation
Aged
Factor Xa Inhibitors
DOI:
10.1111/jce.12928
Publication Date:
2016-01-14T03:29:00Z
AUTHORS (15)
ABSTRACT
Apixaban Thromboembolism Prevention in AF AblationIntroductionStroke can be a life‐threatening complication of atrial fibrillation (AF) catheter ablation. Uninterrupted warfarin treatment contributes to minimizing the risk of stroke complications.Methods and ResultsThis was a prospective, open‐label, randomized, multicenter study assessing the safety and efficacy of apixaban for the prevention of cerebral thromboembolism complicating AF catheter ablation. Two hundred patients with drug‐resistant AF were equally assigned to take either apixaban (5 mg or 2.5 mg twice daily) or warfarin (target international normalized ratio, 2‐3) for at least 1 month before AF ablation. Neither drug regimen was interrupted throughout the operative period. Diffusion‐weighted magnetic resonance imaging was performed for all patients to detect silent cerebral infarction (SCI) after the ablation. Primary outcomes were defined as the occurrence of stroke, transient ischemic attack, SCI, or major bleeding that required intervention. The secondary outcome was minor bleeding. The groups did not statistically differ in patients’ backgrounds or procedural parameters. During AF ablation, the apixaban group required administration of more heparin to maintain an activated clotting time > 300 seconds than the warfarin group (apixaban, 14,000 ± 4,000 units; warfarin, 9,000 ± 3,000 units). Three primary outcome events occurred in each group (apixaban, 2 SCI and 1 major bleed; warfarin, 3 SCI, P = 1.00), and 3 and 4 secondary outcome events occurred in the apixaban and warfarin groups (P = 0.70), respectively.ConclusionApixaban has similar safety and effectiveness to warfarin for the prevention of cerebral thromboembolism during the periprocedural period of AF ablation.
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