Southlake Regional Health Centre, Newmarket, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
Am Heart J. 2018 Mar;197:124-132. doi: 10.1016/j.ahj.2017.12.007. Epub 2017 Dec 8.
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.
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 CHADS-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).
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.
对于成功接受导管消融治疗的心房颤动（房颤）患者，最佳的长期抗栓治疗方案尚未明确。目前，临床实践存在差异，且在消融术后人群中，口服抗凝药与抗血小板治疗相比在整个卒中风险谱中的获益仍不明确。迄今为止，尚无随机试验为临床医生提供关于该治疗问题的信息。
旨在评估利伐沙班是否优于乙酰水杨酸（ASA），以降低在最近一次房颤消融术后至少 1 年无明显复发性房性心律失常的患者中，发生临床显性卒、全身性栓塞或隐匿性卒中的风险。
方法/设计：正在进行一项前瞻性、多中心、开放标签、随机临床试验（NCT02168829），结局评估为盲法。至少有 1 个卒中危险因素（定义为 CHADS-VASc 评分）且在消融术后至少 12 个月无已知房性心律失常复发的房颤患者，随机分配至利伐沙班组（15 mg，每日 1 次）或 ASA 组（75-160 mg，每日 1 次）。主要结局是基于脑磁共振成像的临床显性卒、全身性栓塞和隐匿性卒中的复合终点。主要次要结局包括大出血结局、颅内出血、短暂性脑缺血发作、神经心理学测试、生活质量和经济分析。患者将随访 3 年。预计总体样本量为 1572 例（每组 786 例）。
OCEAN 试验是一项多中心随机对照试验，评估了 2 种抗栓治疗策略在明显成功消融后的房颤患者中存在卒中危险因素时的疗效。我们假设与单独使用 ASA 相比，利伐沙班会减少临床显性卒、全身性栓塞和隐匿性卒中的发生。
