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

Publication ,  Journal Article
Fudim, M; Sayeed, S; Xu, H; Matsouaka, RA; Heidenreich, PA; Velazquez, EJ; Yancy, CW; Fonarow, GC; Hernandez, AF; DeVore, AD
Published in: Circ Heart Fail
April 2020

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.

Duke Scholars

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Published In

Circ Heart Fail

DOI

EISSN

1941-3297

Publication Date

April 2020

Volume

13

Issue

4

Start / End Page

e006645

Location

United States

Related Subject Headings

  • Ventricular Function, Left
  • Valsartan
  • Treatment Outcome
  • Time Factors
  • Tetrazoles
  • Stroke Volume
  • Risk Factors
  • Registries
  • Recovery of Function
  • Randomized Controlled Trials as Topic
 

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Fudim, M., Sayeed, S., Xu, H., Matsouaka, R. A., Heidenreich, P. A., Velazquez, E. J., … DeVore, A. D. (2020). Representativeness of the PIONEER-HF Clinical Trial Population in Patients Hospitalized With Heart Failure and Reduced Ejection Fraction. Circ Heart Fail, 13(4), e006645. https://doi.org/10.1161/CIRCHEARTFAILURE.119.006645
Fudim, Marat, Sabina Sayeed, Haolin Xu, Roland A. Matsouaka, Paul A. Heidenreich, Eric J. Velazquez, Clyde W. Yancy, Gregg C. Fonarow, Adrian F. Hernandez, and Adam D. DeVore. “Representativeness of the PIONEER-HF Clinical Trial Population in Patients Hospitalized With Heart Failure and Reduced Ejection Fraction.Circ Heart Fail 13, no. 4 (April 2020): e006645. https://doi.org/10.1161/CIRCHEARTFAILURE.119.006645.
Fudim M, Sayeed S, Xu H, Matsouaka RA, Heidenreich PA, Velazquez EJ, et al. 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.
Fudim, Marat, et al. “Representativeness of the PIONEER-HF Clinical Trial Population in Patients Hospitalized With Heart Failure and Reduced Ejection Fraction.Circ Heart Fail, vol. 13, no. 4, Apr. 2020, p. e006645. Pubmed, doi:10.1161/CIRCHEARTFAILURE.119.006645.
Fudim M, Sayeed S, Xu H, Matsouaka RA, Heidenreich PA, Velazquez EJ, Yancy CW, Fonarow GC, Hernandez AF, DeVore AD. 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.

Published In

Circ Heart Fail

DOI

EISSN

1941-3297

Publication Date

April 2020

Volume

13

Issue

4

Start / End Page

e006645

Location

United States

Related Subject Headings

  • Ventricular Function, Left
  • Valsartan
  • Treatment Outcome
  • Time Factors
  • Tetrazoles
  • Stroke Volume
  • Risk Factors
  • Registries
  • Recovery of Function
  • Randomized Controlled Trials as Topic