Medical Policy: 06.01.06 

Original Effective Date: September 2000 

Reviewed: July 2019 

Revised: July 2017 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Coronary artery calcium (CAC) scoring is a noninvasive test that has been reported to detect the presence of coronary artery disease (CAD) by measuring the location and extent of calcium in the coronary arteries. The role of CAC as an independent predictor of risk in the cardiovascular assessment, either alone or in combination with conventional risk factors, of both asymptomatic and symptomatic individuals have been studied.

 

The development of fast computed tomography (CT) scanners has allowed the measurement of CAC in clinical practice. Coronary artery calcium has been evaluated in several clinical settings. The most widely studied indication is for the use of CAC in the prediction of future risk for CAD in patients with subclinical disease, with the goal of instituting appropriate risk reducing therapy (e.g. statin therapy, lifestyle modifications) to improve outcomes. In addition, CAC has been evaluated in patients with symptoms potentially consistent with CAD, but in whom a diagnosis is unclear.

 

Detection

Electron beam computed tomography (ECBT; also known as ultrafast CT) and spiral CT (or helical CT) may be used as an alternative to conventional CT scanning due to their faster throughput. In both methods, speed of image acquisition gives them unique value for imaging of the moving heart. The rapid image acquisition time virtually eliminates motion artifact related to cardiac contraction, permitting visualization of the calcium in the epicardial coronary arteries. ECBT software permits quantification of calcium area and density, which are translated into calcium scores. Calcium scores have been investigated as a technique for detecting CAC, both as a diagnostic technique in symptomatic patients to rule out an atherosclerotic etiology of symptoms or, in asymptomatic patients, as an adjunctive method for risk stratification for CAD.

 

EBCT and multi-detector computed tomography were initially the primary fast CT methods for measurement of CAC. A fast CT study for CAC measurement generally takes 10 to 15 minutes and requires only a few seconds of scanning time. However, more recently computed tomography angiography (CTA) has been used to assess coronary calcium. Because of the basic similarity between EBCT and CTA in measuring coronary calcium, it is expected that CTA provides information on coronary calcium that is similar to EBCT.

 

Computed tomography (CT) scan measures have been used to evaluate coronary atherosclerosis. Coronary calcium is present in coronary atherosclerosis, but the atherosclerosis detected may or may not be causing ischemia or symptoms. Coronary calcium measures may be correlated with the presence of critical coronary stenosis or serve as a measure of the patient’s proclivity toward atherosclerosis and future coronary disease. Thus, coronary calcium could serve as a variable to be used in a risk assessment calculation to determine appropriate preventative treatment in asymptomatic patients. Alternatively, in other clinical scenarios, coronary calcium scores might help determine whether there is an atherosclerotic etiology or component to the presenting clinical problem in symptomatic patients, therefore, helping to direct further workup for the clinical problems. In this second scenario, a calcium score of 0 usually indicates that the patient’s clinical problem is unlikely to be due to atherosclerosis and that other etiologies should be more strongly considered. In neither case does the test determine a specific diagnosis. Most clinical studies have examined the use of coronary calcium for its potential use in estimating the risk of future coronary heart disease (CAD) events.

 

Coronary calcium levels can be expressed in many ways. The most widely used is the Agatston score, which is a weighted summed total of calcified coronary artery area observed on computed tomography (CT). This value can be expressed as an absolute number, commonly ranging from 0 to 400. These values can be translated into age and sex-specific percentile values.

  • 0 – no identifiable disease (low risk)
  • 1 to 99 – mild disease
  • 100 to 399 – moderate disease
  • ≥ 400 – severe disease (high risk)

 

Coronary Artery Calcium (CAC) Scoring in Asymptomatic Individuals

Clinical Context and Test Purpose

The purpose of coronary artery calcium (CAC) scoring using computed tomography (CT) in asymptomatic patients is to assess who may benefit from preventative interventions targeted to minimize the risk of atherosclerotic cardiovascular disease (CVD).

 

Patients

The population of interest is individuals who are asymptomatic with risk of CAD.

 

Interventions

The intervention of interest is CAC scoring using fast CT imaging, including electron-beam computed tomography (EBCT) and spiral CT.

 

Comparators

The comparator of interest is CAD risk factor stratification based on standard risk, such as Framingham risk scores (FRS).

 

Outcomes

The outcomes of interest include survival, test accuracy, test validity, morbid events (e.g. major adverse cardiac events (MACEs), need for invasive coronary angiography (ICA), and revascularization. Additional intermediate or surrogate outcomes of interest are changes in cardiac risk profile indicators such as smoking, hyperlipidemia, or hypertension.

 

Timing

CAC scoring is usually initiated or used to modify risk-reduction interventions in individuals asymptomatic for CAD.

 

Setting

The setting is a primary care or general cardiology practice to assess the risk of CAD.

 

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

 

The Multi-Ethnic Study of Atherosclerosis (MESA) Trial is an ongoing, multi-center, prospective longitudinal study of asymptomatic individuals across four racial/ethnic groups to evaluate the long-term cardiovascular outcomes with a 10-year follow-up of 6772 asymptomatic participants after baseline risk assessment (including CAC measurement). The MESA study was launched in 2000. In 2008 interim results were published (median follow-up 3.9 years) that suggest that the CAC score is a predictor of subsequent clinically significant coronary heart disease (CHD) and may provide predictive information beyond that provided by standard risk factors, (that is, the Framingham Risk Score [FRS]). The authors reported that after adjustment for standard risk factors, a doubling of the CAC score resulted in a 20% increase in the risk of a major coronary event (myocardial infarction/death from CHD) and a 25% increase in the risk of any coronary event. A limitation of this study was variation in CT acquisition and reading methods across the six study centers. The authors also caution against using the absolute calcium scores cited in the study and note that ethnic-specific calibrations of CAC scores are needed to adjust for baseline differences between different ethnic groups. Another limitation of this interim report is the small number of measured clinical events (72 non-fatal MI, 17 fatal coronary events, and 73 events of angina pectoris).

 

The data, collected thus far, from the MESA Trial have been studied and reported in multiple published studies.

 

Polonsky et. al. (2010) used data from MESA to determine whether incorporation of calcium score into a risk model based on traditional risk factors improve classification of risk. During a median of 5.8 years of follow-up among a final cohort of 5878, 209 cardiovascular heart disease (CHD) events occurred, of which 122 were myocardial infarction, death from CHD, or resuscitated cardiac arrest. Addition of coronary artery calcium (CAC) score in the model resulted in significant improvements in risk prediction compared with the model without CAC score (NRI=0.25; 95% CI, 0.16 to 0.34; p<0.001). Subjects reclassified to high risk had a similar risk of CHD events as those originally classified as high risk.

 

Elias-Smale et. al. (2011) conducted a study among 2153 asymptomatic participants (69.6 years) who underwent an MDCT scan. During a median follow-up of 3.5 years, 58 coronary heart disease (CHD) events (myocardial infarction or death) occurred. Participants were classified into low (<5%), intermediate (5%-10%), and high (>10%) 5-year risk categories based on a refitted Framingham risk model. For the outcome of CHD, the C statistic improved from 0.693 for the Framingham refitted model to 0.743 by addition of coronary calcium. Reclassification of subjects occurred most substantially in the intermediate-risk group (5-year risk, 5%-10%) where 56% of persons were reclassified. Addition of coronary artery calcium (CAC) scoring reclassified 56% of persons: 36% moved to low risk while 20% moved to high risk, leading to a net gain in reclassification of 18% in persons with an event and a net decline in reclassification of 3% in persons without event, resulting in an NRI of 15% (p<0.01).

 

