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European Heart Journal Advance Access originally published online on July 31, 2006
European Heart Journal 2007 28(20):2485-2490; doi:10.1093/eurheartj/ehl148
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© The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Head-to-head comparison of multislice computed tomography and exercise electrocardiography for diagnosis of coronary artery disease

Marc Dewey1,*, Hans-Peter Dübel2, Tania Schink3, Gert Baumann2 and Bernd Hamm1

1 Department of Radiology, Medical School, Humboldt-Universität zu Berlin, Germany
2 Department of Cardiology, Medical School, Humboldt-Universität zu Berlin, Germany
3 Medical Biometry Charité, Medical School, Humboldt-Universität zu Berlin, Germany

Received 27 March 2006; revised 20 June 2006; accepted 23 June 2006; online publish-ahead-of-print 31 July 2006.

* Corresponding author. Tel: +49 30 4505 27296; fax: +49 30 4505 27996. E-mail address: marc.dewey{at}charite.de


   Abstract
Top
 Abstract
Introduction
 Methods
 Multislice computed tomography
 Results
 Discussion
 Conclusion
 References
 
Aims: To prospectively compare multislice computed tomography (MSCT) and exercise electrocardiography (ex-ECG) for diagnosis of coronary artery disease (CAD) with conventional coronary angiography as the reference standard.

Methods and results: A consecutive cohort of 80 patients with suspected CAD was examined with MSCT using 16 x 0.5 mm detector collimation, ex-ECG, and conventional coronary angiography according to standard protocols. Results were compared using the paired McNemar's test, the {chi}2 test, and 95%CIs. Both the sensitivity and specificity of MSCT [91% (40 of 44 patients, 95%CI 78–97%) and 83% (30 of 36 patients, 95%CI 67–94%)] were significantly higher (P = 0.039 and P < 0.001) than those for ex-ECG [73% (32 of 44 patients, 95%CI 57–85%) and 31% (11 of 36 patients, 95%CI 16–48%)]. The pairwise McNemar's test showed significant differences between MSCT and ex-ECG in the overall diagnosis in patients with suspected CAD (P = 0.036). The rate of non-diagnostic examinations was not significantly (P = 0.078) different between MSCT and ex-ECG [8% (6 of 80 patients, 95%CI 3–16%) vs. 19% (15 of 80 patients, 95%CI 11–29%)].

Conclusion: In this consecutive cohort of patients scheduled to undergo conventional coronary angiography, the performance of MSCT for diagnosis of CAD was superior to that of ex-ECG.

Key Words: Coronary artery • Coronary angiography • Cardiac • Computed tomography • Electrocardiography • Exercise test • Diagnosis • Sensitivity


   Introduction
Top
 Abstract
 Introduction
Methods
 Multislice computed tomography
 Results
 Discussion
 Conclusion
 References
 
Multislice computed tomography (MSCT) is an upcoming alternative for the direct non-invasive assessment of coronary arteries with a fair overall accuracy for diagnosis of coronary artery disease (CAD) on the patient level.1–6 Nevertheless, exercise electrocardiography (ex-ECG) continues to be the most commonly applied non-invasive test for diagnosis of CAD and, unlike MSCT, does not require radiation exposure and contrast agent administration. Thus, a head-to-head comparison of MSCT and ex-ECG would be highly desirable as a basis for directing future research and discussing decision making with regard to the potential role of both tests in CAD. We performed a prospective head-to-head trial on the diagnostic performance of MSCT and ex-ECG in 80 patients with suspected CAD.


   Methods
Top
 Abstract
 Introduction
 Methods
Multislice computed tomography
 Results
 Discussion
 Conclusion
 References
 
Study design
We prospectively compared the diagnostic performance of MSCT and ex-ECG in a consecutive cohort of 80 patients (Table 1) with suspected CAD who were scheduled to undergo conventional coronary angiography, which served as the reference standard in the study. The study was performed according to the intention-to-diagnose design,7 and both non-invasive tests were always performed within 14 days before conventional coronary angiography and conventional coronary angiography was performed without regard to the results of both index tests to avoid partial verification bias.8 Thus, all patients were included in the analysis irrespective of the results of ex-ECG and MSCT. Study analysis was conducted in a blinded fashion. Pretest likelihood of CAD in the 80 patients in the study was 75 ± 27%.9 Patients with unstable angina pectoris, cardiac arrhythmia, pregnancy, and known CAD (including prior myocardial infarction) were not eligible for the study. The study protocol was approved by the institutional review board. All patients gave written informed consent.


