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Published online before print October 19, 2007, 10.1148/radiol.2453061899

(Radiology 2007;245:720.)

A more recent version of this article appeared on December 1, 2007
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© RSNA, 2007

Evidence-based Practice

Coronary Arteries: Diagnostic Performance of 16- versus 64-Section Spiral CT Compared with Invasive Coronary Angiography—Meta-Analysis1

Michèle Hamon, MD, Rémy Morello, MD, John W. Riddell, MD, and Martial Hamon, MD

1 From the Departments of Radiology (Michèle Hamon), Statistics (R.M.), and Cardiology (J.W.R., Martial Hamon), University Hospital of Caen, Avenue Côte de Nacre, 14033 Caen Cedex, Normandy, France. Received November 6, 2006; revision requested January 10, 2007; revision received February 5; accepted March 16; final version accepted May 1. Address correspondence to Michèle Hamon (e-mail: hamon-mi{at}chu-caen.fr).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 ADVANCES IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
Purpose: To perform a meta-analysis to compare the diagnostic performance of 16- versus 64-section computed tomography (CT) for the diagnosis of coronary artery disease (CAD).

Materials and Methods: The MEDLINE database was searched for relevant original articles. Criteria for inclusion of articles were (a) use of multisection spiral CT as a diagnostic test for obstructive CAD, (b) use of the newer generation of multisection spiral CT (16 or 64 section) scanners, and (c) use of coronary angiography as the reference standard for diagnosing obstructive CAD (>50% diameter stenosis was selected as the cutoff criterion for diagnosis of CAD). After data extraction, the analysis was performed according to a random-effects model. Between-study statistical heterogeneity also was assessed by using Cochran Q {chi}2 tests.

Results: Of 328 identified relevant articles, 37 fulfilled all inclusion criteria, with data available for a patient-based analysis in 28. The patient-based analysis included pooled data from 16 studies, corresponding to 1292 patients who underwent 16-section spiral CT, and from 12 studies, corresponding to 695 patients who underwent 64-section spiral CT. Respectively, the results for 16-section CT versus 64-section CT were 95% (95% confidence interval [CI]: 93%, 96%) versus 97% (95% CI: 95%, 98%) for sensitivity (P = .03), 69% (95% CI: 66%, 73%) versus 90% (95% CI: 86%, 93%) for specificity (P < .001), 79% (95% CI: 76%, 82%) versus 93% (95% CI: 91%, 96%) for positive predictive value (PPV) (P < .001), 92% (95% CI: 88%, 94%) versus 96% (95% CI: 92%, 98%) for negative predictive value (P < .001), and 72.05 (95% CI: 31.35, 165.56) versus 181.82 (95% CI: 88.70, 372.71) for diagnostic odds ratio (P = .1).

Conclusion: Sixty-four–section spiral CT has significantly higher specificity and PPV on a per-patient basis compared with 16-section CT for the detection of greater than 50% stenosis of coronary arteries.

Supplemental material: http://radiology.rsnajnls.org/cgi/content/full/2453061899/DC1

© RSNA, 2007


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
 ADVANCES IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
In the past few years, we have witnessed a rapid technologic development in multisection computed tomography (CT). Recent advances have improved medical imaging as a whole and, in particular, have opened up the possibility of assessing coronary artery anatomy noninvasively. Improvement in the diagnosis of coronary artery disease (CAD) is important because it remains the leading cause of mortality in industrialized societies (1). The reference standard for assessment of CAD is invasive coronary angiography, which carries with it a small, but definite, risk of major complications (2).

Several researchers have compared conventional coronary angiography and multisection CT, and initial results with 16- and 64-section CT seem promising for noninvasive assessment of coronary luminal stenosis. Although the newer 64-section CT scanners, with more detectors and faster tube rotation, are supposed to improve the diagnostic performance for detection of CAD, many centers are still using 16-section CT scanners in daily practice. Thus, the purpose of our study was to perform a meta-analysis to compare the diagnostic performance of 16- versus 64-section spiral CT for the diagnosis of CAD.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 ADVANCES IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
Search Strategy
Database searches for English-language articles published until October 2006 were performed in MEDLINE by two investigators independently (Michèle Hamon, Martial Hamon). We combined the medical subject headings for "computed tomography," "multislice computed tomography," and "coronary angiography" with the exploded term "coronary artery disease." We also scanned references in retrieved articles and reviews. The retrieved studies were carefully examined to exclude potentially duplicate or overlapping data, by the same two investigators who performed the database searches. Abstracts from meetings were excluded, as they could not provide adequately detailed data and their results might not be final. Only studies about the evaluation of the presence of a greater than 50% stenosis in obstructive CAD in native coronary arteries by using both conventional invasive coronary angiography and multisection CT in the same subjects were included. Studies were eligible for inclusion regardless of whether or not they referred to subjects who were suspected of having CAD or to subjects in whom CAD was proved. Disagreements were resolved in consensus by the same two authors who examined the retrieved studies.