In 2012, Yeboah et. al. sought to improve the prediction accuracy and reclassification into high and low risk categories using six risk markers (CAC, carotid intima-media thickness, ankle-brachial index, brachial flow-mediate dilation, high-sensitivity C-reactive protein and family history of CHD) using 6814 asymptomatic intermediate risk participants from the MESA (Multi-Ethnic Study of Atherosclerosis) population. Of the 6814 MESA participants from 6 US field centers, 1330 were intermediate risk, without diabetes mellitus, and had complete data on all 6 markers. Recruitment spanned July 2000 to September 2002, with follow-up through May 2011. Probability-weighted Cox proportional hazard models were used to estimate hazard ratios (HRs). Area under the receiver operator characteristic curve (AUC) and net reclassification improvement were used to compare incremental contributions of each marker when added to the FRS, plus race/ethnicity. The main outcome measures included incident CHD defined as myocardial infarction, angina followed by revascularization, resuscitated cardiac arrest, or CHD death. Incident CVD additionally included stroke or CVD death. After 7.6-year median follow-up (IQR, 7.3-7.8), 94 CHD and 123 CVD events occurred. Coronary artery calcium, ankle-brachial index, high-sensitivity CRP, and family history were independently associated with incident CHD in multivariable analyses (HR, 2.60 [95% CI, 1.94-3.50]; HR, 0.79 [95% CI, 0.66-0.95]; HR, 1.28 [95% CI, 1.00-1.64]; and HR, 2.18 [95% CI, 1.38-3.42], respectively). Carotid intima-media thickness and brachial flow-mediated dilation were not associated with incident CHD in multivariable analyses (HR, 1.17 [95% CI, 0.95-1.45] and HR, 0.95 [95% CI, 0.78-1.14]). Although addition of the markers individually to the FRS plus race/ethnicity improved AUC, coronary artery calcium afforded the highest increment (0.623 vs 0.784), while brachial flow-mediated dilation had the least (0.623 vs 0.639). For incident CHD, the net reclassification improvement with coronary artery calcium was 0.659, brachial flow-mediated dilation was 0.024, ankle-brachial index was 0.036, carotid intima-media thickness was 0.102, family history was 0.160 and high-sensitivity CRP was 0.079. Similar results were obtained for incident CVD. The study has limitations. The analysis was limited to the subset of MESA participants with complete data on all six risk markers, which decreased the sample size. There were insufficient numbers of events to demonstrate clearly the superiority of CAC over the other measures in a head-head ROC and NRI analyses. In MESA, they did not specifically define family history of CHD as premature (i.e. before the age of 55 for men and 65 for women). This may have influenced the association of family history with CHD and CVD. The authors concluded, even though our study indicates considerable superiority of CAC over several risk markers for risk prediction of CHD and CVD, several other risk factors should be considered before making broad recommendations about incorporation of CAC into primary prevention screening strategies. One notable concern is that measurement of CAC exposes individuals to small but non-trivial amount of ionizing radiation. Even with the lowest possible radiation dose there remains an uncertainty about the magnitude of long term cancer risks. Similarly, the benefits and risk associated with incidental findings detected during CAC imaging remain unclear. These indirect costs, in addition to the direct financial costs of CAC imaging need to be weighed against the presumed benefits from better discrimination of subjects at high risk for CHD and CVD events to best determine the role of CAC screening of patients with an intermediate risk for a CHD/CVD event. The ultimate decision regarding the optimum test to order should not be based solely on improvement in risk prediction afforded by a test but also cost effectiveness, acceptability to patients and the potential risk and benefits associated with the test. Additional research is warranted to explore further both the costs and benefits for CAC screening in intermediate risk individuals.

 

Won et. al. (2015) conducted a single-center cross-sectional study among 328 consecutive asymptomatic patients with type 2 diabetes who underwent computed tomographic coronary angiography (CTCA) between 2008 and 2009 in a hospital in South Korea to evaluate the predictive value of the coronary artery calcium (CAC) score for obstructive coronary plaques (OCP) assessed by CTCA. On the basis of a CAC score of 0, 1 to 10, 11 to 100, or greater than 100, OCPs were found in 2%, 5%, 15%, and 36% of patients, respectively. On receiver operating characteristic curve analysis, the optimal cutoff CAC score for predicting OCPs was found to be 33, with 83% sensitivity and 81% specificity (AUC=0.853; 95% CI, 0.777 to 0.930; p<0.001). Positive and negative predictive values of a CAC score of 33 for OCPs were 30% and 98%, respectively. On multivariate logistic regression analysis, age (odds ratio [OR], 1.09), microalbuminuria levels (OR=3.43), current smoker (OR= 3.93), and a CAC score greater than 33 (OR=15.85) were found to be independently associated with an increased risk for OCPs (p<0.05).

 

Nakanishi et. al. (2016) conducted a study among 13,092 consecutive asymptomatic individuals without known coronary artery disease (CAD) (mean age, 58 years) clinically referred for a coronary artery calcium (CAC) scan between 1997 and 2011 at a university medical center; the study examined the predictive value of CAC for 5 and 15 year mortality rates among men and women. CAC showed an incremental prognostic value over traditional risk factors among men at 5 years (area under curve [AUC], 0.702 vs 0.655; p=0.002) as well as at 15 years (AUC, 0.723 vs 0.656; p<0.001). In women, the incremental prognostic value of CAC was not statistically significant at 5 years (AUC, 0.650 vs 0.612; p=0.065) but was statistically significant at 15 years (AUC, 0.690 vs 0.624; p<0.001).

 

Blaha et. al. (2016) conducted a study using data from MESA to compare the value of various negative risk markers. The authors evaluated the accuracy of change in risk classification by calculating the net reclassification improvement (NRI) for each of the 13 negative risk markers. During a median of 10.3 years of follow-up among a cohort of 6814, 710 cardiovascular disease (CVD) events occurred. Among all negative risk markers, a coronary artery calcium (CAC) score of 0 was the strongest, with an adjusted mean diagnostic likelihood ratio of 0.41 (SD=0.12) for all CHD. NRI for downward reclassification (10-year CVD risk, <7.5%) of CVD events with CAC scores of 0 in participants with a pretest 10-year CVD risk of 7.5% or higher (n=3833 [3227 participants without events and 606 with events]) was 0.14, higher than other negative risk markers included in the study.

 

Gepner et. al. (2017) prospectively evaluated cardiovascular disease (CVD), coronary heart disease (CHD), and stroke or transient ischemic attack (TIA) events to compare the use of coronary artery calcium (CAC) with carotid plaque scores to predict CVD events; the study used data from the Multi-Ethnic Study of Atherosclerosis (MESA), a population-based cohort of individuals without known CVD. After 11.3 years of follow-up among 4955 participants (mean age, 61.6 years), 709 CVD, 498 CHD, and 262 stroke/TIA events had occurred. CAC score significantly reclassified non-CVD events (3%; 95% CI, 2% to 5%) and CHD events (13%; 95% CI, 5% to 18%). Carotid plaque score did not consistently reclassify CVD or CHD events or nonevents.

 

Summary

Multiple prospective cohort studies have consistently demonstrated the incremental prognostic value of coronary artery calcium (CAC) scoring in predicting coronary heart disease (CHD) and mortality over traditional risk factors among asymptomatic populations over the intermediate and long term. However, considering the heterogeneity of methods applied and inherent limitations of observational studies, there is a need for more evidence on diagnostic accuracy of CAC scoring in predicting CHD risk among the asymptomatic population, preferably from randomized controlled trials (RCTs).

 

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

 

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. The preferred evidence would be from randomized controlled trials (RCTS).

 

Systematic Reviews

In 2012, Whelton et. al. published a meta-analysis of randomized controlled trials (RCTs) that evaluated the impact of coronary artery calcium (CAC) scores on cardiac risk profiles and cardiac procedures. Four trials were identified (total N=2490 participants); the individual trials ranged in size from 50 to 1934 patients. Reviewers pooled data from 4 trials on the impact of calcium scores on blood pressure, three to evaluate the impact on low-density lipoprotein, and from two to determine the impact on high-density lipoprotein. Pooled analysis did not show a significant change in any of these parameters when incorporating calcium scores. Similarly, in 4 studies that looked at the rates of smoking cessation following calcium scores, no significant change was found. Two studies included rates of coronary angiography and two included rates of revascularization. Pooled analysis of these studies did not show a significant change after measurement of coronary calcium.

 

Xie et al (2013) conducted a systematic review to evaluate the prognostic performance of the coronary artery calcium (CAC) score derived from non-triggered CT. In 5 studies, 34,028 cardiac asymptomatic patients were followed for a mean of 45 months (range, 0-72 months). No meta-analysis was performed on the studies because of large heterogeneity in calcium quantification methods, calcium score categorization, and outcomes. During follow-up, 207 cardiovascular deaths and 675 cardiovascular events were observed. Overall, increasing unadjusted and adjusted hazard ratios (HR) were observed with increasing calcium score categories.

 

Mamudu et. al. (2014) conducted a systematic review of studies evaluating the effects of coronary artery calcium (CAC) screening on behavioral modification, risk perception, and medication adherence in asymptomatic adults. Fifteen studies were selected (3 RCTs, 12 observational studies). The size of the study populations ranged from 56 to 6814 individuals. Reviewers primarily provided descriptive results of the studies given the lack of standardization across studies regarding CAC measures and outcome variables. CAC screening improved medication adherence. However, the impact of CAC screening on behavioral and lifestyle factors (BMI, diet, exercise, smoking), perception of CAD risk, and psychosocial effects was nonsignificant compared with baseline.

 

In 2018, the Agency for Healthcare Research and Quality (AHRQ) issued a systematic evidence report for the U.S. Preventative Services Task Force (USPSTF) for non-traditional risk factors in cardiovascular disease risk assessment. The review focuses on three of the most promising nontraditional risk factors: ankle-brachial index (ABI), high sensitivity C-reactive protein (hsCRP), and coronary artery calcium (CAC) score.

 

KQ2. Does Use of Nontraditional Risk Factors in Addition to Traditional Risk Factors to Predict CVD Risk Improve Measures of Calibration, Discrimination, and Risk Reclassification?

 

CAC has the smallest body of evidence, owing to the smaller sample sizes of included cohorts; no IPD meta-analysis presents results for the incremental predictive value of CAC. Nonetheless, CAC consistently appears to result in at least small, and often larger, improvements in discrimination in studies evaluating hard outcomes in all participants using published coefficients (0.02 to 0.102) and model development studies (0.02 to 0.05). Five studies report improvement in discrimination and reclassification from adding CAC to the PCE or models with PCE variables: three published coefficient studies evaluating just two cohorts and two model development studies. Categorical NRI from model development studies in all participants ranged from 0.14 to 0.319 (continuous NRI ranged from 0.20 to 0.28); evaluation of separate components of the NRI shows that improvements in NRI are consistently driven by event NRIs much larger than nonevent NRIs, which were commonly negative (when reported), and sometimes statistically significant. A limited number of studies report sex-stratified analyses; however, without IPD meta-analyses, it is unclear if there are any consistent sex differences in discrimination or reclassification. The bias-corrected NRI was not consistently reported or calculable. Based on limited data, the bias-corrected NRI is not consistently greater than the NRI for all participants.

