Role of Nonenhanced Multidetector CT Coronary Artery Calcium Testing in Asymptomatic and Symptomatic Individuals 1

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1 Note: This copy is for your personal non-commercial use only. To order presentation-ready copies for distribution to your colleagues or clients, contact us at Role of Nonenhanced Multidetector CT Coronary Artery Calcium Testing in Asymptomatic and Symptomatic Individuals 1 Reviews and Commentary n Review Khurram Nasir, MD, MPH Melvin Clouse, MD Arteriosclerotic cardiovascular disease is the leading cause of death in the United States, with coronary artery disease (CAD) accounting for half of all cardiovascular disease deaths. Current risk assessment approaches for coronary heart disease, such as the Framingham risk score, substantially misclassify intermediate- to long-term risk for the occurrence of CAD in asymptomatic individuals. A screening modality such as a simple non contrastenhanced, or noncontrast, computed tomographic (CT) detection of coronary artery calcium (CAC) improves the ability to accurately predict risk in vulnerable groups and adds information above and beyond global risk assessment as shown by the recent Multi-Ethnic Study of Atherosclerosis. In addition, absence of CAC is associated with a very low risk of future CAD and as a result can be used to identify a group among which further testing and pharmacotherapies can be avoided. The Expert Consensus Document by the American College of Cardiology Foundation and the American Heart Association now recommends screening individuals at intermediate risk but did not find enough evidence to recommend CAC testing and further stratification of those in the low- or high-risk categories for CAD. In addition, emerging guidelines have suggested that absence of CAC can act as a gatekeeper for further testing among low- and intermediate-risk patients presenting with chest pain. This review of the current literature outlines the role of CAC testing in both asymptomatic and symptomatic individuals. q RSNA, From the Center for Prevention and Wellness, Baptist Health South Florida, 1691 Michigan Ave, Suite 500, Miami Beach, FL (K.N.); Ciccarone Preventive Cardiology Center, Johns Hopkins University School of Medicine, Baltimore, Md (K.N.); and Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Mass (M.C.). Received May 13, 2011; revision requested June 7; revision received July 4; accepted July 20; final version accepted September 6; final review by M.C. April 24, Address correspondence to K.N. ( khurramn@ baptisthealth.net). q RSNA, 2012 Radiology: Volume 264: Number 3 September 2012 n radiology.rsna.org 637

2 Cardiovascular disease is the leading cause of mortality worldwide, with coronary artery disease (CAD) accounting for half of all cardiovascular disease deaths (1 3). It is estimated that in the next 15 years, 25 million people will die of stroke or heart disease, with 80% of this burden occurring in developing countries (2). In approximately one-half of the individuals, the initial presentation of CAD is either myocardial infarction or sudden death (1). Unfortunately, conventional risk factor assessment can be used to predict only 65% 80% of future cardiovascular events (1), leaving many middle-aged and older individuals to experience a major cardiovascular event despite being classified as Essentials nn Coronary artery calcium (CAC) is an independent predictor of coronary artery disease (CAD) events and improves the ability to predict risk in vulnerable groups, adding information beyond current global risk assessment methods. nn A zero CAC score stands alone as perhaps the most powerful negative risk factor for development of a coronary event. nn Assessment of CAC appears to be the most predictive in the intermediate-risk group. nn Emerging data suggest there are individuals considered to be in the low-risk group who may benefit from CAC screening, especially those with a family history of premature CAD and women younger than 60 years; further studies are needed for both groups. nn CAC testing has value in triaging low- and intermediate-risk patients with chest pain, a role acknowledged by current guidelines as it is associated with a very low risk of future cardiac events and thus the potential to reduce downstream testing and costs. low risk by means of traditional approaches. Because atherosclerosis is the major underlying culprit for the development of clinical CAD, detection of individuals with subclinical atherosclerosis by means of other methods may supplement current risk assessment by more clearly identifying high-risk individuals who harbor advanced subclinical atherosclerosis. Screening studies to detect occult cancers, such as breast and colon cancer, are recommended in appropriaterisk adults to help prevent life-threatening conditions. Although atherosclerotic vascular disease accounts for more death and disability than all types of cancer, a screening tool to detect significant subclinical atherosclerosis and target prevention of future cardiovascular events has not yet been universally adopted (4). Screening for subclinical atherosclerosis to better identify persons at risk for CAD has attracted increasing interest over the past decade. The diagnosis of CAD is based on coronary artery calcification (CAC), and there is a large body of evidence that CAC determined with computed tomography (CT) is an equivalent measure for coronary atherosclerotic burden in adults. A direct relationship has been established between CAC as measured at CT and histologically measured plaque burden. This review will examine in detail the methods, value, and potential role of non contrast-enhanced, or noncontrast, CT assessment of CAD for risk stratification in asymptomatic and symptomatic individuals. CAC and Atherosclerotic Process Calcification of atherosclerotic plaque occurs by means of an active process of mineralization with deposition of hydroxyapatite crystals and not simple mineral precipitation. It begins in the very early stages of atherosclerosis. Studies have demonstrated that cardiac CT is a highly reliable method for identifying arterial calcification with a high sensitivity for detecting significant disease. Rumberger and colleagues (5) first demonstrated a strong relationship (r = 0.90) between CAC measured by using electron beam tomography (EBT) with direct histologic plaque areas in autopsy hearts. Although total atherosclerotic plaque burden was associated strongly with total calcium burden, not all plaques were found to be calcified. Moreover, within a given coronary artery, there is a poor correlation and wide variation between the degree of plaque calcification and