Assessing suitability for sacubitril-valsartan therapy in an Irish cohort: challenges and opportunities

Daly, Aidan; Coughlan, J J; Mross, Thomas; Wafer, Megan; O’Connor, Aoife; Liston, Richard

doi:10.1007/s11845-019-01990-0

Cited by 2 publications

(2 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Patients with HFpEF are at high risk for CV and HF events, especially the weeks after hospitalization 27 . When assessing eligibility based on trial inclusion/exclusion criteria for sacubitril/valsartan in HF populations after a hospitalization with acute decompensated HF, the eligibility has been low at 2–12% 19,28–30 . The limitation in eligibility may be due to the high proportion of coexisting co‐morbidities such as renal dysfunction and hyperkalaemia or a minimum daily dose of angiotensin‐converting enzyme inhibitor/ARB, or excluding patients with ongoing HF hospitalizations as in PARADIGM‐HF.…”

Section: Discussionmentioning

confidence: 99%

“… 27 When assessing eligibility based on trial inclusion/exclusion criteria for sacubitril/valsartan in HF populations after a hospitalization with acute decompensated HF, the eligibility has been low at 2–12%. 19 , 28 , 29 , 30 The limitation in eligibility may be due to the high proportion of coexisting co‐morbidities such as renal dysfunction and hyperkalaemia or a minimum daily dose of angiotensin‐converting enzyme inhibitor/ARB, or excluding patients with ongoing HF hospitalizations as in PARADIGM‐HF. The angiotensin‐converting enzyme inhibitor/ARB criterion is strictly limited to HFrEF patients and is likely not applied in practice in HFmrEF and HFpEF, but the others are of interest also in these patient groups.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

et al. 2021

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 99%