 

Nine studies evaluate more than one nontraditional risk factor and therefore allow for more direct comparison across ABI, hsCRP, and CAC. Overall, CAC appears to be the most promising nontraditional risk factor to add to traditional cardiovascular risk factor assessment. Only two studies using published coefficients evaluated multiple nontraditional risk factors; one evaluated both the PCE and FRS. This study, using the Multi-Ethnic Study of Atherosclerosis (MESA) cohort, found no improvement in discrimination or reclassification for ABI and hsCRP, but the study was limited to lower-risk people because participants taking a statin were excluded from the analyses. However, in this study, CAC did improve both discrimination and reclassification. The other published coefficient analysis using the Heinz Nixdorf Recall cohort evaluated both ABI and CAC added to the FRS and similarly found greater improvement for CAC than ABI. Six model development studies evaluated more than one nontraditional risk factor in addition to the FRS to predict hard CHD or soft CVD events. Five of these six studies included CAC and found statistically significant improvements in discrimination and reclassification; these improvements were greater than effects seen for either ABI and/or hsCRP

 

No studies have evaluated the clinical impact of cardiovascular risk assessment with or without nontraditional risk factors on patient health outcomes. Clinical impact studies should be a priority if any of these nontraditional risk factors are implemented on a targeted population level. Largely speaking, the proliferation of cardiovascular risk assessment literature, particularly model development studies without external validation, will not provide the much-needed clinical answers on nontraditional risk factor assessment. However, there are some exceptions. Given that traditional risk tools can overestimate CVD risk, it is crucial to understand the incremental value of promising nontraditional risk factors on calibration, as well as discrimination and reclassification. More consistent reporting of calibration plots will allow for better understanding of what individuals will benefit from improved calibration and O:E ratios will facilitate comparison of calibration across studies. To understand the true net benefit of reclassification, robust reporting of event and nonevent NRI, and reporting of integrated measures that weight the erroneous misclassification for nonevent proportionally, are important. More studies in diverse populations will aid in understanding whether there are population segments for whom traditional risk factor assessment may underperform to a greater degree and thereby achieve greater benefit from nontraditional risk factor assessment. External validation studies of extended models with nontraditional risk factors are needed. Apart from the ABI Collaboration IPD meta-analysis, none of the extended models has been externally validated.

 

Given that CAC appears to be the most promising nontraditional risk factor, an IPD meta-analysis for CAC (including longer follow-up of included cohorts) would be informative in furthering understanding of reclassification in subpopulations (e.g., intermediate-risk groups, those for whom traditional risk factor assessment typically underperforms), and vet what impact a CAC score of 0 has on appropriate downward classification of people at intermediate or high risk by traditional risk assessment. Well-designed prospective studies that are reflective of real world practice are needed to evaluate the downstream effects of CAC on cardiac imaging and revascularization, as well as incidental findings, since these are common. These include studies that aid in determining whether the identification of incidental findings, and/or increased health care utilization, is a net benefit or net harm.

 

Based on this systematic evidence report it concluded the following: In the absence of true clinical impact studies reporting cardiovascular morbidity and/or mortality, we need to understand the incremental value of risk prediction with nontraditional risk factors, using calibration, discrimination and reclassification. Despite limitations in the reporting of these performance measures as well as limitations in the measures themselves, we can draw some conclusions. There remains scant information on the incremental value of nontraditional risk factors to help with the problem of miscalibration of traditional cardiovascular risk assessment. Evidence from one large IPD meta-analysis suggests that clinicians could use ABI in addition to the FRS to improve upon discrimination and reclassification in populations for whom the FRS model has poor discrimination. While CAC appears to be the most promising nontraditional risk factor to improve discrimination and reclassification, it is based on a smaller body of evidence which lacks IPD meta-analyses. CAC may also result in additional downstream testing/procedures, and it is unclear whether these sequelae represent a net benefit or harm to individuals. One large RCT shows that high-intensity statin therapy in individuals with elevated hsCRP and normal lipid levels can reduce CVD morbidity and mortality, but it is unclear whether these benefits would not also be applicable to individuals with normal hsCRP. The use of hsCRP-guided therapy has not been evaluated against therapy guided by multivariate cardiovascular risk assessment.

 

Randomized Controlled Trials (RCTs)

Rozanski et. al. (2011) conducted an RCT to evaluate the impact of computed tomography (CT) scanning for coronary artery calcium (CAC) on cardiac risk factors. A total of 2137 healthy volunteers were randomized in a 2:1 ratio to CT scanning (n=1424) or no CT scanning (n=713) and followed for 4 years. At baseline, both groups received 1 session of risk factor counseling by a nurse practitioner. The primary end point was 4 year change in cardiovascular disease (CAD) risk factors and Framingham Risk Score (FRS). At the 4 year follow-up, there was differential dropout among the groups, with 88.2% (1256/1424) of follow-up in the scan group versus 81.9% (584/713) in the no-scan group. Compared with the no-scan group, the scan group showed a net favorable change in systolic blood pressure (p=0.02), low-density lipoprotein cholesterol (p=0.04), and waist circumference for those with increased abdominal girth (p=0.01), and a tendency to weight loss among overweight subjects (p=0.07). While there was a mean rise in FRS in the no-scan group (0.7, SD=5.1), FRS remained static in the scan group (0.002, SD=4.9; p=0.003). Downstream medical testing and costs in the scan group were comparable with those of the no-scan group, balanced by lower and higher resource utilization for subjects with normal CAC scans and CAC scores of 400 or higher, respectively.

 

This trial highlights the potential benefit of CAC screening in modifying cardiac risk profile but is not definitive in demonstrating improved outcomes. Trial limitations included differing intensities of interventions between groups and differential dropout. It is possible that the small differences reported in the trial result from bias related to these methodologic limitations. Also, this trial did not compare the impact of other types of risk factor intervention, most notably more intensive risk factor counseling. Finally, the generalizability of the findings is uncertain, because this was a volunteer population that might have been highly motivated for change.

 

Observational Studies

Budoff et. al. (2013) evaluated the association between coronary calcium scores and coronary heart disease (CHD) events during 5 year follow-up of 2232 adults from MESA (discussed above), and 3119 subjects from the Heinz Nixdorf RECALL (Risk factors, Evaluation of Coronary Calcium and Lifestyle Factors) study. Increasing Agatston scores were associated with increased risk of CHD. In MESA, compared with a CAC score of 0, having a score greater than 400 was associated with a hazard for CHD of 3.31 (95% CI, 1.12 to 9.8) after adjusting for CHD risk factors; a score ranging from 100 to 399 was associated with a hazard of 3.27 (95% CI, 1.19 to 8.95). In the RECALL study, compared with a CAC score of 0, having a score greater than 400 was associated with a hazard for CHD of 2.96 (95% CI, 1.22 to 7.19). Lower CAC scores were not significantly associated with CHD after adjusting for other risk factors.

 

Chang et. al. (2015) prospectively evaluated whether coronary artery calcium (CAC) scoring added incremental predictive value to exercise treadmill testing and stress myocardial perfusion single-photon emission computed tomography testing when used to assess risk of cardiac events (a composite of cardiac death, nonfatal myocardial infarction, and the need for coronary revascularization) in a cohort of 988 asymptomatic and symptomatic low-risk patients without known coronary heart disease (CHD). Over a median follow-up of 6.9 years, the cardiac event rate was 11.2% (1.6% per year). Annual event rates were higher in patients with CAC scores above 400 (3.7% per year) compared with those with CAC scores of 10 or less (0.6% per year; p<0.001). The addition of CAC score to risk stratification based on the FRS improved risk prediction.

 

Johnson et. al. (2015) assessed the association between coronary artery calcium (CAC) score and subsequent health behavior change. The study included a convenience sample of 174 adults with CHD risk factors who underwent CAC scoring. The authors found no significant between-group change in risk perception measured by Perception of Risk of Heart Disease Scale scores (CAC score range, 0, 1-10, 11-100, 101-400, >400), with the exception of a small increase in the moderate-risk group (CAC score, 101-400) from 55.5 to 58.7 (p=0.004). All groups demonstrated increases in health-promoting behavior over time.

 

Summary

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

 

While there is evidence CAC scoring has a degree of clinical validity, uncertainty remains in the magnitude of increased risk conferred by a given CAC score. For this reason, a chain of evidence supporting the clinical utility of CAC scoring in this population current cannot be constructed.

 

Multiple prospective studies have found that coronary artery calcium (CAC) scoring is associated with future risk of coronary heart disease (CHD) events. CAC scores likely add to the predictive ability of clinical risk prediction models. However, relevant studies enrolled different populations, assessed different traditional risk factors, and assessed different coronary disease outcomes. Different calcium score cutoffs were analyzed in these studies. Given the variation across studies, the magnitude of increased risk conferred by a given calcium score is still uncertain. Studies that evaluated use of CAC scoring in asymptomatic patients have reported mixed findings on whether the score led to improved cardiovascular risk profiles or improvements in other meaningful clinical outcomes. The meta-analysis of randomized controlled trials (RCTs) did not find significant improvements in cardiac risk profiles, smoking cessation, or incidence of subsequent cardiac procedures with the use of CAC scoring.

