Feasibility and Safety of Dabigatran Versus Warfarin for Periprocedural Anticoagulation in Patients Undergoing Radiofrequency Ablation for Atrial Fibrillation: Results From a Multicenter Prospective Registry

doi:10.1016/j.jacc.2011.12.014

Journal of the American College of Cardiology

Volume 59, Issue 13, 27 March 2012, Pages 1168-1174

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Objectives

The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation.

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 are unknown.

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 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.

Results

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 CHADS₂ 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.

Conclusions

In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.

Key Words

anticoagulation

atrial fibrillation ablation

dabigatran

matched case-control study

periprocedural complications

Abbreviations and Acronyms

ACT

activated clotting time

atrial fibrillation

confidence interval

left atrium

odds ratio

PVAI

pulmonary vein antral isolation

unfractionated heparin

Cited by (0)

: Dr. Lakkireddy receives modest speaker's honorarium from Boehringer Ingelheim, Sanofi, St. Jude Medical, Biotronik, and Estech. Dr. Di Biase is a consultant for Hansen Medical and Biosense Webster. Dr. Monir is on the advisory board of Medtronic; and has received honorarium from Biosense Webster. Dr. Mansour has received research grants from Biosense Webster, St. Jude Medical, MC10, and VOyage Medical; and is a consultant for Biosense Webster and St. Jude Medical. Dr. Reddy has received speaker's honorarium (modest) from Boehringer Ingelheim. Dr. Ruskin is a consultant for Arrhythmia Education Inc., Astellas/Cardiome, Sanofi-Aventis, Third Rock Ventures, Atricure, Bristol-Myers Squibb, and GE Healthcare; honoraria from Med-IQ; is on the scientific steering committee for Pfizer and CryoCath; has equity in Portola; has received fellowship support from St. Jude Medical, Medtronic, and Biosense Webster; is on the clinical oversight committee for CardioFocus; and is on the scientific advisory board for CardioInsight. Dr. Natale is a consultant and/or receives speaker honoraria from Biosense Webster, Medtronic, Biotronik, Boston Scientific, and Life Watch. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.