TY - JOUR
T1 - The Optimal Anti-Coagulation for Enhanced-Risk Patients Post–Catheter Ablation for Atrial Fibrillation (OCEAN) trial
AU - Verma, Atul
AU - Ha, Andrew C.T.
AU - Kirchhof, Paulus
AU - Hindricks, Gerhard
AU - Healey, Jeff S.
AU - Hill, Michael D.
AU - Sharma, Mukul
AU - Wyse, D. George
AU - Champagne, Jean
AU - Essebag, Vidal
AU - Wells, George
AU - Gupta, Dhiraj
AU - Heidbuchel, Hein
AU - Sanders, Prash
AU - Birnie, David H.
N1 - Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2018/3
Y1 - 2018/3
N2 - Background: The optimal long-term antithrombotic regimen for patients after successful catheter-based atrial fibrillation (AF) ablation is not well defined. Presently, practice variation exists, and the benefits of oral anticoagulation over antiplatelet therapy across the entire spectrum of stroke risk profile remain undefined in the postablation population. To date, there are no randomized trials to inform clinicians on this therapeutic question. Objective: The objective was to assess whether rivaroxaban is superior to acetylsalicylic acid (ASA) in reducing the risk of clinically overt stroke, systemic embolism, or covert stroke among patients without apparent recurrent atrial arrhythmias for at least 1 year after their most recent AF ablation procedure. Methods/design: A prospective, multicenter, open-label, randomized trial with blinded assessment of outcomes is under way (NCT02168829). Atrial fibrillation patients with at least 1 stroke risk factor (as defined by the CHA2DS2-VASc score) and without known atrial arrhythmia recurrences for at least 12 months after ablation are randomized to rivaroxaban 15 mg or ASA 75-160 mg daily. The primary outcome is a composite of clinically overt stroke, systemic embolism, and covert stroke based on brain magnetic resonance imaging. Key secondary outcomes include major bleeding outcomes, intracranial hemorrhage, transient ischemic attack, neuropsychological testing, quality of life, and an economic analysis. Subjects will be followed for 3 years. The estimated overall sample size is 1,572 subjects (786 per arm). Discussion: The OCEAN trial is a multicenter randomized controlled trial evaluating 2 antithrombotic treatment strategies for patients with risk factors for stroke after apparently successful AF ablation. We hypothesize that rivaroxaban will reduce the occurrence of clinically overt stroke, systemic embolism, and covert stroke when compared with ASA alone.
AB - Background: The optimal long-term antithrombotic regimen for patients after successful catheter-based atrial fibrillation (AF) ablation is not well defined. Presently, practice variation exists, and the benefits of oral anticoagulation over antiplatelet therapy across the entire spectrum of stroke risk profile remain undefined in the postablation population. To date, there are no randomized trials to inform clinicians on this therapeutic question. Objective: The objective was to assess whether rivaroxaban is superior to acetylsalicylic acid (ASA) in reducing the risk of clinically overt stroke, systemic embolism, or covert stroke among patients without apparent recurrent atrial arrhythmias for at least 1 year after their most recent AF ablation procedure. Methods/design: A prospective, multicenter, open-label, randomized trial with blinded assessment of outcomes is under way (NCT02168829). Atrial fibrillation patients with at least 1 stroke risk factor (as defined by the CHA2DS2-VASc score) and without known atrial arrhythmia recurrences for at least 12 months after ablation are randomized to rivaroxaban 15 mg or ASA 75-160 mg daily. The primary outcome is a composite of clinically overt stroke, systemic embolism, and covert stroke based on brain magnetic resonance imaging. Key secondary outcomes include major bleeding outcomes, intracranial hemorrhage, transient ischemic attack, neuropsychological testing, quality of life, and an economic analysis. Subjects will be followed for 3 years. The estimated overall sample size is 1,572 subjects (786 per arm). Discussion: The OCEAN trial is a multicenter randomized controlled trial evaluating 2 antithrombotic treatment strategies for patients with risk factors for stroke after apparently successful AF ablation. We hypothesize that rivaroxaban will reduce the occurrence of clinically overt stroke, systemic embolism, and covert stroke when compared with ASA alone.
UR - http://www.scopus.com/inward/record.url?scp=85043355360&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2017.12.007
DO - 10.1016/j.ahj.2017.12.007
M3 - Article
C2 - 29447772
AN - SCOPUS:85043355360
SN - 0002-8703
VL - 197
SP - 124
EP - 132
JO - American Heart Journal
JF - American Heart Journal
ER -