Indirect treatment comparison of two pulsed field ablation systems for the treatment of persistent atrial fibrillation.

BACKGROUND

Catheter ablation is beneficial in patients with symptomatic persistent atrial fibrillation (PerAF), and pulsed field ablation (PFA) is a promising energy source to safely and durably create ablation lesions. However, catheter-specific "PFA waveforms and designs" result in effectiveness and safety profiles that are not transferable to other PFA technologies. A head-to-head comparison between the dual-energy, wide-footprint lattice-tip (Sphere-9, Medtronic) and pentaspline PFA catheter (Farawave, Boston Scientific) is not yet available. Consequently, this study aims to perform an indirect treatment comparison (ITC).

METHODS

Outcomes (efficacy, safety, and procedure times) between the SPHERE Per-AF trial (N = 212; NCT05120193) and ADVANTAGE AF trial (N = 260; NCT05443594) studies were compared using matched-adjusted indirect comparison (MAIC) methods. Matching was performed based on subjects' baseline characteristics.

RESULTS

After matching, SPHERE Per-AF showed a higher probability (OR 0.51 (95% CI:0.32 - 0.80), p = 0.003) of 12-month freedom from arrhythmias (77.4%) compared to ADVANTAGE AF (63.5%). There was no evidence of adjusted probability of a primary safety difference (OR 0.76 (95% CI:0.17 - 3.42), p = 0.72) between trials (1.8% vs. 2.3%, respectively). Adjusted procedure and pulmonary vein isolation time were comparable, but fluoroscopy time was significantly shorter in SPHERE Per-AF compared to ADVANTAGE AF (-14.4 min (95% CI:-16.2, -12.5); p < 0.01).

CONCLUSION

PFA is generally safe and efficient; however, in this ITC, SPHERE Per-AF showed a higher probability of treatment success in PerAF patients compared to ADVANTAGE AF. Overall, these results underline possible differences even amongst PFA systems, which must be validated in randomized trials. Until then, MAIC methods fill the current evidence gap. Registry and the Registration No. SPHERE Per-AF: NCT05120193 and ADVANTAGE AF: NCT05443594.