Abstract 18204: Generalizability Of The Paradigm-HF Trial For The Use Of Sacubitril/Valsartan In A Tertiary Care Outpatient Heart Failure Patient Population
Background: The combination of sacubitril/valsartan was recently approved for treatment of symptomatic heart failure and reduced ejection fraction (HFrEF). However, the run-in phase and inclusion/exclusion criteria raise questions as to the generalizability of these results.
Methods: Consecutive HFrEF patients (pts) seen over 22 months were retrospectively assessed for sacubitril/valsartan appropriateness based on the PARADIGM-HF trial and FDA approved indications in a HF Center (HFC) pt population.
Results: Overall, 231/250 pts were NYHA class II-IV (38.2% class II, 44% class III, and 10.9% class IV). The mean EF was 26±0.07 %. Based on PARADIGM-HF inclusion and exclusion criteria, only 17.1% (47) pts were eligible for sacubitril/valsartan use. Based on the FDA-approved indication 90.9% (250) pts were appropriate for sacubitril/valsartan use. Both the average systolic blood pressure (SBP) and glomerular filtration rate (GFR) were higher in patients who met only the PARADIGM-HF criteria vs. both criteria, 138.8±26.9 vs. 118.5±23.0 mmHg, p< 0.001; 81.0± 26.0 vs. 71.4±63.5 mL/min/1.73m2, p=0.31. The main reasons for ineligibility based on PARADIGM-HF criteria were suboptimal doses of angiotensin converting enzyme inhibitor(ACEi)/angiotensin II receptor blocker (ARB) in 75.3% (207), an eGFR<30 mL/min/1.73 m2 in 8% (22), and SBP< 100 mmHg 13.5% (37). Reason for ineligibility for FDA indications was NYHA I 6.9% (19) and allergy/angioedema 1.5% (4). Although not explicit contraindications, documentation indicated 13.5% had a SBP<100 mmHg, 4.4% had ACEi/ARB-induced hypotension, 4% had hyperkalemia and 2.5% had ACEi/ARB-induced renal dysfunction, further questioning appropriateness of use.
Conclusions: A minority of HFrEF pts in a HFC population met inclusion/exclusion criteria, while a majority of these patients meet the FDA indication for sacubitril/valsartan. This difference underscores the importance of following the professional society guidelines for the management of patients in the clinic setting.
Author Disclosures: J. Sackheim: None. D. Chan: None. K. Beers: None. H. Khan: None. L. Papadimitriou: None. M.W. Bloom: None. J. Butler: None. H. Skopicki: Speakers Bureau; Significant; Speaker for Novartis Pharmaceuticals.
- © 2016 by American Heart Association, Inc.