Naccarelli Gerald V, Cappato Riccardo, Hohnloser Stefan H, Marchlinski Francis E, Wilber David J, Xiang Jim, Ma Changsheng, Hess Susanne, Davies David Wyn, Fields Larry E, Natale Andrea
Heart and Vascular Institute, Penn State University College of Medicine, P. O. Box 850, MC H047, 500 University Drive, Room H1511, Hershey, PA, 17033, USA,
J Interv Card Electrophysiol. 2014 Nov;41(2):107-16. doi: 10.1007/s10840-014-9924-9. Epub 2014 Jul 9.
To evaluate the safety of uninterrupted rivaroxaban, a novel oral anticoagulant that directly inhibits factor Xa, and a vitamin K antagonist (VKA) in eligible adult patients with nonvalvular AF (NVAF) who are scheduled for a catheter ablation.
METHODS/DESIGN: This is a prospective, randomized, open-label, active-controlled, global multicenter safety study of up to 250 randomized patients. Eligible patients with paroxysmal or persistent NVAF, a left ventricular ejection fraction >40 %, and a creatinine clearance >50 mL/min will be randomized 1:1 to rivaroxaban 20 mg orally once daily or to dose-adjusted oral VKA (recommended international normalized ratio (INR) 2.0-3.0) and stabilized on anticoagulation therapy for 1-7 days (if no intracardiac thrombus on transesophageal echocardiogram (TEE) immediately prerandomization/post-randomization or if 3 weeks of sufficient anticoagulation is documented) or for 4-5 weeks (if no TEE, no documented 3 weeks of sufficient anticoagulation, or by patient choice). During catheter ablation, heparin will be administered (ACT-targeted range = 300-400 s) after catheter ablation, and VKA will be managed per usual care. The next dose of rivaroxaban will be provided at least 6 h after establishment of hemostasis. The primary endpoint will be the incidence of post-procedure major bleeding events observed during the first 30 ± 5 days post-ablation. Secondary endpoints will include post-procedure thromboembolic events, additional bleeding, time-to-event, and medication adherence.
This study is intended to provide information about the safety characteristics of rivaroxaban in patients with NVAF undergoing catheter ablation.
评估不间断服用利伐沙班（一种直接抑制Xa因子的新型口服抗凝剂）和维生素K拮抗剂（VKA）在计划进行导管消融的符合条件的非瓣膜性房颤（NVAF）成年患者中的安全性。
方法/设计：这是一项前瞻性、随机、开放标签、活性对照的全球多中心安全性研究，随机入组患者最多250例。符合条件的阵发性或持续性NVAF患者，左心室射血分数>40%，肌酐清除率>50 mL/min，将按1:1随机分为每日口服一次20 mg利伐沙班或剂量调整的口服VKA（推荐国际标准化比值（INR）2.0 - 3.0），并在抗凝治疗下稳定1 - 7天（如果在随机分组前/后经食管超声心动图（TEE）检查无心脏内血栓，或有记录显示充分抗凝3周）或4 - 5周（如果未进行TEE检查，无记录显示充分抗凝3周，或根据患者选择）。在导管消融期间，导管消融后将给予肝素（活化凝血时间（ACT）目标范围 = 300 - 400秒），VKA将按常规护理进行管理。利伐沙班的下一剂将在止血确立后至少6小时给予。主要终点将是消融后最初30±5天内观察到的术后大出血事件的发生率。次要终点将包括术后血栓栓塞事件、额外出血、事件发生时间和药物依从性。
本研究旨在提供关于利伐沙班在接受导管消融的NVAF患者中的安全性特征的信息。