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  		Table 1 Demographic data and severity of disease

 
Exercise electrocardiography
Ex-ECG was performed with the patient in a semi-upright position on a bicycle ergometer according to the German guideline on ex-ECG.10 Prior to stress testing, the 12-channel resting ECG was analysed.11 The ECG was monitored continuously throughout the test and blood pressure measured at every load increment stage. In addition, the ECG was recorded every minute with a paper feed of 50 mm/s. Each exercise stage began with 25 or 50 W with a work load increment of 25 W after 3 min until the test was discontinued. Criteria for discontinuation of exercise testing according to the guidelines were: a systolic and diastolic blood pressure of over 230 and 130 mmHg, respectively, a drop in blood pressure of over 10 mmHg, horizontal and downsloping ST-segment depressions of over 0.3 mV or ST-segment elevations of more than 0.1 mV, ventricular tachycardia persisting for over 30 s, increasing number or polytopic premature beats, disturbed intraventricular or atrioventricular transition, exhaustion of the patient, severe dyspnoea, and angina pectoris.10,12,13 The target heart rate was determined according to the following formula: 0.8 x (220–age).12 After discontinuation, ECG recording and blood pressure measurement were continued until values returned to baseline levels.

The stress test response was considered ‘positive’ when at least 0.1 mV horizontal or downsloping ST-segment depression or elevation was measured at least 80 or 60 ms after the J point during exercise or recovery or typical angina pectoris occurred. In case of upsloping ST-segment depression, a change of > 0.15 mV noted at least 80 ms after the J point was classified as a diagnostically relevant change.14 The reader who analysed ex-ECG was blinded to the results of MSCT and also determined the percentage of tests that were non-diagnostic (tests in which neither the target heart rate, angina pectoris nor an electrocardiographic endpoint was reached).


   Multislice computed tomography
Top
 Abstract
 Introduction
 Methods
 Multislice computed tomography
Results
 Discussion
 Conclusion
 References
 
Non-invasive coronary angiography with MSCT was performed during one breath-hold on a scanner using 16 x 0.5 mm detector collimation and 400 ms gantry rotation time (Aquilion, Toshiba, Otawara, Japan). Other parameters were 120 kV, 300 mA, and 0.2 pitch. A non-ionic contrast agent (iodixanol, 320 mg I/mL, GE Healthcare Biosciences, Buckinghamshire, UK) was injected intravenously at a speed of 3.5 mL/s. The manual sure-start feature of the scanner was used to visualize the influx of the contrast medium (bolus-tracking) and to start image acquisition.15 Images were reconstructed with the multisegment approach16 at 10 time points at 10% intervals with the centre of the reconstruction window being between 0 and 90% of the cardiac cycle to obtain optimal image quality for all coronary arteries. As multi-segment reconstruction significantly improves the temporal resolution of MSCT16,17 no beta-blockers were given before the examination. The resulting average heart rate during scanning was 72 bpm (Table 1). Images were reconstructed on a 180-mm field of view resulting in an optimal exploitation of the available resolution of 10 line pairs/cm (0.35 x 0.35 mm in-plane resolution). A semiautomatic analysis tool was used for assessment of the significance (at least 50% diameter reduction) of coronary artery stenoses on curved multiplanar reformations and cross-sections orthogonal to the vessels.15 The reader performing the analysis was blinded to the results of conventional coronary angiography and ex-ECG. All 15 coronary artery segments according to the classification of the American Heart Association with a diameter of at least 1.5 mm on conventional coronary angiography constituted the basis of analysis.18 As for ex-ECG, the patients were classified as positive, negative, or non-diagnostic with MSCT.

Conventional coronary angiography
Conventional coronary angiography was performed after MSCT using standard techniques (Integris 3000, Philips Medical Systems, Best, The Netherlands) with the transfemoral approach after MSCT. Using two orthogonal projections, quantitative coronary angiography was performed to identify significant diameter reductions (at least 50% in the tightest view). The diameter of the reference vessel on conventional coronary angiography had to measure at least 1.5 mm for a stenosis to be included in the analysis, thus comprising all stenoses amenable to revascularization treatment.

