P241 sacubitril/valsartan in heart failure with reduced ejection fraction: real–world experience from italy (the real.it study)

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.