No advantage to outpatient nesiritide infusions in advanced chronic heart failure: FUSION 2

Weekly or twice-weekly outpatient infusions of nesiritide do not prolong survival or prevent future hospitalizations in patients with advanced chronic heart failure and a history of acute decompensation, according to results from FUSION 2.While the primary results were neutral, it is important to note that there was no evidence of renal harm or excess mortality attributed to use of nesiritide, say the researchers presenting their findings at the American College of Cardiology's 56th Annual Scientific Session.FUSION 2 was a randomized, double-blind, placebo-controlled study conducted in 920 stage D CDHF patients. The trial was designed to prospectively evaluate efficacy and safety concerns of serial outpatient NES infusions in stage D patients following promising signals from FUSION I. Patients in FUSION 2 were randomized to NES 2 mcg/kg bolus and 0.01 mcg/kg/min for 4-6 hours (n= 605) or matching placebo (n= 306) once or twice weekly for 12 weeks, with a 4-week taper and 8-week follow-up. Patients were included in the trial if they were NYHA class 3 or 4 with an LVEF At tconclusion of the trial, there were no significant differences in rates of the primary end point of all-cause mortality or cardiovascular or cardiorenal hospitalization or in rates of its individual component events. There were no significant outcome differences for any of a long list of subgroups defined by age, sex, comorbidities, renal and LV function, and NYHA functional class....