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Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial.

Publication ,  Journal Article
Berg, DD; Samsky, MD; Velazquez, EJ; Duffy, CI; Gurmu, Y; Braunwald, E; Morrow, DA; DeVore, AD
Published in: Circ Heart Fail
February 2021

BACKGROUND: In patients stabilized during hospitalization for acute decompensated heart failure (HF), initiation of sacubitril/valsartan compared with enalapril decreased the risk of cardiovascular death or rehospitalization for HF without increasing the risk of adverse events. It is unknown whether potentially high-risk subpopulations have a similar risk-benefit profile. METHODS: 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) 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 cardiovascular death or rehospitalization for HF was adjudicated. Safety outcomes included worsening renal function, symptomatic hypotension, and hyperkalemia. We evaluated heterogeneity in the effect of sacubitril/valsartan on these efficacy and safety outcomes 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). RESULTS: The relative risk reduction in cardiovascular death or rehospitalization for HF with sacubitril/valsartan versus enalapril was consistent across all high-risk subgroups (P interaction=non-significant [NS] for each). 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 (P interaction=NS for each). CONCLUSIONS: 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.

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Published In

Circ Heart Fail

DOI

EISSN

1941-3297

Publication Date

February 2021

Volume

14

Issue

2

Start / End Page

e007034

Location

United States

Related Subject Headings

  • Valsartan
  • Risk
  • Renal Insufficiency
  • Peptide Fragments
  • Natriuretic Peptide, Brain
  • Intensive Care Units
  • Hypotension
  • Hyperkalemia
  • Humans
  • Hospitalization
 

Citation

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Berg, D. D., Samsky, M. D., Velazquez, E. J., Duffy, C. I., Gurmu, Y., Braunwald, E., … DeVore, A. D. (2021). Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial. Circ Heart Fail, 14(2), e007034. https://doi.org/10.1161/CIRCHEARTFAILURE.120.007034
Berg, David D., Marc D. Samsky, Eric J. Velazquez, Carol I. Duffy, Yared Gurmu, Eugene Braunwald, David A. Morrow, and Adam D. DeVore. “Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial.Circ Heart Fail 14, no. 2 (February 2021): e007034. https://doi.org/10.1161/CIRCHEARTFAILURE.120.007034.
Berg DD, Samsky MD, Velazquez EJ, Duffy CI, Gurmu Y, Braunwald E, et al. Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial. Circ Heart Fail. 2021 Feb;14(2):e007034.
Berg, David D., et al. “Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial.Circ Heart Fail, vol. 14, no. 2, Feb. 2021, p. e007034. Pubmed, doi:10.1161/CIRCHEARTFAILURE.120.007034.
Berg DD, Samsky MD, Velazquez EJ, Duffy CI, Gurmu Y, Braunwald E, Morrow DA, DeVore AD. Efficacy and Safety of Sacubitril/Valsartan in High-Risk Patients in the PIONEER-HF Trial. Circ Heart Fail. 2021 Feb;14(2):e007034.

Published In

Circ Heart Fail

DOI

EISSN

1941-3297

Publication Date

February 2021

Volume

14

Issue

2

Start / End Page

e007034

Location

United States

Related Subject Headings

  • Valsartan
  • Risk
  • Renal Insufficiency
  • Peptide Fragments
  • Natriuretic Peptide, Brain
  • Intensive Care Units
  • Hypotension
  • Hyperkalemia
  • Humans
  • Hospitalization