extent of luminal stenosis at coronary angiography (6,7). This can partly be explained by individual variations in coronary artery remodeling, whereby the luminal cross-sectional area and/or external vessel dimensions enlarge and compensate for the increasing area of mural plaque. However, despite the lack of a strong site-by-site correlation between calcification and luminal stenosis, CAC scores calculated by using cardiac CT give a close approximation of the total atherosclerotic burden (7). Protocols for Assessing CAC with Cardiac CT CAC scores were first quantified by means of EBT; however, with the rapid development of multidetector CT, CT has become the most frequently used modality to assess the extent and severity of underlying coronary calcification (8). Neither modality requires intravenous contrast material to determine CAC. In general, EBT used a unique technology enabling ultrafast scan acquisition times in the thin-section, single-section mode with continuous, nonoverlapping sections of 3-mm thickness and an acquisition time of 100 msec in Published online /radiol Content codes: Radiology 2012; 264: Abbreviations: AUC = area under the ROC curve CAC = coronary artery calcium CAD = coronary artery disease CI = confidence interval ECG = electrocardiography FRS = Framingham risk score MESA = Multi-Ethnic Study of Atherosclerosis ROC = receiver operating characteristic Potential conflicts of interest are listed at the end of this article. 638 radiology.rsna.org n Radiology: Volume 264: Number 3 September 2012

3 a prospective gated manner. Electrocardiographic (ECG) triggering is used during end systole or early diastole determined from continuous ECG tracing during the scan. Historically, the most common exposure time is at 80% of the R-R interval (9). However it is important to note that EBT scanners are no longer produced and almost all of CAC testing currently is performed with multidetector CT scanners. The current generation of multidetector CT systems is capable of acquiring up to sections of the heart simultaneously with ECG gating in either a prospective or retrospective mode. Coronary calcification is determined in the axial mode by using prospective ECG triggering at a predetermined offset from the ECG-detected R wave. With prospective gating, the temporal resolution of multidetector CT systems is proportional to the gantry speed, which determines the time to complete one 360 rotation. To reconstruct each section, data from a minimum of 180 plus the angle of the fan beam are required (approximately 220 of the total 360 rotation). The most commonly used 64-section scanners have rotation gantry speeds up to 330 msec (9). Generally 40 consecutive 2.5- to 3-mm-thick images are acquired per cardiac study. On noncontrast cardiac CT images, CAC is defined as a hyperattenuated lesion above a threshold of 130 HU with an area of three or more adjacent pixels (at least 1 mm 2 ). There are currently two CT calcium scoring systems widely used: the original Agatston method (8) and the volume scoring method developed by Callister et al (10). The Agatston scoring method involves multiplication of the calcium area by a number related to CT attenuation. All pixels above a threshold of 130 HU are calculated for every 3 mm 2 section and multiplied by an attenuation factor (8). The score may be variable because of the presence of partial volume artifact. Partial volume effects lead to higher peak values for small calcific lesions but not for large ones. On the other hand, the volume scoring method appears to somewhat resolve the issue of section dependent on minor changes in section thickness. However, it has been demonstrated that there appears to be an excellent correlation between the two scoring methods, and they show similar characterization when applied properly (11). Both methods calculate lesionspecific scores within the left main, left circumflex, left anterior descending, and right coronary arteries and provide total scores for each artery and a sum total across all four arteries. Radiation Dose Although the early detection of coronary atherosclerosis with CAC imaging may enhance risk prediction, the potential benefits must be weighed against potential risk of exposure to ionizing radiation (12). Recent reports suggest that effective radiation dose for CAC testing ranged between 0.8 and 10.5 msv, with a median dose of 2.3 msv (13). Although the radiation dose is low, based on the ALARA ( as low as reasonably achievable ) principle every effort should be made to reduce the radiation dose without reducing the ability to accurately assess CAC burden. The Society of Cardiac Computed Tomography recommends for laboratories performing CAC examinations to monitor studies to keep exposure (doselength product,,200 mgy 3 cm) and effective radiation dose msv. CAC imaging should be performed in the axial mode with prospective ECG triggering and tube voltage of 120 kvp; however, the tube current needs to be selected on the basis of patient size with the scan length limited for the coverage of the heart only (12). CAC in Asymptomatic Individuals Prognostic Value of CAC Efforts have been made to develop noninvasive diagnostic tools to determine the extent of atherosclerosis in asymptomatic patients and to improve detection of those who would benefit from more intensive preventive therapies such as lipid-lowering medication and aspirin. In addition, there is an emerging role for the identification of those individuals with very low risk among whom expensive therapies and further testing can safely be avoided. Table 1 summarizes the findings of all major studies, to our knowledge, that assess the prognostic value of CAC burden among asymptomatic individuals (9,14 29) (Figure). In general there appears to be a consensus in the literature that CAC is an independent predictor of CAD adverse outcome as well as all-cause mortality after taking into account traditional risk factors. These findings were summarized in the recent American College of Cardiology Foundation/American Heart Association Expert Consensus Document on Coronary Artery Calcium Scoring (30), which took into account several of the earlier studies and reported that for CAC scores of , , and greater than 1000, the relative risk ratio was 4.3 (95% confidence interval [CI]: 3.5, 5.2; P,.0001), 7.2 (95% CI: 5.2, 9.9; P,.0001), and 10.8 (95% CI: 4.2, 27.7; P,.0001), respectively. However, critics have cited the limitations of earlier self-referral cohort studies and the validity of the risk factor measures, the multivariable models used, and risk of test-induced bias. These concerns have been addressed by a recent report from the Multi-Ethnic Study of Atherosclerosis (MESA), a population-based cohort, which reported the utility of CAC scoring in predicting future events. According to Detrano et al (27), among nearly 6800 asymptomatic individuals followed for a median of 41 months, the hazard ratios for future hard (ie, major) CAD events (myocardial infarction or myocardial infarction related death) with CAC scores of versus CAC of 0 was 5.3 (95% CI: 2.4, 11.7; P,.0001). The respective hazard ratios with CAC and greater than 300 were 10.8 (95% CI: 4.8, 24.2; P,.0001) and 12.0 (95% CI: 5.4, 26.5; P,.0001), with a 5-year cumulative incidence of CAD events directly associated with higher CAC scores, exceeding 10% in those with scores of greater than 300. These risk ratios are very similar to Radiology: Volume 264: Number 3 September 2012 n radiology.rsna.org 639

