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

Dhanunjaya Lakkireddy, Yeruva Madhu Reddy, Luigi Di Biase, Subba Reddy Vanga, Pasquale Santangeli, Vijay Swarup, Rhea Pimentel, Moussa C. Mansour, Andre D'Avila, Javier E. Sanchez, J. David Burkhardt, Fadi Chalhoub, Prasant Mohanty, James Coffey, Naushad Shaik, George Monir, Vivek Y. Reddy, Jeremy Ruskin, Andrea Natale

Research output: Contribution to journalArticle

240 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1168-1174
Number of pages7
JournalJournal of the American College of Cardiology
Volume59
Issue number13
DOIs
StatePublished - Mar 27 2012
Externally publishedYes

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Warfarin
Atrial Fibrillation
Registries
Safety
Hemorrhage
Dabigatran
Stroke Volume
Anticoagulants
Multicenter Studies
Observational Studies
Therapeutics
Multivariate Analysis
Odds Ratio
Regression Analysis
Confidence Intervals

Keywords

  • anticoagulation
  • atrial fibrillation ablation
  • dabigatran
  • matched case-control study
  • periprocedural complications

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation : Results from a multicenter prospective registry. / Lakkireddy, Dhanunjaya; Reddy, Yeruva Madhu; Di Biase, Luigi; Vanga, Subba Reddy; Santangeli, Pasquale; Swarup, Vijay; Pimentel, Rhea; Mansour, Moussa C.; D'Avila, Andre; Sanchez, Javier E.; Burkhardt, J. David; Chalhoub, Fadi; Mohanty, Prasant; Coffey, James; Shaik, Naushad; Monir, George; Reddy, Vivek Y.; Ruskin, Jeremy; Natale, Andrea.

In: Journal of the American College of Cardiology, Vol. 59, No. 13, 27.03.2012, p. 1168-1174.

Research output: Contribution to journalArticle

Lakkireddy, D, Reddy, YM, Di Biase, L, Vanga, SR, Santangeli, P, Swarup, V, Pimentel, R, Mansour, MC, D'Avila, A, Sanchez, JE, Burkhardt, JD, Chalhoub, F, Mohanty, P, Coffey, J, Shaik, N, Monir, G, Reddy, VY, Ruskin, J & Natale, A 2012, 'Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: Results from a multicenter prospective registry', Journal of the American College of Cardiology, vol. 59, no. 13, pp. 1168-1174. https://doi.org/10.1016/j.jacc.2011.12.014
Lakkireddy, Dhanunjaya ; Reddy, Yeruva Madhu ; Di Biase, Luigi ; Vanga, Subba Reddy ; Santangeli, Pasquale ; Swarup, Vijay ; Pimentel, Rhea ; Mansour, Moussa C. ; D'Avila, Andre ; Sanchez, Javier E. ; Burkhardt, J. David ; Chalhoub, Fadi ; Mohanty, Prasant ; Coffey, James ; Shaik, Naushad ; Monir, George ; Reddy, Vivek Y. ; Ruskin, Jeremy ; Natale, Andrea. / Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation : Results from a multicenter prospective registry. In: Journal of the American College of Cardiology. 2012 ; Vol. 59, No. 13. pp. 1168-1174.
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abstract = "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.",
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author = "Dhanunjaya Lakkireddy and Reddy, {Yeruva Madhu} and {Di Biase}, Luigi and Vanga, {Subba Reddy} and Pasquale Santangeli and Vijay Swarup and Rhea Pimentel and Mansour, {Moussa C.} and Andre D'Avila and Sanchez, {Javier E.} and Burkhardt, {J. David} and Fadi Chalhoub and Prasant Mohanty and James Coffey and Naushad Shaik and George Monir and Reddy, {Vivek Y.} and Jeremy Ruskin and Andrea Natale",
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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

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

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