Physicians' Academy for Cardiovascular Education

Eligibility for ARNI in a real-world HF cohort from Sweden

News - June 23, 2020

Eligibility for sacubitril/valsartan in heart failure across the ejection fraction spectrum: real world data from the Swedish Heart Failure Registry

HFA Discoveries 2020 webinar presented by Gianluigi Savarese (Stockholm, Sweden)

Introduction and methods

In the PARADIGM-HF trial, treatment with sacubitril/valsartan reduced the risk of the primary endpoint, a composite of CV death and HF hospitalization, by 20% compared to enalapril in HF patients with reduced ejection fraction. Sacubitril/valsartan was also tested in HFpEF patients (those with EF ≥45), in the PARAGON-HF trial. Lower rates of CV death and HF hospitalization were observed with sacubitril/valsartan compared to valsartan alone, but the difference was not significant. A prespecified subgroup analysis of PARAGON-HF demonstrated potential efficacy of sacubitril/valsartan in those with EF below the median of 57%. Therefore, the benefit of sacubitril/valsartan in PARADIGM-HF could be extended to mildly reduced EF and may even challenge the definition of HFrEF to inlude HFmrEF.

To increase potential treatment effects in studies and reducing the sample size needed, criteria are applied to patients. The generalizability of findings is therefore questionable, and can lead to limiting implementation of treatments in clinical practice.

In this study, the proportion and characteristics of HF patients with reduced/mildly reduced (EF <50%) and with mildly-reduced/preserved EF (EF ≥40%) who would be eligible for sacubitril/valsartan based on PARADIGM-HF and PARAGON-HF criteria was assessed.

Data of 37,790 outpatients with known EF from the Swedish HF registry (SwedeHF) were used. Two potential scenarios were applied: a literal scenario (all trials inclusion/exclusion criteria which could be assessed in the database) and a pragmatic scenario (considering inclusion/exclusion criteria which may be more likely to influence the likelihood of receiving sacubitril/valsartan in clinical practice).

Main results


Eligibility was assessed in a cohort of real-world Swedish HF patients, of which 81% had EF<50%. Eligibility was similar in those with EF 40-49% and those with EF ≥50%, suggesting that eligibility estimates may be reproduced for EF <50% when a higher cutoff for EF is applied. In addition, this study examined characteristics and outcomes in eligible vs. non-eligible patients.

- Our reporting is based on the information provided by the HFA Discoveries webinar -

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