PVAC Gold ablation failed to meet non-inferiority and had significantly higher AF recurrence at 12 months compared to ST-CF ablation (46.6% vs 26.2%; HR 2.05; 95% CI 1.28-3.29; P=0.003).
RCT (n=208)
randomized
Yes
Does PVAC Gold multi-electrode array reduce AF recurrence in patients with symptomatic paroxysmal atrial fibrillation compared to single-tip contact force ablation?
In patients with paroxysmal atrial fibrillation, the PVAC Gold multi-electrode array failed to show non-inferiority and resulted in significantly higher AF recurrence compared to single-tip contact force ablation, despite shorter procedure times.
Hazard Ratio: 2.05 (95% CI 1.28–3.29)
Absolute Event Rate: 46.6% vs 26.2%
Absolute Risk Reduction: 20.4%
p-value: p=0.003
AIMS: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become increasingly safe and effective with the evolution of single-tip ablation catheters aided by contact force sensing (ST-CF) and single-shot devices such as the second-generation pulmonary vein ablation catheter (PVAC) Gold multi-electrode array. The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF. METHODS AND RESULTS: The primary efficacy endpoint documented AF recurrence ≥30 s was assessed by time-to-first-event analysis after a 90-day blanking period using repeated 7-day Holters. Secondary endpoints include acute success and procedural characteristics. Safety endpoints included procedural complications, stroke/transient ischaemic attack (TIA), tamponade, bleeding, and access site complications. Two hundred and eight patients underwent randomization and PVI (103 assigned to PVAC Gold, 105 to ST-CF). Acute success rates were 95% and 97% for PVAC Gold and ST-CF, respectively. At 12 months, AF recurrence was observed in 46.6% of the PVAC Gold group and in 26.2% of the ST-CF group absolute efficacy difference 20.4% (95% confidence interval, CI 7.5-33.2%), hazard ratio 2.05 (95% CI 1.28-3.29), P = 0.003. PVAC Gold had significantly shorter procedure and ablation times. Complication rates were 5.7% and 4.9% for PVAC Gold and ST-CF, respectively (P = 0.782). CONCLUSION: In this multicentre randomized clinical trial, ablation with ST-CF and PVAC Gold ablation catheters non-inferiority for efficacy was not met. AF recurrence was significantly more frequent in the PVAC Gold group compared to single-tip contact force group. Both groups had similarly low rates of adverse events. PVAC Gold ablation had significantly shorter procedure and ablation times.
Wintgens et al. (Tue,) conducted a rct in paroxysmal atrial fibrillation (n=208). PVAC Gold multi-electrode array vs. single-tip ablation catheter with contact force sensing (ST-CF) was evaluated on AF recurrence ≥30 s assessed by time-to-first-event analysis after a 90-day blanking period (HR 2.05, 95% CI 1.28-3.29, p=0.003). PVAC Gold ablation failed to meet non-inferiority and had significantly higher AF recurrence at 12 months compared to ST-CF ablation (46.6% vs 26.2%; HR 2.05; 95% CI 1.28-3.29; P=0.003).