Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: 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 Pelargonio, Maria Lucia Narducci, Antonio Dello Russo, Michela Casella, Gaetano Fassini, Claudio Tondo, Robert A Schweikert, Andrea Natale, 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 Pelargonio, Maria Lucia Narducci, Antonio Dello Russo, Michela Casella, Gaetano Fassini, Claudio Tondo, Robert A Schweikert, Andrea Natale
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 off-warfarin 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.
Clinical trial registration url: http://www.clinicaltrials.gov. Unique identifier: NCT01006876.
Keywords: atrial fibrillation; catheter ablation; catheter ablation, radiofrequency; stroke; transient ischemic attack; warfarin.
© 2014 American Heart Association, Inc.
Source: PubMed