AWARE
Trial question
What is the role of augmented double wide-area circumferential ablation in patients with paroxysmal AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 398
398 patients (131 female, 267 male)
Inclusion criteria: adult patients with symptomatic paroxysmal AF
Key exclusion criteria: persistent or permanent AF; history of previous catheter or surgical ablation for AF; known intracardiac thrombus; contraindication to systemic oral anticoagulation therapy
Interventions
N=203 augmented double ablation (augmented double wide-area circumferential ablation)
N=195 standard ablation (single wide-area circumferential ablation)
Primary outcome
Recurrent atrial arrhythmia at 1 year
24.6
26.7
26.7 %
20.0 %
13.3 %
6.7 %
0.0 %
Augmented double ablation
Standard ablation
No significant difference ↔
No significant difference in recurrent atrial arrhythmia at 1 year (24.6% vs. 26.7%; RR 0.92, 95% CI 0.66 to 1.29)
Secondary outcomes
No significant difference in repeated catheter ablation (7.4% vs. 10.3%; RR 0.72, 95% CI 0.38 to 1.36)
No significant difference in the rate of ECG-documented AF during the first 90 days post ablation (3.5% vs. 7.2%; RR 0.48, 95% CI 0.19 to 1.16)
No significant difference in hospitalizations related to atrial arrhythmias or procedure-related complications (9.9% vs. 11.8%; RR 0.83, 95% CI 0.47 to 1.47)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with symptomatic paroxysmal AF, augmented double ablation was not superior to standard ablation with respect to recurrent atrial arrhythmia at 1 year.
Reference
Girish M Nair, David H Birnie, Pablo B Nery et al. Standard vs Augmented Ablation of Paroxysmal Atrial Fibrillation for Reduction of Atrial Fibrillation Recurrence: The AWARE Randomized Clinical Trial. JAMA Cardiol. 2023 May 1;8(5):475-483.
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