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Feasibility & Safety of Dabigatran vs Warfarin for Periprocedural Anticoagulation in Patients Undergoing Radiofrequency Ablation for Atrial Fibrillation: Results from a Multicenter Prospective Registry.

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  1. Feasibility & Safety of Dabigatranvs Warfarin for Periprocedural Anticoagulation in Patients Undergoing Radiofrequency Ablation for Atrial Fibrillation: Results from a Multicenter Prospective Registry Dhanunjaya Lakkireddy MD, Yeruva Madhu Reddy MD, Luigi Di Biase MD PhD, Subba Reddy Vanga MD, Pasquale Santangeli MD, Vijay Swarup MD, Rhea Pimentel MD, Moussa C. Mansour MD, Andre D’Avila MD PhD, Javier E.Sanchez MD, J. David Burkhardt MD, Fadi Chalhoub MD, Prasant Mohanty MBBS, MPH, James Coffey MD, Naushad Shaik MD, George Monir MD, Vivek Reddy MD, Jeremy Ruskin MD, Andrea Natale MD

  2. Disclosures • Dr. Lakkireddy received a modest speaker’s honorarium from Boehringer Ingelheim. • Dr. Di Biase is a consultant for Hansen Medical and Biosense Webster. • Dr. Natale is a consultant and or received speaker honoraria from Biosense Webster, Medtronic, Biotronik, Boston Scientific, and Life Watch. • Other co-authors have no conflict of interest relevant to the topic in discussion.

  3. Objectives • The purpose of this study is to evaluate the feasibility and safety of periproceduraldabigatran during atrial fibrillation (AF) ablation. J Am Coll Cardiol 2012;59:1168-74

  4. Background • 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 is unknown. J Am Coll Cardiol 2012;59:1168-74

  5. Methods • 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 on dabigatran therapy had their dose held on the morning of their ablation procedure. They were matched by age, gender and AF type with an equal number of patients undergoing AF ablation on uninterrupted warfarin therapy over the same time period. J Am Coll Cardiol 2012;59:1168-74

  6. Results • Patients (N=290) included those who had a preprocedural dose of dabigatran withheld and matched patients on uninterrupted periprocedural warfarin (both n=145). • Mean age: 60; 79% males; and 57% had paroxysmal AF. • Both groups had similar CHADS2 score, left atrial size and left ventricular ejection fraction. • Three (2.1%) thromboembolic complications occurred in the dabigatran group compared to none in the warfarin group (p = 0.25). The dabigatran group had significantly higher major bleeding (6% vs 1%; p = 0.019); total bleeding (14% vs 6%; p = 0.031) and composite of bleeding and thromboembolic complications (16% vs 6%; p = 0.009) versus warfarin. • Dabigatran use was confirmed as an independent predictor of bleeding or thromboembolic complications (OR 2.76 95% C.I. 1.22-6.25, p = 0.01) in multivariate regression analysis. J Am Coll Cardiol 2012;59:1168-74

  7. Comparison of Procedural Variables Between Cases (Dabigatran) and Controls (Warfarin) AF=Atrial Fibrillation; AFL= Atrial Flutter; mins= minutes; RF= Radiofrequency; PV:=Pulmonary Vein J Am Coll Cardiol 2012;59:1168-74

  8. Comparison of Complications Between Cases (Dabigatran) and Controls (Warfarin) TIA: Transient Ischemic Attack; CVA: Cerebrovascular Accident J Am Coll Cardiol 2012;59:1168-74

  9. Univariate and Multivariate Predictors of Complications (Composite of Bleeding and Thromboembolic Complications) BMI = body mass index; CI = confidence interval J Am Coll Cardiol 2012;59:1168-74

  10. Univariate and Multivariate Predictors of Complications (Composite of Bleeding and Thromboembolic Complications) (cont.) CI = confidence interval; AF = atrial fibrillation; LVEF = left ventricle ejection fraction J Am Coll Cardiol 2012;59:1168-74

  11. Conclusion • In patients undergoing AF ablation, periproceduraldabigatran use significantly increases the risk of bleeding or thromboembolic complications when compared to uninterrupted warfarin therapy. J Am Coll Cardiol 2012;59:1168-74

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