4 Table 1 Summary of Outcomes Studies with CAC in Asymptomatic Individuals Study and Publication Year* Type of Study Follow-up (y) Result Arad et al (14), 2000 Wong et al (15), 2000 Raggi et al (16), 2001 Kondos et al (17), 2003 Shaw et al (18), 2003 Greenland et al (19), 2004 Arad et al (20), 2005 Vliegenthart et al (21), 2005 Taylor et al (22), 2005 Lamonte et al (23), 2005 Observational study, referral based (n = 1172; mean age 6 standard deviation, 53 years 6 11) Observational study, referral based (n = 926; mean age, 54 years) Observational referral-based study (n = 676; mean age, 52 years) Observational study, referral based (n = 5635; age years, 26% women) Observation data series, referral based (n = 10,377; age years) Prospective population-based study (n = 1312; age,.45 years) Prospective population-based study (n = 4613; age, years) Prospective population-based study (n = 1795; age, years) Prospective cohort study (1627 men, 356 women; age, years; U.S. Army based) Retrospective study (6835 men, 3911 women; age, years) Nasir et al (24), 2005 Observation data series (n = 14,812; age, years) Anand et al (25), 2006 Budoff et al (26), 2007 Detrano et al (27), 2007 Becker et al (28), 2008 Erbel et al (29), 2010 Prospective study (510 asymptomatic type 2 diabetic subjects; age, 53 years 6 8) Observation data series, referral based (n = 25,253; mean age, 65 years 6 11) Prospective multiethnic population-based study (MESA) (n = 25,253; mean age, 65 years 6 11) Prospective population-based study (n = 25,253; mean age, 65 years 6 11) Prospective population-based study (n = 4129; age range, years) 3.6 Odds ratio of 20 for CAC score 160 compared with those with CAC score, Overall patients with CAC 271 had a risk ratio of 9 for a coronary heart disease event 2.7 CAC score was predictive of hard (ie, major) CAD events, with an odds ratio of 22 for the CAC score. 90% percentile 3.1 Relative risk of 124 in men with soft (minor) events in the highest quartile (CAC, ); higher CAC score added incremental prognostic information to conventional CAD risk assessment in men for hard coronary heart disease events 5 CAC score is an independent predictor of mortality, with RR 4.0 for score of Hazard ratio of 3.9 for CAC score. 301; CAC score able to be used to modify predicted risk obtained from FRS alone (0.73 for FRS alone and 0.78 for FRS and CAC combined) 4.3 Relative risk for CAD events with CAC. 100 was 11; overall was superior to FRS in prediction of events (ROC curve of 0.79 vs 0.69, P =.006) 3.3 Compared with those with CAC, 100, relative risk for events were 3.1, 4.6, and 8.3 for CAC score of 0 100, , , and.1000, respectively; there was a statistically significant high relative risk,.8, for those with CAC score.1000 regardless of FRS 10-year risk score 20% vs. 20% 3 2% of men with CAC had events versus 0.2% without CAC (P,.0001); controlling for FRS, presence of CAC was associated with an independent 12-fold increase in relative risk; no events in women 3.5 Age-adjusted rates per 1000 person-years were computed according to four CAC categories: 0 CAC and incremental sex-specific thirds of detectable CAC; the respective rates were 0.4, 1.5, 4.8, and 8.7 in men and 0.7, 2.3, 3.1, and 6.3 in women 6.8 When comparing prognosis by CAC score in ethnic minorities compared with non-hispanic whites, relative risk ratios were highest for African-Americans with CAC score 400 exceeding 16.1 (P,.0001). Hispanics with CAC score 400 had relative risk ratios from 7.9 to 9.0, whereas Asians with CAC score 1000 had relative risk ratios 6.6-fold higher (P,.0001) 2.2 Overall rate of death or myocardial infarction according to CAC categories (,100, , ,.1000) was 0% (n = 0), 2.6% (n = 2), 13.3% (n = 4), and 17.9% (n = 5), respectively (P,.0001) 6.8 Compared with those without CAC, the risk-adjusted relative risk ratios for CAC were 2.2-, 4.5-, 6.4-, 9.2-, 10.4-, and 12.5-fold for scores of , , , , , and.1000, respectively (P,.0001) 3.4 Overall the FRS-adjusted risk was 28% higher with doubling of CAC score; CAC was equally predictive in all ethnic groups 3.3 CAC score 75th percentile was associated with a significantly higher annualized event rate for myocardial infarction (3.6% vs 1.6%, P,.05). No cardiac events were observed in patients with CAC of zero 5 Compared with those with a CAC of zero, increasing CAC scores were associated with relative risk of cardiac event fold higher; reclassifying intermediaterisk (defined as 10% 20% and 6% 20%) subjects with CAC, 100 to low-risk category and CAC 400 to high-risk category yielded a net reclassification index of 21.7% (P =.0002) and 30.6% (P,.0001) for FRS, respectively * Reference numbers are in parentheses. Population data are in parentheses. 640 radiology.rsna.org n Radiology: Volume 264: Number 3 September 2012

5 (a) Schematic algorithm for CAC screening in asymptomatic individuals. CRP = C-reactive protein, CTA = CT angiography, FH = family history, LDL = low-density lipoprotein, MS = metabolic syndrome, NCEP = National Cholesterol Education Program. (b) Schematic algorithm for CAC testing in symptomatic individuals with chest pain (source, reference 74). those of previous published studies, confirm the pooled summary findings previously reported, and lay to rest any concern regarding the prognostic value of CAC testing. The extent of CAC has been shown in several studies to predict cardiac events in symptomatic and asymptomatic individuals. However, decisions about the predictive utility of new tests should be based on the additional utility of a new test for risk prediction on the test s performance. When assessing a new test for CAD risk stratification, the most important question is whether it Radiology: Volume 264: Number 3 September 2012 n radiology.rsna.org 641

