PROMPT-AF
Trial question
What is the role of optimized linear ablation combined with ethanol infusion of the vein of Marshall in addition to pulmonary vein isolation in patients with persistent AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 495
495 patients (134 female, 361 male).
Inclusion criteria: adult patients aged 18-80 years with persistent AF for > 3 months undergoing first-time AF ablation.
Key exclusion criteria: paroxysmal AF; LA diameter > 60 mm; LVEF < 30%; life expectancy < 1 year; any contraindication to catheter ablation or anticoagulation.
Interventions
N=246 optimized linear ablation (pulmonary vein isolation plus linear ablation combined with ethanol infusion of the vein of Marshall).
N=249 standard care (pulmonary vein isolation alone).
Primary outcome
Rate of freedom from any documented atrial arrhythmias lasting > 30 seconds, without the use of antiarrhythmic drugs within 12 months
70.7%
61.5%
70.7 %
53.0 %
35.4 %
17.7 %
0.0 %
Optimized linear
ablation
Standard
care
Significant
increase ▲
NNT = 10
Significant increase in the rate of freedom from any documented atrial arrhythmias lasting > 30 seconds, without the use of antiarrhythmic drugs within 12 months (70.7% vs. 61.5%; HR 1.37, 95% CI 1.01 to 1.85).
Secondary outcomes
No significant difference in freedom from atrial arrhythmias at 12 months (73.2% vs. 64.7%; HR 1.35, 95% CI 0.99 to 1.89).
No significant difference in freedom from AF at 12 months (76.4% vs. 69.9%; HR 1.3, 95% CI 0.92 to 1.82).
No significant difference in freedom from atrial arrhythmias after multiple ablations at 12 months (77.6% vs. 72.7%; HR 1.23, 95% CI 0.86 to 1.75).
Safety outcomes
No significant differences in procedure-related adverse events, serious adverse events.
Conclusion
In adult patients aged 18-80 years with persistent AF for > 3 months undergoing first-time AF ablation, optimized linear ablation was superior to standard care with respect to the rate of freedom from any documented atrial arrhythmias lasting > 30 seconds, without the use of antiarrhythmic drugs within 12 months.
Reference
Caihua Sang, Qiang Liu, Yiwei Lai et al. Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial. JAMA. 2025 Feb 4;333(5):381-389.
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