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      Safety and efficacy of dabigatran versus warfarin in patients undergoing catheter ablation of atrial fibrillation: a systematic review and meta-analysis

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          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.

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          Most cited references 15

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          Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry.

          The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation. AF ablation requires optimal periprocedural anticoagulation for minimizing bleeding and thromboembolic complications. The safety and efficacy of dabigatran as a periprocedural anticoagulant for AF ablation are unknown. We performed a multicenter, observational study from a prospective registry including all consecutive patients undergoing AF ablation in 8 high-volume centers in the United States. All patients receiving dabigatran therapy who underwent AF ablation on periprocedural dabigatran, with the dose held on the morning of the procedure, were matched by age, sex, and type of AF with an equal number of patients undergoing AF ablation with uninterrupted warfarin therapy over the same period. A total of 290 patients, including 145 taking periprocedural dabigatran and an equal number of matched patients taking uninterrupted periprocedural warfarin, were included in the study. The mean age was 60 years with 79% being male and 57% having paroxysmal AF. Both groups had a similar CHADS(2) score, left atrial size, and left ventricular ejection fraction. Three thromboembolic complications (2.1%) occurred in the dabigatran group compared with none in the warfarin group (p = 0.25). The dabigatran group had a significantly higher major bleeding rate (6% vs. 1%; p = 0.019), total bleeding rate (14% vs. 6%; p = 0.031), and composite of bleeding and thromboembolic complications (16% vs. 6%; p = 0.009) compared with the warfarin group. Dabigatran use was confirmed as an independent predictor of bleeding or thromboembolic complications (odds ratio: 2.76, 95% confidence interval: 1.22 to 6.25; p = 0.01) on multivariate regression analysis. In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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            Use of dabigatran for periprocedural anticoagulation in patients undergoing catheter ablation for atrial fibrillation.

            Pulmonary vein isolation (PVI) for atrial fibrillation is associated with a transient increased risk of thromboembolic and hemorrhagic events. We hypothesized that dabigatran can be safely used as an alternative to continuous warfarin for the periprocedural anticoagulation in PVI. A total of 999 consecutive patients undergoing PVI were included; 376 patients were on dabigatran (150 mg), and 623 patients were on warfarin with therapeutic international normalized ratio. [corrected] Dabigatran was held 1 to 2 doses before PVI and restarted at the conclusion of the procedure or as soon as patients were transferred to the nursing floor. Propensity score matching was applied to generate a cohort of 344 patients in each group with balanced baseline data. Total hemorrhagic and thromboembolic complications were similar in both groups, before (3.2% versus 3.9%; P=0.59) and after (3.2% versus 4.1%; P=0.53) matching. Major hemorrhage occurred in 1.1% versus 1.6% (P=0.48) before and 1.2% versus 1.5% (P=0.74) after matching in the dabigatran versus warfarin group, respectively. A single thromboembolic event occurred in each of the dabigatran and warfarin groups. Despite higher doses of intraprocedural heparin, the mean activated clotting time was significantly lower in patients who held dabigatran for 1 or 2 doses than those on warfarin. Our study found no evidence to suggest a higher risk of thromboembolic or hemorrhagic complications with use of dabigatran for periprocedural anticoagulation in patients undergoing PVI compared with uninterrupted warfarin therapy.
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              Epidemiology of atrial fibrillation: a current perspective.

              The prevalence of atrial fibrillation (AF) increases with age. Recent population-based data indicate a trend of increasing incidence and prevalence of AF that is incompletely explained by an aging population. A recent population study estimated that the number of Americans afflicted by AF will increase from the current 2.3 million to more than 10 million by 2050. Novel risk factors--obesity and sleep apnea--may partially account for the current AF epidemic. Ethnic differences in the epidemiology of AF have been suggested but not clearly elucidated by population-based studies. The heritability of AF in the general population is strongly supported by population-based data. Genetic epidemiological studies on AF can potentially yield important mechanistic insights that may ultimately lead to novel preventative and therapeutic strategies.
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                Author and article information

                Journal
                Heart
                Heart
                heartjnl
                heart
                Heart
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                1355-6037
                1468-201X
                15 February 2014
                22 July 2013
                : 100
                : 4
                : 324-335
                Affiliations
                [1 ]Département de Rythmologie, Clinique Pasteur , Toulouse, France
                [2 ]Faculty of Medicine, University of Coimbra , Coimbra, Portugal
                [3 ]Heart Institute, Cedars Sinai Medical Center , Los Angeles, California, USA
                [4 ]Paris Cardiovascular Research Center , Paris, France
                Author notes
                [Correspondence to ] Dr Rui Providência, Département de Rythmologie, Clinique Pasteur, 45 avenue de Lombez, BP 27617, Toulouse, 31076 Cedex 3, France; rui_providencia@ 123456yahoo.com
                Article
                heartjnl-2013-304386
                10.1136/heartjnl-2013-304386
                3913219
                23878175
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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                Categories
                1506
                Arrhythmias and Sudden Death
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                Cardiovascular Medicine

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