6 Table 2 Prognostic Value of A CAC Score of Zero among Asymptomatic Individuals Study and Study Type* Sarwar et al (32), meta-analysis Blaha et al (33), retrospective Budoff et al (34), prospective study Total Population No. of Subjects with Zero CAC Follow-up (y) No. of Events 71,595 29,312 (41) CVD events (0.47) 44,052 19,898 (45) deaths (0.52) (50) CHD events (0.52) * Reference numbers are in parentheses. Data are in parentheses are percentages. CHD = coronary heart disease, CVD = cardiovascular disease. European Society of Cardiology (0.66; 95% CI: 0.62, 0.6) scores (P =.03). Importantly, these findings not only support the contention that established cardiac risk factors possess a limited ability to quantitate CAD risk, but also provide evidence that CAC may provide unique information for risk assessment. As we go forward, it will be important to document the degree to which biomarkers or imaging tests, including CAC screening, can appropriately reclassify individuals over standard risk factor assessment for the purposes of more accurately targeting the intensity of treatment. is predictive above and beyond the current standard risk assessment method of choice, the Framingham risk score (FRS), which is an inexpensive, easily available office-based tool. One way to determine additive utility of a new test is through the use of receiver operating characteristic (ROC) curve analyses. The ROC curve is a plot of true-positive rate versus false-positive rate over the entire range of possible cutoff values. The area under the ROC curve (AUC) ranges between 1.0 and 0.5, with 1.0 signifying the perfect test. Studies comparing conventional and newer biomarkers for predicting of cardiovascular events consistently demonstrate that adding a number of newer biomarkers (such as C-reactive protein, interleukins, and other risk stratifiers) only results in small changes in the C statistic, suggesting limited or modest improvement in risk discrimination with additional risk markers (9). However, CAC scanning has been shown to markedly improve the C statistic, which is consistent with a substantial improvement in risk discrimination. Raggi et al (31) were among the first to assess the added contribution of CAC over and above the FRS. In a study of more than asymptomatic individuals followed for nearly 5 years, the C statistic (from ROC analyses) for FRS in estimating risk of all-cause death was 0.67 (95% CI: 0.62, 0.72; P,.0001) for women and 0.68 (95% CI: 0.64, 0.73; P,.0001) for men. When CAC scoring was added to this analysis, the C statistic increased to 0.75 (95% CI: 0.70, 0.80) for women (P,.0001) and 0.72 (95% CI: 0.68, 0.77) for men (P,.0001), indicating a significant improvement in mortality prediction. Greenland et al (19) showed that the ROC curves for prediction of CAD death or nonfatal myocardial infarction was 0.68 for FRS plus CAC score, which was significantly greater than that of the FRS alone (0.63; P,.001) and increasing levels of CAC score was associated with greater risk within each FRS group. Of importance, those in the intermediate FRS risk group with high CAC scores had event rates as high or higher than persons within the high-risk FRS group with lower CAC scores. The populationbased St. Francis Heart Study of 5585 asymptomatic individuals confirmed the findings of previous reports that the CAC score predicted CAD events independently of standard risk factors (20). CAC score was also superior to the FRS in the prediction of events (AUC, vs , P =.0006), and enhanced stratification of those in the FRS categories of low, intermediate, and high risk (P,.0001). Similarly, an improvement in AUC from 0.77 to 0.82 was noted in the MESA study (27). Finally, Becker et al (28) demonstrated in a study that among 1726 asymptomatic individuals followed up for a median of 40 months, the AUC for CAC score (0.81; 95% CI: 0.78, 0.84) was significantly larger than that of the FRS (0.63; 95% CI: 0.59, 0.65), PRO- CAM (0.65; 95% CI: 0.6, 0.68), and Power of Zero CAC A higher burden of CAC is associated with a significantly high risk of future cardiovascular disease events, and the absence of CAC confers a very low risk for future cardiovascular events (Table 2). In a 2009 meta-analysis of 13 studies assessing the relationship of CAC with adverse cardiovascular outcomes that consisted of asymptomatic patients, (41%) patients did not have any evidence of CAC (32). In a follow-up averaging 3 5 years, 154 (0.47%) of patients without CAC experienced a cardiovascular event compared with 1749 (4.14%) of patients with CAC. The cumulative relative risk ratio was 0.15 (95% CI: 0.11, 0.21; P,.001). These findings were confirmed in a large retrospective study (33) and a multiethnic prospective study (34) demonstrating a very low event risk with absence of CAC in asymptomatic individuals (Table 2). While all traditional risk scores and new serum biomarkers are available for quantifying increased risk in asymptomatic patients, none have sufficient sensitivity to exclude clinically important CAD. In the primary prevention population, a zero CAC score stands alone as perhaps the most powerful negative risk factor for near-term development of a coronary event. CAC testing particularly the finding of zero CAC could potentially be cost-saving when used appropriately (35). Among asymptomatic patients, a finding of zero CAC confers such low risk that clinicians might find themselves comfortable prescribing less costly 642 radiology.rsna.org n Radiology: Volume 264: Number 3 September 2012

7 medications to achieve less stringent lipid targets, and focusing on lifestyle therapy without need for further cardiac testing. Candidates for CAC Testing The expert consensus document by the American College of Cardiology Foundation and the American Heart Association (30) provides recommendations for perspective on the current role of CAC testing in clinical practice among asymptomatic individuals to refine CAD preventive efforts. The consensus document states, It may be reasonable to consider use of CAC measurement in among asymptomatic individuals who are at intermediate risk (30). However, the committee did not find enough evidence regarding the utility of CAC testing in further risk-stratifying those considered at low risk as well as those considered at high risk of developing CAD in the next 10 years (30). It is important to note that individuals at high risk do not need screening, as they are already candidates for aggressive preventive strategies, but avoiding those considered at low risk can be problematic. According to national statistics, only 1% of women aged years and 9% aged years have at least intermediate risk on the basis of FRS; the respective frequency is as high as 60% and 92% in men of the same age groups, respectively (36). If current guidelines for low risk are