Why the study?
Previous studies failed to show benefit from adding linear ablation or CFAE to PVI for persistent AF recurrence, prompting evaluation of whether PVI alone is non-inferior.
Does pulmonary vein isolation alone prevent recurrence of atrial arrhythmias non-inferiorly to PVI plus extensive ablation in patients with persistent atrial fibrillation?
Population
512 patients with persistent AF undergoing initial catheter ablation
Comparison
PVI alone vs PVI plus CFAE and/or linear ablation
Design
Randomized non-inferiority trial
Follow-up
12 months
Key result
PVI alone was not noninferior to PVI plus linear or CFAE ablation for preventing recurrence of atrial arrhythmias at 12 months (HR 1.56; 95% CI 1.10-2.24; P=0.3062 for noninferiority).
Authors
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PVI alone may suffice initially in persistent AF; leaves open whether adjunctive ablation improves outcomes in randomized trials.
RCT (n=512)
1:1 ratio
Does pulmonary vein isolation alone prevent recurrence of atrial arrhythmias non-inferiorly to PVI plus extensive ablation in patients with persistent atrial fibrillation?
Hazard Ratio: 1.56 (95% CI 1.1–2.24)
Absolute Event Rate: 71.3% vs 78.3%
p-value: p=0.3062 for noninferiority
In patients with persistent atrial fibrillation, PVI alone failed to demonstrate non-inferiority to PVI plus linear or CFAE ablation for preventing arrhythmia recurrence at 12 months, suggesting the more extensive strategy may improve clinical efficacy.
Inoue et al. (2020) conducted an RCT in Persistent atrial fibrillation (n=512). Pulmonary vein isolation (PVI) alone vs. PVI plus complex fractionated atrial electrogram (CFAE) and/or linear ablation was evaluated on Recurrence of AF, atrial flutter, and/or atrial tachycardia (HR 1.56, 95% CI 1.10-2.24, p=0.3062 for noninferiority). PVI alone was not noninferior to PVI plus linear or CFAE ablation for preventing recurrence of atrial arrhythmias at 12 months (HR 1.56; 95% CI 1.10-2.24; P=0.3062 for noninferiority).
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