What proportion of patients with chronic heart failure are eligible for sacubitril-valsartan?

Pellicori, Pierpaolo; Urbinati, Alessia; Shah, Parin; MacNamara, Alexandra; Kazmi, Syed; Dierckx, Riet; Zhang, Jufen; Cleland, John G.F.; Clark, Andrew L.

Abstract

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.

Citation

Pellicori, P., Urbinati, A., Shah, P., MacNamara, A., Kazmi, S., Dierckx, R., …Clark, A. L. (2017). What proportion of patients with chronic heart failure are eligible for sacubitril-valsartan?. European journal of heart failure, 19(6), 768-778. https://doi.org/10.1002/ejhf.788

• Acceptance Date: Jan 17, 2017
• Online Publication Date: Feb 27, 2017
• Publication Date: 2017-06
• Deposit Date: Mar 17, 2017
• Publicly Available Date: Feb 28, 2018
• Journal: European journal of heart failure
• Print ISSN: 1388-9842
• Electronic ISSN: 1879-0844
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Issue: 6
• Pages: 768-778
• DOI: https://doi.org/10.1002/ejhf.788
• Keywords: Sacubitril–valsartan; LCZ696; Chronic heart failure; PARADIGM-HF
• Public URL: https://hull-repository.worktribe.com/output/449753
• Publisher URL: http://onlinelibrary.wiley.com/doi/10.1002/ejhf.788/abstract?
• Additional Information: Authors' accepted manuscript of article: Pellicori, P., Urbinati, A., Shah, P., MacNamara, A., Kazmi, S., Dierckx, R., Zhang, J., Cleland, J. G.F. and Clark, A. L. (2017), What proportion of patients with chronic heart failure are eligible for sacubitril–valsartan?. Eur J Heart Fail, 19: 768–778. doi:10.1002/ejhf.788