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.