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).