Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation
| Autor: | L. Eugene Fields, Gerald V. Naccarelli, Christian de Chillou, Burkhard J. Hügl, Richard Balasubramaniam, Andrea Natale, Riccardo Cappato, Darryl S. Wells, Johan Vijgen, Susanne Hess, Stefan H. Hohnloser, George Juang, David J. Wilber, Francis E. Marchlinski, C.S. Ma, D. Wyn Davies, Jim Xiang |
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| Přispěvatelé: | Centro Cardiologico Monzino [Milano], Dpt di Scienze Cliniche e di Comunità [Milano] (DISCCO), Università degli Studi di Milano [Milano] (UNIMI)-Università degli Studi di Milano [Milano] (UNIMI)-Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Second Arrhytmia and EP Unit (SA and EP Unit - BERGAMO), GAVAZZENI Hospital, Section of Cardiac Electrophysiology (SCE - PHILADELPHIA), Perelman School of Medicine, University of Pennsylvania [Philadelphia]-University of Pennsylvania [Philadelphia], Division of Clinical Electrophysiology (DCE - FRANKFURT), J.W.Goethe University Hospital, Heart and Vascular Institute (HVI - HERSHEY), Pennsylvania State University (Penn State), Penn State System-Penn State System, Biostatistics and Programming (Biostat Program - Janssen Research), Janssen Research & Development, Department of Cardiology, Loyola University [Chicago], Cardiology Division (Cardio Div - BEIJING), Capital Medical University, Beijing, Medical Affairs (MA - BAYER), Bayer HealthCare Pharmaceuticals Inc [Whippany], Cardiac Electrophysiology (Card Electro - SEATTLE), Swedish Heart and Vascular Institute, Heart and Arrhythmia, Heart and Arrhythmia Care of New York (HACNW), Division of Cardiac Electrophysiology (Div Card Elec - HASSELT), JESSA HOSPITALS, Department of Cardiology and Rhythmology (Dep Card Rhythmo - NEUWIED), Marienhaus Klinikum St Elisabeth (MK St Elisabeth), Department of Cardiology (Dep Cardio - BOURNEMOUTH), Royal Bournemouth Hospital, Service de Cardiologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Waller Department of Cardiology (Waller Dep Cardiol - LONDON), Imperial College London, Department of Medical and Scientific Affairs, Janssen EMEA, Texas Cardiac Arrhythmia Institute (Texas Card Arrh Ins - AUSTIN), St David's Medical Center (St D Med Center - AUSTIN) |
| Rok vydání: | 2015 |
| Předmět: |
Male
Reoperation medicine.medical_specialty Vitamin K medicine.medical_treatment [SDV]Life Sciences [q-bio] Operative Time Activated clotting time Blood Loss Surgical Catheter ablation Drug Administration Schedule [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system Rivaroxaban Recurrence Internal medicine Thromboembolism Atrial Fibrillation medicine Clinical endpoint Humans Single-Blind Method Myocardial infarction Prospective Studies Stroke medicine.diagnostic_test Surrogate endpoint business.industry Atrial fibrillation Middle Aged medicine.disease 3. Good health Treatment Outcome Pulmonary Veins Anesthesia Cardiology Catheter Ablation Oral anticoagulant Female Cardiology and Cardiovascular Medicine business Uninterrupted Anti-Arrhythmia Agents [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology medicine.drug Factor Xa Inhibitors |
| Zdroj: | European Heart Journal European Heart Journal, Oxford University Press (OUP): Policy B, 2015, 36 (28), pp.1805-11. ⟨10.1093/eurheartj/ehv177⟩ |
| ISSN: | 1522-9645 0195-668X |
| DOI: | 10.1093/eurheartj/ehv177⟩ |
| Popis: | Aims VENTURE-AF is the first prospective randomized trial of uninterrupted rivaroxaban and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation (CA). Methods and results Trial size was administratively set at 250, the protocol-specified target. Events were independently and blindly adjudicated. We randomly assigned 248 NVAF patients to uninterrupted rivaroxaban (20 mg once-daily) or to an uninterrupted VKA prior to CA and for 4 weeks afterwards. The primary endpoint was major bleeding events after CA. Secondary endpoints included thromboembolic events (composite of stroke, systemic embolism, myocardial infarction, and vascular death) and other bleeding or procedure-attributable events. Patients were 59.5 ± 10 years of age, 71% male, 74% paroxysmal AF, and had a CHA2DS2-VASc score of 1.6. The average total heparin dose used to manage activated clotting time (ACT) was slightly higher (13 871 vs. 10 964 units; P < 0.001) and the mean ACT level attained slightly lower (302 vs. 332 s; P < 0.001) in rivaroxaban and VKA arms, respectively. The incidence of major bleeding was low (0.4%; 1 major bleeding event). Similarly, thromboembolic events were low (0.8%; 1 ischemic stroke and 1 vascular death). All events occurred in the VKA arm and all after CA. The number of any adjudicated events (26 vs. 25), any bleeding events (21 vs. 18), and any other procedure-attributable events (5 vs. 5) were similar. Conclusion In patients undergoing CA for AF, the use of uninterrupted oral rivaroxaban was feasible and event rates were similar to those for uninterrupted VKA therapy. Name of the Trial Registry Clinicaltrials.gov trial registration number is [NCT01729871][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01729871&atom=%2Fehj%2F36%2F28%2F1805.atom |
| Databáze: | OpenAIRE |
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