Key result
In a real-world HFpEF cohort, 34% met complete PARAGON-HF criteria for sacubitril/valsartan eligibility and 63% met pragmatic criteria, with ineligibility driven mostly by exclusion criteria.
Why the study?
In PARAGON-HF, sacubitril/valsartan improved mortality and morbidity in HFpEF patients with LVEF below the median, prompting assessment of eligibility for sacubitril/valsartan across four scenarios.
What proportion of real-world HFpEF patients are eligible for sacubitril/valsartan based on PARAGON-HF trial criteria?
Observational (n=425)
Yes
What proportion of real-world HFpEF patients are eligible for sacubitril/valsartan based on PARAGON-HF trial criteria?
In a real-world HFpEF cohort, only 34% of patients met the strict PARAGON-HF trial eligibility criteria for sacubitril/valsartan, primarily due to exclusion criteria rather than failing to meet inclusion criteria.
Restricts sacubitril/valsartan to a minority of real-world HFpEF patients; leaves open whether pragmatic criteria improve generalizability.
Aims In the heart failure (HF) with preserved ejection fraction (HFpEF) PARAGON-HF trial, sacubitril/valsartan vs. valsartan improved mortality/morbidity in patients with left ventricular ejection fraction (LVEF) below median (57%). We assessed eligibility for sacubitril/valsartan based on four scenarios. Methods and results Eligibility was assessed 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). Among 425 patients [age 78 (72–83) years, 57% women, 28% LVEF ≤ 57% (median in PARAGON-HF), the trial scenario, identified 34% as eligible. Left atrial enlargement and/or left ventricular hypertrophy were present in 99%. Inclusion criteria not met were diuretic treatment and New York Heart Association class. Important exclusion criteria were estimated glomerular filtration rate <30 mL/min/1.73 m2, haemoglobin <10 g/day, and cancer. In the pragmatic scenario, 63% were eligible. In LVEF below lower limit of normal range, 5.4% were eligible, and in LVEF below mean of normal range, 41% were eligible. In patients with LVEF ≤ 57%, eligibility was 42%, 69%, 21%, and 91% according to the trial scenario, pragmatic scenario, LVEF below lower limit of normal range, and LVEF below mean of normal range, respectively. Conclusions In real-world HFpEF (LVEF ≥ 45%) with N-terminal pro-B-type natriuretic peptide and cardiac structure/function assessed, eligibility for sacubitril/valsartan was according to PARAGON-HF complete criteria 34%, pragmatic criteria 63%, LVEF below lower limit of normal range 5.4%, and LVEF below mean of normal range 41%. Cardiac structural impairment was almost ubiquitous. Ineligibility was more due to exclusion criteria than failing to meet inclusion criteria.
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Lund et al. (2021) conducted an observational in Heart failure with preserved ejection fraction (HFpEF) (n=425). PARAGON-HF trial criteria was evaluated on Eligibility for sacubitril/valsartan according to the trial scenario (all trial criteria). In a real-world HFpEF cohort, 34% met complete PARAGON-HF criteria for sacubitril/valsartan eligibility and 63% met pragmatic criteria, with ineligibility driven mostly by exclusion criteria.
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