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Eligibility of patients with heart failure with preserved ejection fraction for sacubitril/valsartan according to the PARAGON-HF trial

ESC Heart Failure Nov 26, 2021

Lund LH, Savarese G, Venkateshvaran A, et al. - In the heart failure (HF) with preserved ejection fraction (HFpEF) PARAGON-HF trial, patients with left ventricular ejection fraction (LVEF) below median (57%) showed improvement in mortality/morbidity in correlation with receiving sacubitril/valsartan vs valsartan. In this study, eligibility for sacubitril/valsartan was assessed based on four scenarios.

  • Researchers performed assessment of eligibility in the Karolinska-Rennes study (acute HFpEF, LVEF ≥ 45%, and N-terminal pro-B-type natriuretic peptide ≥ 300 pg/mL subsequently assessed as outpatients including echocardiography) in (i) a trial scenario (all trial criteria); (ii) a pragmatic scenario (selected trial criteria); (iii) LVEF below lower limit of normal range (< 54% in women and < 52% in men); and (iv) LVEF below mean of normal range (< 64% in women and < 62% in men).

  • The eligibility for sacubitril/valsartan in real-world HFpEF (LVEF ≥ 45%) with N-terminal pro-B-type natriuretic peptide and cardiac structure/function assessed was 34% by PARAGON-HF complete criteria, 63% by pragmatic criteria, 5.4% by LVEF below lower limit of normal range, and 41% by LVEF below mean of normal range.

  • There was almost ubiquitous cardiac structural impairment.

  • Exclusion criteria more frequently resulted in ineligibility than failing to meet inclusion criteria.

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