BACKGROUND In patients with persistent atrial fibrillation (PersAF), catheter ablation aiming for pulmonary vein isolation (PVI) is associated with moderate clinical effectiveness. We investigated the benefit of continuing previously ineffective class 1C or 3 antiarrhythmic drug therapy (ADT) in the setting of a standardized PVI-only ablation strategy. METHODS In this multicenter, randomized controlled study, patients with PersAF (≥7 days and <12 months) despite ADT were prospectively randomized 1:1 to PVI with ADT continued versus discontinued beyond the blanking period (ADT ON versus ADT OFF). Standardized catheter ablation was performed aiming for durable isolation with stable, contiguous, and optimized radio frequency applications encircling the pulmonary veins (CLOSE protocol). Clinical visits and 1-to-7-day Holter were performed at 3, 6, and 12 months. The primary end point was any documented atrial tachyarrhythmia lasting >30 seconds beyond 3 months. Prospectively defined secondary end points included repeat ablations, unscheduled arrhythmia-related visits, and quality of life among groups. RESULTS Of 200 PersAF patients, 98 were assigned to ADT OFF and 102 to ADT ON. The longest atrial fibrillation episode qualifying for PersAF was 28 (10-90) versus 30 (11-90) days. Clinical characteristics and procedural characteristics were similar. Recurrence of atrial tachyarrhythmia was comparable in both groups (20% OFF versus 21.2% ON). No differences were observed in repeat ablations and unscheduled arrhythmia-related visits. Marked improvement in quality of life was observed in both groups. CONCLUSIONS In patients with PersAF, there is no benefit in continuing previously ineffective ADT beyond the blanking period after catheter ablation. The high success rate of PVI-only might be explained by the high rate of durable isolation after optimized PVI and the early stage of PersAF (POWDER-AF2). REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT03437356.

中文翻译：

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对于持续性心房颤动患者，持续抗心律失常药物治疗对优化肺静脉隔离没有影响：POWDER-AF2 试验的结果。

背景 对于持续性心房颤动 (PersAF) 患者，针对肺静脉隔离 (PVI) 的导管消融具有中等临床效果。我们研究了在标准化的仅 PVI 消融策略的背景下继续先前无效的 1C 或 3 类抗心律失常药物治疗 (ADT) 的益处。方法 在这项多中心、随机对照研究中，尽管接受了 ADT，但仍患有 PersAF（≥7 天且 <12 个月）的患者被前瞻性地以 1:1 的比例随机分配至 PVI，其中继续 ADT 与在空白期后停止 ADT（ADT ON 与 ADT OFF）。进行标准化导管消融，旨在通过围绕肺静脉的稳定、连续和优化的射频应用实现持久隔离（CLOSE 方案）。在 3、6 和 12 个月时进行临床访视和 1 至 7 天的动态心电图。主要终点是任何有记录的房性快速心律失常持续超过 30 秒超过 3 个月。前瞻性定义的次要终点包括重复消融、计划外心律失常相关就诊以及各组的生活质量。结果 200 名 PersAF 患者中，98 名被分配至 ADT OFF，102 名被分配至 ADT ON。符合 PersAF 资格的最长房颤发作时间为 28 (10-90) 天和 30 (11-90) 天。临床特征和手术特征相似。两组房性快速心律失常的复发率相当（OFF 20% vs ON 21.2%）。在重复消融和计划外心律失常相关就诊中没有观察到差异。两组的生活质量均显着改善。结论 对于 PersAF 患者，在导管消融后的空白期之后继续先前无效的 ADT 没有任何益处。仅 PVI 的高成功率可能是由于优化 PVI 后的高持久隔离率和 PersAF (POWDER-AF2) 的早期阶段。注册网址：https://www.clinicaltrials.gov；唯一标识符：NCT03437356。