Dapagliflozin to Reduce Early Recurrence After Catheter Ablation for Atrial Fibrillation: The DARE-AF Randomized Clinical Trial.

However, no randomized trial to date has tested whether SGLT2 inhibitors reduce AF recurrence after ablation in patients without established indications.

然而，迄今为止，还没有随机试验来验证SGLT2抑制剂是否能在没有既定适应症的患者中减少消融后的房颤复发。

We therefore investigated the effect of dapagliflozin on prevention of early recurrence of AF after catheter ablation in patients without current indications for SGLT2 inhibitors.

因此，我们研究了达格列净对预防无SGLT2抑制剂当前适应症患者导管消融后早期房颤复发的影响。

Methods

The DARE-AF trial (Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation) was a prospective, open-label, parallel-assignment randomized controlled trialthat enrolled 200 patients with persistent AF between July 2024 and March 2025, scheduled to undergo a first catheter ablation procedure and without established indications for dapagliflozin (diabetes, heart failure, or chronic kidney disease).

DARE-AF试验（达格列净对导管消融后房颤复发的影响）是一项前瞻性、开放标签、平行分配的随机对照试验，招募了200名持续性房颤患者，这些患者计划在2024年7月至2025年3月期间进行首次导管消融手术，并且没有达格列净的既定适应症（糖尿病、心力衰竭或慢性肾脏病）。

Patients were randomly assigned at a 1:1 ratio to dapagliflozin (10 mg once daily for 3 months after the ablation) or control.

患者以1:1的比例随机分配接受达格列净（在消融后每日一次10毫克，持续3个月）或对照治疗。

The primary end point was AF burden at 3 months after ablation, assessed by 7-day single-lead ECG patches.

主要终点是消融后3个月的房颤负荷，通过7天单导联心电图贴片进行评估。

Secondary outcomes included time to events, quality of life, and improvement of atrial remodeling.

次要结果包括事件发生时间、生活质量以及心房重塑的改善。

Results

A total of 200 patients (mean age 58.5 years, 19.5% women, 29.0% with persistent AF ≥1 year) were randomized, and 198 patients (98 in the dapagliflozin group, 100 in the control group) were included in the primary analysis.

共有200名患者（平均年龄58.5岁，女性占19.5%，持续性房颤≥1年者占29.0%）被随机分配，198名患者（达格列净组98人，对照组100人）被纳入主要分析。

Three months after ablation, the difference in AF burden was insignificant between the dapagliflozin group and the control group (7.5±23.6% versus 8.1±25.5%; P=0.48).

消融术后三个月，达格列净组与对照组之间的房颤负荷差异不显著（达格列净组为7.5±23.6%，对照组为8.1±25.5%；P=0.48）。

Atrial arrhythmia recurrence occurred in 29 patients (29.6%) in the dapagliflozin group and 28 patients (28.0%) in the control group (hazard ratio, 1.11 [95% CI, 0.66-1.86]; P=0.70).

达格列净组中有29名患者（29.6%）和对照组中有28名患者（28.0%）出现了心房心律失常的复发（风险比，1.11 [95% 置信区间，0.66-1.86]；P=0.70）。

No significant between-group differences were observed in changes in quality of life or left atrial diameter.

在生活质量或左心房直径的变化中，未观察到组间显著差异。

Conclusions

Three-month treatment with dapagliflozin did not reduce the early recurrence of arrhythmia after catheter ablation in patients with persistent AF.

使用达格列净治疗三个月，并未减少持续性房颤患者导管消融后心律失常的早期复发。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT06433479.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT06433479.