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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Outcomes of anatomical versus functional testing for coronary artery disease
Pamela S Douglas1, Udo Hoffmann, Manesh R Patel
1From the Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (P.S.D., M.R.P., D.B.M., H.R.A.-K., R.J.D., C.B.F., M.H., A.S.K., M.W.K., E.J.V., E.Y., K.L.L.); Massachusetts General Hospital, Harvard Medical School (U.H., M.H.P.), and Tufts Medical Center, Tufts University School of Medicine (J.E.U.) - both in Boston; New Mexico Heart Institute, Albuquerque (B.C.); Cardiology Associates, Mobile, AL (J.C.); North Dallas Research Associates, Dallas (M.A.K.); Cardiac Study Group, Puyallup, WA (V.M.); and the National Heart, Lung, and Blood Institute, Bethesda, MD (L.S.C.).
Insights
Initial coronary computed tomographic angiography (CTA) did not improve clinical outcomes for patients with suspected coronary artery disease (CAD) compared to functional testing. This large trial found no significant difference in major adverse events over two years.
Area of Science:
- Cardiology
- Diagnostic Imaging
- Clinical Trials
Background:
- Coronary artery disease (CAD) is often suspected in symptomatic patients, necessitating diagnostic testing.
- Limited randomized trial data exist to guide the choice between anatomical and functional testing strategies for CAD evaluation.
Purpose of the Study:
- To compare the clinical outcomes of initial coronary computed tomographic angiography (CTA) versus functional testing in symptomatic patients with suspected CAD.
- To assess secondary outcomes including invasive cardiac catheterization without obstructive CAD and radiation exposure.
Main Methods:
- 10,003 symptomatic patients were randomized to either initial CTA or functional testing (exercise ECG, nuclear stress, or stress echo).
- The primary endpoint was a composite of death, myocardial infarction, unstable angina hospitalization, or major procedural complication.
- Follow-up was conducted for a median of 25 months.
Main Results:
- No significant difference in the primary composite endpoint was observed between the CTA group (3.3%) and the functional testing group (3.0%) (aHR, 1.04; 95% CI, 0.83 to 1.29).
- CTA was associated with fewer catheterizations revealing no obstructive CAD (3.4% vs. 4.3%, P=0.02), but more patients in the CTA group underwent catheterization within 90 days.
- While median cumulative radiation exposure was lower with CTA, overall mean exposure was higher due to a greater proportion of patients undergoing catheterization.
Conclusions:
- Initial CTA strategy did not improve clinical outcomes compared to functional testing in symptomatic patients with suspected CAD.
- The choice of initial noninvasive testing strategy did not significantly alter major clinical events in this population over a median of two years.
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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