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).
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?
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?
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.
Answers are grounded in this paper and cite their sources.
PVI alone may suffice initially in persistent AF; leaves open whether adjunctive ablation improves outcomes in randomized trials.
AIMS: Previous studies could not demonstrate any benefit of more intensive ablation in addition to pulmonary vein isolation (PVI) including complex fractionated atrial electrogram (CFAE) and linear ablation for recurrence in the initial catheter ablation of persistent atrial fibrillation (AF). This study aimed to establish the non-inferiority of PVI alone to PVI plus these additional ablation strategies. METHODS AND RESULTS: Patients with persistent AF who underwent an initial catheter ablation (n = 512, long-standing persistent AF; 128 cases) were randomly assigned in a 1:1 ratio to either PVI alone (PVI-alone group) or PVI plus CFAE and/or linear ablation (PVI-plus group). After excluding 15 cases who did not receive procedures, we analysed 249 and 248 patients, respectively. The primary endpoint was recurrence of AF, atrial flutter, and/or atrial tachycardia, and the non-inferior margin was set at a hazard ratio of 1.43. In the PVI-plus group, 85.1% of patients had linear ablation and 15.3% CFAE ablation. After 12 months, freedom from the primary endpoint occurred in 71.3% of patients in the PVI-alone group and in 78.3% in the PVI-plus group [hazard ratio = 1.56 (95% confidence interval: 1.10-2.24), non-inferior P = 0.3062]. The procedure-related complication rates were 2.0% in the PVI-alone group and 3.6% in the PVI-plus group (P = 0.199). CONCLUSION: This randomized trial did not establish the non-inferiority of PVI alone to PVI plus linear ablation or CFAE ablation in patients with persistent AF, but implied that the PVI plus strategy was promising to improve the clinical efficacy (NCT03514693).
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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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