RESUMO
Rate control is fundamental in the treatment of patients with atrial fibrillation (AF). The independent association of heart rate with outcomes and range of heart rate associated with best outcomes remains uncertain. We assessed the relationship between heart rate and clinical outcomes in patients with persistent or permanent AF enrolled in the randomized, double-blind ARISTOTLE trial. In patients with persistent or permanent AF, a faster heart rate is associated with a modest, but statistically significant increase in death and heart failure hospitalizations. TRIAL REGISTRATION: ClinicalTrials.gov (NCT00412984).
RESUMO
The ATHENA clinical trial enrolled 4,628 patients in 37 countries and evaluated the efficacy of dronedarone 400 mg twice daily versus placebo for the prevention of cardiovascular hospitalisation or death from any cause in patients with paroxysmal or persistent atrial fibrillation or atrial flutter. The trial showed a statistically significant 24% reduction in the primary endpoint cardiovascular hospitalisations or all-cause death. In the current paper, parameters that drive the cost-effectiveness of dronedarone on top of standard therapy versus likely comparators, i.e. amiodarone, sotalol and flecainide, were investigated by means of a health economic model based on the ATHENA clinical trial. Dronedarone is cost-effective, and ICERs are low versus amiodarone with 5,340; 4,620; 3,850 and 5,630 per QALY gained for Canada, Italy, Sweden and Switzerland, respectively. The most significant driving factor for the cost-effectiveness of dronedarone is the increased survival rate for patients on dronedarone.