Statistical analysis
All data are expressed as means ± SD or rates and medians are given in addition for comparison with literature values. The pairwise McNemar's test was used to compare per-patient sensitivity, specificity, and non-diagnostic rate in comparison with conventional coronary angiography as the reference standard. For the calculation of both sensitivity and specificity, non-diagnostic patients were considered to be false-negative or false-positive, respectively (conservative approach), according to the intention-to-diagnose principle7 using a 2 x 3 table for comparison with the reference test as described.19,20 The Fisher exact test was used to analyse the per-patient negative and positive predictive value of MSCT and ex-ECG in comparison with conventional coronary angiography as the reference standard. For all diagnostic accuracy parameters, the associated 95% CIs are given. The overall per-patient diagnosis as given by MSCT and ex-ECG were compared using the pairwise McNemar's test. If at least one coronary artery segment was deemed to be non-diagnostic with MSCT and there was no coronary stenosis detected in the respective patient, the patient was considered to be non-diagnostic according to the intention-to-diagnose design.7 The sample size of the present study is mainly due to time constraints and was not determined by power analysis before starting the study. Statistical analyses were conducted using SPSS version 12.0. A P-value of 0.05 or less was considered significant.


   Results
Top
 Abstract
 Introduction
 Methods
 Multislice computed tomography
 Results
Discussion
 Conclusion
 References
 
Conventional coronary angiography as the reference standard was successfully performed in all 80 patients and no relevant cardiovascular events occurred between the tests. Thus, all 80 eligible patients were available for the intention-to-diagnose analysis of the diagnostic performance of MSCT and ex-ECG.

MSCT was successfully performed in all of the 80 patients. The median effective dose of MSCT was estimated to be 11.8 mSv using CT-Expo version 1.3.21 One of the 80 patients could not undergo the bicycle exercise test because of physical inability. The median exercise workload was 125 W (mean: 117 ± 35 W). The resulting mean maximum heart rate during the ex-ECG of 126 ± 22 bpm (median: 129) corresponded to 101 ± 18% of the mean target heart rate (125 ± 7 bpm, median: 126). Thirty of the 80 patients (38%) did not achieve the target heart rate with an average difference to the target heart rate of 19 ± 16 bpm (median: 15). The mean maximum systolic and diastolic blood pressure during ex-ECG were 191 ± 32 mmHg (median: 189) and 93 ± 16 (median: 90), respectively.

Diagnostic accuracy
Both the sensitivity and specificity of MSCT [91% (40 of 44 patients, 95%CI 78–97%) and 83% (30 of 36 patients, 95%CI 67–94%)] were significantly higher (P = 0.039 and P < 0.001, Figure 1) than those for ex-ECG [73% (32 of 44 patients, 95%CI 57–85%) and 31% (11 of 36 patients, 95%CI 16–48%)]. Figures 2 and 3 demonstrate examples of patients with and without CAD correctly detected with the two tests. Among the 25 negative patients who were not correctly detected with ex-ECG, nine patients did not achieve the target heart rate (non-diagnostic) and 16 patients were false-positive (four of these did not reach the target heart rate). Also the per-patient negative and positive predictive values were significantly higher for MSCT than for ex-ECG (Table 2). With regard to the overall per-patient diagnosis given by both tests, the pairwise McNemar's test showed significant differences between MSCT and ex-ECG in the assessment of patients with suspected CAD (P = 0.036, Table 3).


Figure 1
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  		Figure 1 Sensitivity and specificity of MSCT and ex-ECG for CAD. The error bars depict the 95%CI for the sensitivities and specificities. MSCT was significantly more sensitive (P = 0.039) and specific (P < 0.001) than ex-ECG.

 

Figure 2
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  		Figure 2 Comparison of MSCT and ex-ECG with conventional coronary angiography in a patient with significant disease in the RCA. Significant stenosis (arrows) in the distal segment of the RCA as seen with MSCT using a curved multiplanar reformation along the vessel (top right panel) and conventional coronary angiography (bottom right panel). During ex-ECG significant ST-segment depression was observed in II, III, and aVF during stress (left panel).

