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Randomized Controlled Trial
. 2025 Feb 4;333(5):381-389.
doi: 10.1001/jama.2024.24438.

Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial

Caihua Sang  1 , Qiang Liu  2 , Yiwei Lai  1 , Shijun Xia  1 , Ruhong Jiang  2 , Songnan Li  1 , Qi Guo  1 , Qifan Li  1 , Mingyang Gao  1 , Xueyuan Guo  1 , Lihong Huang  1 , Nian Liu  1 , Chenxi Jiang  1 , Song Zuo  1 , Xiaoxia Liu  1 , Mengmeng Li  1 , Weili Ge  3 , Shangming Song  4 , Lianghua Chen  4 , Shuanglun Xie  5 , Jiangang Zou  6 , Ke Chen  7 , Xiangfei Liu  8 , Hesheng Hu  9 , Xinhua Wang  10 , Jinlin Zhang  11 , Zhaojun Wang  12 , Chi Wang  13   14 , Liu He  1 , Chao Jiang  1 , Ribo Tang  1 , Ning Zhou  1 , Yunlong Wang  1 , Deyong Long  1 , Xin Du  1   13 , Chenyang Jiang  2 , Laurent Macle  15 , Jianzeng Dong  1 , Changsheng Ma  1 ; PROMPT-AF investigators
Collaborators, Affiliations
Randomized Controlled Trial

Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial

Caihua Sang et al. JAMA. .

Abstract

Importance: Success rates of pulmonary vein isolation (PVI) are modest for persistent atrial fibrillation (AF). Additional linear ablation beyond PVI has not been proved superior to PVI alone in randomized trials. Ethanol infusion of the vein of Marshall (EIVOM) facilitates ablation at the mitral isthmus and may lead to improved effectiveness of a linear ablation strategy.

Objective: To determine whether linear ablation with radiofrequency energy combined with EIVOM added to PVI improves sinus rhythm maintenance compared with PVI alone in patients with persistent AF.

Design, setting, and participants: The PROMPT-AF trial is an investigator-initiated, multicenter, open-label, randomized trial involving 12 tertiary hospitals in China. A total of 498 patients aged 18 to 80 years, with AF persisting for more than 3 months, undergoing first-time AF ablation, were enrolled and randomized from August 27, 2021, to July 16, 2023.

Interventions: Patients were randomized to undergo PVI alone or PVI plus EIVOM and linear ablation (intervention). The latter group first underwent EIVOM, followed by PVI and linear ablation of the left atrial roof, mitral isthmus, and cavotricuspid isthmus.

Main outcomes and measures: The primary end point was freedom from any documented atrial arrhythmias lasting more than 30 seconds, without the use of antiarrhythmic drugs within 12 months. Secondary outcomes included freedom from atrial arrhythmia recurrence, AF, atrial arrhythmia recurrence after multiple procedures, and documented atrial tachycardia or atrial flutter with or without antiarrhythmic drugs; AF burden; and improvement in quality of life. Patients were monitored with wearable single-lead electrocardiographic (ECG) patches, worn for 24 hours a week, supplemented by symptom-triggered ECGs and Holter monitoring.

Results: Among 498 randomized patients, 495 (99.4%) were included in the primary analysis (mean age, 61.1 years [SD, 9.7] years, 361 male [72.9%]). After 12 months, 174 of 246 patients (70.7%) assigned to undergo PVI plus EIVOM and linear ablation and 153 of 249 patients (61.5%) assigned to undergo PVI alone remained free from atrial arrhythmias without taking antiarrhythmic drugs (hazard ratio, 0.73; 95% CI, 0.54-0.99, P = .045). The intervention effect was consistent across all prespecified subgroups. The comparison of secondary outcomes did not demonstrate significant results.

Conclusion: Among patients with persistent AF, linear ablation combined with EIVOM in addition to PVI significantly improved freedom from atrial arrhythmias within 12 months compared with PVI alone.

Trial registration: ClinicalTrials.gov Identifier: NCT04497376.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Sang reported receiving lecture fees from Johnson & Johnson. Dr Jiang reported receiving honoraria or lecture fees from Johnson & Johnson, Abbott, Boston Scientific, and Bayer. Dr Macle reported receiving grants from Biosense-Webster, and honoraria or lecture fees Biosense-Webster, Abbott, Boston Scientific, and Medtronic outside the submitted work. Dr Dong reported receiving lecture fees from Johnson & Johnson. Dr Ma reported receiving lecture fees from Bristol Myers Squibb, Pfizer, Johnson & Johnson, Boehringer-Ingelheim, and Bayer. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Linear Ablation Combined With Ethanol Infusion via the Vein of Marshall in Addition to Pulmonary Vein Isolation
A, EIVOM was the first step of the procedure. The upper panel shows the selective VOM venography (blue arrows) acquired via an over-the-wire balloon. The lower panel shows contrast staining (blue chain) after ethanol infusion. B, After EIVOM, bilateral pulmonary vein isolation (PVI) and linear ablation in the roof, mitral isthmus, and cavotricuspid isthmus were performed. C, Voltage map at the end of the procedure.
Figure 2.
Figure 2.. Patient Recruitment and Study Flow of the PROMPT-AF Trial
AF indicates atrial fibrillation. aScreening log was not systematically collected from the participating centers
Figure 3.
Figure 3.. Freedom From Recurrence of Atrial Arrhythmias Without Antiarrhythmic Drugs
See this image and copyright information in PMC

Comment in

References

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