Author + information
- Received April 27, 2018
- Revision received August 23, 2018
- Accepted August 24, 2018
- Published online November 19, 2018.
- Daniel B. Mark, MD, MPHa,b,c,∗ (, )@DanMarkMD,
- Patricia A. Cowper, PhDa,
- Kevin J. Anstrom, PhDa,b,
- Shubin Sheng, PhDa,
- Melanie R. Daniels, BAa,
- J. David Knight, MSa,
- Khaula N. Baloch, MPHa,
- Linda Davidson-Ray, MAa,
- Mona Fiuzat, PharmDd,
- James L. Januzzi Jr., MDe,
- David J. Whellan, MD, MHSf,
- Ileana L. Piña, MD, MPHg,
- Justin A. Ezekowitz, MBBCh, MSch,
- Kirkwood F. Adams, MDi,
- Lawton S. Cooper, MD, MPHj,
- Christopher M. O’Connor, MDk@coconnormd and
- G. Michael Felker, MD, MHSb,c
- aOutcomes Research Group, Duke Clinical Research Institute, Durham, North Carolina
- bClinical Trials Group, Duke Clinical Research Institute, Durham, North Carolina
- cDivision of Cardiology, Duke University Medical Center, Durham, North Carolina
- dDivision of Clinical Pharmacology, Duke University Medical Center, Durham, North Carolina
- eCardiology Division, Massachusetts General Hospital, Boston, Massachusetts
- fThomas Jefferson University, Philadelphia, Pennsylvania
- gDepartment of Medicine, Albert Einstein College of Medicine, Bronx, New York
- hCanadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada
- iUniversity of North Carolina-Chapel Hill, Chapel Hill, North Carolina
- jDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland
- kInova Heart and Vascular Center, Fairfax, Virginia
- ↵∗Address for correspondence:
Dr. Daniel B. Mark, Outcomes Research Group, Duke Clinical Research Institute, P.O. Box 17969, Durham, North Carolina 27715 OR 2400 Pratt Street, Room 0311, Durham, North Carolina 27705.
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)
This study was supported by grants R01 HL105451, R01 HL105448, and R01 HL105457 from the National Heart, Lung, and Blood Institute/National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Roche Diagnostics provided support for NT-proBNP testing. Dr. Mark has received grant funding from Merck, Oxygen Therapeutics, Bristol-Myers Squibb, AstraZeneca, University of Calgary, Eli Lilly & Company, AGA Medical, St. Jude Medical, and Tufts University; and has received consulting fees from CeleCor and NovoNordisk. Dr. Cowper has received grant funding from AstraZeneca, Eli Lilly, GE Healthcare, Bristol-Myers Squibb, Pfizer, Tenax Therapeutics, Gilead, Bayer, and Novartis. Dr. Anstrom has received consulting fees from AstraZeneca, Boehringer Ingelheim, Janssen, and Promedior. Ms. Daniels has received consulting fees from CeleCor Therapeutics. Dr. Fiuzat has received research funding from Roche Diagnostics. Dr. Januzzi has received grant funding from Roche Diagnostics, Abbott Diagnostics, Siemens, Singulex, Prevencio, and Cleveland Heart Labs; and has received consulting income from Roche Diagnostics, Abbott Diagnostics, Novartis, MyoKardia, and Singulex. Dr. Whellan has received research funding from the National Institutes of Health, CVR Global, and ResMed; and has received consulting funds from Fibrogen, CVRx, Cytokinetics, and CSL Behring. Dr. Ezekowitz has received grant funding from and has served as a consultant for Amgen, Merck, Bayer, AstraZeneca, Bristol-Myers Squibb, and Luitpold; and has received grant support from the Canadian Institutes of Health Research. Dr. Adams has received research and consulting funding from Roche Diagnostics. Dr. O'Connor has received grant funding from Roche Diagnostics. Dr. Felker has received grant funding from the National Heart, Lung, and Blood Institute, American Heart Association, Roche Diagnostics, Cytokinetics, Merck, and Amgen; and has received consulting fees from Roche Diagnostics, Cytokinetics, Amgen, Novartis, Bristol-Myers Squibb, Myokardia, Innolife, V-Wave, EBR systems, Cardionomic, and Alnylam. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 27, 2018.
- Revision received August 23, 2018.
- Accepted August 24, 2018.
- 2018 American College of Cardiology Foundation
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