 

Coronary Artery Calcium (CAC) Scoring in Symptomatic Patients

In certain clinical situations, such as patients presenting with chest pain, it is uncertain whether the symptoms are due to CAD. Coronary calcium measurement has been proposed as a method to rule out CAD in certain patients if their CAC score is 0. The presence of any coronary calcium can be a sensitive but not specific test for coronary disease because CAD rarely occurs in the absence of coronary calcium, False positives occur because the calcium may not be associated with an ischemic lesion. The absence of any coronary calcium can be a specific test for the absence of coronary disease and direct the diagnostic workup toward other causes of the patient’s symptoms. In this context, coronary calcium measurement is not used to make a positive diagnosis but as a diagnostic “filter” to rule out an atherosclerotic cause for the patient’s symptoms.

 

Clinical Context and Test Purpose

The use of coronary artery calcium (CAC) scoring with computed tomography (CT) in symptomatic patients can rule out the atherosclerotic etiology of CAD.

 

Patients

The population of interest includes individuals who have signs and/or symptoms suggested of CAD.

 

Interventions

The intervention of interest isCC scoring using fast CT imaging, including EBCT and spiral CT.

 

Comparators

The comparators of interest is standard diagnostic testing (functional testing, exercise electrocardiography [ECG])

 

Outcomes

The outcomes of interest include over survival, test accuracy, test validity, morbid events (e.g. major adverse cardiac events [MACEs], need for ICA (interventional coronary angiography) and revascularization)

 

Timing

The timing of use of CT CAC scoring is when individuals require evaluation for persistent stable angina or experience onset of acute chest pain.

 

Setting

The setting is a cardiology practice or emergent care setting for patients undergoing evaluation of chest pain.

 

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

 

Systematic Reviews

Chaikriangkrai et. al. (2016) conducted a systematic review and meta-analysis to examine the prognostic value and accuracy of a coronary artery calcium (CAC) score of 0 for identifying patients presenting with acute chest pain at acceptable low risk for future cardiovascular events. The systematic review included only prospective cohort studies that used multidetector computed tomography (MDCT) or electron beam computed tomography (EBCT) to calculate CAC scores using the Agatston method and reported major adverse cardiac events (MACEs) at 1 month and beyond the index emergency department visit. Eight studies evaluating 3556 patients with a median follow-up of 10.5 months were selected. Reviewers conducted a subgroup analysis of 6 studies at predominantly white patients (n=2432 patients) to estimate the prognostic accuracy indices of CAC scores (0, >0) for cardiovascular events (MACEs, all-cause deaths, nonfatal myocardial infarction). Pooled sensitivity, specificity, as well as positive and negative likelihood ratios were 96% (I2=0%), 60% (I2=15.1%), 2.36 (I2=0%), and 0.07 (I2=0%), respectively.

 

Randomized Controlled Trials (RCTs)

Lubbers et. al. (2016) conducted a multicenter RCT to compare the effectiveness and safety of a cardiac CT algorithm with functional testing in patients with symptoms (stable chest pain or angina equivalent symptoms) suggestive of coronary artery disease (CAD). A total of 350 patients with stable angina were prospectively randomized 2:1 to cardiac CT and functional testing, such as exercise ECG, myocardial perfusion imaging, or stress echocardiography. Patients in the cardiac CT arm (n=242) initially underwent calcium scanning followed by computed tomography angiography (CCTA) if the Agatston calcium score was between 1 and 400. CAD was ruled out if the patients had a CAC score of 0. The original primary end point of the trial was the proportion of patients undergoing catheter angiography followed by revascularization, but because of insufficient funding, authors could not assess that end point and chose clinical effectiveness as the alternative primary outcome, defined as the absence of chest pain complaints after 1 year. After 1 year, fewer patients randomized to CT reported angina symptoms that those in the functional testing group (39% vs 25%, p=0.012), although the proportion of patients with similar or worsened symptoms was comparable (26% vs 29%, p=0.595). The tiered protocol study design is a strength of this study, but the unplanned change in end points limits analysis and conclusions.

 

Observational Studies

In 2014, Hulten et. al. published results from a retrospective cohort study among symptomatic patients without a history of coronary artery disease (CAD) to evaluate the accuracy of coronary artery calcium (CAC) scoring for excluding coronary stenosis, using computed tomography angiography (CTA) as the criterion standard. The study included 1145 patients who had symptoms possibly consistent with CAD who underwent non-contrast CAC scoring and contrast-enhanced CTA from 2004 to 2011. For detection of greater than 50% stenosis, CAC had a sensitivity, specificity, and negative predictive value of 98%, 55%, and 99%, respectively. For prediction of cardiovascular death or myocardial infarction, the addition of either or both CAC and CTA to a clinical prediction score did not significantly improve prognostic value.

 

Chaikriangkrai et. al. (2015) retrospectively evaluated whether coronary artery cacliums (CAC) added incremental value to computed tomography angiography (CTA) for predicting coronary artery stenosis in 805 symptomatic patients without known coronary heart disease (CHD). CAC score was significantly associated with the presence of coronary artery stenosis on CTA. Both CAC score and the presence of CTA stenosis were significantly associated with MACE (major adverse cardiac event) rates, including cardiac death, nonfatal myocardial infarction, and late coronary revascularization. Patients with more than 50% stenosis on CTA had higher MACE rates, compared with those who had a normal CTA (4.5% vs 0.1%, p<0.001) and with those who had less than 50% stenosis (4.5% vs 1.4%, p=0.002). Those with a CAC score of more than 400 had higher MACE rates than those with scores between 1 and 100 (4.2% vs 1.4%, p=0.014) and those with scores of 0 (4.2% vs 0% p<0.001). The addition of CAC score to a risk prediction model for MACE, which included clinical risk factors and CTA stenosis, significantly improved the model’s predictive performance (global X2 score, 108 vs 70, p=0.019).

 

In 2015, Pursnani et. al. published results from a subgroup analysis of the ROMICAT II trial. It evaluated the incremental diagnostic value of coronary artery calcium (CAC) scoring plus computed tomography angiography (CTA) in low- to intermediate-risk patients presenting to the emergency department with symptoms (chest pain or angina equivalent of ≥5 minutes duration within 24 hours) suggesting acute coronary syndrome (ACS). The ROMICAT II trial randomized patients with possible ACS to CTA as part of an initial evaluation or to the standard emergency department evaluation strategy, as directed by local caregivers. As part of the trial protocol, all patients undergoing CTA had a CAC scan; the present analysis included 473 patients who underwent both CTA and CAC scanning. Among these patients, the ACS rate (defined as unstable angina and myocardial infarction during the index hospitalization) was 8% (n=38). Patients with lower CAC scores were less likely to have a discharge diagnosis of ACS. Among 253 patients with a CAC score of 0, 2 (0.8%) patients were diagnosed with ACS (95% CI, 0.1% to 2.8%). Receiver operating characteristic curve analysis was used to predict the risk of ACS by CAC score greater than 0, continuous CAC score, CTA results, and combined CAC and CTA score. The optimal cut point of CAC for ACS detection was 22 (C statistic, 0.81), with 318 (67%) patients having a CAC score less than 22. All CTA strategies had high sensitivity for ACS detection, without significant differences in stenosis thresholds. CAC was inferior to CTA for predicting ACS (C range, 0.86 vs 0.92; p=0.03). The addition of CAC score to CTA (i.e., using selective CTA only for patients with CAC score >22 or >0) did not significantly improve the detection of ACS (CAC+CTA C=0.93 vs CTA C=0.92; p=0.88). Overall, this trial suggested that CAC scoring does not provide incremental value beyond CTA in predicting the likelihood of ACS in a low- to intermediate-risk population presenting to the emergency department.

 

Summary

Systematic reviews and meta-analyses have reported a very low negative likelihood ratio for coronary artery calcium (CAC) score in predicting major adverse cardiac events (MACEs) and significant coronary stenosis, suggesting the potential value of calcium score of 0 in ruling out an atherosclerotic etiology of disease. However, multiple observational studies with angiographic (computed tomography angiography [CTA] or interventional coronary angiography [ICA]) have suggested that a CAC score of 0 may not rule out the presence of significant atherosclerotic coronary artery disease (CAD) among symptomatic patients.

 

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy or avoid unnecessary testing.

 

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would from randomized controlled trials (RCTs).

 

Systematic Reviews

The 2016 systematic review by Chaikriangkrai et. al. (discussed above) assessed studies of relevance to our analysis of clinical utility. Specifically, in 8 studies (total N=3556 patients), those with a coronary artery calcium (CAC) score of 0 had a significantly lower risk of MACEs (major adverse cardiac events) compared with patients with CAC scores greater than 0 (RR=0.06; 95% CI, 0.04 to 0.11; p<0.001; I2=0%). The risk difference was 0.19 (95% CI, 0.11 to 0.27).

