Medline ® Abstract for Reference 44
of 'Perioperative management of patients receiving anticoagulants'
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.
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, Dello Russo A, Casella M, Fassini G, Tondo C, Schweikert RA, Natale A
Circulation. 2014;129(25):2638. Epub 2014 Apr 17.
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.
From the Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin (L.D.B., J.D.B., P.S., P.M., J.E.S., R. Horton, G.J.G., J.Z., B.R., S.M., A.N.); Albert Einstein College of Medicine, Montefiore Hospital, New York, NY (L.D.B.); Department of Biomedical Engineering, University of Texas, Austin (L.D.B., A.N.); Department of Cardiology, University of Foggia, Foggia, Italy (L.D.B., P.S.); Ospedale dell'Angelo, Mestre Venice, Italy (S.T., A.R.); University of Kansas, Kansas City (D.L., M.R.); California Pacific Medical Center, San Francisco (S.H., R. Hongo, S.B., A.N.); University of Kentucky, Lexington (C.S.E.); University of Tor Vergata, Rome, Italy (G. Forleo); University of Sacred Heart, Rome, Italy (G.P., M.L.N.); Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy (A.D.R., M.C., G. Fassini, C.T.); Akron General Hospital, Akron, OH (R.A.S.); Division of Cardiology, Stanford University, CA (A.N.); Case Western Reserve University, Cleveland,