Periprocedural Stroke and Bleeding Complications in Patients undergoing Catheter Ablation of Atrial Fibrillation with Different Anticoagulation Management: Results from the "COMPARE" Randomized Trial Luigi Di Biase, David Burkhardt, Pasquale Santangeli, Prasant Mohanty, Javier Sanchez, Rodney Horton, G. Joseph Gallinghouse, Sakis Themistoclakis, Antonio Rossillo, Dhanunjaya Lakkireddy, Madhu Reddy, Steven Hao, Richard Hongo, Salwa Beheiry, Jason Zagrodzky, Rong Bai, Sanghamitra Mohanty, Claude S. Elayi, Giovanni Forleo, Gemma Pelargonio, Maria Lucia Narducci, Antonio Dello Russo, Michela Casella, Gaetano Fassini, Claudio Tondo, Robert A. Schweikert and Andrea Natale Circulation. published online April 17, 2014; Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2014 American Heart Association, Inc. All rights reserved. Print ISSN: 0009-7322. Online ISSN: 1524-4539

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DOI: 10.1161/CIRCULATIONAHA.113.006426

Periprocedural Stroke and Bleeding Complications in Patients undergoing Catheter Ablation of Atrial Fibrillation with Different Anticoagulation Management: Results from the "COMPARE" Randomized Trial Running title: Di Biase et al.; AF ablation on Warfarin Luigi Di Biase, MD, PhD1,2,3,4; David Burkhardt, MD1; Pasquale Santangeli, MD1,4; Prasant Mohanty, MPH, MBBS1; Javier Sanchez, MD1; Rodney Horton, MD1; G. Joseph Gallinghouse, MD1; Sakis Themistoclakis, MD5; Antonio Rossillo, MD5; Dhanunjaya Lakkireddy, MD6; Madhu Reddy, MD6; Steven Hao, MD7; Richard Hongo, MD7; Salwa Beheiry, RN7; Jason Zagrodzky, MD1; Rong Bai, MD1; Sanghamitra Mo Mohanty, oha hant n y, M nt MD D1; Luc Lucia cia Na cia Nard Narducci, rduc rd ucci ci,, Claude S. Elayi, MD8; Giovanni Forleo, MD9; Gemma Pelargonio, MD10; Mariaa Lu 10 11 11 11 MD ; Antonio Dello Russo, MD ; Michela Casella, MD ; Gaetano Fassin Fassini, i i, i MD MD ; Claudio Tondo, MD11; Robert A. Schweikert, MD12; Andrea Natale, MD1,3,7 1

Texas Te exa xass Cardiac Card Ca rdiaac Arrhythmia rd Arrh Ar rhythmia Institute at St. David’s David’ d’s Medical Cent d’ Center, ter e , Au Aus Austin, sti , TX; 2Albert Einstein stin 3 Collleg lle e of Medicine, Med dic icin i e, at in at Montefiore Mont Mo nttef efio fio iore re Hospital, Hos ospi piita tall, l, N ew w Yor orrk, N Y De Y; Dept p ooff Bi pt B Biomedical om med edic ical ic a E al Engineering, ngin ng in nee eeri r ng, ri College New York, NY; 4 U University niversity y ooff T Texas, exa xaas, A Austin, ussti tin, n, T TX; X; De X; Dept of of Cardiology, Carrdi rdiolo ogy gy,, University Univ Un iveerssity ooff Fo Fogg Foggia, ggia gg ia, Fog F Foggia, oggi ggia,, It Ital Italy; ally;; 5 Ospedale Ospeda daale ddell’Angelo, ell’An Angelo An lo o, Mestre Me ree V Venice, enicee, IItaly; taly y; 6Un University niv iver errsiity of of Kansas, Kannsas, Kansas Kans Ka nsas City, Cit ityy, KS; KS; 7 California Cali Ca lifo li forn fo rnia rn ia Pacific Pacif iffic Medical Med edic i al Center, C nt Ce nter er, San San Francisco, Fran Fran anci cisc ci sco, o C o, CA; A; 8Un University Univ iver ersi er sity si ty ooff Ke Kent Kentucky, ntuc nt ucky uc ky, Le ky Lexi Lexington, xiing ngtton, ton, KY;; 9Un KY University Univ iver ersi sity ty y ooff To Torr Ve Verg Vergata, rg gat ata, a,, R Rome, ome, om e,, Italy; Ita taly ly y; 10Un University Univ iver ersi sity ty y ooff Sa Sacr Sacred cred ed H Heart, eart ea rt,, Ro Rome Rome, me,, It Ital Italy; aly; y; 11 Cardiacc Arrhythmia Arrh Ar rhyt rh ythm yt hmia hm iaa Research Res esea e rc ea rchh Centre, C nt Ce ntre re,, Centro re Cent Ce ntro nt ro Cardiologico Card Ca rdio iolo io lo ogi gico co Monzino Mon onzi zino zi no IIRCCS, RCCS RC CS,, Mi CS Mila Milan, l n, Italy; 12 Akron General Ak G l Hospital, H it l Akron, Ak OH OH

Address for Correspondence: Andrea Natale, MD, FACC, FHRS, FESC Texas Cardiac Arrhythmia Institute at St. David’s Medical Center 3000 N. I-35, Suite 720 Austin, TX 78705 Tel: 521-544-8186 Fax: 512-544-8184 E-mail: [email protected]

Journal Subject Code: Anticoagulants:[184] Coumarins

1 Downloaded from http://circ.ahajournals.org/ at Vanderbilt University Eskind Biomedical Library on May 1, 2014

DOI: 10.1161/CIRCULATIONAHA.113.006426

Abstract

Background—Periprocedural thromboembolic (TE) 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 TE 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 TE 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 ony end ppoint of warfarin arm. Incidence of TE events in the 48 hours ppost-ablation was the pprimary he study. The study enrolled 1584 patients; 790 assigned to discontinue warfarin in n (group (gr g ouup I) and and the 794 to continuous warfarin (group II). No statistical difference in the baseline characteristics was observed. There were 39 TE [3.7% (29) strokes and 1.3% (10) TIA] events in group I; 2 (0.87%) AF (pa AF paro roxxysm ro smal al), ) 4 (2.3%) (2. 2 3% 3%)) in i persistent perssiste pe tent AF, AF, and and 333 (8.5%) (8 in long ng standing stand din ingg persistent p rsis pe i te t nt n (LSP) inn P PAF (paroxysmal), in AF.. Only 2 (0.25%) (0 0.25% .2 25% %) strokes stro ro oke kess in LSP LSP patients pat atiientss were weree observed obser ervved er ved in in group gro roup up II II (p (p

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.

Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural...
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