followed, the vast majority of nondiabetic women who are younger than 70 years would not be candidates for further risk stratification with CAC testing, whereas the majority of men older than 60 years would be candidates for further risk stratification (36). Thus, a large number of women who may be at higher CAD risk may never become candidates for CAC testing. At the same time, the practicality of conducting additional screening for all such women becomes an important question. The salient point is that individuals considered at low risk according to current risk-based strategies are at significant longer-term risk of coronary heart disease, warranting that this issue be revisited. One approach would be to identify a subgroup, within in the low-risk group, of those who are more likely to harbor significant CAC. Testing them may potentially be a cost-effective approach. Recent evidence has strongly implicated the presence of a family history of premature CAD as an independent risk factor strongly associated with higher burden of subclinical atherosclerosis (37 39); however, a positive family history of CAD does not factor into most global risk algorithms such as the FRS. Nasir et al (37) reported that nearly one-fourth to onethird of self-referred patients with a family history of premature CAD (especially in siblings) with zero to one CAD risk factors had CAC scores of 100 or greater. Similarly, in the MESA cohort, 25% of individuals classified as low risk according to the FRS with a family history of premature CAD had significant CAC (38). In addition, Michos et al (39) have shown that a subgroup of women with a FRS of less than 10% and a family history of premature CAD with multiple metabolic risk factors will have significant atherosclerosis. This approach will likely identify individuals who may benefit from atherosclerosis screening even though they are considered low risk by means of traditional approaches. Recently published Appropriate Use Criteria for Cardiac Computed Tomography, apart from judging CAC testing as appropriate for patients at intermediate risk for coronary heart disease (FRS, 10% 20%), also deemed it appropriate for the specific subset of lowrisk patients in whom a family history of premature coronary heart disease was present (40). Inflammation is considered to be central to the pathogenesis of atherosclerosis, and numerous inflammatory biomarkers have been evaluated as risk factors or risk markers for future cardiovascular events (41). To date, highsensitivity C-reactive protein (hscrp) is the most studied inflammatory biomarker. A meta-analysis of more than 20 observational studies demonstrated that C-reactive protein levels are associated with incident coronary heart disease, with an adjusted odds ratio of 1.45 (95% CI: 1.25, 1.68) among those with hscrp in the highest versus lowest tertiles (42). To date, few studies comparing hscrp with CAC have shown that, after taking other risk factors into account, although CAC remains an independent predictor of cardiovascular events in multivariable models, no significant association with incident coronary heart disease has been noted with hscrp (20 23). In fact, within the MESA, hscrp has not been shown to be different among those having cardiac events versus those not having cardiac events in the total population (27), those with low/normal low-density lipoprotein levels (43), or in the absence of CAC (34). Repeat CAC Testing A proposed use of CAC screening is to track atherosclerotic changes over time by using serial measurements. There are several published studies of outcomes related to CAC progression. The first study demonstrated that CAC progression in 495 asymptomatic subjects was strongly associated with future cardiovascular events (44). The associated relative risk for acute myocardial infarction for patients exhibiting 15% or greater CAC progression per year was increased 17.2-fold (95% CI: 4.1, 71.2) when compared with those without CAC progression (P,.0001). In a more recent study, Budoff et al (45) followed 4609 individuals with repeat CAC testing. The interscan time was 3.1 years. These individuals were followed for an average of 5.4 years (standard deviation) after the second scan (range, 1.0 year to 16 years). During this period 288 deaths were observed. After adjusting for baseline score, age, sex, and time between scans, CAC progression was associated with a threefold higher risk of all-cause mortality (hazard ratio: 3.34; 95% CI: 2.65, 4.21; P,.0001). However, to our knowledge to date, the above results suggest that repeat CT testing can improve the predictive value of future events; the effect of therapeutic intervention, especially the effect of statins on the rate of progression of Radiology: Volume 264: Number 3 September 2012 n radiology.rsna.org 643

8 Table 3 Effect of Statin Therapy on CAC Progression Study* Study Type Treatment Modality No. of Subjects Follow-up Duration (y) Pre- and Posttreatment LDL Change in CAC Progression Rate Callister et al (47) Retrospective Any statin vs no statin Unreported baseline vs LDL, % reduction Budoff et al (48) Prospective Any statin vs no statin Not reported 61% reduction Houslay et al (49) RCT Atorvastatin vs placebo Mean LDL from 135 to 67 with statin 44% increase (not significant) Terry et al (50) RCT Simvastatin vs placebo 80 1 Mean LDL from 128 to 75 No change with statin Schmermund et al (51) RCT 80 mg atorvastatin vs LDL from 106 to 87 with 80 mg, No change 10 mg atorvastatin no change with 10mg Raggi et al (52) RCT 80 mg atorvastatin vs LDL 175 to 92 with atorvastatin, No change 40 mg pravastatin 173 to 129 with pravastatin Arad et al (53) RCT 20 mg atorvastatin vs placebo LDL 146 to 98 with statin No change Note. LDL = low-density lipoprotein, RCT = randomized controlled trial. * Reference numbers are in parentheses. Table 4 Behavioral and Medication Changes according to CAC Score Change Noted Downstream Study Result Behavioral change Orakzai et al (54) Higher CAC independently strongly associated with dietary changes and increased exercise Medication adherence Kalia et al (55) Increased lipid-lowering medication adherence with increasing CAC score (score 0 = 44%, 1 99 = 62%, = 75%,.400 = 92%) Medication initiation Nasir et al (56) 34% 83% increased chance of initiation of aspirin, blood pressure lowering and lipid-lowering medication with higher CAC CAC, is controversial (46). The earlier published retrospective and prospective cohorts suggested a reduction in the rate of CAC progression (47,48). However to date, the above results have not been replicated in randomized controlled trials (49 53) (Table 3). We believe more data are needed to justify the incremental