 

Subgroup analyses in the 5 studies evaluating death or nonfatal myocardial infarction showed that the patients with a CAC score of 0 had a significantly lower risk of death or nonfatal myocardial infarction compared with patients with CAC scores greater than 0 (RR=0.19; 95% CI, 0.08 to 0.47; I2=0%). The risk difference was 0.03 (95% CI, 0 to 0.05). The pooled event rate for death or nonfatal myocardial infarction with a CAC score of 0 (0.5%/year [0.04 death/myocardial infarction per 100 patient-months, or 6 deaths/myocardial infarction in 13,656 patient-months]) was significantly lower than with a CAC scores greater than 0 (3.5%/year [0.29 death/myocardial infarction per 100 patient-months, or 33 deaths/myocardial infarction in 11,350 patient-months]).

 

Observational Studies

Yerramasu et. al. (2014) prospectively assessed an evaluation algorithm including coronary artery calcium (CAC) scoring for patients presenting to a rapid access chest pain clinic with stable chest pain possibly consistent with coronary heart disease (CHD). Three hundred patients presenting with acute chest pain to 1 of 3 chest pain clinics underwent CAC scoring. If the CAC score was 1000 or more Agatston units, interventional coronary angiography (ICA) was performed; if the CAC score was less than 1000, (computed tomography coronary angiography) CTCA was performed. All patients with a CAC score of 0 and low pretest likelihood of CHD had no obstructive CHD on CTCA and were event-free during follow-up. Of the 18 patients with CAC scores from 400 to 1000, 17 (94%) had greater than 50% obstruction on subsequent CTCA and were referred for further evaluation, 14 (78%) of whom had obstructive CHD. Of 15 patients with CAC scores 1000 or more and who were referred for coronary angiography, obstructive CHD was present in 13 (87%). This study suggested that CAC scoring can be used in the acute chest pain setting to stratify decision making for further testing.

 

Ten Kate et. al. (2013) prospectively evaluated the accuracy of cardiac computed tomography (CT), including coronary artery calcium (CAC) scoring with or without computed tomography coronary angiography (CTCA), in distinguishing heart failure due to coronary artery disease (CAD) from heart failure due to non-CAD causes. Data on the predictive ability of a negative CAC score in ruling out CAD was also included. The study included 93 symptomatic patients with newly diagnosed heart failure of unknown etiology, all of whom underwent CAC scoring. Those with a CAC score greater than 0 underwent CTCA and, if the CTCA was positive for CAD (>20% luminal diameter narrowing), interventional coronary angiography (ICA) was recommended. Forty-six percent of patients had a CAC score of 0. At a mean follow-up of 20 months, no patient with a CAC score of 0 had a myocardial infarction, underwent percutaneous coronary intervention, had a coronary artery bypass graft, or had signs of CAD.

 

Summary

Currently, evidence from nonrandomized observational studies suggests very low short or long term risk of cardiovascular events or death in patients having calcium scores of 0 compared with those having positive (more than 0) calcium scores. However, considering the inconsistency in evidence regarding the diagnostic accuracy of calcium scoring and lack of evidence from randomized controlled trials (RCTs), further research is needed to examine the clinical utility of ruling out atherosclerotic coronary artery disease (CAD) based on coronary artery calcium (CAC) score of 0.

 

Summary of Evidence

For individuals who are asymptomatic with risk of coronary artery disease (CAD) who receive coronary artery calcium (CAC) scoring, the evidence includes multiple systematic reviews, randomized controlled trials (RCTs) and nonrandomized observational studies. There is extensive evidence on the predictive value of CAC score screening for cardiovascular disease among asymptomatic patients, and this evidence has demonstrated that scanning has incremental predictive accuracy above traditional risk factor measurement. However, high-quality evidence demonstrating that the use of CAC scores in clinical practice leads to changes in patient management or in individual risk behaviors that improve cardiac outcomes is lacking. USPSTF 2018 recommendation for cardiovascular disease risk assessment with nontraditional risk factors that includes coronary artery calcium (CAC) score, found inadequate evidence to assess whether treatment decisions guided by coronary artery calcium (CAC) score results, when added to existing CVD risk assessment models, lead to reduced incidence of CVD events or mortality. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

For individuals with signs and/or symptoms suggested of coronary artery disease (CAD) who receive coronary artery calcium (CAC) scoring before other diagnostic testing, the evidence includes prospective and retrospective nonrandomized studies. CAC scoring has potential as a diagnostic test to rule out CAD in patients presenting with symptoms or as a “gatekeeper” test before invasive imaging is performed. Evidence from observational studies has suggested that negative results on CAC scoring rule out CAD with good reliability. However, the evidence has been inconsistent, with some studies reporting lack of value when using a zero calcium score to rule out CAD. Further prospective trials would be needed to demonstrate that such strategy is effective in practice and is at least as effective as alternative strategies for ruling out CAD. To demonstrate that use of calcium scores improves the efficiency or accuracy of the diagnostic workup of symptomatic patients, rigorous defining exactly how CAC scores are used in combination with other tests to triage patients would be necessary. The evidence is insufficient to determine the effects of technology on net health outcomes.

 

Practice Guidelines and Position Statements

American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA)

In 2010, the American College of Cardiology Foundation and the American Heart Association, issued a guideline for the assessment of cardiovascular risk in asymptomatic adults, which included the following recommendation regarding computed tomography for coronary artery calcium (CAC) scoring:

  • Class IIa recommendation: Measurement of CAC is reasonable for cardiovascular risk assessment in asymptomatic adults at intermediate risk (10% to 20% 10 year risk). (Level of Evidence: B)
  • Class IIb recommendation: Measurement of CAC may be reasonable for cardiovascular risk assessment in persons at low to intermediate risk (6% to 10% 10 year risk). (Level of Evidence: B)
  • Class III recommendation: No Benefit. Persons as low risk (<6% 10 year risk) should not undergo CAC measurement for cardiovascular risk assessment. (Level of Evidence: B)

 

In 2012, the American College of Cardiology (ACC)/ American Heart Association (AHA) released guidelines for the diagnosis and management of patients with stable ischemic heart disease that include the same recommendation related to CAC scoring for Class IIb:

  • Class IIb recommendation: For patients with low to intermediate pretest probability of obstructive IHD, non-contrast cardiac computed tomography to determine the coronary artery calcium score may be considered. (Level of Evidence: C)

 

In 2014, ACC/AHA issued focused update to the 2012 guideline on the diagnosis and management of patients with stable ischemic heart disease with no additional recommendations related to CAC scoring.

 

U.S. Preventive Services Task Force (USPSTF)

In 2018 the U.S. Preventative Services Task Force (USPSTF) updated their 2009 recommendation regarding cariovascular disease: risk assessment with non-traditional risk factors. The USPSTF concludes that current evidence is insufficient to assess the balance of benefits and harms of adding ankle-brachial index (ABI), high-sensitivity C-reative protein (hsCRP) level, or coronary artery calcium (CAC) score to traditional risk assessment for cardiovascular disease (CVD) in asymptomatic adults to prevent CVD events.

 

Cardiovascular disease risk assessment in the United States has been generally based on the Framingham Risk Score and, more recently, the Pooled Cohort Equations (PCE). However, both have been documented to overestimate and underestimate risk in some persons. Therefore, identification of additional tests (for nontraditional risk factors) that could improve risk prediction, including the ABI, hsCRP level, and CAC score, is of interest

 

The USPSTF found only 1 study that directly assessed the potential benefit on clinical outcomes of adding 1 of these 3 nontraditional risk factors (ABI, hsCRP level, and CAC score) to traditional risk assessment models. This fair-quality randomized clinical trial (RCT) assigned asymptomatic volunteers (N = 2137) with no history of CVD to CAC scoring plus risk factor assessment counseling vs risk factor assessment counseling alone. At 4 years, there was no difference in CVD outcomes between the 2 groups; however, the study was not adequately powered to detect a difference in patient health outcomes. The USPSTF found no studies that assessed the incremental benefit on health outcomes of adding the ABI or hsCRP level to traditional risk factor assessment. The Viborg Vascular (VIVA) screening trial recently reported interim results; this trial randomized men aged 65 to 74 years to invitation for a triple screening (screening for high blood pressure, abdominal aortic aneurysm, and peripheral artery disease using the ABI) or no screening and found a decrease in mortality with screening; however, it was not possible to determine how much of the decrease was attributable to screening for peripheral artery disease and how much was attributable to screening for abdominal aortic aneurysm and high blood pressure, both of which are already recommended screenings.