Study Eligibility
We included a study if (a) multisection CT was used as a diagnostic test for obstructive CAD (>50%-diameter stenosis was selected as the cutoff criterion for diagnosis of CAD by using conventional invasive angiography as the reference standard); (b) a newer-generation multisection CT scanner (16 or 64 section) was used; (c) results were reported in absolute numbers of true-positive, false-positive, true-negative, and false-negative results or sufficiently detailed data for deriving these numbers was presented; and (d) coronary angiography was used as the reference standard for the diagnosis of obstructive CAD. Studies were excluded for the following reasons: (a) They included patients who had undergone coronary artery bypass graft surgery, (b) they included patients who had undergone percutaneous coronary intervention for long-term stent patency assessment, (c) they included a subset of patients who underwent prior heart transplantation, or (d) they included fewer than 30 enrolled patients.

Data Extraction
The same two investigators who performed the database searches also performed the data extraction independently, and discrepancies were resolved in consensus. The following information was extracted from each study: first author, year of publication, and journal; study population characteristics including sample size (number of patients evaluated with both tests, number of patients excluded); number of patients with documented CAD; sex; mean age and standard deviation; mean heart rate and standard deviation; prevalence of CAD; relative timing of the two imaging procedures and blinding of a reader to evaluation results of one test when evaluating the results of the other and to the clinical condition of the tested subject; technical characteristics of the multisection CT scanner, including type and brand of machine used, rotation time (in milliseconds), collimation (in millimeters); technical parameters for multisection CT acquisition; radiation dose (in millisieverts); use of tube modulation; amount of iodinated contrast medium (in grams); and rate of ß-adrenergic blocking agent usage.

Basis of assessment (minimum coronary artery diameter in millimeters) and rate of unassessable and excluded segments (in percentages) were also recorded. Data were recorded separately, whenever available, at the level of segments and subjects. The study quality conformed to the Quality Assessment of Studies of Diagnostic Accuracy Included in Systematic Reviews guidelines (3).

Data Synthesis and Statistical Analysis
Categoric variables from individual studies are presented as percentages calculated by dividing the number in the subset by the total number and continuous variables are presented as mean values with the standard deviation. Measures of diagnostic accuracy are reported as point estimates (with 95% confidence intervals [CIs]). The analysis was performed with data at the coronary artery segment level and at the patient level.

With true-positive, true-negative, false-positive, and false-negative results, we computed sensitivity, specificity, positive and negative likelihood ratios (LRs), and diagnostic odds ratios (4). Although sensitivity and specificity are well known as measures of diagnostic accuracy, these results may be influenced by the prevalence of disease in tested subjects. The positive LR (the ratio between sensitivity and specificity subtracted from one) provides an estimate of the probability of a positive test in a patient with disease, and the negative LR (the ratio between sensitivity subtracted from one and specificity) gives an estimate of the probability of a negative test among patients with disease. Both LRs are independent from prevalence rates, and there is consensus that a positive LR greater than 10 and a negative LR less than 0.1 provide reliable evidence of satisfactory diagnostic performance (5).

Finally, the information from both positive and negative LRs can be combined in a single parameter, the diagnostic odds ratio, computed as the ratio of the positive LR to the negative LR. This single parameter provides an estimate of how much greater the odds of having the disease are for the people with a positive test result than they are for the people with a negative test result. Although LRs are the recommended summary statistics for systematic reviews of diagnostic studies, predictive values also may be of interest for clinicians, even if they vary widely in their dependence on disease prevalence. Such limitations of predictive values notwithstanding, these values were also computed and reported as exploratory data.

