P5678Real world eligibility and prognostic relevance for sacubitril/valsartan in unselected heart failure outpatients: data from an Italian registry (IN-HF outcome)

Abstract

Background: Although Angiotensin-Receptor-Neprilysin Inhibitors (ARNI) are recommended by all international guidelines for outpatients with chronic heart failure (CHF) and reduced ejection fraction (EF) who remain symptomatic despite optimal conventional drug treatment, uptake of this proven beneficial therapy in clinical practice takes time. In Italy ARNI are reimbursed by the National Health Service since March 2017 within criteria set by the national Medicines Agency (AIFA) mandating patient inclusion in a dedicated AIFA monitoring registry (AIFA-MR). Aim and methods: We aimed to assess the eligibility profile for ARNI treatment of CHF patients who had been enrolled in a nation-wide all comers HF outpatient Italian Registry according to the drug's indication criteria from PARADIGM-HF and AIFA-MR, respectively. Discrepancy of inclusion thresholds for NYHA class, LVEF, eGRF and potassium between AIFA-MR and PARADIGM-HF criteria are reported in the figure. Results: Among 1026 patients enrolled in the registry, ARNI-eligible subjects differed from ineligible ones for younger age, lower proportion of women (16%, p=.003, and 18%, p=.012, vs 25%), and higher proportion implanted an ICD (34%, p <35%, selects a subgroup with higher 1-year CV mortality and hospitalization rates. Pro-vided that tolerability is confirmed, AIFA-MR criteria may identify patients with higher event rates at one year, who could particularly benefit from ARNI and may enhance treatment cost-effectiveness. Funding Acknowledgements: The study was partially supported by an unre-stricted grant by Novartis, Abbott. and Medtronic, Italy.