Representativeness of the PIONEER-HF Clinical Trial Population in Patients Hospitalized With Heart Failure and Reduced Ejection Fraction

Circ Heart Fail. 2020 Apr;13(4):e006645. doi: 10.1161/CIRCHEARTFAILURE.119.006645. Epub 2020 Apr 6.

Abstract

Background: In PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-pro BNP in Patients Stabilized From an Acute Heart Failure Episode), the in-hospital initiation of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure (ADHF) was well-tolerated and led to improved outcomes. We aim to determine the representativeness of the PIONEER-HF trial among patients hospitalized for ADHF using real-world data.

Methods: The study population was derived from all patients discharged alive for ADHF in the Get With The Guidelines-HF registry from 2006 to 2018 with HF with reduced ejection fraction (HFrEF; all HFrEF with ADHF). We then determined the proportion of patients meeting PIONEER-HF eligibility criteria (PIONEER-HF eligible) and those meeting a set of limited eligibility criteria (actionable cohort). Rates of HF readmissions and all-cause mortality were then compared between the all HFrEF with ADHF, PIONEER-HF eligible, and actionable cohorts using linked Medicare claims data.

Results: A total of 99 767 patients with HFrEF in Get With The Guidelines-HF were hospitalized for ADHF. PIONEER-HF inclusion criteria were met by 71 633 (71.8%) patients, and both inclusion and exclusion criteria were met by 20 704 (20.8%) patients. Further, 68 739 (68.9%) patients met the criteria for the actionable cohort. Among the Centers for Medicare and Medicaid-linked patients, the HF rehospitalization rate at 1 year was 35.1% (95% CI, 34.5-35.8) for all HFrEF with ADHF patients, 32.6% (95% CI, 31.3-33.9) for the PIONEER-HF eligible cohort, and 33.1% (95% CI, 32.3-33.9) for the actionable cohort. The 1-year all-cause mortality was 36.7% (95% CI, 36.1-7.4) for all HFrEF with ADHF patients, 31.6% (95% CI, 30.3-32.9) for the PIONEER-HF eligible cohort, and 32.2% (95% CI, 31.4-33.0) for the actionable cohort.

Conclusions: Patient characteristics and clinical outcomes for patients eligible for PIONEER-HF only modestly differ when compared with those encountered in routine practice, suggesting that the in-hospital initiation of sacubitril/valsartan should be routinely considered for patients with HFrEF hospitalized for ADHF.

Keywords: brain natriuretic peptide; enalapril; heart failure; hospitalization; sacubitril valsartan.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aminobutyrates / adverse effects
  • Aminobutyrates / therapeutic use*
  • Angiotensin II Type 1 Receptor Blockers / adverse effects
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use*
  • Biomarkers / blood
  • Biphenyl Compounds
  • Clinical Decision-Making
  • Drug Combinations
  • Eligibility Determination
  • Evidence-Based Medicine
  • Female
  • Heart Failure / blood
  • Heart Failure / drug therapy*
  • Heart Failure / mortality
  • Heart Failure / physiopathology
  • Humans
  • Male
  • Middle Aged
  • Natriuretic Peptide, Brain / blood
  • Neprilysin / antagonists & inhibitors
  • Patient Admission*
  • Patient Selection
  • Peptide Fragments / blood
  • Protease Inhibitors / adverse effects
  • Protease Inhibitors / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Recovery of Function
  • Registries
  • Risk Factors
  • Stroke Volume / drug effects*
  • Tetrazoles / adverse effects
  • Tetrazoles / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Valsartan
  • Ventricular Function, Left / drug effects*

Substances

  • Aminobutyrates
  • Angiotensin II Type 1 Receptor Blockers
  • Biomarkers
  • Biphenyl Compounds
  • Drug Combinations
  • Peptide Fragments
  • Protease Inhibitors
  • Tetrazoles
  • pro-brain natriuretic peptide (1-76)
  • Natriuretic Peptide, Brain
  • Valsartan
  • Neprilysin
  • sacubitril and valsartan sodium hydrate drug combination