Feasibility and safety of uninterrupted periprocedural apixaban administration in patients undergoing radiofrequency catheter ablation for atrial fibrillation: Results from a multicenter study

doi:10.1016/j.hrthm.2015.02.028

Heart Rhythm

Volume 12, Issue 6, June 2015, Pages 1162-1168

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https://doi.org/10.1016/j.hrthm.2015.02.028 Get rights and content

Background

Periprocedural anticoagulation management with uninterrupted warfarin and a “therapeutic” international normalized ratio is the best approach for reducing both thromboembolic and bleeding complications in the setting of catheter ablation for atrial fibrillation (AF).

Objective

The purpose of this study was to evaluate the safety and feasibility of uninterrupted apixaban in this setting.

Methods

This was a prospective multicenter registry of AF patients undergoing radiofrequency catheter ablation at 4 institutions in United States and Europe with uninterrupted apixaban. These patients were compared with an equal number of patients, matched for age, gender, and type of AF, undergoing AF ablation on uninterrupted warfarin. The apixaban group was comprised of consecutive patients who had taken their last dose of apixaban the morning of the procedure. A subset of 29 patients in the apixaban group underwent diffusion magnetic resonance imaging (dMRI) to detect silent cerebral ischemia.

Results

A total of 400 patients (200 patients in each group) were included in the study. The average age was 65.9 ± 9.9 years, 286 (71.5%) were male, and 334 (83.5%) had nonparoxysmal AF. There were no statistical differences with regard to major complications (1% vs 0.5%, P = 1), minor complications (3.5% vs 2.5%, P = .56), or total bleeding complications (4.5% vs 3%, P = .43) between the apixaban and warfarin groups. There were no symptomatic thromboembolic complications. All dMRIs were negative for “new” silent cerebral ischemia in the apixaban group.

Conclusion

Uninterrupted apixaban administration in patients undergoing AF ablation seems to be feasible and effective in preventing clinical and silent thromboembolic events without increasing the risk of major bleeding.

Introduction

Catheter ablation is a valid therapeutic option for treatment of atrial fibrillation (AF).¹ The procedure is relatively complex, and often the outcome is related to the operator’s experience. Both bleeding and thromboembolic events are the most dangerous periprocedural complications.2, 3, 4, 5, 6

Periprocedural anticoagulation management with uninterrupted warfarin and a “therapeutic” international normalized ratio (INR) is the best approach for reducing both thromboembolic and bleeding complications, especially in patients with nonparoxysmal atrial fibrillation (NPAF).7, 8, 9 In addition, uninterrupted warfarin protects against silent cerebral ischemia (SCI).¹⁰

In recent years, novel oral anticoagulants (NOACs) have been introduced for prevention of stroke in patients with AF.11, 12, 13, 14 These drugs have shown noninferiority to warfarin in preventing stroke without increasing the bleeding risk. No randomized study evaluating the safety and feasibility of these drugs in the setting of AF ablation has been reported.¹⁵ Nonrandomized studies have evaluated the safety and feasibility of dabigatran and rivaroxaban in the setting of AF ablation.16, 17, 18, 19, 20, 21, 22, 23, 24, 25 Few data are available regarding apixaban (direct factor Xa inhibitor), the latest oral anticoagulant approved for preventing thromboembolism in patients with nonvalvular AF in the setting of AF ablation.15, 16

In this prospective multicenter study, we sought to evaluate the safety and feasibility of uninterrupted apixaban administration in the setting of catheter ablation for AF.

Section snippets

Methods

We performed a prospective multicenter registry of AF patients undergoing their first radiofrequency catheter ablation at 4 institutions in United States and Europe between June 2013 and July 2014 with uninterrupted apixaban administration. This was not a randomized controlled trial. The registry was approved by respective institutional review boards and informed consent was obtained from all patients.

