3.2.1 Primary endpoint
The primary endpoint (any therapy delivered by the ICD) occurred in 30
patients: 10 patients in the new programming group (16%) and 30
patients in the conventional programming group (32%) (p=0.010).
Subjects who experienced the primary endpoint did not differ from those
who remained event-free, regarding basal characteristics, cardiovascular
risk factors, NYHA class and medications. The new programming was
significantly associated with a reduction in any therapy delivered by
the defibrillator (HR=0.265, 95% CI 0.121-0.577, p=0.001) (table 2).
Adjusted model for age, gender, ischemic HF, AF and standard HF
medication (ACEI/ARB/ARNi, beta-blockers and aldosterone antagonists)
showed similar results (HR 0.266 95% CI 0.120-0.591, p=0.001).
Kaplan-Meier survival curve demonstrated that long-term survival free
from therapies is better in patients with reduced therapy programming
(logrank, p<0.001) (figure 2).