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

Gianluigi Savarese, Camilla Hage, Lina Benson, Benedikt Schrage, Tonje Thorvaldsen, Anna Lundberg, Marat Fudim, Cecilia Linde, Ulf Dahlström, Giuseppe Mc Rosano, Lars H Lund
Journal of Internal Medicine 2020 August 9

BACKGROUND: Randomized controlled trials (RCT) generalizability may be limited due to strict patient selection.

OBJECTIVE: In a real-world heart failure (HF) population, we assessed eligibility for sacubitril/valsartan based on PARADIGM-HF (sacubitril/valsartan effective) / PARAGON-HF [sacubitril/valsartan effective in mildly-reduced ejection fraction (EF)].

METHODS: Outpatients from the Swedish HF Registry (SwedeHF) were analyzed. In SwedeHF, EF is recorded as <30, 30-39, 40-49 and ≥50%. In PARAGON-HF, sacubitril/valsartan was effective with EF≤57% (i.e. median). We defined reduced EF / PARADIGM-HF as EF<40%, mildly-reduced EF / PARAGON-HF ≤median as EF 40-49%, and normal EF / PARAGON-HF >median as EF ≥50%. We assessed 2 scenarios: 1) criteria likely to influence treatment decisions (pragmatic scenario); 2) all criteria (literal scenario).

RESULTS: Of 37,790 outpatients, 57% had EF<40%, 24% EF 40-49%, and 19% EF≥50%. In the pragmatic scenario, 63% were eligible in EF<50% (67% for EF<40% and 52% for 40-49%) and 52% in EF≥40% (52% for EF≥50%). For the literal scenario, 32% were eligible in EF<50% (38% of EF<40%, 20% of EF 40-49%) and 22% in EF≥40% (25% for EF≥50%). Eligible vs. non-eligible patients had more severe HF, more comorbidities and overall worse outcomes.

CONCLUSION: In a real-world HF outpatient cohort, 81% of patients had EF <50%, with 63% eligible for sacubitril/valsartan based on pragmatic criteria and 32% eligible based on literal trial criteria. Similar eligibility was observed for EF 40-49% and ≥50%, suggesting that our estimates for EF<50% may be reproduced whether or not a higher cut-off for EF is considered.

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