PROMISE Economic Substudy
PROspective Multicenter Imaging Study for Evaluation of Chest Pain
ClinicalTrials.gov: NCT01174550
Patient Population:
- 9,649 patients presenting to emergency department with chest pain
- 45 yrs or older
- new or worsening chest pain suspicious for clinically significant coronary artery disease
Trial Design: Randomized, parallel assignment, open label
Intervention: coronary CT angiography, stress echo, nuclear stress test, exercise ECG
Primary Endpoint: Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization.
Sponsors: NIH, NHLBI
Economic Substudy
Principal Investigator:
Daniel B. Mark, MD
PROMISE TRIAL: ECONOMIC STUDY
Overview
The PROMISE economic study design involved three major components: 1) collection of empirical resource use data and hospital cost data, 2) an “as randomized” comparison of within-study medical costs, and 3) a lifetime cost-effectiveness analysis, which was not performed because the hypothesized primary clinical benefits for CTA were not found.
Results
Ann Intern Med. 2016;165(2):94-102.
Economic outcomes with anatomical versus functional diagnostic testing for coronary artery disease.
Mark DB, Federspiel JJ, Cowper PA, Anstrom KJ, Hoffmann U, Patel MR, Davidson-Ray L, Daniels MR, Cooper LS, Knight JD, Lee KL, Douglas PS; PROMISE Investigators.
OPEN ACCESS from PubMed Central
Abstract
BACKGROUND:
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.
OBJECTIVE:
To conduct an economic analysis for PROMISE (a major secondary aim of the study).
DESIGN:
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.
SETTING:
190 U.S. centers.
PATIENTS:
9649 U.S. patients enrolled in PROMISE between July 2010 and September 2013. Median follow-up was 25 months.
MEASUREMENTS:
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.
RESULTS:
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.
LIMITATION:
Cost weights for test strategies were obtained from sources outside PROMISE.
CONCLUSIONS:
Computed tomography angiography and functional diagnostic testing strategies in patients with suspected CAD have similar costs through 3 years of follow-up.
DOI: 10.7326/M15-2639
In The News
PROMISE Economic Substudy
ACC 2015
March 15, 2015
American College of Cardiology Annual Scientific Sessions
San Diego, California, USA
Dr. Mark discusses the economic implications of using coronary CT angiography to assess stable chest pain patients in the emergency department.
PROMISE Publications
Genders TSS, Coles A, Hoffmann U, Patel MR, Mark DB, Lee KL, Steyerberg EW, Hunink MGM, Douglas PS; CAD Consortium and the PROMISE Investigators.
JACC Cardiovasc Imaging. 2017 Jun 9. pii: S1936-878X(17)30447-3. doi: 10.1016/j.jcmg.2017.02.020. [Epub ahead of print]
- PMID: 28624401
Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the PROMISE Trial.
Lu MT, Ferencik M, Roberts RS, Lee KL, Ivanov A, Adami E, Mark DB, Jaffer FA, Leipsic JA, Douglas PS, Hoffmann U.
JACC Cardiovasc Imaging. 2017 Apr 7. pii: S1936-878X(17)30262-0. doi: 10.1016/j.jcmg.2016.11.024. [Epub ahead of print]
- PMID: 28412436
Hoffmann U, Ferencik M, Udelson JE, Picard MH, Truong QA, Patel MR, Huang M, Pencina M, Mark DB, Heitner JF, Fordyce CB, Pellikka PA, Tardif JC, Budoff M, Nahhas G, Chow B, Kosinski AS, Lee KL, Douglas PS; PROMISE Investigators.
Circulation. 2017 Jun 13;135(24):2320-2332. doi: 10.1161/CIRCULATIONAHA.116.024360. Epub 2017 Apr 7.
- PMID: 28389572
Fordyce CB, Douglas PS, Roberts RS, Hoffmann U, Al-Khalidi HR, Patel MR, Granger CB, Kostis J, Mark DB, Lee KL, Udelson JE; Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Investigators.
JAMA Cardiol. 2017 Apr 1;2(4):400-408. doi: 10.1001/jamacardio.2016.5501.
- PMID: 28199464
Shah R, Yow E, Jones WS, Kohl LP 3rd, Kosinski AS, Hoffmann U, Lee KL, Fordyce CB, Mark DB, Lowe A, Douglas PS, Patel MR.
Am Heart J. 2017 Feb;184:1-9. doi: 10.1016/j.ahj.2016.10.014. Epub 2016 Oct 26.
- PMID: 27892881
Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease.
Mark DB, Federspiel JJ, Cowper PA, Anstrom KJ, Hoffmann U, Patel MR, Davidson-Ray L, Daniels MR, Cooper LS, Knight JD, Lee KL, Douglas PS; PROMISE Investigators.
Ann Intern Med. 2016 Jul 19;165(2):94-102. doi: 10.7326/M15-2639. Epub 2016 May 24.
- PMID: 27214597 Free PMC Article
Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS; PROMISE Investigators.
Circulation. 2016 May 24;133(21):1995-2007. doi: 10.1161/CIRCULATIONAHA.115.020259. Epub 2016 Apr 27.
- PMID: 27143676 Free PMC Article
Hemal K, Pagidipati NJ, Coles A, Dolor RJ, Mark DB, Pellikka PA, Hoffmann U, Litwin SE, Daubert MA, Shah SH, Ariani K, Bullock-Palmer RP, Martinez B, Lee KL, Douglas PS.
JACC Cardiovasc Imaging. 2016 Apr;9(4):337-46.
- PMID: 27017234 Free PMC Article
Outcomes of anatomical versus functional testing for coronary artery disease.
Douglas PS, Hoffmann U, Patel MR, Mark DB, Al-Khalidi HR, Cavanaugh B, Cole J, Dolor RJ, Fordyce CB, Huang M, Khan MA, Kosinski AS, Krucoff MW, Malhotra V, Picard MH, Udelson JE, Velazquez EJ, Yow E, Cooper LS, Lee KL; PROMISE Investigators.
N Engl J Med. 2015 Apr 2;372(14):1291-300. doi: 10.1056/NEJMoa1415516. Epub 2015 Mar 14.
- PMID: 25773919 Free PMC Article
Douglas PS, Hoffmann U, Lee KL, Mark DB, Al-Khalidi HR, Anstrom K, Dolor RJ, Kosinski A, Krucoff MW, Mudrick DW, Patel MR, Picard MH, Udelson JE, Velazquez EJ, Cooper L; PROMISE investigators.
Am Heart J. 2014 Jun;167(6):796-803.e1. doi: 10.1016/j.ahj.2014.03.003. Epub 2014 Mar 18.
- PMID: 24890527 Free PMC Article