 

The USPSTF found no trials evaluating the additional benefit of adding the ABI, hsCRP level, or CAC score to traditional risk assessment models for guiding decisions about specific interventions to prevent CVD. The USPSTF found a few studies evaluating the use of a nontraditional risk factor as a single intervention to guide decisions about specific preventive medications compared with usual care. Two RCTs (total N = 4626) compared using the ABI to guide decisions to start aspirin therapy vs usual care and found no benefit in CVD outcomes at 7 years of follow-up. However, both studies used atypical cutoff points for diagnosing peripheral artery disease, and the results may not be applicable to current practice. One RCT (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin [JUPITER]; N = 17,802) compared hsCRP screening vs usual care to guide high-intensity statin therapy and found benefit at 1.9 years of follow-up in the reduction of CVD events in the hsCRP group.9 However, because the study only randomized persons with elevated hsCRP levels, it is not known whether patients with lower hsCRP levels would also have benefited from high-intensity statin therapy. Further, many of these patients met criteria for statin therapy based on traditional CVD risk assessment and would already have been candidates for treatment. One study (n = 1005) of using CAC score to guide statin therapy found no benefit at 4 years in the reduction of CVD events.33

 

A systematic review that addressed the effect of screening with CAC score on risk perception, adherence to medication, and behavioral therapies found only 2 studies comparing traditional CVD risk assessment vs CAC score. Neither of these studies found that screening with CAC score was superior to traditional CVD risk assessment for preventive medication use or risk factor management

 

The USPSTF found adequate evidence that adding the ABI, hsCRP level, and CAC score to existing CVD risk assessment models results in small improvements in discrimination and reclassification. However, the clinical meaning of these changes is largely unknown. Evidence on adding the ABI, hsCRP level, and CAC score to the Pooled Cohort Equations is sparse, which makes it difficult to infer the clinical significance of these findings. The USPSTF found inadequate evidence to assess whether treatment decisions guided by the ABI, hsCRP level, or CAC score, in addition to risk factors in existing CVD risk assessment models, leads to reduced incidence of CVD events or mortality. Few studies were available and were either underpowered or used atypical test thresholds for intervention. The USPSTF found adequate evidence to bound the harms of early detection and interventions as small. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of using the ABI, hsCRP level, or CAC score in risk assessment for CVD in asymptomatic adults to prevent CVD events.

 

Response to Public Comment

Several comments noted that the addition of nontraditional risk factors, especially CAC score, is useful for patients whose risk stratification is unclear or for those who fall into intermediate-risk groups. The USPSTF did not find convincing evidence that adding nontraditional risk factors to traditional risk factors improves reclassification in intermediate-risk groups. As clinical practice moves toward a single threshold for treatment, this concern may no longer be relevant in clinical decision making. Some comments also expressed belief that CAC score testing leads to better adherence to preventive therapies (ie, medications and lifestyle changes). The USPSTF carefully reviewed the available evidence and concluded that CAC score testing showed no benefit over traditional CVD risk assessment in preventive medication use or risk factor control. The USPSTF added language to address this point.

 

American College of Cardiology (ACA)/American Heart Association (AHA)

In 2019, the American College of Cardiology (ACA)/American Heart Association (AHA) released guideline on the primary intervention of cardiovascular disease that included the following recommendations:

  • For individuals with intermediate predicted risk (> 7.5% to <20%) by the Pooled Cohort Equation (PCE) or for select adults with borderline (5% to < 7.5% ) predicted risk, coronary artery calcium measurement can be useful tool in refining risk assessment for preventative interventions (e.g. statin therapy).
  • Coronary artery calcium (CAC) might also be considered in refining risk for selected low risk adults (<5% 10 year risk), such as those with a strong family history of premature coronary heart disease (CHD).
  • Coronary artery calcium (CAC) may refine ASCVD risk estimates among lower risk (<5%) younger adults (< 45 years) and older adults (>75 years) of age, but more data are needed to support its use in these subgroups.
  • Coronary artery calcium measurement is not intended as a “screening” test for all but rather may be used as a decision aid in select adults to facilitate the clinician-patient discussion.

 

Prior Approval:

Not applicable

 

Policy:

Coronary artery calcium (CAC) scoring by means of computed tomography (CT) is considered investigational for all indications.

 

Based on the peer reviewed medical literature to include a systematic review by AHRQ on behalf of the USPSTF for their updated 2018 insufficient recommendation regarding cardiovascular disease risk assessment with nontraditional risk factors that includes coronary artery calcium (CAC) score, because of the lack of high-quality evidence demonstrating improved clinical outcomes or impact to treatment management from the use of coronary artery calcium (CAC) score either as screening tests to risk stratify asymptomatic patients or as a diagnostic test in symptomatic patients the use of coronary artery calcium scoring by means of computed tomography (CT) is considered investigational.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • S8092 Electron beam computed tomography (also known as ultrafast CT, cine CT)
  • 75571 Computed tomography, heart, without contrast material, with quantitative evaluation of coronary calcium

 

Selected References:

