USA: Treating high-risk patients hospitalized for acute decompensated heart failure with sacubitril/valsartan reduces the risk of CV death or re-hospitalization for heart failure, show results from the PIONEER-HF study. The findings of the study are published in the journal Circulation: Heart Failure.
Initiation of sacubitril/valsartan versus enalapril in patients stabilized during hospitalization for acute decompensated HF decreases the risk of rehospitalization for HF or cardiovascular (CV) death without increasing the risk of adverse events. Whether potentially high-risk subpopulations have a similar risk-benefit profile is not known.
Against this background, David D. Berg, Harvard Medical School, Boston, MA, and colleagues performed PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP [N-terminal pro-B type natriuretic peptide] in Patients Stabilized From an Acute HF Episode). PIONEER-HF was a multicenter, randomized, double-blind trial of in-hospital initiation of sacubitril/valsartan (n=440) versus enalapril (n=441) in patients stabilized during hospitalization for acute decompensated HF.
The composite of rehospitalization for HF or cardiovascular death was adjudicated. Safety outcomes included symptomatic hypotension, worsening renal function, and hyperkalemia.
The researchers evaluated heterogeneity in the effect of sacubitril/valsartan on these safety in selected subgroups of clinical concern -- patients with baseline systolic blood pressure ≤118 mm Hg (median; n=448), baseline NT-proBNP >2701 pg/mL (median; n=395), estimated glomerular filtration rate <60 mL/minute per 1.73 m2 (n=455), ≥1 additional hospitalization for HF within the prior year (n=343), admission to the ICU during the index hospitalization (n=96), inotrope use during the index hospitalization (n=68), and severe congestion (n=219).
Key findings of the study include:
The relative risk reduction in cardiovascular death or rehospitalization for HF with sacubitril/valsartan versus enalapril was consistent across all high-risk subgroups.
The risks of worsening renal function, symptomatic hypotension, and hyperkalemia with sacubitril/valsartan versus enalapril were also consistent in each high- versus low-risk subgroup.
"In high-risk subpopulations admitted for acute decompensated HF, treatment with sacubitril/valsartan after initial stabilization conferred a consistent reduction in cardiovascular death or rehospitalization for HF and was well tolerated," concluded the authors.
The study titled, "Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial," is published in the journal Circulation: Heart Failure.
DOI: https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.120.007034