LAUSR

Introduction In the PIONEER-HF trial, the in-hospital initiation of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure (ADHF) was well-tolerated and led to a greater reduction in N-terminal pro-B natriuretic peptide compared with enalapril, and reduced HF hospitalizations. In this study, we aimed to: (1) determine eligibility for the PIONEER-HF trial among patients in a contemporary registry population with ADHF and HF with reduced ejection fraction (”all HFrEF”), (2) determine eligibility for sacubitril/valsartan using criteria most relevant to daily clinical practice (“actionable” cohort), and (3) compare long-term outcomes between the all HFrEF, PIONEER-HF trial eligible, and actionable cohorts using linked Medicare claims data. Methods The initial study population was derived from all patients discharged alive in the Get With The Guidelines-HF(GWTG-HF) registry between January 2006 and June 2018 with a left ventricular ejection fraction ≤40%. We derived cohorts meeting PIONEER-HF trial eligibility criteria and a set of clinically relevant criteria. Rates of HF-readmissions and all-cause mortality 1-year post index discharge were obtained linking the GWTG-HF registry with Medicare fee-for-service claims. Results Total of 99,767 patients in GWTG-HF were hospitalized for ADHF and HFrEF. 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%). 68,739 (68.9%) patients met the criteria for the actionable cohort (Figure). Among the CMS-linked patients, the 1-year all-cause mortality was 36.7% for all HFrEF patients, 32.2% for the actionable cohort and 31.6% for the PIONEER-HF trial eligible cohort (Log rank test P Conclusions Patient characteristics and clinical outcomes in participants enrolled in PIONEER-HF only modestly differ compared with those encountered in routine practice, suggesting the findings of this trial may be broadly generalizable.