Dabigatran vs Warfarin in Ablation for Atrial Fibrillation
Background Dabigatran etexilate, a new thrombin inhibitor, has been shown to be comparable to warfarin in patients with atrial fibrillation (AF). However, there is a limited body of evidence on the efficacy and safety of using dabigatran among patients undergoing AF catheter ablation.
Objective A random effects meta-analysis was performed of controlled trials comparing dabigatran and warfarin in paroxysmal/persistent AF patients undergoing catheter ablation.
Methods Data sources included Medline, Embase, and Cochrane (from inception to April 2013). Three independent reviewers selected studies comparing warfarin to dabigatran. Descriptive and quantitative information was extracted from each selected study, regarding periprocedural all cause mortality, thromboembolic events and major bleeding, as well as modalities of periprocedural anticoagulation bridging.
Results After a detailed screening of 228 search results, 14 studies were identified enrolling a total of 4782 patients (1823 treated with dabigatran and 2959 with warfarin). No deaths were reported. No significant differences were found between patients treated with dabigatran and warfarin as regards thromboembolic events (0.55% dabigatran vs 0.17% warfarin; risk ratios (RR)=1.78, 95% CI 0.66 to 4.80; p=0.26) and major bleeding (1.48% dabigatran vs 1.35% warfarin; RR=1.07, 95% CI 0.51 to 2.26; p=0.86). No difference was found between the 110 mg twice daily and 150 mg twice daily dabigatran dosages concerning major bleeding (0% vs 1.62%, respectively; RR=0.19, 95% CI 0.01 to 3.18; p=0.25) and thromboembolism (0% vs 0.40%, respectively; RR=0.72, 95% CI 0.04 to 12.98; p=0.82).
Conclusions In the specific setting of AF catheter ablation, this first pooled analysis suggests that patients treated with dabigatran have a similar incidence of thromboembolic events and major bleeding compared to warfarin, with low event rates overall.
Atrial fibrillation (AF) is the most prevalent sustained arrhythmia and its prevalence is likely to rise steeply until 2050. Stroke and systemic embolism are among the most feared complications of AF and can be effectively tackled by anticoagulation.
Catheter ablation is currently recommended (class IIa, level of evidence C) as an interventional alternative for the treatment of patients with AF having symptomatic recurrences despite antiarrhythmic therapy. Over the last 13 years this has become a very commonly performed procedure for the treatment of symptomatic AF patients.
Rigorous anticoagulation in the setting of AF catheter ablation has been demonstrated to be of prime importance. The recent large phase III trials involving the use of novel oral anticoagulants confirmed the non-inferiority, and even superiority in some cases, of dabigatran, rivaroxaban, and apixaban compared to warfarin in AF patients. However, since a planned AF catheter ablation procedure was listed as an exclusion criteria in those trials, the efficacy and safety results cannot be extended to that setting. The 2012 Expert Consensus Statement on the management of patients with AF, by the Heart Rhythm Society, European Heart Rhythm Association, and European Cardiac Arrhythmia Society, highlights the limited clinical experience with the new anticoagulants in AF catheter ablation. Thus, even though dabigatran is being widely used and has been in vogue longer than the other new agents, strong evidence towards its utilisation in patients undergoing AF ablation is lacking. Further, the presence of controversial results in controlled trials with warfarin has led cardiologists to question its safety and efficacy.
We therefore aimed to systematically evaluate, using a meta-analysis, all evidence concerning the use of dabigatran versus warfarin in catheter ablation for AF. The main objectives of this study were: (1) evaluate the efficacy and safety of dabigatran compared to warfarin; (2) determine whether there were significant differences between the 110 mg twice daily and 150 mg twice daily dosages of dabigatran; and (3) study the management of periprocedural bridging anticoagulation.
Abstract and Introduction
Abstract
Background Dabigatran etexilate, a new thrombin inhibitor, has been shown to be comparable to warfarin in patients with atrial fibrillation (AF). However, there is a limited body of evidence on the efficacy and safety of using dabigatran among patients undergoing AF catheter ablation.
Objective A random effects meta-analysis was performed of controlled trials comparing dabigatran and warfarin in paroxysmal/persistent AF patients undergoing catheter ablation.
Methods Data sources included Medline, Embase, and Cochrane (from inception to April 2013). Three independent reviewers selected studies comparing warfarin to dabigatran. Descriptive and quantitative information was extracted from each selected study, regarding periprocedural all cause mortality, thromboembolic events and major bleeding, as well as modalities of periprocedural anticoagulation bridging.
Results After a detailed screening of 228 search results, 14 studies were identified enrolling a total of 4782 patients (1823 treated with dabigatran and 2959 with warfarin). No deaths were reported. No significant differences were found between patients treated with dabigatran and warfarin as regards thromboembolic events (0.55% dabigatran vs 0.17% warfarin; risk ratios (RR)=1.78, 95% CI 0.66 to 4.80; p=0.26) and major bleeding (1.48% dabigatran vs 1.35% warfarin; RR=1.07, 95% CI 0.51 to 2.26; p=0.86). No difference was found between the 110 mg twice daily and 150 mg twice daily dabigatran dosages concerning major bleeding (0% vs 1.62%, respectively; RR=0.19, 95% CI 0.01 to 3.18; p=0.25) and thromboembolism (0% vs 0.40%, respectively; RR=0.72, 95% CI 0.04 to 12.98; p=0.82).
Conclusions In the specific setting of AF catheter ablation, this first pooled analysis suggests that patients treated with dabigatran have a similar incidence of thromboembolic events and major bleeding compared to warfarin, with low event rates overall.
Introduction
Atrial fibrillation (AF) is the most prevalent sustained arrhythmia and its prevalence is likely to rise steeply until 2050. Stroke and systemic embolism are among the most feared complications of AF and can be effectively tackled by anticoagulation.
Catheter ablation is currently recommended (class IIa, level of evidence C) as an interventional alternative for the treatment of patients with AF having symptomatic recurrences despite antiarrhythmic therapy. Over the last 13 years this has become a very commonly performed procedure for the treatment of symptomatic AF patients.
Rigorous anticoagulation in the setting of AF catheter ablation has been demonstrated to be of prime importance. The recent large phase III trials involving the use of novel oral anticoagulants confirmed the non-inferiority, and even superiority in some cases, of dabigatran, rivaroxaban, and apixaban compared to warfarin in AF patients. However, since a planned AF catheter ablation procedure was listed as an exclusion criteria in those trials, the efficacy and safety results cannot be extended to that setting. The 2012 Expert Consensus Statement on the management of patients with AF, by the Heart Rhythm Society, European Heart Rhythm Association, and European Cardiac Arrhythmia Society, highlights the limited clinical experience with the new anticoagulants in AF catheter ablation. Thus, even though dabigatran is being widely used and has been in vogue longer than the other new agents, strong evidence towards its utilisation in patients undergoing AF ablation is lacking. Further, the presence of controversial results in controlled trials with warfarin has led cardiologists to question its safety and efficacy.
We therefore aimed to systematically evaluate, using a meta-analysis, all evidence concerning the use of dabigatran versus warfarin in catheter ablation for AF. The main objectives of this study were: (1) evaluate the efficacy and safety of dabigatran compared to warfarin; (2) determine whether there were significant differences between the 110 mg twice daily and 150 mg twice daily dosages of dabigatran; and (3) study the management of periprocedural bridging anticoagulation.
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