Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
| Status: | Withdrawn |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/17/2016 |
| Start Date: | May 2012 |
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.
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.
- 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.
- 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.
Inclusion Criteria:
- All patients undergoing catheter ablation for atrial fibrillation
Exclusion Criteria:
- none (retrospective trial)
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