Real-world off-label Sacubitril/Valsartan dosing and clinical outcomes in patients with heart failure and end-stage kidney disease
S I ImAbstract
Background
Sacubitril/Valsartan represent one of the cornerstone treatments to treat chronic heart failure with reduced ejection fraction. However, the choices of Sacubitril/Valsartan dose guided by the decision-making process of the physician, which considers specific according to kidney functions are inconsistent in the real-world practice.
Objective
The objective of the present study is to evaluate the effects of real-world Off-label dose of Sacubitril/Valsartan on long-term clinical outcomes in HF patients with end-stage kidney disease (ESKD).
Methods
Our database of HF patients diagnosed with ESKD from 2015 to 2025 was used to obtain laboratory, echocardiography, electrocardiogram (ECG), and clinical outcomes data. Inclusion criteria were all HF patients using Sacubitril/Valsartan with ESKD undergoing hemodialysis. And we compared arrhythmic events, re-hospitalization, and cardiovascular events according to LV ejection fraction (LVEF) change using off-label real -world dose of Sacubitril/Valsartan.
Results
Among 379 patients with HF and ESKD (75.1±11.9 years), 240 (63.5%) patients had LVEF improvement using Sacubitril/Valsartan. Difference in the baseline characteristics was not observed among patients. During the median 24-month follow-up, there was no significant difference of arrhythmic events, re-hospitalization, and cardiovascular events according to off-label real-world dose of Sacubitril/Valsartan (P=0.609). In multivariate analysis, lower incidence of premature ventricular complex (PVC) was independent risk factors for LVEF improvement events (OR 0.950; CI 0.908-0.983; P=0.032). Cut-off of PVC burden> 2866.5 beats/24 hours (Sensitivity 0.422; Specificity 0.966; AUC = 0.752; P=0.005) was associated with decreased LVEF.
Conclusions
There was no significant difference of arrhythmic events, re-hospitalization, and cardiovascular events according to off-label real-world dose of Sacubitril/Valsartan. Instead, PVC> 2866 beats/24 hours was independent risk factor for heart failure aggravationin HF patients with ESKD.figure 1ROC