Prospective Multicenter Imaging Study for Evaluation of Chest Pain - PROMISE
The goal of the trial was to evaluate anatomical testing compared with functional testing among low- to intermediate-risk patients with chest pain suspicious for coronary artery disease.
Contribution to the Literature: The PROMISE trial showed that coronary CTA, while not superior, is an alternative to stress testing among low- to intermediate-risk patients presenting with chest pain.
Low- to intermediate-risk patients with chest pain were randomized to evaluation with an anatomical strategy (n = 4,996) versus a functional strategy (n = 5,007). Patients randomized to an anatomical strategy underwent a 64-slice coronary computed tomography angiography (CTA), while patients randomized to a functional strategy underwent exercise electrocardiography (ECG), exercise imaging, or pharmacologic imaging.
- Total number of enrollees: 10,003
- Duration of follow-up: median 25 months
- Mean patient age: 61 years
- Percentage female: 53%
- Percentage diabetics: 21%
- Among either group who underwent a functional test, 68% underwent nuclear stress testing, 22% underwent stress echocardiography, and 10% underwent exercise ECG
- Patients with chest pain suspicious for coronary disease
- No history of coronary disease or prior evaluation
- Age ≥55 years for men or ≥65 years for women without risk factors
- Age 45-54 years for men or 50-64 years for women with at least one cardiac risk factor
- Unstable hemodynamics or arrhythmias
- Urgent evaluation for rule-out acute coronary syndrome
- Congenital, valvular, or cardiomyopathic heart disease
The primary outcome, all-cause mortality, myocardial infarction, unstable angina hospitalization, or major complication from a cardiovascular procedure occurred in 3.3% of the anatomical testing group versus 3.0% of the functional testing group (p = 0.75).
Among women, a positive CTA vs. a negative CTA was more strongly associated with subsequent clinical events (hazard ratio [HR] 5.9, 95% confidence interval [CI] 3.3-10.4) than a positive stress test vs. a negative stress test (HR 2.3, 95% CI 1.2-4.3). Among men, the association between a positive CTA vs. a negative CTA was HR 2.8, 95% CI 1.8-4.5, and a positive stress test vs. a negative stress test was HR 4.4, 95% CI 2.8-7.1.
- Catheterization within 90 days: 12.2% vs. 8.1%, respectively
- Invasive catheterization showing no obstructive coronary disease: 3.4% vs. 4.3% (p = 0.02), respectively
- Cumulative radiation exposure: 12.0 mSv vs. 10.1 mSv (p < 0.001), respectively
Economic comparison: Coronary CTA was associated with a small, but nonsignificant increase in costs over a median of 2 years versus functional testing.
Quality of life: Quality-of-life measures improved over time in both groups; however, there was no difference between anatomical testing versus functional testing over 2 years.
Among low- to intermediate-risk patients with chest pain, anatomical testing with coronary CTA was not superior to functional testing. However, coronary CTA resulted in similar adverse events compared with functional testing and thus represents an acceptable mode of evaluation of these patients. The prognostic information for a CTA appears to vary according to gender. Anatomical testing was associated with an increased frequency of cardiac catheterization; however, it was associated with a lower frequency of invasive catheterization showing nonobstructive coronary disease. Anatomical testing was also associated with increased radiation exposure and a nonsignificant increase in total costs.
Mark DB, Anstrom KJ, Sheng S, et al. 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. Circulation 2016;Apr 27:[Epub ahead of print].
Pagidipati NJ, Hemal K, Coles A, et al. Sex Differences in Functional Stress Test Versus CT Angiography in Symptomatic Patients With Suspected CAD: Insights From PROMISE. J Am Coll Cardiol 2016;Apr 4:[Epub ahead of print].
Presented by Dr. Neha J. Pagidipati at the American College of Cardiology Scientific Session, Chicago, IL, April 4, 2016.
Douglas PS, Hoffmann U, Patel MR, et al., on behalf of the PROMISE Investigators. Outcomes of Anatomical Versus Functional Testing for Coronary Artery Disease. N Engl J Med 2015;Mar 14:[Epub ahead of print].
Editorial Comment: Kramer CM. Cardiovascular Imaging and Outcomes -- PROMISEs to Keep. N Engl J Med 2015;Mar 14:[Epub ahead of print].
Presented by Dr. Pamela S. Douglas at ACC.15, San Diego, CA, March 14, 2015.
Economic comparison presented by Dr. Daniel B. Mark at ACC.15, San Diego, CA, March 15, 2015.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Stable Ischemic Heart Disease, Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Computed Tomography, Nuclear Imaging, Chronic Angina
Keywords: ACC Annual Scientific Session, Anaphylaxis, Angina, Unstable, Angiography, Cardiac Catheterization, Chest Pain, Constriction, Pathologic, Coronary Artery Disease, Electrocardiography, Hospitalization, Myocardial Infarction, National Heart, Lung, and Blood Institute (U.S.), Prospective Studies, Renal Insufficiency, Stroke, Diagnostic Imaging, Angina, Stable, Tomography, Emission-Computed
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