氟卡尼预防卵圆孔未闭封堵术后房性心律失常：AFLOAT 研究，一项随机临床试验。

Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial.

机构信息

ACTION Study Group, CESP, INSERM U1018, Department of Cardiology, Ambroise Paré Hospital (AP-HP), Université de Versailles-Saint Quentin, Boulogne, France (M.H.-M.).

ACTION Study Group, INSERM UMRS1166, ICAN-Institute of Cardiometabolism and Nutrition, Sorbonne Université (P.G., M.L., T.R., Y.T., M.E.G., D.B., J.S., N.H., G.D., G.M.), Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.

出版信息

Circulation. 2024 Nov 19;150(21):1659-1668. doi: 10.1161/CIRCULATIONAHA.124.071186. Epub 2024 Sep 2.

DOI:10.1161/CIRCULATIONAHA.124.071186

PMID:39222035

Abstract

BACKGROUND

The real incidence of atrial arrhythmia (AA) after patent foramen ovale (PFO) closure and whether this complication can be prevented remain unknown. We assessed whether flecainide is effective to prevent AA during the first 3 months after PFO closure, and whether 6 months of treatment with flecainide is more effective than 3 months to prevent AA after PFO closure.

METHODS

AFLOAT (Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia Trial) is a prospective, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the end points (PROBE [Prospective Randomized Open, Blinded End Point] design). Patients were randomized in a 1:1:1 ratio after PFO closure to receive flecainide (150 mg once daily in a sustained-release dose) for 3 months, flecainide (150 mg once daily in a sustained-release dose) for 6 months, or no additional treatment (standard of care) for 6 months. The primary end point was the percentage of patients with at least 1 episode of AA (≥30 seconds) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. The secondary end point was the percentage of patients with at least 1 episode of AA (≥30 seconds) recorded with insertable cardiac monitor during the 3- to 6-month period after PFO closure.

RESULTS

A total of 186 patients were included (mean age, 54 years; 68.8% men) and AA (≥30 seconds) occurred in 53 patients (28.5%) during the 6-month follow-up; 86.8% of these AA events occurred in the first month after PFO closure. The primary outcome occurred in 33 of 123 (26.8%) and 16 of 63 (25.4%) patients receiving flecainide for at least 3 months or standard of care, respectively (risk difference, 1.4% [95% CI, -12.9% to 13.8%]; NS). The secondary end point occurred in 3 of 60 (5.0%), 4 of 63 (6.3%), and 5 of 63 (7.9%) patients receiving flecainide for 6 months, for 3 months, or standard of care, respectively (risk difference, -2.9% [95% CI, -12.7% to 6.9%], and risk difference, -1.6% [95% CI, -11.8% to 8.6%], respectively).

CONCLUSIONS

In the first 6 months after successful PFO closure, AA (≥30 seconds) occurred in 28.5% of cases, mostly in the first month after the procedure. Flecainide did not prevent AA after PFO closure.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05213104.

摘要

背景

卵圆孔未闭（PFO）封堵后房性心律失常（AA）的实际发生率以及这种并发症是否可以预防仍不清楚。我们评估了氟卡尼在 PFO 封堵后 3 个月内是否有效预防 AA，以及氟卡尼治疗 6 个月是否比 3 个月更能预防 PFO 封堵后的 AA。

方法

AFLOAT（氟卡尼降低卵圆孔未闭封堵后房颤或心动过速风险评估试验）是一项前瞻性、多中心、随机、开放标签、优效性试验，所有终点均采用盲法评估（PROBE[前瞻性随机开放盲终点]设计）。PFO 封堵后，患者以 1:1:1 的比例随机接受氟卡尼（150mg 每日 1 次持续释放剂量）治疗 3 个月、氟卡尼（150mg 每日 1 次持续释放剂量）治疗 6 个月或不接受额外治疗（标准护理）6 个月。主要终点是在 PFO 封堵后 3 个月内通过可植入心脏监测器进行长期监测时记录到至少 1 次 AA（≥30 秒）的患者比例。次要终点是在 PFO 封堵后 3 至 6 个月期间通过可植入心脏监测器记录到至少 1 次 AA（≥30 秒）的患者比例。

结果

共纳入 186 例患者（平均年龄 54 岁；68.8%为男性），在 6 个月的随访期间，53 例（28.5%）患者发生 AA（≥30 秒）；这些 AA 事件中有 86.8%发生在 PFO 封堵后的第一个月。主要结局发生在接受氟卡尼治疗至少 3 个月或标准护理的 123 例患者中的 33 例（26.8%）和 63 例患者中的 16 例（25.4%）（风险差异，1.4%[95%CI，-12.9%至 13.8%]；NS）。次要终点发生在接受氟卡尼治疗 6 个月的 60 例患者中的 3 例（5.0%）、接受氟卡尼治疗 3 个月的 63 例患者中的 4 例（6.3%）和接受标准护理的 63 例患者中的 5 例（7.9%）（风险差异，-2.9%[95%CI，-12.7%至 6.9%]，风险差异，-1.6%[95%CI，-11.8%至 8.6%]）。