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).