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30 Multislice CT in Coronary Heart Disease KCE Reports 82 analysis were 99% (92-100), 87% (65-97), 96% (89-99), and 95% (74-100), respectively. The overall radiation exposure for MSCT was estimated as 11.1 to 14.4 (men to women) mSv. 3.2.4 Outcome studies 72, 79, 80 3.2.4.1 Rubinshtein et al. This research group from Haifa, Israel, performed two outcome studies on 64-SCT. In one trial, patients with chronic chest pain and in the other, patients admitted to the ED because of a suspected ACS were studied. In a retrospective trial, 103 patients with chest pain suspected to be ischemic in origin and with a negative or nondiagnostic exercise treadmill test, underwent 64-SCT. 80 Scans with sufficient diagnostic quality were obtained in 100 of the 103 patients. Quality was “severely suboptimal” in 3 (and these were excluded) and moderate in 17. In 26 out of 29 in whom MSCT indicated obstructive CAD, this was confirmed by CCA. In the 71 patients without obstructive CAD on MSCT, CCA was nevertheless performed in 20 of them (“clinically driven”) and detected CAD in 3 patients during a 12-month follow-up period. In the remaining 51 patients, there were no major adverse clinical events during follow-up. The ED study was prospective in nature and enrolled 58 patients with chest pain possibly ischemic in origin but with high risk ACS being excluded (no new ECG changes, no elevated biomarkers). 72, 79 MSCT showed normal coronary vessels (no or trivial atheroma) in 15 patients, nonobstructive plaque in 20 patients, and obstructive coronary disease (>50% luminal narrowing) in 23. By further investigation (new elevation of cardiac biomarkers, abnormal myocardial perfusion scintigraphy and/or invasive angiography), ACS was diagnosed in 20 of the 23 MSCT-positive patients. During a 15-month follow-up period, no deaths or myocardial infarctions occurred in the 35 patients discharged from the ED after initial triage and MSCT findings. One patient underwent late PCI. MSCT reportedly led to a change in the planned management strategy in 43% of the patient cohort. 3.2.4.2 Goldstein et al. 67 This study represents the one and only RCT that studied the effect of MSCT on patients’ outcome. It enrolled 197 patients with chest pain, admitted to the ED and estimated at low risk for serious future events. 99 patients were randomised to further testing with MSCT and 98 with myocardial perfusion scintigraphy (MPS). If MSCT or MPS indicated severe CAD, the patient was sent for CCA. If MSCT was inconclusive, patients were sent for MPS and subsequently for CCA if deemed necessary. MSCT alone immediately excluded or identified CAD disease as the source of chest pain in 75% of patients, including 67 with normal coronary arteries and 8 with severe disease referred for CCA. The remaining 25% of patients required stress testing, owing to intermediate severity lesions or non-diagnostic MSCTs. MSCT evaluation reduced diagnostic time compared with the MPS arm, and lowered costs as far as the decision to the need of CCA was concerned. It should be noticed that patients initially referred to MSCT underwent 30% more (139 vs. 106) radiotoxic procedures than those randomised to MPS, and had a sixfold increase in revascularisations (in 6 patients vs. 1) without any effect on 6-month outcomes, incorporating death, ACS, readmissions and late office visits. This study will be further discussed in the chapter on economic evaluation. 3.3 LITERATURE REVIEW SUMMARY The diagnostic performance of 64-SCT in native coronary arteries as reported in recently (i.e. in 2007/2008) published primary diagnostic trials is summarised in Table 7. Trials are grouped according to whether a standard or a dual-source 64-SCT device was studied. Table 8 lists the absolute numbers of positively and negatively MSCT results by per-patient analysis from these trials. In this table, all inconclusive
KCE Reports 82 Multislice CT in Coronary Heart Disease 31 examinations are counted as false positives since, in real world circumstances, a positive MSCT would obviously lead to the performance of a CCA. 64-SCT is almost as good as CCA in terms of detecting true positives: from Table 8 it can be calculated that of 608 patients with obstructive CAD on CCA, 596 were correctly identified by 64-SCT. 64-SCT performs less well in detecting true negatives: of 469 patients with no significant stenoses on CCA, 83 were false positive by 64-SCT. In order to obtain a pooled estimate of the diagnostic performance of 64-SCT, we executed a meta-analysis of the results using software package Meta-DiSc version 1.4 (Unit of clinical biostatistics, the Ramo y Cajal Hospital, Madrid, Spain). 105 The data from Hausleiter et al. 77 were not included in this meta-analysis because these authors did not provide per-patient data for 16- and 64-SCT examinations separately. The results from Meijboom’s prevalence study 83 were also not incorporated because they allegedly were included in the same authors’ gender study, as discussed earlier. The pooled estimates, resulting from this meta-analysis, are added to the data from the original papers in Table 7. Comprehensive calculations are shown in the appendix to this report.
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KCE reports 33 Effects and costs of
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