Daniel B. Mark, MD, MPH; Jerome J. Federspiel, MD; Patricia A. Cowper, PhD; Kevin J. Anstrom, PhD; Udo Hoffmann, MD, MPH; Manesh R. Patel, MD; Linda Davidson-Ray, MA; Melanie R. Daniels, BA; Lawton S. Cooper, MD; J. David Knight, MS; Kerry L. Lee, PhD; Pamela S. Douglas, MD; for the PROMISE Investigators *
Disclaimer: The content of this article 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.
Acknowledgment: The authors thank the coordinators at the PROMISE sites who enrolled the study participants and collected the study data (see the Appendix) and the patients who agreed to participate in this trial.
Grant Support: By grants R01HL098237, R01HL098236, R01HL098305, and R01HL098235 from the National Heart, Lung, and Blood Institute.
Disclosures: Dr. Mark reports grants from the National Institutes of Health during the conduct of the study; grants from Eli Lilly and Company, Gilead Sciences, Bristol-Myers Squibb, AGA Medical Corporation, Merck, Oxygen Therapeutics, AstraZeneca, and Medtronic outside the submitted work; and personal fees from Medtronic, CardioDx, St. Jude Medical, and Milestone outside the submitted work. Dr. Federspiel reports grants from the National Institutes of Health during the conduct of the study. Dr. Cowper reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study and grants from GE Healthcare, Bristol-Myers Squibb, Pfizer, Eli Lilly and Company, Tenax Therapeutics, Gilead Sciences, AGA Medical Corporation, and AstraZeneca outside the submitted work. Dr. Anstrom reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr. Hoffmann reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study; grants from HeartFlow, Siemens Healthcare, the Radiological Society of North America, Genentech, Kowa Company, and the American College of Radiology Imaging Network outside the submitted work; and personal fees from the American Heart Association outside the submitted work. Dr. Patel reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study; grants from Janssen Pharmaceutica, AstraZeneca, Maquet, and the Patient-Centered Outcomes Research Institute outside the submitted work; and personal fees from Genzyme, Bayer, and Janssen Pharmaceutica outside the submitted work. Mr. Knight reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr. Douglas reports grants from HeartFlow and GE Healthcare outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2639.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: See the Supplement. Statistical code: Not available. Data set: Available according to National Institutes of Health requirements.
Requests for Single Reprints: Daniel B. Mark, MD, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.
Current Author Addresses: Drs. Mark, Federspiel, Cowper, Anstrom, Patel, Lee, and Douglas; Ms. Davidson-Ray; Ms. Daniels; and Mr. Knight: Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.
Dr. Hoffmann: Radiological Associates, 55 Fruit Street, Boston, MA 02114-2696.
Dr. Cooper: National Heart, Lung, and Blood Institute, RKL2 BG RM 10108, 6701 Rockledge Drive, Bethesda, MD 20817.
Author Contributions: Conception and design: D.B. Mark, J.J. Federspiel, P.A. Cowper, M.R. Patel, L.S. Cooper, K.L. Lee.
Analysis and interpretation of the data: D.B. Mark, J.J. Federspiel, P.A. Cowper, K.J. Anstrom, M.R. Daniels, L.S. Cooper, K.L. Lee, P.S. Douglas.
Drafting of the article: D.B. Mark.
Critical revision of the article for important intellectual content: D.B. Mark, J.J. Federspiel, P.A. Cowper, K.J. Anstrom, M.R. Patel, M.R. Daniels, L.S. Cooper, K.L. Lee, P.S. Douglas.
Final approval of the article: D.B. Mark, J.J. Federspiel, P.A. Cowper, K.J. Anstrom, U. Hoffmann, M.R. Patel, L. Davidson-Ray, M.R. Daniels, L.S. Cooper, J.D. Knight, K.L. Lee, P.S. Douglas.
Provision of study materials or patients: P.S. Douglas.
Statistical expertise: D.B. Mark, J.J. Federspiel, K.J. Anstrom, K.L. Lee.
Obtaining of funding: D.B. Mark, M.R. Daniels, K.L. Lee, P.S. Douglas.
Administrative, technical, or logistic support: L. Davidson-Ray, M.R. Daniels, P.S. Douglas.
Collection and assembly of data: D.B. Mark, J.J. Federspiel, P.A. Cowper, M.R. Patel, L. Davidson-Ray, J.D. Knight, K.L. Lee, P.S. Douglas.
PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain) found that initial use of at least 64-slice multidetector computed tomography angiography (CTA) versus functional diagnostic testing strategies did not improve clinical outcomes in stable symptomatic patients with suspected coronary artery disease (CAD) requiring noninvasive testing.
To conduct an economic analysis for PROMISE (a major secondary aim of the study).
Prospective economic study from the U.S. perspective. Comparisons were made according to the intention-to-treat principle, and CIs were calculated using bootstrap methods. (ClinicalTrials.gov: NCT01174550)
190 U.S. centers.
9649 U.S. patients enrolled in PROMISE between July 2010 and September 2013. Median follow-up was 25 months.
Technical costs of the initial (outpatient) testing strategy were estimated from Premier Research Database data. Hospital-based costs were estimated using hospital bills and Medicare cost–charge ratios. Physician fees were taken from the Medicare Physician Fee Schedule. Costs were expressed in 2014 U.S. dollars, discounted at 3% annually, and estimated out to 3 years using inverse probability weighting methods.
The mean initial testing costs were $174 for exercise electrocardiography; $404 for CTA; $501 to $514 for pharmacologic and exercise stress echocardiography, respectively; and $946 to $1132 for exercise and pharmacologic stress nuclear testing, respectively. Mean costs at 90 days were $2494 for the CTA strategy versus $2240 for the functional strategy (mean difference, $254 [95% CI, −$634 to $906]). The difference was associated with more revascularizations and catheterizations (4.25 per 100 patients) with CTA use. After 90 days, the mean cost difference between the groups out to 3 years remained small.
Cost weights for test strategies were obtained from sources outside PROMISE.
Computed tomography angiography and functional diagnostic testing strategies in patients with suspected CAD have similar costs through 3 years of follow-up.
National Heart, Lung, and Blood Institute.
Mark DB, Federspiel JJ, Cowper PA, Anstrom KJ, Hoffmann U, Patel MR, et al. Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease. Ann Intern Med. [Epub ahead of print 24 May 2016]165:94–102. doi: 10.7326/M15-2639
Download citation file:
© 2019
Published: Ann Intern Med. 2016;165(2):94-102.
DOI: 10.7326/M15-2639
Published at www.annals.org on 24 May 2016
Cardiology, Coronary Heart Disease, High Value Care, Hospital Medicine.