Serial outpatient infusions of nesiritide over 12 Weeks decrease hospitalization and mortality in chronic decompensated heart failure compared to “standard” therapy: a subgroup analysis of the fusion trial

Abstract

Background: Patients with chronic decompensated heart failure have a high rate of rehospitalization [50% within 6 mos] and annual mortality [>30%] despite use of standard therapy for heart failure. Systolic dysfunction, NYHA class IV heart failure and renal dysfunction impose significant death and hospitalization risk. Nesiritide has proven effective for treatment of acute heart failure but its impact on chronic heart failure in patients at high risk for re-hospitalization and death is under investigation. Methods: FUSION (multicenter open label pilot study) enrolled 210 patients (NYHA class III/IV; 6-min walk ≤400 m) receiving optimal therapy [71% B-Blockers; 57% ACE-inhibitors; 14% ARBs] who had ≥2 acutely decompensated heart failure events requiring intravenous therapy in the past 12 months. Patients were randomized to Standard Care (SC, inotropes permitted) or weekly 0.005 or 0.01 μg/kg/min nesiritide (no inotropes). This analysis examines the effect of nesiritide vs. SC over 12 weeks in patients with EF40% and NYHA class III with creatinine > 1.5 mg dL, or EF40% and NYHA class IV. Results: The subgroup comprised 52% (109/210) of the study population; 35 SC, 38 0.005 nesiritide and 36 0.01 nesiritide. Baseline characteristics were similar in all groups. Two patients in each nesiritide group experienced an adverse event that led to discontinuation of an infusion. Conclusion: In FUSION patients at highest risk for re-hospitalization and death, serial outpatient infusions of nesiritide were well tolerated and conferred a favorable impact on reduced hospitalization and mortality. ∗ Week 12 Death or Hospitalization Week 12 Mortality SC 24 (70.4%) 5 (14.7%) 0.005 Nesiritide 19 (50.0%) 5 (13.3%) 0.01 Nesiritide 16 (44.4%) ∗ p<0.05 by stratified log rank test 2 (5.6%) All Nesiritide 35 (47.3%) ∗ p<0.05 by stratified log rank test 7 (9.5%) ∗ p<0.05 by stratified log rank test Open table in a new tab