Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure.
Publication/Presentation Date
11-27-2018
Abstract
BACKGROUND: The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial prospectively compared the efficacy of an N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided heart failure treatment strategy (target NT-proBNP level < 1,000 pg/ml) with optimal medical therapy alone in high-risk patients with heart failure and reduced ejection fraction. When the study was stopped for futility, 894 patients had been enrolled.
OBJECTIVES: The purpose of this study was to assess treatment-related quality-of-life (QOL) and economic outcomes in the GUIDE-IT trial.
METHODS: The authors prospectively collected a battery of QOL instruments at baseline and 3, 6, 12, and 24 months post-randomization (collection rates 90% to 99% of those eligible). The principal pre-specified QOL measures were the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and the Duke Activity Status Index (DASI). Cost data were collected for 735 (97%) U.S.
RESULTS: Baseline variables were well balanced in the 446 patients randomized to the NT-proBNP-guided therapy and 448 to usual care. Both the KCCQ and the DASI improved over the first 6 months, but no evidence was found for a strategy-related difference (mean difference [biomarker-guided - usual care] at 24 months of follow-up 2.0 for DASI [95% confidence interval (CI): -1.3 to 5.3] and 1.1 for KCCQ [95% CI: -3.7 to 5.9]). Total winsorized costs averaged $5,919 higher in the biomarker-guided strategy (95% CI: -$1,795, +$13,602) over 15-month median follow-up.
CONCLUSIONS: A strategy of NT-proBNP-guided HF therapy had higher total costs and was not more effective than usual care in improving QOL outcomes in patients with heart failure and a reduced ejection fraction. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).
Volume
72
Issue
21
First Page
2551
Last Page
2562
ISSN
1558-3597
Published In/Presented At
Mark, D. B., Cowper, P. A., Anstrom, K. J., Sheng, S., Daniels, M. R., Knight, J. D., Baloch, K. N., Davidson-Ray, L., Fiuzat, M., Januzzi, J. L., Jr, Whellan, D. J., Piña, I. L., Ezekowitz, J. A., Adams, K. F., Cooper, L. S., O'Connor, C. M., & Felker, G. M. (2018). Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure. Journal of the American College of Cardiology, 72(21), 2551–2562. https://doi.org/10.1016/j.jacc.2018.08.2184
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
30466512
Department(s)
Administration and Leadership
Document Type
Article