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

Daniel B. Mark, Patricia A. Cowper, Kevin J. Anstrom, Shubin Sheng, Melanie R. Daniels, J. David Knight, Khaula N. Baloch, Linda Davidson-Ray, Mona Fiuzat, James L. Januzzi, David J. Whellan, Ileana L. Pina, Justin A. Ezekowitz, Kirkwood F. Adams, Lawton S. Cooper, Christopher M. O'Connor, G. Michael Felker

Research output: Contribution to journalArticle

2 Citations (Scopus)

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. patients. 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)

Original languageEnglish (US)
Pages (from-to)2551-2562
Number of pages12
JournalJournal of the American College of Cardiology
Volume72
Issue number21
DOIs
StatePublished - Nov 27 2018

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Heart Failure
Economics
Quality of Life
Biomarkers
Cardiomyopathies
Natriuretic Peptides
Therapeutics
Confidence Intervals
Costs and Cost Analysis
Medical Futility
Random Allocation
Surveys and Questionnaires

Keywords

  • biomarkers
  • economics
  • heart failure
  • left ventricular dysfunction
  • quality of life

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Mark, D. B., Cowper, P. A., Anstrom, K. J., Sheng, S., Daniels, M. R., Knight, J. D., ... 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

Economic and Quality-of-Life Outcomes of Natriuretic Peptide–Guided Therapy for Heart Failure. / Mark, Daniel B.; Cowper, Patricia A.; Anstrom, Kevin J.; Sheng, Shubin; Daniels, Melanie R.; Knight, J. David; Baloch, Khaula N.; Davidson-Ray, Linda; Fiuzat, Mona; Januzzi, James L.; Whellan, David J.; Pina, Ileana L.; Ezekowitz, Justin A.; Adams, Kirkwood F.; Cooper, Lawton S.; O'Connor, Christopher M.; Felker, G. Michael.

In: Journal of the American College of Cardiology, Vol. 72, No. 21, 27.11.2018, p. 2551-2562.

Research output: Contribution to journalArticle

Mark, DB, Cowper, PA, Anstrom, KJ, Sheng, S, Daniels, MR, Knight, JD, Baloch, KN, Davidson-Ray, L, Fiuzat, M, Januzzi, JL, Whellan, DJ, Pina, IL, Ezekowitz, JA, Adams, KF, Cooper, LS, O'Connor, CM & Felker, GM 2018, 'Economic and Quality-of-Life Outcomes of Natriuretic Peptide–Guided Therapy for Heart Failure', Journal of the American College of Cardiology, vol. 72, no. 21, pp. 2551-2562. https://doi.org/10.1016/j.jacc.2018.08.2184
Mark, Daniel B. ; Cowper, Patricia A. ; Anstrom, Kevin J. ; Sheng, Shubin ; Daniels, Melanie R. ; Knight, J. David ; Baloch, Khaula N. ; Davidson-Ray, Linda ; Fiuzat, Mona ; Januzzi, James L. ; Whellan, David J. ; Pina, Ileana L. ; Ezekowitz, Justin A. ; Adams, Kirkwood F. ; Cooper, Lawton S. ; O'Connor, Christopher M. ; Felker, G. Michael. / Economic and Quality-of-Life Outcomes of Natriuretic Peptide–Guided Therapy for Heart Failure. In: Journal of the American College of Cardiology. 2018 ; Vol. 72, No. 21. pp. 2551-2562.
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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. patients. 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)",
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author = "Mark, {Daniel B.} and Cowper, {Patricia A.} and Anstrom, {Kevin J.} and Shubin Sheng and Daniels, {Melanie R.} and Knight, {J. David} and Baloch, {Khaula N.} and Linda Davidson-Ray and Mona Fiuzat and Januzzi, {James L.} and Whellan, {David J.} and Pina, {Ileana L.} and Ezekowitz, {Justin A.} and Adams, {Kirkwood F.} and Cooper, {Lawton S.} and O'Connor, {Christopher M.} and Felker, {G. Michael}",
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T1 - Economic and Quality-of-Life Outcomes of Natriuretic Peptide–Guided Therapy for Heart Failure

AU - Mark, Daniel B.

AU - Cowper, Patricia A.

AU - Anstrom, Kevin J.

AU - Sheng, Shubin

AU - Daniels, Melanie R.

AU - Knight, J. David

AU - Baloch, Khaula N.

AU - Davidson-Ray, Linda

AU - Fiuzat, Mona

AU - Januzzi, James L.

AU - Whellan, David J.

AU - Pina, Ileana L.

AU - Ezekowitz, Justin A.

AU - Adams, Kirkwood F.

AU - Cooper, Lawton S.

AU - O'Connor, Christopher M.

AU - Felker, G. Michael

PY - 2018/11/27

Y1 - 2018/11/27

N2 - 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. patients. 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)

AB - 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. patients. 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)

KW - biomarkers

KW - economics

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KW - left ventricular dysfunction

KW - quality of life

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