Sacubitril/valsartan for heart failure with reduced ejection fraction: A first real-life observational study in Poland

Background: Despite the progress in the treatment of heart failure with reduced ejection fraction (HFrEF), the prognosis remains unfavorable.

Objectives: To evaluate the effectiveness, tolerance and safety after one-year follow-up of Polish patients with stable chronic HFrEF treated with sacubitril/valsartan.

Material and methods: This was an observational multicenter study conducted in 3 centers (Kraków, Łódź and Warszawa) specializing in heart failure (HF). We enrolled 89 HFrEF patients (aged 59.3 ±13.5 years, 82% males) in NYHA class II-IV (ambulatory). Clinical, laboratory and echocardiographic parameters were evaluated at baseline and after a one-year follow-up. The composite endpoint was defined as death or urgent HF hospitalization.

Results: After 1 year, 80% of patients used 50% or more of the target dose of sacubitril/valsartan. After a year of treatment, there were significant improvements of HF symptoms, N-terminal prohormone B-type natriuretic peptide (NT proBNP), ejection fraction (EF), and distance in six-minute walk test (6MWP) (all p < 0.001). Patients treated with the highest dose of sacubitril/valsartan exhibited the greatest benefits. The safety profile was favorable and consistent with that previously reported; however, therapy discontinuation due to side effects occurred in 11% of patients. The independent predictors for composite endpoint (n = 24, 26.9%) were history of HF hospitalization, tricuspid annular plane systolic excursion (TAPSE) and angiotensin-converting-enzyme inhibitor (ACEI)-naive patients.

Conclusions: Treatment of chronic HFrEF patients with sacubitril/valsartan is safe and is associated with significant clinical and objective improvement. The non-survivors had more advanced HF, so the initiation and uptitration of sacubitril/valsartan should be done early.