population exposure to radiation and cost associated with repeat CT testing to assess change until it is better understood what therapies may be of benefit and how clinicians should utilize this data in clinical practice (46). Until then, consensus guidelines do not support serial measurement of CAC for the purposes of tracking the effects of therapeutic interventions (30). Downstream Effects of CAC on Lifestyle Changes and Medication Use Emerging evidence also indicates that identifying those with a higher subclinical atherosclerotic burden detected at CAC testing may stimulate improved lifestyle changes and adherence to cardioprotective medications, which is the cornerstone of reducing future events in high-risk individuals (54 56) (Table 4 ). The result of these studies suggest that CAC found at cardiac CT may add much needed motivation to asymptomatic patients recommended for lifestyle modification and drug therapy; however, properly designed randomized trials remain necessary to evaluate the true role of CAC testing in improving clinical outcomes from improved risk factor modification. CAC Testing and Downstream Testing and Costs Although assessing the prognostic value of CAD screening is paramount, the socioeconomic issue of cascading costly downstream testing must be addressed in this environment of curtailing health care expenditures (57). Shaw et al (58) recently showed that the majority of individuals with either zero or minimal CAC (1 10) had very few downstream additional cardiac tests, whereas the majority of testing was noticed in those individuals with advanced CAC. Noninvasive testing was infrequent and medical costs were low in subjects with low CAC scores; however, both rose progressively with increasing CAC score (P,.001), particularly in 31 (2.2% of subjects) that had CAC scores of 1000 or greater. Similarly, invasive coronary angiography rose progressively with increasing scores (P,.001) but occurred exclusively in subjects first undergoing noninvasive testing and overall was performed in only 19.4% of subjects with CAC scores of 1000 or greater. Importantly, it was clearly shown that invasive procedures were not performed immediately after CAC testing but were performed in a stepwise manner preceded by functional imaging with either 644 radiology.rsna.org n Radiology: Volume 264: Number 3 September 2012

9 Table 5 Meta-Analysis of CAC Association with Acute Coronary Syndrome, Significant CAD, and Myocardial Ischemia Finding No. of Patients CAC = 0 CAC. 0 Sensitivity (%) Specificity (%) PPV (%) NPV (%) Acute coronary syndrome (42) 248 (48) Significant CAD at invasive angiography 10, (20) 8414 (80) Myocardial ischemia (26) 2744 (74) Source. Reference 32. Note. Data in parentheses are percentages. NPV = negative predictive value, PPV = positive predictive value. exercise stress testing or stress perfusion imaging. The median costs were minimal, $25 to $35 for those subjects with no or low CAC, which was 78% of those screened. Most of the cost was for ECG testing, which is often part of the initial assessment of individuals with hypertension, a feature observed in nearly 60% of this low-risk group (58). This study did not take into account the actual cost of the CAC testing, which is estimated to be $100 $200 as reported by Blaha et al (35) on the basis of Medicare Current Procedural Terminology, or CPT, codes. Blumenthal et al (57) estimated that for every 100 individuals screened for CAC, only 8% would have CAC scores greater than 400. The majority of individuals with a CAC score greater than 400 (5% 7% of those screened) eventually underwent stress echocardiography or myocardial perfusion testing and nearly one-half of these underwent invasive coronary angiography. In comparison, only 14 individuals of the 78% screened with CAC scores of 0 10 would undergo some sort of stress imaging, and only one subject would proceed to invasive coronary angiography in 6 years of follow-up. Although the emerging data are encouraging, there is an urgent need for a prospective randomized trial comparing the current traditional risk factors based approach with one supplemented by subclinical atherosclerotic screening to determine whether this approach can save lives in a manner that is cost effective. CAC in Symptomatic Individuals Prognostic Value of CAC Although extensively studied in asymptomatic individuals, CAC testing has similarly been shown to provide diagnostic value in symptomatic individuals mostly presenting with chest pain, thus identifying a subclass with no CAC and therefore low risk for future events. In a recent meta-analysis, Sarwar et al (32) pooled seven studies assessing the prognostic value of CAC in the symptomatic population that included a total of 3924 patients; of these, 921 (23%) patients did not have any evidence of CAC. Only 17 (1.8%) of 921 patients without CAC experienced a cardiovascular event during follow-up (mean duration, 42 months) as compared with 270 (8.99%) of 3003 patients with CAC. The cumulative relative risk ratio was 0.09 (95% CI: 0.04, 0.20; P,.0001). It is important to note that although the likelihood of the absence of zero CAC score was lower in symptomatic versus asymptomatic patients (23% versus 40%), symptomatic patients without CAC also had a significantly lower event rate than those with CAC (1.8% versus 8.99%). In spite of the fact that the absence of CAC is associated with a significantly favorable prognosis, little data are available, to our knowledge, on the true role of CAC in symptomatic individuals and how best to incorporate CAC information into the overall risk stratification algorithm in combination with other diagnostic tests, including contrast-enhanced coronary CT angiography and/or stress myocardial perfusion imaging (35). Role of CAC Testing in Chest Pain and Gatekeeper for Advanced Testing In recent years, the development of contrast-enhanced coronary multidetector CT has enabled the identification of exclusively noncalcified plaque and has generated great enthusiasm about its potential for identifying vulnerable plaques and its prognostic value in absence of CAC. Among asymptomatic individuals, the data are scarce is this regard. To the best of our knowledge, there is only one study that has addressed this issue. In a study of 1000 asymptomatic Korean individuals who underwent both CAC testing and contrast-enhanced multidetector CT, Choi et al (59) demonstrated that in only 4% of the subjects the presence of noncalcified plaques was the only manifestation of CAD and in a follow-up of 17 months it conferred no additional prognostic value. The current appropriateness criteria also do not endorse the use of contrast-enhanced multidetector CT in risk stratification for asymptomatic individuals (40). Aside from the long-term prognostic value in asymptomatic patients, there is value in CAC testing to rule out acute coronary syndrome in low-risk patients with chest pain. CAC could also serve as a gatekeeper for advanced testing for invasive coronary angiography and myocardial perfusion imaging. In the largest published meta-analysis to our knowledge (Table 5), the presence of CAC showed sensitivity of 99%, 98%, and 88% for identifying those with acute coronary syndrome, significant CAD at invasive coronary angiography, and myocardial perfusion defects, respectively (32). On the other hand, the respective negative predictive value for ruling out these conditions with absence of CAC were 99%, 93%, and 93%, respectively (32). However, as pointed out by Blaha et al (35), it is important to keep in Radiology: Volume 264: Number 3 September 2012 n radiology.rsna.org 645

