Vascular Biomarkers in the Prediction of Clinical Cardiovascular Disease The Strong Heart Study Mary J. Roman, Jorge R. Kizer, Lyle G. Best, Elisa T. Lee, Barbara V. Howard, Nawar M. Shara, Richard B. Devereux Abstract—We compared the ability of separately measured intimal-medial thickness and atherosclerotic plaque to predict incident cardiovascular disease. American Indian men and women from the Strong Heart Study who were free of cardiovascular disease were evaluated with carotid ultrasound and cardiovascular disease risk factor assessment. End-diastolic intimal-medial thickness of the common carotid arteries was measured and averaged. Arterial mass (cross-sectional area) was calculated from intimal-medial thickness and end-diastolic diameter. Atherosclerosis was defined by focal plaque (discrete thickening 50% relative to the adjacent wall) and the number of carotid segments containing plaque (plaque score); 2441 participants (age 638 years) were followed-up for a mean of 7.72.8 years, during which time 495 experienced incident cardiovascular disease events. Time-to-event analyses were performed in groups stratified according to diabetes and hypertension status. Cardiovascular disease events were predicted by presence and extent of atherosclerosis in all groups; intima-medial thickness and arterial mass were only associated with outcomes when neither hypertension nor diabetes was present. Unequivocal evidence of atherosclerosis (plaque) and its extent (plaque score) are independently associated with incident cardiovascular disease events in individuals without preexisting cardiovascular disease regardless of diabetes and hypertension status. Hypertension-related increases in intima-media thickness and arterial mass appear to limit their use as measures of early or diffuse atherosclerosis and, hence, association with cardiovascular disease outcomes. These findings support the utility of separate assessment of focal atherosclerosis and intimal-medial thickness in epidemiological studies, trials, and risk stratification protocols. (Hypertension. 2012;59:29-35.) Key Words: cardiovascular disease prognosis carotid arteries epidemiological methods D uplex carotid ultrasonography traditionally has been used as a clinical tool to evaluate the presence of significant stenosis in the setting of asymptomatic carotid bruit or clinical cerebrovascular disease. More recently, the technique has been utilized in epidemiological studies to detect subclinical vascular disease (intimal-medial thickness [IMT] and nonobstructive plaque) and to assess its relation to cardiovascular disease (CVD) risk factors and prevalent and incident cardiovascular disease. 1 Studies examining the prog- nostic value of carotid ultrasonography have varied in meth- odology. Importantly, IMT and plaque have not always been separately evaluated. Focal plaque is a direct manifestation of atherosclerosis, whereas IMT has been considered a measure of diffuse or early atherosclerosis. However, IMT is increased by hypertension because of medial hypertrophy unrelated to atherosclerosis 2 and is not increased in chronic inflammatory diseases despite markedly premature subclinical (and clini- cal) atherosclerosis manifest by focal plaque. 3–5 Thus proto- cols reporting wall thicknesses that incorporate focal plaque thickness conflate the 2 entities and thereby potentially overstate the prognostic importance of IMT. Although a number of studies have separately examined IMT and plaque in relation to CVD outcomes, several limitations are noteworthy. Multivariable analyses including standard CVD risk factors have not always been performed to examine the independent or additive associations of carotid ultrasound findings. 6–8 Some studies have limited CVD events to either myocardial infarction 6,9,10 or stroke. 11,12 Other studies have examined combined carotid and femoral artery IMT 7,8 or have used study-specific internal reference values of multiple averaged IMT segments. 13 Thus, the present study was designed to evaluate the separate prognostic associations of definite carotid atherosclerosis (presence and extent of plaque) and common carotid artery (CCA) wall thickness Received August 28, 2011; first decision September 16, 2011; revision accepted October 11, 2011. From the Division of Cardiology (M.J.R., J.R.K., R.B.D.), Weill Cornell Medical College, New York, NY; Missouri Breaks Industries Research (L.G.B.), Timber Lake, SD; Center for American Indian Health Research (E.T.L.), University of Oklahoma Health Sciences Center, Oklahoma City, OK; Medstar Health Research Institute (B.V.H., N.M.S.), Washington, DC. Correspondence to Mary J. Roman, Division of Cardiology, Weill Cornell Medical College, 525 East 68th Street, New York, NY 10021. E-mail mroman@med.cornell.edu © 2011 American Heart Association, Inc. Hypertension is available at http://hyper.ahajournals.org DOI: 10.1161/HYPERTENSIONAHA.111.181925 29 by guest on April 9, 2017 http://hyper.ahajournals.org/ Downloaded from