Outcomes of Anatomical versus Functional Testing for Coronary Artery Disease
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BACKGROUND: Many patients have symptoms suggestive of coronary artery disease (CAD) and are often evaluated with the use of diagnostic testing, although there are limited data from randomized trials to guide care. METHODS: We randomly assigned 10,003 symptomatic patients to a strategy of initial anatomical testing with the use of coronary computed tomographic angiography (CTA) or to functional testing (exercise electrocardiography, nuclear stress testing, or stress echocardiography). The composite primary end point was death, myocardial infarction, hospitalization for unstable angina, or major procedural complication. Secondary end points included invasive cardiac catheterization that did not show obstructive CAD and radiation exposure. RESULTS: The mean age of the patients was 60.8±8.3 years, 52.7% were women, and 87.7% had chest pain or dyspnea on exertion. The mean pretest likelihood of obstructive CAD was 53.3±21.4%. Over a median follow-up period of 25 months, a primary end-point event occurred in 164 of 4996 patients in the CTA group (3.3%) and in 151 of 5007 (3.0%) in the functional-testing group (adjusted hazard ratio, 1.04; 95% confidence interval, 0.83 to 1.29; P=0.75). CTA was associated with fewer catheterizations showing no obstructive CAD than was functional testing (3.4% vs. 4.3%, P=0.02), although more patients in the CTA group underwent catheterization within 90 days after randomization (12.2% vs. 8.1%). The median cumulative radiation exposure per patient was lower in the CTA group than in the functional-testing group (10.0 mSv vs. 11.3 mSv), but 32.6% of the patients in the functional-testing group had no exposure, so the overall exposure was higher in the CTA group (mean, 12.0 mSv vs. 10.1 mSv; P<0.001). CONCLUSIONS: In symptomatic patients with suspected CAD who required noninvasive testing, a strategy of initial CTA, as compared with functional testing, did not improve clinical outcomes over a median follow-up of 2 years. (Funded by the National Heart, Lung, and Blood Institute; PROMISE ClinicalTrials.gov number, NCT01174550.).
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The majority of FHS (100%), NLST (91%), PROMISE (77%), and ROMICAT-II (66%) participants were non-Hispanic whites.
“The majority of FHS (100%)44, NLST (91%)18, PROMISE (77%)45, and ROMICAT-II (66%)46 participants were non-Hispanic whites.”
From Deep convolutional neural networks to predict cardiovascular risk from computed tomography (2021) · cites this paper as [45]
Further analysis of PROMISE showed that a substantial proportion of myocardial infarctions occurred in patients with nonobstructive coronary artery disease identified by CTA, disease that would not be detected by functional testing and could prompt important changes in prevention strategies.
“Further analysis showed that a substantial proportion of myocardial infarctions occurred in patients with nonobstructive CAD identified by CTA, disease that would not be detected by functional testing and could prompt important changes in prevention strategies.”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [231]
PROMISE randomly assigned 8966 patients with stable chest pain (1908 with diabetes mellitus) to either CTA or functional testing and showed no difference in outcomes over a median of 2 years of follow-up.
“PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), which randomly assigned 8966 patients with stable chest pain (1908 with diabetes mellitus) to either CTA or functional testing and showed no difference in outcomes over a median of 2 years of follow-up.”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [231]
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- Authors
- Douglas, P. S., Hoffmann, U., Patel, M. R., Mark, D. B., Al-Khalidi, H. R., Cavanaugh, B., Cole, J., Dolor, R. J., Fordyce, C. B., Huang, M., Khan, M. A., Kosinski, A. S., Krucoff, M. W., Malhotra, V., Picard, M. H., Udelson, J. E., Velazquez, E. J., Yow, E., Cooper, L. S., & Lee, K. L.
- Affiliations
- Tufts Medical Center (US)
- Massachusetts General Hospital (US)
- Duke University (US)
- New Mexico Heart Institute (US)
- Tufts University (US)
- National Heart, Lung, and Blood Institute (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-04-02
- Volume
- 372
- Issue
- 14
- Pages
- 1291-1300
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4473773
- OpenAlex
- W2160133249
- Cited by
- 1,543
- References
- 22
- Citations by year
- 2026: 100 · 2025: 108 · 2024: 120 · 2023: 124 · 2022: 136 · 2021: 157 · 2020: 144 · 2019: 135 · 2018: 112 · 2017: 155 · 2016: 165 · 2015: 85
- FWCI
- 139.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- AstraZeneca
- Gilead Sciences
- Alnylam Pharmaceuticals
- Ikaria
- Otsuka Pharmaceutical
- Biosensors International Group
- St. Jude Medical
- Abbott Vascular
- National Heart, Lung, and Blood Institute (R01HL098237, K24HL113128, R01HL098235, R01HL098305, R01HL098236)
- Janssen Pharmaceuticals
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Cardiac Imaging and Diagnostics
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Keywords
- coronary artery disease, coronary CT angiography, exercise electrocardiography, nuclear stress testing, stress echocardiography, noninvasive cardiac testing, radiation exposure, myocardial infarction, unstable angina, primary endpoint, PROMISE trial, chest pain, diagnostic strategy comparison, obstructive coronary artery disease, major adverse cardiac events
- MeSH terms
- Aged, Angina, Unstable, Chest Pain, Coronary Artery Disease, Electrocardiography, Exercise Test, Female, Follow-Up Studies, Cardiac Catheterization, Humans, Male, Middle Aged, Mortality, Myocardial Infarction, Tomography, X-Ray Computed, Coronary Angiography, Echocardiography, Stress, Kaplan-Meier Estimate
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