10 mind that the value of zero CAC in asymptomatic is within low-risk symptomatic individuals, with little role in those who are high risk and symptomatic and thus is at the end of the prior probability spectrum. To elaborate this point, an excellent example is the study by Haberl et al (60), who evaluated the role of CAC among 133 high-risk symptomatic patients with positive stress tests who were thus referred for invasive coronary angiography. In this highrisk population, only 18% had zero CAC, with 32% demonstrating significant stenoses (.50%) at invasive angiography. Similarly the CORE-64 study showed little utility for CAC testing in individuals considered high risk and already referred for invasive coronary angiography because of their concerning clinical presentation (61). In these patients, absence of CAC was not able to exclude important CAD. Blaha et al (35) argues that based on Bayesian analysis there will likely never be a noninvasive test that conclusively excludes obstructive CAD in symptomatic patients with a high pretest likelihood of CAD. In these high risk individuals, even CT angiography cannot be used to comfortably exclude obstructive CAD. As Meijboom et al (62) indicated, in those with high pretest probability of CAD the estimated posttest likelihood of significant CAD after a negative CT angiogram remained at 17%. The absence of CAC indicates a low pretest probability for significant CAD when tested in the appropriate low-to-intermediate risk symptomatic population. In the ROMICAT (Rule Out Myocardial Infarction using Computer Assisted Tomography) study, just one out of 368 low-risk patients presenting to the emergency department had an acute coronary syndrome in the absence of calcified plaque (63), and these findings are similar to the pooled data of Sarwar et al (32). In another study, 263 low-to-intermediate risk patients presenting to the emergency department with chest pain underwent routine evaluation as well as CAC testing (64). In a subgroup of 133 patients with a CAC score of zero, only one (,1%) had cardiac chest pain, and of the 31 patients shown to have cardiac chest pain, 30 (97%) had evidence of CAC at CT. All patients who subsequently met the criteria for myocardial infarction had CAC. The absence of CAC was used to accurately exclude acute coronary syndrome in these low-risk patients presenting with chest pain in the emergency department and, in addition, give an excellent long-term prognosis. The largest study to date, to our knowledge, included 1031 patients who presented with chest pain in the emergency department and were followed up for clinical events (65). Cardiac events occurred in 32 patients (3.1%) during the index hospitalization (n = 28) or after hospital discharge (n = 4) (mean, 7.4 months). Only two events occurred among 625 patients with a CAC score of 0 (0.3%; 95% CI: 0.04%, 1.1%). In another landmark study by Georgiou et al (66), which consisted of low- to intermediate-risk patients who presented to the emergency department with chest pain, with a 7-year follow-up, the annual event rate was just 0.6% with a CAC of zero. In the most recent emergency department study, Fernandez- Frieria et al (67) found that just two of 133 low- to intermediate-risk patients with a zero CAC score had obstructive CAD. The most convincing evidence regarding the ability of CAC in its capacity as gatekeeper among symptomatic individuals is provided by the CONFIRM (Coronary CT Angiography Evaluation For Clinical Outcomes International Multicenter) registry. The study consisted of low- or intermediaterisk symptomatic individuals who underwent coronary CT angiography for further risk stratification. Almost half of these had no CAC (n = 5128 [51%]). The negative predictive values for ruling out significant CAD ( 50% and 70%) were 96% and 99%, respectively (68). Recently Kwon et al (69) compared the prognostic value of contrast-enhanced multidetector CT in addition to CAC testing in low- and intermediaterisk symptomatic individuals. In their study using ROC analysis, the superiority of coronary CT angiography compared to CAC scoring was demonstrated by a significantly greater AUC (0.892 vs 0.810, P,.001). However, when critically analyzed, 63% of the study population were noted to have zero CAC. The event rate in this population was just 1% during 2.5 years of follow-up, which was exactly the same as that observed among those individuals with a normal coronary CT angiogram (1%), thus demonstrating prognostic value of additional testing in the absence of CAC. In a similar fashion, Hadamitzky et al (70) followed up 2223 patients suspected of having CAD who were undergoing contrast-enhanced coronary multidetector CT along with CAC testing; patients were followed up for a median of 28 months. Contrastenhanced coronary multidetector CT had significant incremental predictive value when compared with CAC testing (AUC = 0.89 vs 0.82; P,.0001); however, in those with CAC of zero, no events were noted during the median follow-up interval, suggesting no added prognostic value of identifying exclusively noncalcifed plaque at the cost of added radiation dose and cost. Thus, there is a potential role for the absence of CAC to serve as a gatekeeper prior to studies requiring multidetector CT angiography, single photon emission computed tomography, and invasive arteriography in low- to intermediate-risk populations (Table 5). In addition, the meta-analysis shows the value of CAC assessment in layered cardiac testing (33). This approach has been evaluated by Nieman et al (71) in a total of 471 consecutive patients with new stable chest pain. In this study, 175 patients (37%) had a CAC of zero and only three of 170 had obstructive CAD demonstrated on CT angiograms. Only one case was confirmed by means of quantitative coronary angiography. Van Werkhoven et al (72) have restated that a CAC of zero effectively rules out CAD in patients with nonanginal chest pain in the low- or intermediate-risk pretest group. However, they did not reliably rule out the presence of significant CAD in patients with a high pretest likelihood (9% of patients with a zero CAC score had significant CAD). Similarly, Esteves et al (73) showed that among 206 individuals in the intermediate-risk 646 radiology.rsna.org n Radiology: Volume 264: Number 3 September 2012