  • Agatston, A.S., Janowitz, W.R., Holdner, F.J., et al. Quantification of coronary artery calcium using ultrafast computed tomography. Journal of the American College of Cardiology. 2000; 15:827-32.
  • Arad, Y., Spadaro, L.A., Goodman, K., et al. Predictive value of electron beam computed tomography of the coronary arteries. 19 month follow-up of 1173 asymptomatic subjects. Circulation. 1996; 93(11):1951-3.
  • Blue Cross and Blue Shield Association. Electron beam computed tomography. Technology Evaluation Center Assessments. 1994; 9(16):1-15.
  • Budoff, M.J., Georgiou, D., Brody, A., et al. Ultrafast computed tomography as a diagnostic modality in the detection of coronary artery disease. Circulation. 1996; 93:898-904.
  • Detrano, R.C. Coronary artery scanning using electron beam computed tomography. American Journal of Cardiac Imaging. 1996; 10(2):97-100.
  • Secci, A., Wong, N., Tang, W., et al. Electron beam computed tomographic coronary calcium as a predictor of coronary events: comparison of two protocols. Circulation. 1997; 96(4):1122-9.
  • Teng, W., Wong, N.D., Abrahamson, D., et al. Relation of electron beam computed tomography screening for coronary calcium to cardiovascular risk and disease: a review. Coronary Artery Disease. 1996; 7:383-9.
  • Thompson, G.R., Forbat, S., Underwood, R. Electron-beam CT scanning for detection of coronary calcification and prediction of coronary heart disease. QJM. 1996; 89(8):565-70.
  • Wexler, L., Brundage, B., Crouse, J., et al. Coronary artery calcification: pathophysiology, epidemiology, imaging methods, and clinical implications. A statement for health professionals from the American Heart Association Writing Group. Circulation. 1996; 94(5):1175-97.
  • Wong, N.D., Detrano, R.C., Diamond, G., et al. Does coronary artery screening by electron beam computed tomography motivate potentially beneficial lifestyle behaviors? American Journal of Cardiology. 1996; 78:1220-3.
  • O'Malley PG, Feurstein IM, Taylor AJ. Impact of electron beam tomography, with or without case management, on motivation, behavioral change, and cardiovascular risk profile: a randomized controlled trial. JAMA. 2003 May 7;289(17):2215-23.
  • Greenland P, Gaziano JM. Selecting Asymptomatic Patients for Coronary Computed Tomography for Electrocardiographic Exercise Testing. N Engl J Med 2003, Jul. 239;5.
  • Tiechholz LE, Petrillo S, Larson AJ, Klig V. Quantitative assessment of atherosclerosis by electron beam tomography. Am J Cardiol. 2002 Dec 15;90(12):1416-9.
  • Raggi P, Callister TQ, Cooil B, Russo DJ, Lippolis NJ, Patterson RE. Evaluation of chest pain in patients with low to intermediate pretest probability of coronary artery disease by electron beam computed tomography. Am J Cardiol. 2000 Feb. 1:85(3):283-8.
  • ECRI. Computed Tomography for Predicting Coronary Artery Disease Risk. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; 2004 Apr. 39 p. (Windows on medical technology; no. 107).
  • Almeda FQ, Shah R, Senter S et al. Clinical and angiographic profile of patients with markedly elevated coronary calcium scores (>/=1000) detected by electron beam computed tomography. Cardiovasc Radiat Med. 2004 Jul-Sep; 5(3):109-12.
  • Ratliff NB 3rd, Jorgensen CR, Gobel et al. Lack of usefulness of electron beam computed tomography for detecting coronary allograft vasculopathy.  Am J Cardiol. 2004 Jul 15; 94(2):2002-6.
  • ECRI. Computed Tomography for Cardiovascular Disease Screening. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2006 Nov. (Health Technology Forecast).
  • Budoff MJ, Achenbach S, Blumenthal RS et al. Assessment of coronary artery disease by cardiac computed tomography: a scientific statement from the American Heart Association Committee on Cardiovascular Imaging and Intervention, Council on Cardiovascular Radiology and Intervention, and Committee on Cardiac Imaging, Council on Clinical Cardiology. Circulation 2006 Oct 17;114(16):1761-91.
  • Greenland P, Bonow RO, Brundage BH, Budoff MJ,  American College of Cardiology Foundation Clinical Expert . Consensus Task Force (ACCF/AHA Writing Committee to Update the 2000    Expert Consensus Document on Electron Beam Computed Tomography); Society ofAtherosclerosis Imaging and Prevention; Society of Cardiovascular ComputedTomography.Circulation. 2007 Jan 23;115(3):402-26. Epub 2007 Jan 12.
  • Michos ED, Vasamreddy CR, Becker DM, Yanek LR, Moy TF, Fishman EK, Becker LC,Blumenthal RS. Women with a low Framingham risk score and a family history of premature coronary heart disease have a high prevalence of subclinical coronary atherosclerosis. Am Heart J. 2005 Dec;150(6):1276-81.
  • Polonsky TS, McClelland RL, Jorgensen NW et al. Coronary Artery Calcium Score and Risk Classification for Coronary Heart Disease Prediction. JAMA. Apr 28, 2010; 303(16):1610-16.
  • ECRI. Calcium scoring may be useful screening for chest pain in emergency departments. Plymout Meeting (PA): ECRI Health Technology Information Service; 2010 February 12. (Health Technology Forecast).
  • Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Preventive Services for Adults. 17th edition. September 2011. Accessed November 2011.
  • Ferket BS, Genders TS, Colkesen EB et al. Systematic review of guidelines on imaging of asymptomatic coronary artery disease. J Am Coll Cardiol. 2011 Apr 12;57(15):1591-600.
  • Rana JS, Gransar H, Wong ND et al. Comparative value of coronary artery calcium and multiple blood biomarkers for prognostication of cardiovascular events. Am J Cardiol. 2012 May 15;109(10):1449-53. Epub 2012 Mar 16.
  • Sniderman AD, Thanassoulis G, lawler PR et al. Comparison of coronary calcium screening versus broad statin therapy for patients at intermediate cardiovascular risk. Am J Cardiol. 2012 May 9. [Epub ahead of print].
  • Jacobs PC, Gondrie MJ, can der Graaf Y et al. Coronary artery calium can predict all-cause mortality and cardiovascular events on low-dose CT screening for lung cancer. AJR Am J Roentgenol. 2012 Mar;198(3):505-11.
  • Okwuosa TM, Greenland P, Burke GL et al. Prediction of coronary artery calcium progression in individuals with low Framingham Risk Score: the Multi-Ethnic Study of Atherosclerosis. JACC Cardiovasc Imaging. 2012 Feb;5(2):144-53.
  • U.S. Preventative Services Task Force. Updated the 2009 recommendation in July 2018. Cardiovascular Disease Risk Assessment with Nontradional Risk Factors.
  • 2010 ACCF/AHA Guideline for Assessment of Cardiovascular Risk in Asymptomatic Adults. Circulation 2010; 122:e636.
  • 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk. Journal of the American Cardiology j.jacc.2015.11.005.
  • UpToDate. Screening for Coronary Heart Disease. Frank G. Yanowitz, M.D.. Topic last updated December 4, 2018.
  • UpToDate. Diagnostic and Prognostic Implications of Coronary Artery Calcification Detected by Computed Tomography. Thomas C. Garber, M.D., PhD, FACC, FAHA, Christopher M. Kramer, M.D., FACC, FAHA. Topic last updated June 6, 2019.
  • Nishant R. Shah, M.D., Stephanie A. Coulter, M.D., An Evidence Based Guideline for Coronary Calcium Scoring in Asymptomatic Patients Without Coronary Heart Disease, Vol 39, Number 2, 2012.
  • Raimund Erbel, et al. Progression of Coronary Artery Calcification Seems to be Inevitable, but Predictable – Results of The Heinze Nixdorf Recall (HNR) Study. European Heart Journal. doi:10.1093/curheartj/ehu288  
  • Update. Screening for Coronary Heart Disease in Patients with Diabetes Mellitus. Jeroen J Bax, M.D., PhD, Frans J TH Wackers, M.D., PhD, Victoria Delgado M.D., PhD. Topic last updated April 29, 2016.
  • Budoff MJ, Mohlenkamp S, McClelland R, et al. A comparison of outcomes with coronary artery calcium scanning in unselected populations: the Multi-Ethnic Study of Atherosclerosis (MESA) and Heinz Nixdorf RECALL study (HNR). J Cardiovasc Comput Tomogr. May-Jun 2013;7(3):182-191. PMID 23849491
  • Martin SS, Blaha MJ, Blankstein R, et al. Dyslipidemia, coronary artery calcium, and incident atherosclerotic cardiovascular disease: implications for statin therapy from the multi-ethnic study of atherosclerosis. Circulation. Jan 7 2014;129(1):77-86. PMID 24141324
  • Miedema MD, Duprez DA, Misialek JR, et al. Use of coronary artery calcium testing to guide aspirin utilization for primary prevention: estimates from the multi-ethnic study of atherosclerosis. Circ Cardiovasc Qual Outcomes. May 2014;7(3):453-460. PMID 24803472
  • Silverman MG, Blaha MJ, Krumholz HM, et al. Impact of coronary artery calcium on coronary heart disease events in individuals at the extremes of traditional risk factor burden: the Multi-Ethnic Study of Atherosclerosis. Eur Heart J. Sep 1 2014;35(33):2232-2241. PMID 24366919
  • Gibson AO, Blaha MJ, Arnan MK, et al. Coronary artery calcium and incident cerebrovascular events in an asymptomatic cohort. The MESA Study. JACC Cardiovasc Imaging. Nov 2014;7(11):1108-1115. PMID 25459592
  • Chang SM, Nabi F, Xu J, et al. Value of CACS compared with ETT and myocardial perfusion imaging for predicting long-term cardiac outcome in asymptomatic and symptomatic patients at low risk for coronary disease: clinical implications in a multimodality imaging world. JACC Cardiovasc Imaging. Feb 2015;8(2):134-144. PMID 25677886
  • Hou ZH, Lu B, Gao Y, et al. Prognostic value of coronary CT angiography and calcium score for major adverse cardiac events in outpatients. JACC Cardiovasc Imaging. Oct 2012;5(10):990-999. PMID 23058065
  • Meyer M, Henzler T, Fink C, et al. Impact of coronary calcium score on the prevalence of coronary artery stenosis on dual source CT coronary angiography in Caucasian patients with an intermediate risk. Acad Radiol. Nov 2012;19(11):1316-1323. PMID 22897947
  • Petretta M, Daniele S, Acampa W, et al. Prognostic value of coronary artery calcium score and coronary CT angiography in patients with intermediate risk of coronary artery disease. Int J Cardiovasc Imaging. Aug 2012;28(6):1547-1556. PMID 21922205
  • Whelton SP, Nasir K, Blaha MJ, et al. Coronary artery calcium and primary prevention risk assessment: what is the evidence? An updated meta-analysis on patient and physician behavior. Circ Cardiovasc Qual Outcomes. Jul 1 2012;5(4):601-607. PMID 22811506
  • Mamudu HM, Paul TK, Veeranki SP, et al. The effects of coronary artery calcium screening on behavioral modification, risk perception, and medication adherence among asymptomatic adults: a systematic review. Atherosclerosis. Oct 2014;236(2):338-350. PMID 25128971
  • Johnson JE, Gulanick M, Penckofer S, et al. Does Knowledge of Coronary Artery Calcium Affect Cardiovascular Risk Perception, Likelihood of Taking Action, and Health-Promoting Behavior Change? J Cardiovasc Nurs. Jan 14 2014. PMID 24434820
