PROVIDE-HF primary results: Patient-reported outcomes inVestigation following initiation of drug therapy with Entresto (Sacubitril/valsartan) in heart failure.

BACKGROUND In PARADIGM-HF, sacubitril/valsartan improved quality of life (QOL) vs. enalapril in heart failure with reduced ejection fraction (HFrEF), yet limited data are available regarding QOL changes after sacubitril/valsartan initiation in routine practice. METHODS PROVIDE-HF was a prospective study within a national research network (PCORnet) of HFrEF outpatients recently initiated on sacubitril/valsartan vs. controls with recent ACE-I/ARB initiation/dose change. The primary endpoint was mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12weeks. Other endpoints included responder analyses: ≥5-point and≥20-point KCCQ increase. Adjusted QOL change was estimated after propensity score weighting. RESULTS Overall, 270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control). The groups had similar demographics and HF details: median EF 28% and NT-proBNP 1083pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference+4.76; P=.027) and were more likely to have a≥5-point and≥20-point response (all P<.05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI: -0.89, 9.99; P=.101) and likelihood of ≥5-point increase (OR 1.55; 95% CI: 0.84, 2.86; P=.16); ≥20-pt increase remained statistically significant (OR 3.79; 95% CI: 1.47, 9.73; P=.006). CONCLUSIONS In this prospective HFrEF study of sacubitril/valsartan initiation compared with recent ACE-I/ARB initiation/dose change, the between-group difference in the primary endpoint, mean KCCQ change at 12weeks, was not statistically significant following adjustment, but sacubitril/valsartan initiation was associated with early improvements in QOL and a higher likelihood of ≥20-pt improvement in KCCQ at 12weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice.