Eligibility of sacubitril-valsartan in a real-world heart failure population: a community-based single-centre study

Abstract

Aims: This study aims to investigate the eligibility of the Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) study to a real-world heart failure population.

Methods and results: Medical records of all heart failure patients living within the catchment area of Umeå University Hospital were reviewed. This district consists of around 150 000 people. Out of 2029 patients with a diagnosis of heart failure, 1924 (95%) had at least one echocardiography performed, and 401 patients had an ejection fraction of ≤35% at their latest examination. The major PARADIGM-HF criteria were applied, and 95 patients fulfilled all enrolment criteria and thus were eligible for sacubitril-valsartan. This corresponds to 5% of the overall heart failure population and 24% of the population with ejection fraction ≤ 35%. The eligible patients were significantly older (73.2 ± 10.3 vs. 63.8 ± 11.5 years), had higher blood pressure (128 ± 17 vs. 122 ± 15 mmHg), had higher heart rate (77 ± 17 vs. 72 ± 12 b.p.m.), and had more atrial fibrillation (51.6% vs. 36.2%) than did the PARADIGM-HF population.

Conclusions: Only 24% of our real-world heart failure and reduced ejection fraction population was eligible for sacubitril-valsartan, and the real-world heart failure and reduced ejection fraction patients were significantly older than the PARADIGM-HF population. The lack of data on a majority of the patients that we see in clinical practice is a real problem, and we are limited to extrapolation of results on a slightly different population. This is difficult to address, but perhaps registry-based randomized clinical trials will help to solve this issue.

Keywords: Eligibility; HFrEF; Heart failure; PARADIGM-HF; Real-world population; Sacubitril-Valsartan.

Figure 1

Selection of patients eligible for sacubitril–valsartan in the Umeå heart failure population when applying major inclusion and exclusion criteria from the PARADIGM‐HF trial. (A) First selection including LVEF ≤ 35% and ACE inhibitor or ARB in target dose. (B) Second selection including LVEF ≤ 40% and ACE inhibitor or ARB in half dose. In both (A) and (B) the following exclusion criteria were applied; NTproBNP < 600 pg/mL, eGFR < 30 mL/min, systolic blood pressure < 95 mmHg, and serum potassium level ≥ 5.4 mmol/L. ACE, angiotensin‐converting enzyme; ARB, angiotensin receptor blocker; eGFR, estimated glomerular filtration rate; LVEF, left ventricular ejection fraction; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide; PARADIGM‐HF, Prospective Comparison of Angiotensin Receptor–Neprilysin Inhibitor (ARNI) with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure.