Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation nagement results from the role of coumadin in preventing thromboembolism in atrial fibrillation (AF) patients undergoing catheter ablation (COMPARE) randomized trial

Luigi Di Biase, J. David Burkhardt, Pasquale Santangeli, Prasant Mohanty, Javier E. Sanchez, Rodney Horton, G. Joseph Gallinghouse, Sakis Themistoclakis, Antonio Rossillo, Dhanunjaya Lakkireddy, Madhu Reddy, Steven Hao, Richard Hongo, Salwa Beheiry, Jason Zagrodzky, Bai Rong, Sanghamitra Mohanty, Claude S. Elayi, Giovanni Forleo, Gemma PelargonioMaria Lucia Narducci, Antonio Dello Russo, Michela Casella, Gaetano Fassini, Claudio Tondo, Robert A. Schweikert, Andrea Natale

Research output: Contribution to journalArticle

242 Citations (Scopus)

Abstract

Background-Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. Methods and Results-This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ?1 were included. Patients were randomly assigned in a 1:1 ratio to the offwarfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001). Conclusion-This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin.

Original languageEnglish (US)
Pages (from-to)2638-2644
Number of pages7
JournalCirculation
Volume129
Issue number25
DOIs
StatePublished - Jun 24 2014

Fingerprint

Catheter Ablation
Thromboembolism
Warfarin
Atrial Fibrillation
Stroke
Hemorrhage
Low Molecular Weight Heparin
Transient Ischemic Attack
Incidence
Multicenter Studies
Odds Ratio
Confidence Intervals

Keywords

  • Atrial fibrillation
  • Catheter ablation
  • Catheter ablation radiofrequency
  • Stroke
  • Transient ischemic attack
  • Warfarin

ASJC Scopus subject areas

  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Cite this

Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation nagement results from the role of coumadin in preventing thromboembolism in atrial fibrillation (AF) patients undergoing catheter ablation (COMPARE) randomized trial. / Di Biase, Luigi; Burkhardt, J. David; Santangeli, Pasquale; Mohanty, Prasant; Sanchez, Javier E.; Horton, Rodney; Gallinghouse, G. Joseph; Themistoclakis, Sakis; Rossillo, Antonio; Lakkireddy, Dhanunjaya; Reddy, Madhu; Hao, Steven; Hongo, Richard; Beheiry, Salwa; Zagrodzky, Jason; Rong, Bai; Mohanty, Sanghamitra; Elayi, Claude S.; Forleo, Giovanni; Pelargonio, Gemma; Narducci, Maria Lucia; Russo, Antonio Dello; Casella, Michela; Fassini, Gaetano; Tondo, Claudio; Schweikert, Robert A.; Natale, Andrea.

In: Circulation, Vol. 129, No. 25, 24.06.2014, p. 2638-2644.

Research output: Contribution to journalArticle

Di Biase, L, Burkhardt, JD, Santangeli, P, Mohanty, P, Sanchez, JE, Horton, R, Gallinghouse, GJ, Themistoclakis, S, Rossillo, A, Lakkireddy, D, Reddy, M, Hao, S, Hongo, R, Beheiry, S, Zagrodzky, J, Rong, B, Mohanty, S, Elayi, CS, Forleo, G, Pelargonio, G, Narducci, ML, Russo, AD, Casella, M, Fassini, G, Tondo, C, Schweikert, RA & Natale, A 2014, 'Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation nagement results from the role of coumadin in preventing thromboembolism in atrial fibrillation (AF) patients undergoing catheter ablation (COMPARE) randomized trial', Circulation, vol. 129, no. 25, pp. 2638-2644. https://doi.org/10.1161/CIRCULATIONAHA.113.006426
Di Biase, Luigi ; Burkhardt, J. David ; Santangeli, Pasquale ; Mohanty, Prasant ; Sanchez, Javier E. ; Horton, Rodney ; Gallinghouse, G. Joseph ; Themistoclakis, Sakis ; Rossillo, Antonio ; Lakkireddy, Dhanunjaya ; Reddy, Madhu ; Hao, Steven ; Hongo, Richard ; Beheiry, Salwa ; Zagrodzky, Jason ; Rong, Bai ; Mohanty, Sanghamitra ; Elayi, Claude S. ; Forleo, Giovanni ; Pelargonio, Gemma ; Narducci, Maria Lucia ; Russo, Antonio Dello ; Casella, Michela ; Fassini, Gaetano ; Tondo, Claudio ; Schweikert, Robert A. ; Natale, Andrea. / Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation nagement results from the role of coumadin in preventing thromboembolism in atrial fibrillation (AF) patients undergoing catheter ablation (COMPARE) randomized trial. In: Circulation. 2014 ; Vol. 129, No. 25. pp. 2638-2644.
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abstract = "Background-Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. Methods and Results-This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ?1 were included. Patients were randomly assigned in a 1:1 ratio to the offwarfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7{\%} strokes [n=29] and 1.3{\%} transient ischemic attacks [n=10]) in group 1: two events (0.87{\%}) in patients with paroxysmal AF, 4 (2.3{\%}) in patients with persistent AF, and 33 (8.5{\%}) in patients with long-standing persistent AF. Only 2 strokes (0.25{\%}) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95{\%} confidence interval, 3.1-55.6; P<0.001). Conclusion-This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin.",
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T1 - Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation nagement results from the role of coumadin in preventing thromboembolism in atrial fibrillation (AF) patients undergoing catheter ablation (COMPARE) randomized trial

AU - Di Biase, Luigi

AU - Burkhardt, J. David

AU - Santangeli, Pasquale

AU - Mohanty, Prasant

AU - Sanchez, Javier E.

AU - Horton, Rodney

AU - Gallinghouse, G. Joseph

AU - Themistoclakis, Sakis

AU - Rossillo, Antonio

AU - Lakkireddy, Dhanunjaya

AU - Reddy, Madhu

AU - Hao, Steven

AU - Hongo, Richard

AU - Beheiry, Salwa

AU - Zagrodzky, Jason

AU - Rong, Bai

AU - Mohanty, Sanghamitra

AU - Elayi, Claude S.

AU - Forleo, Giovanni

AU - Pelargonio, Gemma

AU - Narducci, Maria Lucia

AU - Russo, Antonio Dello

AU - Casella, Michela

AU - Fassini, Gaetano

AU - Tondo, Claudio

AU - Schweikert, Robert A.

AU - Natale, Andrea

PY - 2014/6/24

Y1 - 2014/6/24

N2 - Background-Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. Methods and Results-This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ?1 were included. Patients were randomly assigned in a 1:1 ratio to the offwarfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001). Conclusion-This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin.

AB - Background-Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. Methods and Results-This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ?1 were included. Patients were randomly assigned in a 1:1 ratio to the offwarfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001). Conclusion-This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin.

KW - Atrial fibrillation

KW - Catheter ablation

KW - Catheter ablation radiofrequency

KW - Stroke

KW - Transient ischemic attack

KW - Warfarin

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