TY - JOUR
T1 - Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation
T2 - Results from a multicenter prospective registry
AU - Lakkireddy, Dhanunjaya
AU - Reddy, Yeruva Madhu
AU - Di Biase, Luigi
AU - Vanga, Subba Reddy
AU - Santangeli, Pasquale
AU - Swarup, Vijay
AU - Pimentel, Rhea
AU - Mansour, Moussa C.
AU - D'Avila, Andre
AU - Sanchez, Javier E.
AU - Burkhardt, J. David
AU - Chalhoub, Fadi
AU - Mohanty, Prasant
AU - Coffey, James
AU - Shaik, Naushad
AU - Monir, George
AU - Reddy, Vivek Y.
AU - Ruskin, Jeremy
AU - Natale, Andrea
N1 - Funding Information:
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.
PY - 2012/3/27
Y1 - 2012/3/27
N2 - 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 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. Conclusions: In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.
AB - 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 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. Conclusions: In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.
KW - anticoagulation
KW - atrial fibrillation ablation
KW - dabigatran
KW - matched case-control study
KW - periprocedural complications
UR - https://www.scopus.com/pages/publications/84858709300
UR - https://www.scopus.com/pages/publications/84858709300#tab=citedBy
U2 - 10.1016/j.jacc.2011.12.014
DO - 10.1016/j.jacc.2011.12.014
M3 - Article
C2 - 22305113
AN - SCOPUS:84858709300
SN - 0735-1097
VL - 59
SP - 1168
EP - 1174
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 13
ER -