We computed all statistics for individual studies and then combined them by using a random-effects model, weighting each point estimate by the inverse of the sum of its variance and the between-study variance. Between-study statistical heterogeneity was also assessed by using Cochran Q {chi}2 tests (cutoff for statistical significance, P ≤ .1). Furthermore, as diagnostic parameters are by definition interdependent, independent weighting may sometimes give spurious results and provide biased estimates. Weighted symmetric summary receiver operating characteristic plots, with pertinent areas under the curve, were thus computed in order to overcome this problem of interdependence, by using the Moses-Shapiro-Littenberg method (6–8).

For analysis of both 16- and 64-section CT on a per-patient basis, the standard error of the log diagnostic odds ratio was plotted against the log diagnostic odds ratio.

Statistical computations were performed with a social sciences software package (SPSS 14.0; SPSS, Chicago, Ill) and software for meta-analysis (9), and significance testing was performed with the two-tailed test, with an {alpha} level of .05.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 ADVANCES IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
Through database searches, we identified 328 potentially relevant citations. After title and/or abstract assessment, we retrieved as complete reports 151 studies. From this number, 114 studies were excluded because (a) 16- or 64-section CT was not employed, (b) only graft or stent patency or atherosclerotic plaque assessment was evaluated, (c) the studies included overlapping data, (d) the studies were in a language other than English, (e) it was impossible to find or calculate absolute numbers from presented data, or (f) no systematic angiographic control was performed. Thus, we finally included 37 studies in the systematic review (Fig 1).


Figure 1
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  		Figure 1: Flow diagram of the reviewing process.

 
All studies were published between January 2002 and October 2006 (Tables 1, 2). The median per-patient prevalence of CAD was 59% (range, 8%–100%). Mean rate of nonevaluable scans was 4.4% and 1.9% for 16- and 64-section CT, respectively (P = .002). Heart rate control with ß-adrenergic blocking agents was used in 64% of patients who underwent 16-section CT and in 55% of patients who underwent 64-section CT (P < .001). The rate of unassessable segments ranged from 1% to 29% (mean, 12%) and from 0% to 12% (mean, 4%) for 16- and 64-section CT, respectively (P < .001) (Tables 1, 2). The basis of assessment among the studies and effective radiation doses are given in Table 1 for 16-section CT and Table 2 for 64-section CT.


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  		Table 1. Characteristics of Included Studies in Which 16-Section CT Was Used

 

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  		Table 2. Characteristics of Included Studies in Which 64-Section CT Was Used

 
Diagnostic Performance of 16- versus 64-Section CT
Segment-based meta-analysis.—Per-segment analysis results were pooled from 33 studies (20 studies corresponding to 16510 segments examined with 16-section CT and 13 studies corresponding to 10388 segments examined with 64-section CT) (Table 3, Fig 2). Per-segment analysis at 16-section CT provided the following results: sensitivity of 77% (95% CI: 75%, 79%), specificity of 91% (95% CI: 91%, 92%), positive predictive value (PPV) of 60% (95% CI: 59%, 62%), negative predictive value (NPV) of 96% (95% CI: 96%, 96%), positive LR of 17.40 (95% CI: 9.93, 30.51), negative LR of 0.14 (95% CI: 0.06, 0.30), and diagnostic odds ratio of 122.3 (95% CI: 52.3, 285.9). For 64-section CT, the results were as follows: sensitivity of 88% (95% CI: 86%, 89%), specificity of 96% (95% CI: 96%, 97%), PPV of 79% (95% CI: 77%, 81%), NPV of 98% (95% CI: 98%, 98%), positive LR of 24.0 (95% CI: 19.4, 29.8), negative LR of 0.10 (95% CI: 0.06, 0.17), and diagnostic odds ratio of 231.9 (95% CI: 141.6, 379.6). Heterogeneity was significant for all the aforementioned diagnostic performance measures with 16-section CT (P < .001) and 64-section CT (P < .001).


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  		Table 3. Per-Segment and per-Patient Analysis

 

Figure 2
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  		Figure 2: Diagnostic performance of 16-section CT (white bars) compared with 64-section CT (black bars) on a per-segment basis (P < .001 for all).

