Background: Sacubitril/valsartan reduced heart failure (HF)-related hospitalizations and cardiovascular mortality in PARADIGM-HF and has become a foundational treatment for HF with reduced ejection fraction (HFrEF). However, data of its routine real-world use is limited, and evidence from Italian settings is lacking.
Aim of the study. The REAL.IT study aimed to characterize the demographics, pharmacotherapy, clinical characteristics, and outcomes of sacubitril/valsartan-treated Italian patients with HFrEF.
Methods. Electronic medical records of patients initiating sacubitril/valsartan from October 2016 to June 2019 at nine specialized hospital outpatient HF Centers across Italy were reviewed.
Results. Overall, 924 adults (mean age 64.5 years, 84.6% male) were included. Clinical characteristics are shown in Table 1. At baseline, 38.7% had an ischemic HF etiology, 45.9% hypertension, 23.2% atrial fibrillation, 25.4% diabetes mellitus, 26.1% an implantable cardioverter-defibrillator, 31.9% coronary artery bypass grafting. There were no clear patterns of patient selection over time. As shown in Table 1, during follow-up NYHA class improved in 37.5% after a mean of 5.3 ± 3.8 months; 36.1% and 16.7% of patients were in NYHA class III during characterization and after one year of follow-up, respectively. Left ventricular ejection fraction (LVEF) improved ≥5% in 56.3% of patients at one year; 39.7% had ≥30% reduction of N-terminal pro-B-type natriuretic peptide; 2.2% had hyperkalemia during characterization and 2.6% during follow-up; 3.8% had hypotension during characterization and 12% during follow-up. A total of 50 (5.8%) of patients had device implantation (ICD/CRT) during follow-up. HF-related hospitalization was recorded in 19.6% of patients during follow-up; 3.8% of patients died, approximately 1.3% from cardiovascular causes.
Conclusions. Our real-world data confirm the favorable effectiveness and tolerability of sacubitril/valsartan observed in pivotal randomized controlled trials.