Effectiveness:
Effectiveness endpoint, which incorporated atrial arrythmia recurrence,
AAD usage, acute procedural failure, cardioversion, repeat procedures,
was met in 59.9% of patients (Figure 3), this met the study performance
goal of 50%, which was based on similar prior trials. Examination of
individual components revealed that the primary endpoint contributors
were AAD usage and documented recurrence. Overall freedom from
recurrence of atrial arrythmia was confirmed in 79.9% of patients.
Documented recurrence of atrial arrhythmias occurred in 20.1% of
patient as of 12m follow-up, with recurrence of AF in 17.3%, AFL 3.5%,
and AT 1.9%), Figure 3. Kaplan Meier analysis of AAD usage revealed a
sharp drop in freedom from AADs shortly following blanking, which was
partly attributable to relatively high AAD usage. Notably, 38 of the 46
patients that had treatment failure only due to AAD usage, i.e., with no
documented recurrence or other events, received AADs at the same dose or
lower than baseline. Examination of AAD usage across follow-up, suggests
a marked decrease in AAD usage over the course of the trial, from 60.1%
of patients on Class I/III AADs (typical for control of AF)
pre-discharge to only 10.1% on Class I/III AADs at 12m follow-up, 13
pts on Class I (11 flecainide, 2 propafenone, 18 pts on Class III (6
amiodarone, 2 dofetilide, 3 dronedarone, 7 sotalol), Figure 3C.