Understanding the PROMPT-AF Trial: A Breakthrough in Persistent AF Management
The PROMPT-AF trial marks an important step forward in our understanding of how to manage persistent atrial fibrillation (AF) more effectively. Conducted as an investigator-initiated, multicenter, open-label randomized trial, PROMPT-AF sought to address whether adding optimized linear ablation with radiofrequency energy and EIVOM (electrocardiographically guided voltage mapping) to pulmonary vein isolation (PVI) could improve outcomes for patients undergoing their first ablation for persistent AF.
Study Highlights
The PROMPT-AF trial included 498 patients, aged 18 to 80 years, all of whom had experienced AF for more than three months. These individuals were randomized into two groups:
- PVI plus EIVOM and linear ablation (n = 246)
- PVI alone (n = 249)
The trial’s primary outcome measured freedom from atrial arrhythmias without the need for antiarrhythmic drugs after 12 months. Secondary outcomes included freedom from arrhythmia recurrence, AF burden, and quality of life.
Key Findings
- Primary Outcome: The addition of linear ablation with EIVOM to PVI demonstrated a significant benefit. Patients in the combination group achieved a 70.7% freedom rate from atrial arrhythmias compared to 61.5% in the PVI-alone group. This translates to a hazard ratio (HR) of 0.73 (95% CI, 0.54-0.99; p = .045).
- Secondary Outcomes: No significant differences were observed between the two groups in terms of:
- Freedom from atrial arrhythmia recurrence
- AF burden
- Improvement in quality of life
What Do These Results Mean?
The PROMPT-AF trial underscores that, for patients with persistent AF, combining optimized linear ablation with PVI and EIVOM enhances the ability to maintain sinus rhythm without antiarrhythmic drugs. However, the lack of improvement in secondary outcomes, such as AF burden and quality of life, raises questions about the clinical significance of these findings in real-world settings.
Conclusion
The PROMPT-AF trial provides robust evidence that adding EIVOM and linear ablation to PVI improves rhythm control in persistent AF. This trial offers a valuable data point for clinicians considering advanced strategies for first-time ablation in patients with persistent AF.
As ongoing research continues to refine the best approaches for managing AF, PROMPT-AF serves as an important reminder of the nuanced benefits of personalized treatment approaches in this complex condition.