Multicenter Trial Validation for Quantitative Analysis of Same-Day Rest-Stress Technetium-99m-Sestamibi Myocardial Tomograms

The accuracy of an automated quantitative analysis of same-day rest/stress 99mTc sestamibi SPECT images for detection and localization of coronary artery disease (CAD) was assessed in a multicenter trial consisting of 161 patients from 7 different clinical sites utilizing various camera computer systems. Of the 161 patients, 102 had angiographically documented coronary artery disease, 22 had normal coronary arteriograms, and 37 had a low (< 5%) likelihood of coronary artery disease based on their age, sex, symptoms and the results of their exercise electrocardiograms. The patients were studied using previously optimized image acquisition and processing protocols. An additional population consisting of 45 patients with single-vessel disease were evaluated to determine the optimal criteria for detection of CAD. The quantitative analysis method was associated with an overall sensitivity of 87%, specificity of 36%, and normalcy rate (true negative rate in the low likelihood patients) of 81%. Sensitivity for overall detection of disease was similar (90%) in patients with and without myocardial infarction (90% versus 89%). The sensitivities and specificities for identification of disease in individual coronary arteries were, respectively, 69% and 76% for LAD, 70% and 80% for LCX, and 77% and 85% for RCA. The results of this study demonstrate that the new objective quantitative method for analysis of same-day rest/stress 99mTc sestamibi SPECT images is accurate for detection and localization of CAD and correlates highly with expert visual interpretation.