11 group referred for rubidium-82 myocardial perfusion positron emission tomography (PET)/CT, 99 (48%) had a CAC score of zero and only one had inducible ischemia demonstrated at PET, thus further elucidating the role of a CAC score of zero to potentially identify individuals who will probably not benefit from further advanced testing. In the recently published study from the CONFIRM registry, a very low major event rate was noted in those with CAC scores of zero (0.9%) over a follow-up period of 2.1 years (68). In these individuals, the lowest event rates were noted among those who had a normal multidetector CT angiogram (0.6%), with 8% of these events being revascularization and the rest of them hard events that is, death or myocardial infarction (92%). On the other hand, the authors noted slightly higher event rates among the few individuals who had nonobstructive (1.3%) or CAD of 50% or more stenosis (3.9%); however, they noted most of the events were revascularization (69% and 71%), suggesting the bias of detecting disease leading to downstream procedures. Of note, the multidetector CT angiography number needed to scan among individuals with zero CAC to identify one individual at risk for late revascularization was 338 and as high as 947 for myocardial infarction and 1597 for death; as a result, the data lead to questions regarding the cost-effectiveness of proceeding with the contrast-enhanced portion of cardiac CT in absence of a CAC of zero for prognostication purposes (68). It is important to note that, based on the strong data in this area, the American College of Cardiology/American Heart Association 2007 Expert Consensus Document endorsed the use of CAC scoring as a filter before invasive coronary angiography or hospital admission for patients with chest pain symptoms, especially those with symptoms atypical for cardiac ischemia (30). They argue that a finding of zero CAC is associated with such a favorable nearterm prognosis that low-risk patients with chest pain at presentation, equivocal ECG, and negative cardiac enzymes could be safely discharged without further testing. This population accounts for 55% 60% of chest pain presentations (30). The National Institute for Health and Clinical Excellence clinical guidelines have also acknowledged the role of CAC in layered testing among patients presenting with chest pain (74). They recommend initial CAC testing for those in the low/intermediate risk group with chest pain and no further testing if the CAC is zero on the grounds that significant CAD has been ruled out with a high degree of accuracy. However, if the CAC score is 1 400, the guidelines recommend coronary CT angiography, and those with a CAC score greater than 400 are to proceed directly to invasive coronary angiography because coronary CT angiography will not likely be informative in the presence of a high CAC score (74). These data reinforce our assessment that when CAC is used as a gatekeeper for downstream advanced testing in symptomatic individuals, pretest likelihood of CAD should always be taken into account. Absence of CAC has great potential in reducing downstream cost if used in low- to intermediate-risk symptomatic patients (35). Disclosures of Potential Conflicts of Interest: K.N. No potential conflicts of interest to disclose. M.C. No potential conflicts of interest to disclose. References 1. Rosamond W, Flegal K, Furie K, et al. Heart disease and stroke statistics: 2008 update a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2008;117(4):e25 e Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases: part I general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation 2001;104(22): Fuster V, Voute J, Hunn M, Smith SC Jr. Low priority of cardiovascular and chronic diseases on the global health agenda: a cause for concern. Circulation 2007;116(17): Shaw LJ, Blumenthal RS, Raggi P. Screening asymptomatic low-risk individuals for coronary heart disease: issues and controversies. J Nucl Cardiol 2004;11(4): Rumberger JA, Simons DB, Fitzpatrick LA, Sheedy PF, Schwartz RS. Coronary artery calcium area by electron-beam computed tomography and coronary atherosclerotic plaque area: a histopathologic correlative study. Circulation 1995;92(8): Rumberger JA, Sheedy PF, Breen JF, Schwartz RS. Electron beam computed tomographic coronary calcium score cutpoints and severity of associated angiographic lumen stenosis. J Am Coll Cardiol 1997;29(7): Sangiorgi G, Rumberger JA, Severson A, et al. Arterial calcification and not lumen stenosis is highly correlated with atherosclerotic plaque burden in humans: a histologic study of 723 coronary artery segments using nondecalcifying methodology. J Am Coll Cardiol 1998;31(1): Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol 1990;15(4): Nasir K, Budoff MJ, Post WS, et al. Electron beam CT versus helical CT scans for assessing coronary calcification: current utility and future directions. Am Heart J 2003;146: Callister TQ, Cooil B, Raya SP, Lippolis NJ, Russo DJ, Raggi P. Coronary artery disease: improved reproducibility of calcium scoring with an electron-beam CT volumetric method. Radiology 1998;208(3): Nasir K, Raggi P, Rumberger JA, et al. Coronary artery calcium volume scores on electron beam tomography in 12,936 asymptomatic adults. Am J Cardiol 2004;93(9): Voros S, Rivera JJ, Berman DS, et al. Guideline for minimizing radiation exposure during acquisition of coronary artery calcium scans with the use of multidetector computed tomography: a report by the Society for Atherosclerosis Imaging and Prevention Tomographic Imaging and Prevention Councils in collaboration with the Society of Cardiovascular Computed Tomography. J Cardiovasc Comput Tomogr 2011;5(2): Kim KP, Einstein AJ, Berrington de González A. Coronary artery calcification screening: estimated radiation dose and cancer risk. Arch Intern Med 2009;169(13): Arad Y, Spadaro LA, Goodman K, Newstein D, Guerci AD. Prediction of coronary events with electron beam computed tomography. J Am Coll Cardiol 2000;36(4): Radiology: Volume 264: Number 3 September 2012 n radiology.rsna.org 647

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