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Published on: February 28, 2012
Dabigatran vs warfarin for radiofrequency catheter ablation of atrial fibrillation
Jin-Seok Kim1, Fei She, Krit Jongnarangsin
1Cardiovascular Medicine, University of Michigan, Ann Arbor, MI 48105-5853, USA.
Insights
Dabigatran, when temporarily held before and resumed after radiofrequency catheter ablation (RFA) for atrial fibrillation (AF), shows comparable safety and effectiveness to uninterrupted warfarin. This study indicates dabigatran is a viable alternative for periprocedural anticoagulation in AF patients undergoing RFA.
Area of Science:
- Cardiology
- Pharmacology
- Medical Procedures
Background:
- Uncertainty exists regarding the safety and efficacy of dabigatran compared to uninterrupted warfarin for anticoagulation during radiofrequency catheter ablation (RFA) in atrial fibrillation (AF) patients.
- Periprocedural anticoagulation management is critical for preventing thromboembolic events and bleeding complications in AF patients undergoing RFA.
Purpose of the Study:
- To compare the safety and efficacy of dabigatran, using a novel administration protocol, with uninterrupted warfarin for periprocedural anticoagulation in patients undergoing RFA of AF.
- To evaluate bleeding and thromboembolic complication rates in AF patients receiving either dabigatran or warfarin during RFA.
Main Methods:
- A case-control analysis included 763 patients undergoing RFA of AF, with 191 receiving dabigatran and 572 receiving uninterrupted warfarin for periprocedural anticoagulation.
- Anticoagulation was initiated at least 4 weeks prior to RFA. Dabigatran was held the day before the procedure and resumed 4 hours post-hemostasis, while warfarin was uninterrupted.
- Safety outcomes included major and minor bleeding, and pericardial tamponade. Efficacy was assessed by the absence of thromboembolic complications.
Main Results:
- No intracardiac thrombus was detected in patients receiving dabigatran. Thromboembolic complications were absent in both groups.
- Major bleeding rates were 2.1% for dabigatran vs. 2.1% for warfarin (P=1.0), and minor bleeding rates were 2.6% vs. 3.3% (P=0.8), respectively.
- Pericardial tamponade occurred in 1% of dabigatran patients and 1.2% of warfarin patients (P=1.0), with all patients recovering fully.
Conclusions:
- Dabigatran, when administered with a 24-hour interruption before and a 4-hour resumption after RFA, demonstrates comparable safety and efficacy to uninterrupted warfarin for periprocedural anticoagulation in AF patients.
- The findings suggest that this dabigatran protocol is a safe and effective alternative to warfarin for AF patients undergoing RFA, with similar complication rates.
Background:
It is not clear whether dabigatran is as safe and effective as uninterrupted anticoagulation with warfarin during radiofrequency catheter ablation (RFA) of atrial fibrillation (AF).
Objective:
To compare the safety and efficacy of dabigatran by using a novel administration protocol and uninterrupted anticoagulation with warfarin for periprocedural anticoagulation in patients undergoing RFA of AF.
Methods:
In this case-control analysis, 763 consecutive patients (mean age 61±10 years) underwent RFA of AF using dabigatran (N = 191) or uninterrupted warfarin (N = 572) for periprocedural anticoagulation. In all patients, anticoagulation was started≥4 weeks before RFA. Dabigatran was held after the morning dose on the day before the procedure and resumed 4 hours after vascular hemostasis was achieved.
Results:
A transesophageal echocardiogram performed in all patients receiving dabigatran did not demonstrate an intracardiac thrombus. There were no thromboembolic complications in either group. The prevalence of major (4 of 191, 2.1%) and minor (5 of 191, 2.6%) bleeding complications in the dabigatran group were similar to those in the warfarin group (12 of 572, 2.1%; P = 1.0 and 19 of 572, 3.3%; P = .8, respectively). Pericardial tamponade occurred in 2 of 191 (1%) patients in the dabigatran group and in 7 of 572 (1.2%) patients in the warfarin group (P = 1.0). All patients who had a pericardial tamponade, including 2 in the dabigatran group, had uneventful recovery after perdicardiocentesis. On multivariate analysis, international normalized ratio (odds ratio [OR] 4.0; 95% confidence interval [CI] 1.1-15.0; P = .04), clopidogrel use (OR 4.2; 95% CI 1.5-12.3; P = .01), and CHA2DS2-VASc score (OR 1.4; 95% CI 1.1-1.8; P = .01) were the independent risk factors of bleeding complications only in the warfarin group.
Conclusions:
When held for approximately 24 hours before the procedure and resumed 4 hours after vascular hemostasis, dabigatran appears to be as safe and effective as uninterrupted warfarin for periprocedural anticoagulation in patients undergoing RFA of AF.
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