An amino-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided treatment strategy did not improve outcomes compared with a usual care strategy in high-risk patients with heart failure and reduced ejection fraction (HFrEF), according to data published in JAMA.
The Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure (GUIDE-IT) study was discontinued due to lack of efficacy evidence for the biomarker-guided treatment group compared with usual care. The study planned to randomly assign 1100 patients with high-risk heart failure, defined as a low ejection fraction ≤40%, significantly elevated NT-proBNP, and a history of a prior heart failure hospitalization in the past year.
A total of 894 patients were enrolled between January 16, 2013, and September 20, 2016, at 45 clinical sites in the United States and Canada. Patients who were randomly assigned to an NT-proBNP-guided strategy (n=446) had heart failure therapy titrated with a target goal of NT-proBNP less than 1000 pg/mL. Patients who received usual care (n=448) had heart failure care in accordance with published guidelines, with an emphasis on titration of neurohormonal therapies for heart failure.
The primary end point of the study was the composite of time-to-first heart failure hospitalization or cardiovascular mortality, which occurred in 37% of patients in the biomarker-guided group and 37% of patients in the usual care group (adjusted hazard ratio [HR], 0.98). Cardiovascular mortality occurred in 12% of the biomarker-guided group and in 13% of the usual care group (HR, 0.94).
The investigators note that none of the secondary end points differed between the two groups, including all-cause mortality, total hospitalizations for heart failure, days alive and not hospitalized for cardiovascular reasons, health-related quality of life, resource use, cost-effectiveness, and safety.
“The primary finding of this study is that in high-risk patients with HFrEF, a strategy of guiding therapy based on concentrations of NT-proBNP was not more effective than a usual care strategy in reducing the composite end point of time-to-first HF hospitalization or cardiovascular death,” the researchers wrote.
“Although there were more adjustments to therapy in the biomarker-guided group, neither doses of guideline directed medical therapy, the achieved NT-proBNP concentrations, nor clinical outcomes were significantly different between the treatment groups,” they concluded.
Felker GM, Anstrom KJ, Adams KF, et al. Effect of natriuretic peptide-guided therapy on hospitalization or cardiovascular mortality in high-risk patients with heart failure and reduced ejection fraction: A randomized clinical trial. JAMA. 2017;318(8):713-720. doi:10.1001/jama.2017.10565