The apixaban group comprised all consecutive patients who were taking twice daily 5- or 2.5-mg

Baseline and procedural characteristics

A total of 400 patients (200 patients in the apixaban group, 200 patients in the warfarin group) were included in the study. The average age of the study population was 65.9 ± 9.9 years; 286 (71.5%) were male, and 66 patients (16.5%) had paroxysmal type AF. Baseline demographics, clinical parameters, and medication usage are listed in Table 1. There were no differences with regard to race, body mass index, hypertension, diabetes, prior stroke and/or TIA, coronary artery disease, heart failure,

Main study findings

This is the first prospective multicenter study showing that uninterrupted apixaban strategy (last dose taken the morning of the AF procedure) is feasible, safe, and not statistically different from uninterrupted warfarin in preventing periprocedural bleeding and thromboembolic complications during AF ablation. In addition, apixaban showed an important protection against SCI in a subset of patients.

These data are novel and important, especially in light of the fact that the majority of the

Conclusion

In our multicenter experience, uninterrupted apixaban administration (last dose taken on the morning of the procedure) in patients undergoing AF ablation seems to be feasible and effective in preventing clinical and silent thromboembolic events without increasing the risk of major bleedings.

Clinical Perspectives

Uninterrupted warfarin has been shown to be the most favorable anticoagulation management approach to reduce both thromboembolic and bleeding complications, especially in patients

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Periprocedural stroke and management of major bleeding complications in patients undergoing catheter ablation of atrial fibrillation: the impact of periprocedural therapeutic international normalized ratio

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Ablation of atrial fibrillation under therapeutic warfarin reduces periprocedural complications: evidence from a meta-analysis

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A total of 6186 patients (3180 on apixaban [51.4%], 2528 on rivaroxaban [40.9%], 404 on dabigatran [6.5%], and 74 on edoxaban [1.2%]) were analyzed. The mean age of the study population was 69.4 ± 10.3 years; 4194 patients (67.8%) were male, and 5120 patients (82.8%) had persistent and long-standing persistent AF. The mean CHA₂DS₂-VASc score was 2.86 ± 1.58; the mean CHADS₂ score was 1.65 ± 1.14. Intracardiac echocardiography ruled out left atrial appendage and left atrial thrombi in all patients and revealed “smoke” in 1672 patients (27.03%). Transient ischemic attack was noted in 1 patient with long-standing persistent AF in the setting of a missed dose of rivaroxaban before ablation.
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: Dr. Di Biase is a consultant for Biosense Webster, Boston Scientific, and St. Jude Medical; and has received speaker honoraria/travel from Medtronic, AtriCure, EPiEP, and Biotronik. Dr. Natale has received speaker honoraria from Boston Scientific, Biosense Webster, St. Jude Medical, Biotronik, and Medtronic; and is a consultant for Biosense Webster, St. Jude Medical, and Janssen. Dr. Burkhardt is a consultant for Stereotaxis, Biosense Webster, and Boehringer-Ingelheim.

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Feasibility and safety of uninterrupted periprocedural apixaban administration in patients undergoing radiofrequency catheter ablation for atrial fibrillation: Results from a multicenter study

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Methods

Baseline and procedural characteristics

Main study findings

Conclusion

Clinical Perspectives

Heart Rhythm

Thromb Res

J Am Coll Cardiol

Heart Rhythm

Am J Cardiol

J Am Coll Cardiol

Heart Rhythm

Am J Cardiol

Can J Cardiol

J Am Coll Cardiol

Thromb Res

Thromboembolic risk and anticoagulation strategies in patients undergoing catheter ablation for atrial fibrillation

Curr Cardiol Rep

Complications of catheter ablation for atrial fibrillation: incidence and predictors

J Cardiovasc Electrophysiol

Incidence and predictors of periprocedural cerebrovascular accident in patients undergoing catheter ablation of atrial fibrillation

J Cardiovasc Electrophysiol

Periprocedural stroke and management of major bleeding complications in patients undergoing catheter ablation of atrial fibrillation: the impact of periprocedural therapeutic international normalized ratio

Circulation

Ablation of atrial fibrillation under therapeutic warfarin reduces periprocedural complications: evidence from a meta-analysis

Circ Arrhythm Electrophysiol