Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation
Hugh Calkins, Stephan Willems, Edward P Gerstenfeld, Atul Verma, Richard Schilling, Stefan H Hohnloser, Ken Okumura, Harvey Serota, Matias Nordaby, Kelly Guiver, Branislav Biss, Marc A Brouwer, Massimo Grimaldi, RE-CIRCUIT Investigators, Carlo de Asmundis, Philippe Debruyne, Luc Pierard, Christophe Scavée, Bruno Schwagten, Hannes van Acker, Frank van Heuverswyn, Felix Ayala-Paredes, Christopher Lane, Evan Lockwood, Kevin Michael, Carlos Morillo, Gilles O’Hara, Jean-Pierre Cebron, Philippe Chevalier, Christian DeChillou, Pascal Defaye, Jean-Claude Deharo, Guillaume Duthoit, Eloi Marijon, Alexis Mechulan, Frédéric Sacher, Hendrik Bonnemeier, Tillmann Dahme, Hüseyin Ince, Thomas Neumann, Daniel Steven, Ekrem Ücer, Markus Zabel, Leonardo Calo, Manuela Cireddu, Endrju Menardi, Sakis Themistoclakis, Claudio Tondo, Kenshi Fujii, Atsushi Iwasa, Yasuya Inden, Masaomi Kimura, Masato Murakami, Yoshimasa Murakami, Kazuhiro Satomi, Wataru Shimizu, Masato Watarai, Yukihiko Yoshida, José-Luís Merino, Angel Moya Mitjans, Lluís Mont, Joaquín Osca Asensi, Ángel Alonso Pedrote Martínez, Elvis Teijeira-Fernández, Cornelis P Allaart, Jonas S G de Jong, Richard J Folkeringa, Tim A Simmers, Olga L Barbarash, Vadim Kuznetsov, Aleksandr Nedoshivin, Tatiana Novikova, Amiran S Revishvili, Ilya Staroverov, Sharad Agarwal, Timothy Betts, Derek Connelly, Neil Hobson, Fong Leong, James McCready, John Paisey, Muzahir Tayebjee, Andrew Thornley, Jameel Ahmed, Hiroko Beck, Sean Beinart, Sanjay Bindra, Sanders Chae, Jie Cheng, Zayd Eldadah, David Feigenblum, Charles Fuenzalida, Maheer Gandhavadi, Paul Garabelli, Edward Gerstenfeld, Mario Gonzalez, Jodie Hurwitz, Colleen Johnson, Rajesh Kabra, Marcin Kowalski, Gurudutt Kulkarni, Nassir Marrouche, John Miller, Paul Mounsey, Blake Norris, Gearoid O’Neill, Henri Roukoz, Uma Srivatsa, James Talano, Aaditya Vora, Brian Wong, John Camm, Riccardo Cappato, Harry Crijns, David Kenigsberg, Jan G P Tijssen, James Januzzi, Joe Garasic, Steen Pehrson, Daniel Kolansky, Michael McDonald, Andrew Van Tosh, Jonathan Sturm, André Peeters, Karen Hirsch, Hugh Calkins, Stephan Willems, Edward P Gerstenfeld, Atul Verma, Richard Schilling, Stefan H Hohnloser, Ken Okumura, Harvey Serota, Matias Nordaby, Kelly Guiver, Branislav Biss, Marc A Brouwer, Massimo Grimaldi, RE-CIRCUIT Investigators, Carlo de Asmundis, Philippe Debruyne, Luc Pierard, Christophe Scavée, Bruno Schwagten, Hannes van Acker, Frank van Heuverswyn, Felix Ayala-Paredes, Christopher Lane, Evan Lockwood, Kevin Michael, Carlos Morillo, Gilles O’Hara, Jean-Pierre Cebron, Philippe Chevalier, Christian DeChillou, Pascal Defaye, Jean-Claude Deharo, Guillaume Duthoit, Eloi Marijon, Alexis Mechulan, Frédéric Sacher, Hendrik Bonnemeier, Tillmann Dahme, Hüseyin Ince, Thomas Neumann, Daniel Steven, Ekrem Ücer, Markus Zabel, Leonardo Calo, Manuela Cireddu, Endrju Menardi, Sakis Themistoclakis, Claudio Tondo, Kenshi Fujii, Atsushi Iwasa, Yasuya Inden, Masaomi Kimura, Masato Murakami, Yoshimasa Murakami, Kazuhiro Satomi, Wataru Shimizu, Masato Watarai, Yukihiko Yoshida, José-Luís Merino, Angel Moya Mitjans, Lluís