Luigi Di Biase1, J David Burkhardt1, Pasquale Santangeli1, Prasant Mohanty1, Javier E Sanchez1, Rodney Horton1, G Joseph Gallinghouse1, Sakis Themistoclakis1, Antonio Rossillo1, Dhanunjaya Lakkireddy1, Madhu Reddy1, Steven Hao1, Richard Hongo1, Salwa Beheiry1, Jason Zagrodzky1, Bai Rong1, Sanghamitra Mohanty1, Claude S Elayi1, Giovanni Forleo1, Gemma Pelargonio1, Maria Lucia Narducci1, Antonio Dello Russo1, Michela Casella1, Gaetano Fassini1, Claudio Tondo1, Robert A Schweikert1, Andrea Natale2. 1. 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, OH (A.N.); and Interventional Electrophysiology, Scripps Clinic, La Jolla, CA (A.N.). 2. 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, OH (A.N.); and Interventional Electrophysiology, Scripps Clinic, La Jolla, CA (A.N.). dr.natale@gmail.com.
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 todiscontinue 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.
RCT Entities:
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.
Authors: Melanie Gunawardene; S Willems; B Schäffer; J Moser; R Ö Akbulak; M Jularic; C Eickholt; J Nührich; C Meyer; P Kuklik; S Sehner; V Czerner; B A Hoffmann Journal: Clin Res Cardiol Date: 2016-07-19 Impact factor: 5.460
Authors: Hugh Calkins; Gerhard Hindricks; Riccardo Cappato; Young-Hoon Kim; Eduardo B Saad; Luis Aguinaga; Joseph G Akar; Vinay Badhwar; Josep Brugada; John Camm; Peng-Sheng Chen; Shih-Ann Chen; Mina K Chung; Jens Cosedis Nielsen; Anne B Curtis; D Wyn Davies; John D Day; André d'Avila; N M S Natasja de Groot; Luigi Di Biase; Mattias Duytschaever; James R Edgerton; Kenneth A Ellenbogen; Patrick T Ellinor; Sabine Ernst; Guilherme Fenelon; Edward P Gerstenfeld; David E Haines; Michel Haissaguerre; Robert H Helm; Elaine Hylek; Warren M Jackman; Jose Jalife; Jonathan M Kalman; Josef Kautzner; Hans Kottkamp; Karl Heinz Kuck; Koichiro Kumagai; Richard Lee; Thorsten Lewalter; Bruce D Lindsay; Laurent Macle; Moussa Mansour; Francis E Marchlinski; Gregory F Michaud; Hiroshi Nakagawa; Andrea Natale; Stanley Nattel; Ken Okumura; Douglas Packer; Evgeny Pokushalov; Matthew R Reynolds; Prashanthan Sanders; Mauricio Scanavacca; Richard Schilling; Claudio Tondo; Hsuan-Ming Tsao; Atul Verma; David J Wilber; Teiichi Yamane Journal: Heart Rhythm Date: 2017-05-12 Impact factor: 6.343
Authors: Sanghamitra Mohanty; Amelia W Hall; Prasant Mohanty; Sameer Prakash; Chintan Trivedi; Luigi Di Biase; Pasquale Santangeli; Rong Bai; J David Burkhardt; G Joseph Gallinghouse; Rodney Horton; Javier E Sanchez; Patrick M Hranitzky; Amin Al-Ahmad; Vishwanath R Iyer; Andrea Natale Journal: J Interv Card Electrophysiol Date: 2016-01 Impact factor: 1.900