Use of sacubitril/valsartan in patients with heart failure with reduced ejection fraction was associated with a reduction in mitral regurgitation, according to a new analysis of the PROVE-HF trial.
An analysis of 724 people from within the trial with interpretable mitral regurgitation data, results of the analysis suggest use of sacubitril/valsartan was associated with a 45% relative reduction in prevalence of grade 3-4+ mitral regurgitation at 6 months and this was sustained out to 12 months, with an observed relative reduction of 44.7%.
An exploratory open-label study designed with the intent of examining potential cardiac remodeling associated with use of sacubitril/valsartan among patients with heart failure with reduced ejection fraction, the original results of the PROVE-HF trial provided evidence suggesting the reductions in NT-proBNP observed with the agent were significantly correlated with improvements in markers of cardiac volume and function at 12 months. Presented at ESC Congress 2019 and simultaneously published in JAMA, the prospective, single-group trial enrolled 794 patients.
After exclusion of those without interpretable mitral regurgitation data and those with prior mitral valve procedures, 724 individuals were included in the current analysis, which was presented at the Heart Failure Society of America (HFSA) 2022 annual scientific meeting by Michael Felker, MD, professor of medicine at Duke University School of Medicine. The cohort of patients included in the HFSA 2022 data had a mean age of 65.0±12.4 years, 1.5% were men, and 72.9% were White. Investigators noted 76.4% of patients were using an ACE or ARB at baseline and 46.1% had nonischemic heart failure.
As part of the trial protocol for PROVE-HF echocardiograms were performed at baseline, 6 months, and 12 months. These were interpreted in a blinded fashion and categorized on a scale of 0 (none), 1+ (trace), 2+ mild, 3+ (moderate) and 4+ (severe).
Results of the investigators’ analyses indicated improvement in mitral regurgitation was observed from baseline through 12 months. Specifically, the prevalence of 3-4+ mitral regurgitation decreased from 14.9% to 8.2% at 6 months, which represents a 45.0% relative reduction in prevalence. At 12 months, the prevalence of 3-4+ was 8.4%, which reprints a 44.7% relative reduction.
Further analysis suggested those who experienced a decrease in 3-4+ mitral regurgitations experienced greater reductions in NT-proBNP from baseline to 12 months (912 vs 1512 pg/mL; P=.01), exhibited greater improvement in left ventricular remodeling (11.0% vs. 7.6%; P=.05), and had significantly improved KCCQ-23 scores (82.3 vs. 72.9; P compared with nonresponders.
This study, “Association Between Sacubitril/Valsartan Initiation and Mitral Regurgitation Severity in Heart Failure With Reduced Ejection Fraction: The PROVE-HF Study,” was presented at HFSA 2022 and simultaneously published in Circulation.