  • Shreibati JB, Baker LC, McConnell MV, et al. Outcomes after coronary artery calcium and other cardiovascular biomarker testing among asymptomatic medicare beneficiaries. Circ Cardiovasc Imaging. Jul 2014;7(4):655-662. PMID 24777939
  • Yerramasu A, Lahiri A, Venuraju S, et al. Diagnostic role of coronary calcium scoring in the rapid access chest pain clinic: prospective evaluation of NICE guidance. Eur Heart J Cardiovasc Imaging. Feb 9 2014. PMID 24513880
  • Pursnani A, Chou ET, Zakroysky P, et al. Use of coronary artery calcium scanning beyond coronary computed tomographic angiography in the emergency department evaluation for acute chest pain: the ROMICAT II trial. Circ Cardiovasc Imaging. Mar 2015;8(3). PMID 25710925
  • Hulten E, Bittencourt MS, Ghoshhajra B, et al. Incremental prognostic value of coronary artery calcium score versus CT angiography among symptomatic patients without known coronary artery disease. Atherosclerosis. Mar 2014;233(1):190-195. PMID 24529143
  • Chaikriangkrai K, Velankar P, Schutt R, et al. Additive prognostic value of coronary artery calcium score over coronary computed tomographic angiography stenosis assessment in symptomatic patients without known coronary artery disease. Am J Cardiol. Mar 15 2015;115(6):738-744. PMID 25604930
  • Fihn S, Blankenship J, Alexander K, et al. ACC/AHA/AATS/PCNA/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease. J Am Coll Cardiol. 2014;64(18):1929-1949.
  • Pursani A, Massaro JM, D’Agostino RB Sr, et. al. Guideline-based statin eligibility, coronary artery calcification and cardiovascular events, JAMA 2015 Jul 14;314(2):134-41. PMID 26172893
  • Blaha MJ, Cainzos-Achirica M, Greenland P, et. al. Role of coronary artery calcium score of zero and other negative risk markers for cardiovascular disease: The multi-ethnic study of atherosclerosis (MESA). Circulation 2016 Mar 1:133(9):849-58. PMID 26801055
  • Johnson JE, Gulanick M, Penckofer S, et. al. Dose knowledge of coronary artery calcium effect cardiovascular risk perception, likelihood of taking action, and health-promoting behavior change? J Cardiovasc Nurs 2015 Jan-Feb:30(1):15-25. PMID 24434820
  • Korley FK, George RT, Jaffe AS, et. al. Low high-sensitivity troponin I and zero coronary artery calcium score identifies coronary CT angiography candidates in whom further testing could be avoided. Acad Radiol 2015 Aug;22(8):1060-7. PMID 26049777
  • Xie X, Zhao Y, de Bock GH, et al. Validation and prognosis of coronary artery calcium scoring in nontriggered thoracic computed tomography: systematic review and meta-analysis. Circ Cardiovasc Imaging. Jul 2013;6(4):514-521. PMID 23756678 
  • Choi AD, Leifer ES, Yu J, et al. Prospective evaluation of the influence of iterative reconstruction on the reproducibility of coronary calcium quantification in reduced radiation dose 320 detector row CT. J Cardiovasc Comput Tomogr. Sep-Oct 2016;10(5):359-363. PMID 27591767 
  • Williams MC, Golay SK, Hunter A, et al. Observer variability in the assessment of CT coronary angiography and coronary artery calcium score: substudy of the Scottish COmputed Tomography of the HEART (SCOT-HEART) trial. Open Heart. May 2015;2(1):e000234. PMID 26019881
  • Nakanishi R, Li D, Blaha MJ, et al. All-cause mortality by age and gender based on coronary artery calcium scores. Eur Heart J Cardiovasc Imaging. Nov 2016;17(11):1305-1314. PMID 26705490 
  • Gepner AD, Young R, Delaney JA, et al. Comparison of carotid plaque score and coronary artery calcium score for predicting cardiovascular disease events: the multi-ethnic study of atherosclerosis. J Am Heart Assoc. Feb 14 2017;6(2). PMID 28196817
  • Elias-Smale SE, Wieberdink RG, Odink AE, et al. Burden of atherosclerosis improves the prediction of coronary heart disease but not cerebrovascular events: the Rotterdam Study. Eur Heart J. Aug 2011;32(16):2050-2058. PMID 21606087 
  • Won KB, Chang HJ, Niinuma H, et al. Evaluation of the predictive value of coronary artery calcium score for obstructive coronary artery disease in asymptomatic Korean patients with type 2 diabetes mellitus. Coron Artery Dis. Mar 2015;26(2):150-156. PMID 25356815
  • Rozanski A, Gransar H, Shaw LJ, et al. Impact of coronary artery calcium scanning on coronary risk factors and downstream testing the EISNER (Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research) prospective randomized trial. J Am Coll Cardiol. Apr 12 2011;57(15):1622-1632. PMID 21439754 
  • Kelkar AA, Schultz WM, Khosa F, et al. Long-term prognosis after coronary artery calcium scoring among low-intermediate risk women and men. Circ Cardiovasc Imaging. Apr 2016;9(4):e003742. PMID 27072301
  • Chaikriangkrai K, Palamaner Subash Shantha G, Jhun HY, et al. Prognostic value of coronary artery calcium score in acute chest pain patients without known coronary artery disease: systematic review and meta-analysis. Ann Emerg Med. Dec 2016;68(6):659-670. PMID 27765299
  • Lubbers M, Dedic A, Coenen A, et al. Calcium imaging and selective computed tomography angiography in comparison to functional testing for suspected coronary artery disease: the multicentre, randomized CRESCENT trial. Eur Heart J. Apr 14 2016;37(15):1232-1243. PMID 26746631
  • Dharampal AS, Rossi A, Dedic A, et al. Restriction of the referral of patients with stable angina for CT coronary angiography by clinical evaluation and calcium score: impact on clinical decision making. Eur Radiol. Oct 2013;23(10):2676-2686. PMID 23774892 
  • Yoon YE, Chang SA, Choi SI, et al. The absence of coronary artery calcification does not rule out the presence of significant coronary artery disease in Asian patients with acute chest pain. Int J Cardiovasc Imaging. Feb 2012;28(2):389-398. PMID 21347595 
  • Gottlieb I, Miller JM, Arbab-Zadeh A, et al. The absence of coronary calcification does not exclude obstructive coronary artery disease or the need for revascularization in patients referred for conventional coronary angiography. J Am Coll Cardiol. Feb 16 2010;55(7):627-634. PMID 20170786
  • ten Kate GJ, Caliskan K, Dedic A, et al. Computed tomography coronary imaging as a gatekeeper for invasive coronary angiography in patients with newly diagnosed heart failure of unknown aetiology. Eur J Heart Fail. Sep 2013;15(9):1028-1034. PMID 23759285
  • Malik S, Zhao Y, Budoff M, et. al. Coronary artery calcium score for long-term risk classification in individuals with type-2 diabetes and metabolic syndrome from the multi-ethnic study of atherosclerosis. JAMA Cardiol 2017 Dec 1;2(12):1332-1340. PMID 29117273
  • Han D, Hartaigh BO, Gransar H, et. al. Incremental prognostic value of coronary computed tomography angiography over coronary calcium scoring for major adverse cardiac events in elderly asymptomatic individuals. Eur Heart J Cardiovasc Imaging 2018 Jun 1;19(6):675-683. PMID 28977374
  • Lee KY, Hwang BH, Kim TH, et. al. Computed tomography angiography images of coronary artery stenosis provided a better prediction of risk than traditional risk factors in asymptomatic individuals with type 2 diabetes: a long-term study of clinical outcomes. Diabetes Care 2017 Sep;40(9):1241-1248. PMID 28663384
  • Takamura H, Fujimoto S, Kondo T, et. al. Incremental prognostic value of coronary computed tomography angiography: high risk plaque characteristics in asymptomatic patients. Atheroscler Thromb 2017 Nov 1; 24(11):1174-1185. PMID 28674321
  • Lin JS, Evans CV, Johnson E, et. al. Nontraditional risk factors in cardiovascular disease risk assessment: updated evidence report and systematic review for the US Preventative Services Task Force. JAMA 2018 Jul 17;320(3):281-297. PMID 29998301
  • Patel J, Al Rifai M, Shea S, et. al. Basic vs more complex definitions of family history in the prediction of coronary heart disease: the Multi-Ethnic Study of Atherosclerosis. Mayo Clin Proc 2018 Sep;93(9):1213-1223. PMID 29555305
  • Mahabadi AA, Mohlenkamp S, Lehmann N, et. al. CAC score improves coronary and CV risk assessment above statin indication by ESC and AHA/ACC primary prevention guidelines. JACC Cardiovasc Imaging 2017 Feb;10(2):143-153. PMID 27665163
  • McClelland RL, Jorgensen NW, Budoff M, et. al. 10-year coronary heart disease risk prediction using coronary artery calcium and traditional risk factors: derivation in the MESA (Multi-Ethnic Study of Atherosclerosis) with validation in the HNR (Heinz Nixdorf Recall) Study and the DHS (Dallas Heart Study) J Am Coll Cardiol 2015 Oct 13;66(15):1643-53. PMID 26449133
  • Carr JJ, Jacobs DR Jr, Terry JG, et. al. Association of coronary artery calcium in adults aged 32 to 46 years with incident coronary heart disease and death. JAMA Cardiol 2017 Apr 1;2(4):391-399. PMID 28196265
  • Mortensen MB, Fuster V, Muntendam P, et. al. A simple disease guided approach to personalize ACC/AHA recommended statin allocation in elderly people: the BioImage Study. J Am Coll Cardiol 2016 Aug 30;68(9):881-91. PMID 27561760
  • Yano Y, O’Donnell CJ, Kuller L. et, al. Association of coronary artery calcium score vs age with cardiovascular risk in older adults: an analysis of pooled population based studies. JAMA Cardiol 2017 Sep 1;2(9):986-994. PMID 28746709
  • Pender A, Lloyd-Jones DM, Stone NJ, et. al. Refining statin prescribing in lower-risk individuals: informing risk/benefit decisions. J Am Coll Cardiol 2016 Oct 11;68(15):1690-1697. PMID 27712783
  • Mitchell JD, Fergestrom N, Gage BF, et. al. Impact of statins on cardiovascular outcomes following coronary artery calcium scoring. J Am Coll Cardiol 2018 Dec 25;72(25):3233-3242. PMID 30409567
  • Agency for Healthcare Research and Quality (AHRQ). Risk Factors in Cardiovascular Disease Risk Assessment: A Systematic Evidence Report for the U.S. Preventative Services Task Force. 
  • Greenland P, Blaha MJ, Budoff MJ, et. al. Coronary calcium score and cardiovascular risk. Am Coll Cardiol 2018;72:434-477
  • American Heart Association. Coronary calcium test could help clarify heart disease risk and control cholesterol. American Heart Association News. Published November 13, 2018
  • Arnett DK, Blumenthal RS, Albert MA, et. al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. J Am Coll Cardiol 2019, March 17  
  • Yeboah J, McClelland RL, Polonsky TS, et.al Comparison of novel risk markers for improvement in cardiovascular risk assessment in intermediate risk individuals. JAMA 2012 Aug 22;308(8):788-95. PMID 22910756

 

Policy History:

  • July 2019 - Annual Review, Policy Renewed
  • July 2018 - Annual Review, Policy Renewed
  • July 2017 - Annual Review, Policy Revised
  • July 2016 - Annual Review, Policy Revised
  • August 2015 - Annual Review, Policy Revised
  • September 2014 - Annual Review, Policy Revised
  • October 2013 - Annual Review, Policy Renewed
  • November 2012 - Annual Review, Policy Renewed
  • November 2011 - Annual Review, Policy Renewed
  • November 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.