 

Figure 3
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  		Figure 3 Significant CAD correctly ruled out with the two non-invasive tests and confirmed on conventional coronary angiograms. No significant stenoses were observed in this patient in all coronary arteries using MSCT (A, B, and D) and conventional coronary angiography (C and E), whereas there were also no significant changes in the ST-segment during rest and stress ECG (left panel). Panels A, B, and D show no stenoses on curved multiplanar reformations of MSCT coronary angiography along the left anterior descending, left circumflex, and RCA, respectively; whereas Panels C and E show the conventional coronary angiograms of the left and RCA system, respectively.

 

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  		Table 2 Comparison of diagnostic accuracy of MSCT and ex-ECG on the per-patient level

 

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  		Table 3 Per-patient comparison of ex-ECG and MSCT for identifying patients with CAD in a 3 x 3 table

 
The six non-diagnostic results using MSCT were all caused by motion artefacts of the right coronary artery (RCA) resulting from insufficient temporal resolution. In these cases, significant motion artefacts that limited diagnostic assessment were in addition also present in the left coronary artery and the left circumflex artery (CX) in one patient each. Of the patients who underwent ex-ECG, 15 reported typical angina pectoris during the test. Of these 15 patients, 11 were true positive as demonstrated by conventional coronary angiography resulting in a predictive value of angina pectoris (73%, 95%CI 45–92%) comparable with the overall positive predictive value of ex-ECG (67%, 95%CI 52–80%). When the patients achieved the target heart rate, the sensitivity of ex-ECG increased when compared with patients who did not achieve the target heart rate [78% (21 of 27 patients, 95%CI 58–91%) vs. 65% (11 of 17 patients, 95%CI 38–86%)], however, this difference was not significant (P = 0.548, unpaired {chi}2 test).

Severe CAD (three-vessel disease) was correctly detected by ex-ECG in 11 of 13 (85%, 95%CI 55–98%) and by MSCT in all 13 patients (100%, 95%CI 75–100%). One of the two false-negative patients with three-vessel disease on ex-ECG did not reach the target heart rate and both of them had normal ECG tracings during and after the test. All of the four left main (LM) coronary artery stenoses were correctly detected using the two non-invasive tests. Interestingly, during ex-ECG three of these four patients had typical symptoms but no positive ECG stress test response.


   Discussion
Top
 Abstract
 Introduction
 Methods
 Multislice computed tomography
 Results
 Discussion
Conclusion
 References
 
Non-invasive detection or exclusion of CAD in patients with low-to-intermediate likelihood of CAD is a useful clinical approach both from a clinical22 and economic perspective.23,24 Ex-ECG is the most commonly applied non-invasive test for diagnosis of CAD. MSCT allows direct visualization of the coronary arteries and recent reports have shown this diagnostic approach to be highly accurate.1–6,16,25 The head-to-head comparison presented here shows that the diagnostic performance of MSCT is superior to that of ex-ECG. Although MSCT involves administration of an iodinated contrast agent and radiation exposure, it might therefore be preferable over ex-ECG for non-invasive diagnosis of CAD in certain patients. However, larger multi-centre studies on the prognostic importance of MSCT are still missing, which are especially important in view of the large number of studies available in support of the use of ex-ECG (including the stress test response),26 especially for risk stratification.27 On the other hand, calcified and non-calcified subclinical coronary artery plaques identified on the MSCT coronary angiogram may provide similar prognostic information.

The effective dose of MSCT coronary angiography (11.8 mSv) and the need to inject an iodinated contrast agent are further causes of concern about this new non-invasive test. It is important to note that also ex-ECG has a certain risk, the most relevant being myocardial infarction or death which have been confirmed in multiple surveys to occur in approximately 10 out of 10 000 tests.28 From a workflow perspective, it is relevant that the time needed to perform an MSCT coronary angiography including the analysis and reporting (about 25–35 min) is longer than that of ex-ECG (~15–25 min). Moreover, the cost of MSCT (out-patient reimbursement rate for a contrast-enhanced chest CT in Germany {approx}175{euro}) is much higher than that of ex-ECG (out-patient reimbursement in Germany {approx}33{euro}). Thus, from an economic perspective it appears to be necessary to also compare the cost-effectiveness of MSCT and ex-ECG in future randomized prospective studies. Furthermore, it is an important clinical drawback of MSCT that, in contrast to ex-ECG, patients with arrhythmia cannot be adequately evaluated and were therefore excluded from the present study. This might be considered a limitation of the study design, as excluding these patients from the study may have favoured MSCT over ex-ECG. It should be noted, however, that tachyarrhythmia and bradyarrhythmia are considered relative contraindications to ex-ECG.10

