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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 2012

Detailed Description

– 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.

Arms, Groups and Cohorts

  • dabigatran group
    • All patients receiving dabigatran as periprocedural anticoagulation during the study time period
  • warfarin group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Any significant complication
    • Time Frame: 30 days before or after catheter ablation
    • Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen

Participating in This Clinical Trial

Inclusion Criteria

  • All patients undergoing catheter ablation for atrial fibrillation Exclusion Criteria:

  • none (retrospective trial)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • William Beaumont Hospitals
  • Collaborator
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.