Mont, Joaquín Osca Asensi, Ángel Alonso Pedrote Martínez, Elvis Teijeira-Fernández, Cornelis P Allaart, Jonas S G de Jong, Richard J Folkeringa, Tim A Simmers, Olga L Barbarash, Vadim Kuznetsov, Aleksandr Nedoshivin, Tatiana Novikova, Amiran S Revishvili, Ilya Staroverov, Sharad Agarwal, Timothy Betts, Derek Connelly, Neil Hobson, Fong Leong, James McCready, John Paisey, Muzahir Tayebjee, Andrew Thornley, Jameel Ahmed, Hiroko Beck, Sean Beinart, Sanjay Bindra, Sanders Chae, Jie Cheng, Zayd Eldadah, David Feigenblum, Charles Fuenzalida, Maheer Gandhavadi, Paul Garabelli, Edward Gerstenfeld, Mario Gonzalez, Jodie Hurwitz, Colleen Johnson, Rajesh Kabra, Marcin Kowalski, Gurudutt Kulkarni, Nassir Marrouche, John Miller, Paul Mounsey, Blake Norris, Gearoid O’Neill, Henri Roukoz, Uma Srivatsa, James Talano, Aaditya Vora, Brian Wong, John Camm, Riccardo Cappato, Harry Crijns, David Kenigsberg, Jan G P Tijssen, James Januzzi, Joe Garasic, Steen Pehrson, Daniel Kolansky, Michael McDonald, Andrew Van Tosh, Jonathan Sturm, André Peeters, Karen Hirsch
Abstract
Background: Catheter ablation of atrial fibrillation is typically performed with uninterrupted anticoagulation with warfarin or interrupted non-vitamin K antagonist oral anticoagulant therapy. Uninterrupted anticoagulation with a non-vitamin K antagonist oral anticoagulant, such as dabigatran, may be safer; however, controlled data are lacking. We investigated the safety of uninterrupted dabigatran versus warfarin in patients undergoing ablation of atrial fibrillation.
Methods: In this randomized, open-label, multicenter, controlled trial with blinded adjudicated end-point assessments, we randomly assigned patients scheduled for catheter ablation of paroxysmal or persistent atrial fibrillation to receive either dabigatran (150 mg twice daily) or warfarin (target international normalized ratio, 2.0 to 3.0). Ablation was performed after 4 to 8 weeks of uninterrupted anticoagulation, which was continued during and for 8 weeks after ablation. The primary end point was the incidence of major bleeding events during and up to 8 weeks after ablation; secondary end points included thromboembolic and other bleeding events.
Results: The trial enrolled 704 patients across 104 sites; 635 patients underwent ablation. Baseline characteristics were balanced between treatment groups. The incidence of major bleeding events during and up to 8 weeks after ablation was lower with dabigatran than with warfarin (5 patients [1.6%] vs. 22 patients [6.9%]; absolute risk difference, -5.3 percentage points; 95% confidence interval, -8.4 to -2.2; P<0.001). Dabigatran was associated with fewer periprocedural pericardial tamponades and groin hematomas than warfarin. The two treatment groups had a similar incidence of minor bleeding events. One thromboembolic event occurred in the warfarin group.
Conclusions: In patients undergoing ablation for atrial fibrillation, anticoagulation with uninterrupted dabigatran was associated with fewer bleeding complications than uninterrupted warfarin. (Funded by Boehringer Ingelheim; RE-CIRCUIT ClinicalTrials.gov number, NCT02348723 .).
Source: PubMed