Comparison with previous studies
The non-diagnostic rate of ex-ECG as reported in the literature (18–31%)29,30 is comparable with the results of the present study. Also the sensitivity of ex-ECG in the present study is comparable with results of meta-analyses of this diagnostic test,31,32 whereas the specificity is considerably lower. This might be because of the intention-to-diagnose design7 of our study and the fact that the so-called verification bias was avoided in the present study, whereas most of the studies available for the meta-analyses of ex-ECG neither avoided verification bias nor implemented an intention-to-diagnose design as stated by Gibbons et al.32 It has also been reported that patients included in studies on ex-ECG represent a highly selected group that includes only ~3% of the intended clinical population (e.g. because patients who did not reach the target heart rate or discontinued ex-ECG were excluded) and thus misrepresents the clinical situation.30 Moreover, the medium to high pretest likelihood (75%) and prevalence (55%) of CAD and the fact that all patients were included in the analysis irrespective of the results of the index tests (e.g. target heart rate not achieved) might have further contributed to the low specificity of ex-ECG. The sensitivity, specificity, and accuracy of MSCT in the present study were comparable with the results of previous studies that reported per-patient diagnostic performance.1–6 As multisegment reconstruction significantly improves the temporal resolution of MSCT,16,17 no beta-blockers were given before the examination. The same diagnostic accuracy can be achieved with multisegment reconstruction at uninfluenced (high) heart rates as achievable using standard halfscan reconstruction in patients with low heart rates after beta-blockade.6,16 However, Hoffmann et al.33 have shown that image quality (slightly) decreases also with multisegment reconstruction at high heart rates compared with the results obtained using multisegment reconstruction in patients with lower heart rates. Thus, the use of beta-blockers might have further improved the results of MSCT coronary angiography in the present study. The imaging time of MSCT, and therefore also the breath-hold time and contrast agent amount needed, will be further reduced with scanners employing 64 detector rows that have recently become available.3,34–38 A study comparing 16- and 64-slice CT for coronary angiography in a single patient cohort is highly desirable but has not been performed. Future studies will have to determine the value of 64-slice scanners in comparison with ex-ECG. Despite enormous technical challenges it might become possible with newly developed 256-slice CT scanners to examine the entire heart and coronary artery tree within a single heartbeat as shown in preliminary volunteer studies.39

Study limitations
The present study is, to our best knowledge, the first head-to-head comparison of MSCT and ex-ECG, but it has limitations. Only 80 patients were included in this single-centre study. Thus, the results cannot be easily generalized to all patients with suspected CAD. However, the analysis on the per-patient level is an advantage of the study, as many of the studies performed so far did not report per-patient diagnostic performance of MSCT coronary angiography. We did not keep record of the number of patients who were screened for inclusion. Nevertheless, the intention-to-diagnose design, the intraindividual comparison, the avoidance of verification bias, and the consecutive inclusion of patients for the present comparison of MSCT and ex-ECG are methodological strengths of this trial.


   Conclusion
Top
 Abstract
 Introduction
 Methods
 Multislice computed tomography
 Results
 Discussion
 Conclusion
References
 
The sensitivity and specificity of MSCT are superior to those of ex-ECG in patients scheduled to undergo conventional coronary angiography for suspected CAD. Because of its diagnostic superiority over ex-ECG in this intermediate prevalence study, MSCT might be preferred for future clinical application in patients with suspected CAD and a low-to-intermediate pretest likelihood of disease. However, multi-centre studies on the clinical performance and prognostic value of MSCT remain highly desirable and should be awaited before widespread clinical application of this new diagnostic test.

Conflict of interest: M. D. is one of the principal investigators in a multi-centre study on CT coronary angiography (CorE64) sponsored by Toshiba Medical Systems and reports having received grant support (together with B. H.) from GE Healthcare Biosciences (formerly: Amersham Buchler) and Bracco-Altana Pharma for analysing CT and MR coronary angiography and lecture fees from Toshiba Medical Systems.


   References
Top
 Abstract
 Introduction
 Methods
 Multislice computed tomography
 Results
 Discussion
 Conclusion
 References
 

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