 
Patient-based meta-analysis.—Per-patient results were reported, and thus pooled, in 28 studies (including 16 studies corresponding to 1292 patients who underwent 16-section CT and 12 studies corresponding to 695 patients who underwent 64-section CT) (Table 3). The study of Probst et al (22) was excluded from the analysis because of zero values for false-positive, false-negative, and true-negative results; thus, variance is infinite and CIs could not be computed.

Per-patient analysis provided the following results, respectively, for 16- and 64-section CT (Fig 3; Figures E1–E5 [http://radiology.rsnajnls.org/cgi/content/full/2453061899/DC1]): 95% (95% CI: 93%, 96%) versus 97% (95% CI: 95%, 98%) sensitivity, 69% (95% CI: 66%, 73%) versus 90% (95% CI: 86%, 93%) specificity, 3.5 (95% CI: 2.67, 5.86) versus 7.49 (95% CI: 4.67, 12.00) positive LR, 0.07 (95% CI: 0.04, 0.13) versus 0.06 (95% CI: 0.03, 0.09) negative LR, 72.05 (95% CI: 31.35, 165.56) versus 181.82 (95% CI: 88.70, 372.71) diagnostic odds ratio, and 0.95 (95% CI: 0.91, 0.99) versus 0.98 (95% CI: 0.96, 0.99) symmetric area under the curve (Fig 4). The pooled PPVs for the per-patient analysis with 16- and 64-section CT, respectively, were 79% (95% CI: 76%, 82%) and 93% (95% CI: 91%, 96%), whereas the NPVs were 92% (95% CI: 88%, 94%) and 96% (95% CI: 92%, 98%), respectively. The rates of false-positive results were 13.6% and 4% for 16- and 64-section CT, respectively (P < .001).


Figure 3
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  		Figure 3: Diagnostic performance of 16-section CT (white bars) compared with 64-section CT (black bars) on a per-patient basis (P = .03 for sensitivity, P < .001 for the other values).

 

Figure 4
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  		Figure 4: Plot of symmetric summary receiver operating characteristic (SROC) on a per-patient basis for comparison of multisection CT with coronary angiography. Left: 16-section CT. Right: 64-section CT. The receiver operating characteristic curve provides a graphical display of diagnostic accuracy, by plotting specificity subtracted from one on the horizontal axis and sensitivity on the vertical axis. The pertinent area under the curve (AUC) and Cochran Q statistic (Q*) (the point where sensitivity and specificity are maximal), both with standard errors (SE), are also included.

 
Heterogeneity was significant for all the aforementioned diagnostic performance measures with 16-section CT (P < .001). With 64-section CT, there was significant heterogeneity for specificity, PPV, and positive LR. Funnel plots for 16- and 64-section CT on a per-patient basis are shown in Figure E6 (http://radiology.rsnajnls.org/cgi/content/full/2453061899/DC1). Quality assessment for all included studies is shown in Table 4.


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  		Table 4. Quality Assessment

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
ADVANCES IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
In our study, pooled diagnostic performance measures improved with 64-section CT compared with 16-section CT in a per-segment analysis, especially for sensitivity. In the more clinically relevant per-patient analysis, sensitivity (95%) was good with 16-section CT and there was no significant improvement in sensitivity (97%) with 64-section CT (P = .03). The NPV was also excellent with 16- and 64-section CT (92% vs 96%), making them excellent tools to rule out CAD. The real improvement in the comparison of 16- and 64-section CT on a per-patient basis was observed with the significant increase in specificity from 69% to 90% (P < .001) and in the increase in the PPV from 79% to 93% (P < .001). Sixty-four–section CT is more accurate in determining healthy subjects and, thus, can aid in avoiding additional invasive angiography. This point is of great importance for daily practice and represents a major advantage of 64-section CT compared with 16-section CT. According to our pooled results, unnecessary coronary angiography would have been performed on the basis of multisection CT results in 14% of patients who underwent 16-section CT and in 4% of patients who underwent 64-section CT.

Technical improvements with 64-section CT offer multiple advantages compared with 16-section CT. Shortening total scan time from more than 20 seconds with 16-section CT to 9–13 seconds with 64-section CT increases clinical feasibility. This improvement facilitates breath holding, reduces the occurrence of respiratory arrhythmias, and minimizes the effect of tachycardia and extrasystoles. With 16-section CT, 4.4% of patients had nonevaluable scans, whereas with 64-section CT, 1.9% of patients had them.

