“Real World” eligibility for sacubitril/valsartan in unselected heart failure patients: Data from the Swedish Heart Failure Registry

Background: PARADIGM-HF demonstrated the benefits of sacubitril/valsartan (LCZ696) over enalapril in patients with heart failure and reduced ejection fraction (HFREF). How widely applicable sacubitril/valsartan treatment is in unselected patients with HFREF is not known. The aim was to establish the eligibility of patients with HFREF for treatment with sacubitril/valsartan, according to the criteria used in PARADIGM-HF, in the Swedish Heart Failure Registry (SwedeHF). Methods: Patients were considered potentially eligible if they were not hospitalized and were symptomatic (NYHA class II-IV), had a reduced LVEF (<=40%) and were prescribed an angiotensin converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) at a dose equivalent to enalapril 10mg daily. In these patients, we evaluated further eligibility according to the main additional PARADIGM-HF inclusion criteria. Data were analysed on the basis of complete entries for the main inclusion and exclusion criteria. Results: Of 51,060 patients in the SHFR, 22,822 (44.7%) were outpatients. 12,914 (56.6%) were in NYHA functional class II-IV with an LVEF <=40%. Of these, 6,462 (50.0%) were not prescribed at least enalapril 10mg daily or equivalent. The denominator used for further analysis was the 6,452 patients who were treated with at least enalapril 10mg daily or equivalent. Overall, 5015 (77.7%) were eligible for treatment with sacubitril/valsartan, with consistent results in the two analyses (Figure 1). The most common reason for ineligibility was low natriuretic peptide levels. Only a small proportion of patients were ineligible due to low eGFR or serum potassium levels. Conclusions: Over 77% of patients in an unselected HFREF population treated with an equivalent of at least 10 mg enalapril daily were eligible for treatment with sacubitril/valsartan according to the main inclusion/exclusion criteria of PARADIGM-HF.