Clinical Outcomes When Utilizing Sacubitril-Valsartan Vs. ACEi/ARB In Patients With HF And Ejection Fractions Spanning From Reduced To Preserved - A Retrospective, Parallel, Multi-Group Study

Abstract

<h3>Introduction</h3> Health outcomes- all-cause hospitalization (hosp), HF hosp, HF-related emergency dept. (ED) visits and a composite of all 3 outcomes provide important information about the benefits of using pharmacological therapy in patients with HF. It is important to assess real-world outcomes after Food and Drug Admin. indication expansion of sacubitril/valsartan (sac/val). <h3>Hypothesis</h3> Patients treated with sac/val vs. ACEi/ARB will have improved post-index date 6-month hosp and ED visit health outcomes. <h3>Methods</h3> Within 12 hospitals and over 100 outpatient practices (OPD) in OH and FL within a large healthcare system, adult patients prescribed sac/val between August 2015 through July 2018 were matched to patients prescribed ACEi/ARB (based on age, sex, EF, comorbidity status, index date, hospital vs. OPD index date and systolic BP) and health outcomes were assessed. Differences in outcomes of sac/val treated vs. matched ACEi/ARB controls were compared using linear, logistic, and Poisson models with generalized estimating equations. <h3>Results</h3> Of 3588 patients (1794 per group), 3413 (95.1%) had sac/val initiated in OPD. Baseline mean (SD) age was 64.2 (13.0) yrs, 70.3% were male, 20.7% were Black, mean systolic BP was 122.1 (16.1) mmHg, mean NTproBNP (n=2574) was 3732.4 (6453.0) pg/mL and estimated glomerular filtration rate (eGFR) was normal (>60 ml/min/1,73²) in 76.2% of patients and of those with kidney dysfunction, the mean was 47.3 (12.1) ml/min/1,73². By HF factors, 40.2% had dilated cardiomyopathy and 47.6% were NYHA-functional class II. Mean EF% was 29.0 (9.9) but spanned from under 10% (2.4%) to 60% with 90.3% as HFrEF and 349 (9.7%) as HFmidrangeEF. Of medications, 92.4% were on beta-blocker, 43% were on a mineralocorticoid receptor antagonist and 63.1% were on a loop diuretic. From baseline to 6 months, 50 patients died (16 sac/val vs. 34 ACEi/ARB; <i>p</i>=0.011). At 6-month assessment, sac/val use was associated with lower rates of all-cause and HF hosp, HF ED visits and the composite outcome (all <i>p</i> <0.001); see Figure of event rate (%) odds ratios. <h3>Conclusions</h3> Among a heterogenous sample of patients with HF (EFs spanned from 10-60%), utilization of sac/val was associated with fewer deaths at 6 months and improvement in 6-month all-cause and HF hosp, HF-related ED visits and the composite outcome. In future analyses, it will be important to determine patient and provider factors that facilitated sac/val use and improved clinical outcomes.