Michael D Ezekowitz1, Riccardo Cappato2, Allan L Klein3, A John Camm4, Chang-Sheng Ma5, Jean-Yves Le Heuzey6, Mario Talajic7, Maurício I Scanavacca8, Panos E Vardas9, Paulus Kirchhof10, Stefan H Hohnloser11, Melanie Hemmrich12, Vivian Lanius13, Isabelle Ling Meng14, Peter Wildgoose15, Martin van Eickels14. 1. Cardiovascular Research Foundation, New York, NY; Jefferson Medical College, Philadelphia, PA. 2. Arrhythmia and Electrophysiology Center, University of Milan, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy; Department of Cardiology, Heraklion University Hospital, Heraklion (Crete), Greece. 3. Department of Cardiovascular Medicine, Cleveland Clinic Heart and Vascular Institute, Cleveland, OH. 4. Division of Clinical Sciences, St George's, University of London, London, United Kingdom. 5. Cardiology Division, Beijing AnZhen Hospital, Capital Medical University, Beijing, China. 6. Division of Cardiology and Arrhythmology, Hôpital Européen Georges Pompidou, Université Paris V René-Descartes, Paris, France. 7. Department of Medicine, Research Center, Montreal Heart Institute, Université de Montréal, Montreal, Canada. 8. Arrhythmia Clinical Unit of Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil. 9. Department of Cardiology, Heraklion University Hospital, Heraklion (Crete), Greece. 10. University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom; Department of Cardiology and Angiology, University Hospital Münster, Münster, Germany. 11. Department of Cardiology, Division of Clinical Electrophysiology, J.W. Goethe University, Frankfurt, Germany. 12. Global Clinical Development, Bayer Vital GmbH, Leverkusen, Germany. 13. Global Research and Development Statistics, Bayer HealthCare, Berlin, Germany. 14. Global Medical Affairs, Bayer HealthCare, Berlin, Germany. 15. Janssen Scientific Affairs, LLC, Raritan, NJ.
Abstract
BACKGROUND: Anticoagulation before, during, and after cardioversion is effective in reducing stroke risk in patients with atrial fibrillation. OBJECTIVE: The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily (15 mg if creatinine clearance is 30-49 mL/min) compared with dose-adjusted vitamin K antagonists (VKAs; international normalized ratio 2.0-3.0) in patients scheduled for elective cardioversion. METHODS: This is a prospective, randomized, open-label, parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of >48 hours or unknown duration. Patients will be randomized 2:1 (rivaroxaban:VKA) using 2 cardioversion strategies: the first approach is early cardioversion with the precardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy (heparin + VKA). In these patients, transesophageal echocardiography will be encouraged to exclude atrial thrombi. The alternative approach is delayed cardioversion. Rivaroxaban or VKA will be administered for 21 to 56 days before cardioversion. All patients will receive study treatment for 6 weeks postcardioversion. The primary efficacy end point is a composite of all strokes, transient ischemic attacks, noncentral nervous system systemic emboli, myocardial infarctions, and cardiovascular deaths. Each primary end point component will be evaluated separately, and additional composites will be investigated. The principal safety end point is major bleeding. CLINICAL CONTEXT: This will be the first prospective study of a novel oral anticoagulant in the setting of cardioversion. It will provide important information regarding the use of rivaroxaban in the periods preceding and after cardioversion in a broad patient population.
RCT Entities:
BACKGROUND: Anticoagulation before, during, and after cardioversion is effective in reducing stroke risk in patients with atrial fibrillation. OBJECTIVE: The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily (15 mg if creatinine clearance is 30-49 mL/min) compared with dose-adjusted vitamin K antagonists (VKAs; international normalized ratio 2.0-3.0) in patients scheduled for elective cardioversion. METHODS: This is a prospective, randomized, open-label, parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of >48 hours or unknown duration. Patients will be randomized 2:1 (rivaroxaban:VKA) using 2 cardioversion strategies: the first approach is early cardioversion with the precardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy (heparin + VKA). In these patients, transesophageal echocardiography will be encouraged to exclude atrial thrombi. The alternative approach is delayed cardioversion. Rivaroxaban or VKA will be administered for 21 to 56 days before cardioversion. All patients will receive study treatment for 6 weeks postcardioversion. The primary efficacy end point is a composite of all strokes, transient ischemic attacks, noncentral nervous system systemic emboli, myocardial infarctions, and cardiovascular deaths. Each primary end point component will be evaluated separately, and additional composites will be investigated. The principal safety end point is major bleeding. CLINICAL CONTEXT: This will be the first prospective study of a novel oral anticoagulant in the setting of cardioversion. It will provide important information regarding the use of rivaroxaban in the periods preceding and after cardioversion in a broad patient population.
Authors: Stefan H Hohnloser; Riccardo Cappato; Michael D Ezekowitz; Thomas Evers; Kurtulus Sahin; Paulus Kirchhof; Isabelle Ling Meng; Martin van Eickels; A John Camm Journal: Europace Date: 2015-10-20 Impact factor: 5.214
Authors: Axel Brandes; Harry J G M Crijns; Michiel Rienstra; Paulus Kirchhof; Erik L Grove; Kenneth Bruun Pedersen; Isabelle C Van Gelder Journal: Europace Date: 2020-08-01 Impact factor: 5.214