Primary and secondary endpoint
Two patients in the RFA group were lost to follow-up. Two patients died within one year, and these two patients belonged to the RFA group. One patient died of respiratory failure in another hospital, and the other patient died of sepsis. Only one of these two patients had an AF recurrence before death.
In the RFA group, eight out of 16 patients had a composite outcome of ATA or use of an AAD (7 patients with ATA and 1 patient with AAD). In the CBA group, seven out of 16 patients had a composite outcome of ATA or use of an AAD (2 patients with ATA and 5 patients with AAD). For the primary endpoint, freedom from a composite outcome of a documented recurrence of any ATA or a prescription of an AAD at one year was 58.4% in the RFA group and 68.2% in the CBA group (Log-rank: p =0.571) (Figure 2). For the secondary outcome, freedom from a documented recurrence of any ATA at one year was 63.5% in the RFA group and 90.9% in the CBA group (Log-rank: p =0.042) (Figure 3).
A subgroup analysis of PAF revealed that freedom from a composite outcome of a documented recurrence of any ATA or a prescription of an AAD at one year was 60.6% in the RFA group and 70.6% in the CBA group (Figure 4). Freedom from a documented recurrence of any ATA at one year in patients with PAF was 60.6% in the RFA group and 94.1% in the CBA group (Log-rank: p =0.026) (Figure 5).