This increase in temporal and also spatial resolution allows a lower occurrence of motion artifact and a better analysis of more distal branches. Results from the current 64-section CT showed a significant improvement in the proportion of assessable segments (an average of 12% of segments were of poor quality with 16-section CT compared with an average of 4% with 64-section CT). Analysis of all coronary segments was possible in almost all studies in which 64-section CT was performed.

However, 64-section CT has limitations, such as the requirement for a regular, and preferably low, heart rate. Use of ß-adrenergic blocking agents in patients with a heart rate of more than 70 beats per minute is still required in most studies, which indicates the importance of future development in temporal resolution to make this technique applicable to more patients (47).

Another common factor that affects the evaluation of the coronary artery lumen in multisection CT is the presence of extensive calcification, which is still a problem with 64-section CT, although the degree of artifact seems to be less severe (a smaller voxel size reduces the partial volume effects and minimizes the degree of calcium blooming artifacts).

Image resolution also may be compromised in morbidly obese patients because of x-ray attenuation. Among other shortcomings of multisection CT, compared with coronary angiography, are the x-ray exposure and the relatively higher radiation dose that the patient receives (48,49). The effective radiation dose for invasive coronary angiography is known to be in the range of 2–5 mSv. In our meta-analysis, the effective radiation dose varied on the basis of the presence of the tube current modulation and ranged from 8 to 16 mSv for 16-section CT and from 8 to 21 mSv for 64-section CT in the articles in which this information was provided. This substantial variation in x-ray dose may be reduced by the routine use of dose-saving algorithms, as suggested in a recent study (50).

Data abstraction and quality assessment were performed by independent reviewers, and resolution of any divergences was reached in consensus. Thus, the interoperator agreement could not be quantitatively assessed. Substantial heterogeneity was observed in the pooled results for 16-section CT, and the heterogeneity was explained by differences in reconstruction algorithms, cardiac cycle phases chosen for reconstruction, software used for analysis, experience of the readers, volume and flow rate of the contrast agent injected, and also differences in patient characteristics.

Funnel plots are asymmetric for 16- and 64-section CT, thus suggesting that investigators in studies with smaller numbers of patients tend to report higher accuracy. One possible explanation is publication bias: Studies with smaller numbers of patients in which investigators report lower accuracy may be less likely to be submitted or accepted for publication.

It should also be emphasized that these results were obtained in patients who were selected to undergo coronary angiography; thus, at presentation, in these patients, there was a reasonably high pretest probability of CAD. The median prevalence of CAD was as high as 59% among the included studies, and it ranged from 8% to 100%. However, in practice, multisection CT is more likely to be applied to patients in whom there is a low to intermediate probability of CAD. Whether or not the performance of multisection CT can be reproduced in patients in whom there is a lower prevalence of CAD remains to be assessed. This finding highlights the need for studies in which the diagnostic performance of multisection CT can be evaluated in a less selected patient population before its application can be established as an alternative to coronary angiography.

In summary, the results of our meta-analysis demonstrate, at the more clinically relevant patient-based level, a high sensitivity and NPV with both 16- and 64-section CT in selected patients with a high prevalence of CAD. These results suggest that multisection CT may represent a useful alternative to coronary angiography to reliably rule out CAD in selected patients. However, 16-section CT is limited by a high rate of false-positive results and nonevaluable scans, which would lead to the use of conventional angiography. With improved spatial resolution and shorter acquisition times, the diagnostic performance of multisection CT has been significantly improved with the development of 64-section CT. Increased clinical feasibility and improvement in image quality with fewer unassessable coronary artery segments leads to a significant increase in specificity and PPV and represents a major advantage of 64-section CT compared with 16-section CT.


   ADVANCES IN KNOWLEDGE
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 ADVANCES IN KNOWLEDGE
IMPLICATION FOR PATIENT CARE
 References
 


   IMPLICATION FOR PATIENT CARE
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 ADVANCES IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
References
 


   FOOTNOTES
 

Abbreviations: CAD = coronary artery disease • CI = confidence interval • LR = likelihood ratio • NPV = negative predictive value • PPV = positive predictive value

Guarantors of integrity of entire study, all authors; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, all authors; statistical analysis, all authors; and manuscript editing, all authors

Authors stated no financial relationship to disclose.


   References
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 ADVANCES IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 

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