Clinical Cardiac Electrophysiology Section, The Ohio State University, Columbus, Ohio.
Heart Rhythm Program, Southlake Regional Health Centre, Ontario, Canada.
J Cardiovasc Electrophysiol. 2020 Jun;31(6):1289-1297. doi: 10.1111/jce.14483. Epub 2020 Apr 24.
The VICTORY AF Study was designed to evaluate the risk of the procedure and/or device-related strokes in patients with PersAF on warfarin undergoing ablation with a phased radiofrequency (RF) system.
The VICTORY AF trial was a prospective, multicenter, single-arm, investigational study. PersAF patients on vitamin K antagonism without major structural heart disease or history of stroke/transient ischemic attack undergoing phased RF ablation for atrial fibrillation (AF) were included. The primary outcome was the incidence of the procedure and/or device-related stroke within 30 days of the ablation by a board-certified neurologist's assessment. The secondary outcomes were an acute procedural success, 6 months effectiveness (defined as the reduction in AF/atrial flutter episodes lasting ≥10 minutes by 48-hour Holter 6 months postablation) and the number of patients with pulmonary vein (PV) stenosis.
A total of 129 (108 PersAF, 21 long-standing PersAF) patients were treated (mean age: 60.6 ± 7.7; 79.8% male, 54.3% CHA2Ds2-VASc score ≥ 2). Two nondisabling strokes were reported (1.6%); one before discharge and the second diagnosed at the 30-day visit. Due to slow enrollment, the study was terminated before reaching the 95% one-sided upper confidence boundary for stroke incidence. Acute procedural success was 93.8%, and at 6 months, 72.8% of patients demonstrated ≥90% reduction in AF burden, 78.9% were off all antiarrhythmic drugs. There were no patients with PV stenosis of greater than 70%.
VICTORY AF demonstrated a 1.6% incidence of stroke in PersAF undergoing ablation with a phased RF system which did not meet statistical confidence due to poor enrollment. The secondary outcomes suggest comparable efficacy to phased RF in the tailored treatment of permanent AF trial. Rigorous clinical evaluation of the stroke risk of new AF ablation technologies as well as restriction to Vitamin K antagonist anticoagulation appears to be unachievable goals in a clinical multicenter IDE trial of AF ablation in the current era.
VICTORY AF 研究旨在评估服用华法林的持续性房颤（PersAF）患者接受相控射频（RF）消融治疗时与手术和/或器械相关的中风风险。
VICTORY AF 试验是一项前瞻性、多中心、单臂、研究性试验。纳入无主要结构性心脏病或中风/短暂性脑缺血发作病史、正在接受相控 RF 消融治疗房颤（AF）的服用维生素 K 拮抗剂的 PersAF 患者。主要结局是由董事会认证的神经科医生评估的消融术后 30 天内与手术和/或器械相关的中风发生率。次要结局为急性手术成功率、6 个月疗效（定义为消融后 6 个月 48 小时动态心电图中 AF/房扑发作持续时间≥10 分钟的减少≥48 小时）以及肺静脉（PV）狭窄患者数量。
共治疗了 129 例（108 例 PersAF，21 例持续性长程 PersAF）患者（平均年龄：60.6±7.7；79.8%为男性，54.3%的 CHA2Ds2-VASc 评分≥2）。报告了 2 例非致残性中风（1.6%）；1 例在出院前，另 1 例在 30 天就诊时诊断。由于入组缓慢，该研究在达到中风发生率 95%单侧置信上限之前提前终止。急性手术成功率为 93.8%，6 个月时，72.8%的患者 AF 负荷减少≥90%，78.9%的患者停用所有抗心律失常药物。无 PV 狭窄大于 70%的患者。
VICTORY AF 在接受相控 RF 系统消融治疗的 PersAF 中显示出 1.6%的中风发生率，但由于入组人数较少，未达到统计学置信度。次要结局表明，在永久性 AF 试验中，相控 RF 系统治疗持续性 AF 的疗效相当。在当前时代，对新的 AF 消融技术的中风风险进行严格的临床评估以及限制维生素 K 拮抗剂抗凝似乎是无法实现的目标，无法在 AF 消融的临床多中心 IDE 试验中实现。
