Abstract 18877: The Scope of Sacubitril/Valsartan Eligibility Post-Heart Failure Hospitalization: Findings From the Get With the Guidelines-Heart Failure Registry
Introduction: The FDA approved Sacubitril/Valsartan for patients with heart failure with reduced ejection fraction (HFrEF) in 2015 based on the PARADIGM-HF trial. The FDA labeling differs from strict eligibility criteria used in PARADIGM-HF, however, and the scope of patients hospitalized for HFrEF and eligible for Sacubitril/Valsartan is unknown.
Hypothesis: We aimed to describe patients with HFrEF by eligibility for Sacubitril/Valsartan under FDA labeling and more restrictive PARADIGM-HF criteria.
Methods: We analyzed hospitalizations for HFrEF (EF ≤40%) in the Get With The Guidelines-Heart Failure registry from 2011-2013. In-hospital deaths and records missing any values needed to determine eligibility were excluded. Patients were grouped as “FDA-eligible” (HFrEF, K ≤5.2 mEq/L, no known ACEI/ARB contraindication, discharge systolic blood pressure (SBP) ≥90 mmHg) or “FDA-excluded”. The FDA-eligible group was subdivided into “PARADIGM-eligible” (EF ≤35%, SBP ≥100 mmHg, minimum BNP/ NT-proBNP and eGFR values, ACEI/ARB and beta-blocker at discharge) and “PARADIGM-excluded”. We compared baseline and in-hospital group characteristics with Wilcoxon rank-sum and Chi-square tests.
Results: Overall, 28,932 hospitalizations for HFrEF were included, and 69% were FDA-eligible. Compared to FDA-excluded, the FDA-eligible group had lower Cr and BNP/NT-proBNP, but similar EF (Table). Among FDA-excluded patients, 89% had ACEI/ARB contraindication and 12% had discharge SBP <90 mmHg. PARADIGM-excluded patients were distinguished by EF 35-40% (34%), discharge SBP <100mHg (29%), and eGFR <30 mL/min/1.73 m2 (23%).
Conclusions: The majority of hospitalized HFrEF patients are eligible for Sacubitril/Valsartan at discharge by FDA label, but this group includes a large cohort ineligible for PARADIGM-HF, in whom outcomes may differ from trial results. Further study is warranted to demonstrate similarity in risks/ benefits for FDA label-indicated patients.
Author Disclosures: K.S. Parikh: None. S. Lippmann: None. M. Greiner: None. P.A. Heidenreich: None. C.W. Yancy: Consultant/Advisory Board; Modest; Thoratec. G.C. Fonarow: Other; Significant; Serves as Vice Chair of the ACC/AHA Task Force on Performance Measures. A.F. Hernandez: Other Research Support; Modest; Amgen, AstraZeneca, Bayer, Merck, Novartis. Honoraria; Modest; AstraZeneca, Boston Scientific, Novartis.
- © 2016 by American Heart Association, Inc.