Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation

Study Overview
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Brief Summary
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Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.

Detailed Description
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Data from patients collected from 4 US and 1 Canadian medical center Retrospective record review of all patients that had undergone catheter ablation of atrial fibrillation during the time period beginning with the initiation of dabigatran therapy for stroke prophylaxis at each center and ending in November 2011. Dabigatran study group comprised of all patients that received dabigatran for stroke prophylaxis during the study time period. Warfarin comparison group to be selected from all patients that received warfarin for stroke prophylaxis during the identical study time period. Warfarin patients will be numbered sequentially A subgroup of warfarin patients identical in number to the dabigatran patients at each center will be selected using random number generator. Patient data sets will be de-identified and compiled Master data set to be stored in Excel file Statistics to be performed with SAS (Cary, NC) Continuous data to be expressed as means ± S.D., compared with unpaired t-tests Categorical data will be compared with Fisher's exact test or Chi-square Complications including any thromboembolic events or any bleeding events will be recorded and the prevalence compared.

Official Title
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Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing catheter ablation for atrial fibrillation Exclusion Criteria: none (retrospective trial)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dabigatran group<br>All patients receiving dabigatran as periprocedural anticoagulation during the study time period | |
| warfarin group<br>A randomly selected group of patients treated with warfarin during the study time period matching the number of dabigatran treated patients in the same time period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical stroke, TIA or systemic embolic complication | Thromboembolic complication recorded in clinical records. | 30 days before or after catheter ablation | 
| Bleeding complication | Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding. | 30 days before or after catheter ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any significant complication | Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen | 30 days before or after catheter ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, catheter ablation, dabigatran, warfarin, oral anticoagulation