Only 24% of real-world heart failure patients with reduced ejection fraction were eligible for sacubitril-valsartan, and they were significantly older than the PARADIGM-HF trial population.
Observational (n=2,029)
No
What proportion of a real-world heart failure population is eligible for sacubitril-valsartan based on PARADIGM-HF criteria?
Only a small minority (24%) of real-world HFrEF patients meet the strict eligibility criteria of the PARADIGM-HF trial, highlighting the challenge of extrapolating trial results to older, more comorbid clinical populations.
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.
Norberg et al. (2018) conducted an observational in Heart failure (n=2,029). PARADIGM-HF eligibility criteria vs. PARADIGM-HF trial population was evaluated on Eligibility for sacubitril-valsartan among patients with ejection fraction ≤ 35%. Only 24% of real-world heart failure patients with reduced ejection fraction were eligible for sacubitril-valsartan, and they were significantly older than the PARADIGM-HF trial population.