Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 May 24;133(21):1995-2007.
doi: 10.1161/CIRCULATIONAHA.115.020259. Epub 2016 Apr 27.

Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial

Daniel B Mark  1 , Kevin J Anstrom  2 , Shubin Sheng  2 , Khaula N Baloch  2 , Melanie R Daniels  2 , Udo Hoffmann  2 , Manesh R Patel  2 , Lawton S Cooper  2 , Kerry L Lee  2 , Pamela S Douglas  2 ; PROMISE Investigators
Affiliations
Randomized Controlled Trial

Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial

Daniel B Mark et al. Circulation. .

Abstract

Background: The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial found that initial use of ≥64 detector-row computed tomography angiography versus standard functional testing strategies (exercise ECG, stress nuclear methods, or stress echocardiography) did not improve clinical outcomes in 10 003 stable symptomatic patients with suspected coronary artery disease requiring noninvasive testing. Symptom burden and quality of life (QOL) were major secondary outcomes.

Methods and results: We prospectively collected a battery of QOL instruments in 5985 patients at baseline and 6, 12, and 24 months postrandomization. The prespecified primary QOL measures were the Duke Activity Status Index and the Seattle Angina Questionnaire frequency and QOL scales. All comparisons were made as randomized. Baseline variables were well balanced in the 2982 patients randomly assigned to computed tomography angiography testing and the 3003 patients randomly assigned to functional testing. The Duke Activity Status Index improved substantially in both groups over the first 6 months following testing, but we found no evidence for a strategy-related difference (mean difference [anatomic - functional] at 24 months of follow-up, 0.1 [95% confidence interval, -0.9 to 1.1]). Similar results were seen for the Seattle Angina Questionnaire frequency scale (mean difference at 24 months, -0.2; 95% confidence interval, -0.8 to 0.4) and QOL scale (mean difference at 24 months, -0.2; 95% confidence interval, -1.3 to 0.9). None of the secondary QOL measures showed a consistent strategy-related difference.

Conclusions: In symptomatic patients with suspected coronary artery disease who required noninvasive testing, symptoms and QOL improved significantly. However, a strategy of initial anatomic testing, in comparison with functional testing, did not provide an incremental benefit for QOL over 2 years of follow-up.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01174550.

Keywords: chest pain; coronary artery disease; diagnosis; patient outcome assessment; quality of life.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Subgroup analysis of the Duke Activity Status Index. CAD equivalent was defined as diabetes, peripheral vascular disease, or cerebrovascular disease.
Figure 2
Figure 2
Subgroup analysis of the Seattle Angina Questionnaire Anginal Frequency scale. CAD equivalent was defined as diabetes, peripheral vascular disease, or cerebrovascular disease.
Figure 3
Figure 3
Subgroup analysis of the Seattle Angina Questionnaire Quality of Life scale. CAD equivalent was defined as diabetes, peripheral vascular disease, or cerebrovascular disease.
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Mark DB, Shaw LJ, Lauer MS, O'Malley PG, Heidenreich P. 34th Bethesda Conference: Task force #5--Is atherosclerosis imaging cost effective? J Am Coll Cardiol. 2003;41:1906–17. - PubMed
    1. Kassirer JP. Our stubborn quest for diagnostic certainty. A cause of excessive testing. N Engl J Med. 1989;320:1489–91. - PubMed
    1. 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 Outcomes of anatomical versus functional testing for coronary artery disease. N Engl J Med. 2015;372:1291–300. - PMC - PubMed
    1. 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, the PROMISE Investigators PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial. Am Heart J. 2014;167:796–803 e1. - PMC - PubMed
    1. Mark DB. Assessing quality-of-life outcomes in cardiovascular clinical research. Nat Rev Cardiol. 2016 Feb 18; doi: 10.1038/nrcardio.2016.10. [Epub ahead of print] - PubMed

Publication types

Associated data