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What proportion of patients with chronic heart failure are eligible for sacubitril-valsartan?
Pierpaolo Pellicori1, Alessia Urbinati1, Parin Shah1
1Department of Cardiology, Castle Hill Hospital, Hull York Medical School (at University of Hull), Kingston upon Hull, UK.
Insights
Only 21% of heart failure with reduced ejection fraction patients met PARADIGM-HF trial criteria for sacubitril-valsartan. Eligibility increased to 60% when background medication was disregarded, highlighting potential for wider use.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Sacubitril-valsartan, an ARB-neprilysin inhibitor, demonstrated superior efficacy over enalapril in select heart failure (HF) patients per the PARADIGM-HF trial.
- The proportion of HF patients eligible for sacubitril-valsartan in routine clinical practice remains unclear.
Purpose of the Study:
- To determine the proportion of patients with heart failure who would meet the eligibility criteria for the PARADIGM-HF trial in a real-world clinical setting.
- To assess the impact of background medication on sacubitril-valsartan eligibility.
Main Methods:
- Retrospective analysis of 1396 patients with heart failure with reduced ejection fraction (HFrEF) and NT-proBNP measurements from a community HF clinic (2001-2014).
- Application of PARADIGM-HF randomization entry criteria, including symptoms, NT-proBNP levels, and current treatment with ACE inhibitors or ARBs.
- Evaluation of eligibility based on strict adherence to criteria and a broader approach ignoring background medication.
Main Results:
- Only 172 out of 379 patients (45%) on target ACE inhibitor/ARB doses met the key PARADIGM-HF entry criteria initially.
- Common reasons for ineligibility included lack of symptoms (32%) and NT-proBNP <600 ng/L (49%).
- Overall, 21% of HFrEF patients met randomization criteria, with an additional 21% becoming eligible during follow-up. Ignoring background medication increased initial eligibility to 50% and overall to 71%.
Conclusions:
- A significant minority (21%) of HFrEF patients referred to a community clinic met the strict PARADIGM-HF randomization criteria.
- Eligibility for sacubitril-valsartan significantly increases (to 60%) when background medication use is not a limiting factor, suggesting broader potential application.
- Findings underscore the need to consider clinical practice variations and guideline recommendations (e.g., ESC Guidelines) when assessing sacubitril-valsartan eligibility.
Aims:
The PARADIGM-HF trial showed that sacubitril-valsartan, an ARB-neprilysin inhibitor, is more effective than enalapril for some patients with heart failure (HF). It is uncertain what proportion of patients with HF would be eligible for sacubitril-valsartan in clinical practice.
Methods And Results:
Between 2001 and 2014, 6131 patients consecutively referred to a community HF clinic with suspected HF were assessed. The criteria required to enter the randomized phase of PARADIGM-HF, including symptoms, NT-proBNP, and current treatment with or without target doses of ACE inhibitors or ARBs, were applied to identify the proportion of patients eligible for sacubitril-valsartan. Recognizing the diversity of clinical opinion and guideline recommendations concerning this issue, entry criteria were applied singly and in combination. Of 1396 patients with reduced left ventricular ejection fraction (≤40%, HFrEF) and contemporary measurement of NT-proBNP, 379 were on target doses of an ACE inhibitor or ARB at their initial visit and, of these, 172 (45%) fulfilled the key entry criteria for the PARADIGM-HF trial. Lack of symptoms (32%) and NT-proBNP <600 ng/L (49%) were common reasons for failure to fulfil criteria. A further 122 patients became eligible during follow-up (n = 294, 21%). However, if background medication and doses were ignored, then 701 (50%) were eligible initially and a further 137 became eligible during follow-up.
Conclusions:
Of patients with HFrEF referred to a clinic such as ours, only 21% fulfilled the PARADIGM-HF randomization criteria, on which the ESC Guidelines are based; this proportion rises to 60% if background medication is ignored.
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