Pilot Results of the Early Detection by Ultrasound of Carotid Artery Intima–Media Thickness Evaluation (EDUCATE) Study

Background Limitations of current models for risk stratification are known. Noninvasive imaging is being advocated as an adjunct to improve risk prediction; however, studies documenting outcomes are rare. Therefore, we aimed to evaluate the negative and positive predictive values of carotid atherosclerosis for future cardiovascular events. Methods The Early Detection by Ultrasound of Carotid Artery intima media Thickness Evaluation (EDUCATE) study prospectively enrolled 253 consecutive young to middle-aged adults undergoing elective coronary angiography. Bilateral carotid ultrasound and lipid profiles were performed. Carotid atherosclerosis was defined as intima media thickness ≥1.0 mm in the main body, or focal plaque within the body, bulb, or proximal branch. Future events included major (death, myocardial infarction, stroke) and minor (revascularization and new onset heart failure). Results Of the enrolled patients 236 completed all tests; mean age was 51 ± 8 years; 58% women. Sensitivity, specificity, and negative predictive values for carotid atherosclerosis in predicting severe coronary artery disease were 72%, 49% and 79%, with an odds ratio (OR) of 2.2 (95% confidence interval [CI] 1.2–4.0). Of patients suffering major events, 90% had carotid atherosclerosis. Only 1 of 95 without carotid atherosclerosis experienced a major event. Kaplan-Meier analysis revealed differences in event-free survival in favor of subjects without carotid atherosclerosis for major (P = .051) and any event (P = .015). Cox analysis revealed a hazard ratio (HR) of 2.7 (95% CI 1.2–6.2; P = .020) for predicting future events. The relationship remained significant after adjusting for traditional risk factors (HR 2.5, 95% CI 1.1–5.9; P = .034). Conclusions Carotid atherosclerosis is associated with severe coronary artery disease and future events. Negative carotid ultrasound is associated with excellent prognosis.