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Abstract

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Original ResearchVolume 72, Issue 21, November 2018

JOURNAL:J Am Coll Cardiol. Article Link

Economic and Quality-of-Life Outcomes of Natriuretic Peptide–Guided Therapy for Heart Failure

DB Mark, PA Cowper, KJ Anstrom et al. Keywords: biomarker; economics; heart failure; left ventricular dysfunction; quality of life

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 proB-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. patients.

 

RESULTS - Baseline variables were well balanced in the 446 patients randomized to the NT-proBNPguided 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-proBNPguided 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)