Study results published in the Journal of the American College of Cardiology found that an N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided treatment strategy was more costly and non-superior to usual care, comprised of recommended therapy titration to doses established in prior trials, in patients with heart failure (HF) and reduced ejection fraction (EF).
A total of 1100 patients from 45 clinical sites in the United States and Canada who presented with chronic HF and an EF of ≤40 were randomly assigned to an NT-proBNP-guided treatment strategy (n=446) or usual care (n=448). Patients in the NT-proBNP- guided strategy underwent medical therapy titration with a goal of achieving a pg/ml NT-proBNP level <1000. Structured interviews performed at baseline and 3, 6, 12, and 24 months after randomization were used to collect and compare data on quality of life (QoL). The Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and the Duke Activity Status Index (DASI) were used to identify pre-specified QoL measures. In addition, researchers examined the costs associated with either treatment strategy in 735 US patients.
A ≥10-point improvement in the 4 KCCQ composite scales (ie, physical limitations, total symptoms, QoL, and social limitations) was observed in 51.7% of patients in the biomarker-guided group and 48.8% of patients in the usual care group at 6-month follow-up. The investigators found no difference between the two treatment groups in terms of KCCQ and DASI improvements at 24-month follow-up (mean difference [biomarker-guided vs usual care], 2.0 [DASI] [95% CI, −1.3 to 5.3] and 1.1 [KCCQ] [95% CI, −3.7 to 5.9]). Over median 15-month follow-up, the total winsorized costs were $5919 higher on average for patients receiving a biomarker-guided strategy (95% CI, −$1795 to $13,602).
The limited follow-up due to early study termination as well as the inclusion of patients who were treated by clinicians who were highly experienced with treating HF represent potential limitations of this study.
The researchers in this trial suggest that their findings may be the result of study investigators not being “aggressive enough in their pharmacotherapy responses to biomarker feedback.”
Mark DB, Cowper PA, Anstrom KJ, et al. Economic and quality-of-life outcomes of natriuretic peptide-guided therapy for heart failure. J Am Coll Cardiol. 2018;72(21):2551-2562.