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46 Multislice CT in Coronary Heart Disease <strong>KCE</strong> Reports 82<br />

terms of mortality and morbidity up to 6 months are not any different between <strong>the</strong><br />

arms.<br />

Moreover, despite <strong>the</strong> apparent safety of both strategies (absence of adverse<br />

complications), 10% of <strong>the</strong> patients in <strong>the</strong> MSCT arm had to undergo a radiotoxic test<br />

twice (MSCT+nuclear testing) and 4% even three times (MSCT+nuclear testing+CCA).<br />

Iodinated contrast also presents a potential harm in MSCT evaluation. Although 8 CCAs<br />

out of 12 were positive in <strong>the</strong> MSCT-arm against only 1 out of 7 in <strong>the</strong> ”standard of<br />

care”-arm, this does not necessarily mean anything for <strong>the</strong> prognosis of <strong>the</strong> patients<br />

with a positive CCA.<br />

The numbers of patients were too small to evaluate <strong>the</strong> true incidence of false positive<br />

cases and false negative cases, especially in a population with a low prevalence.<br />

Recently <strong>the</strong> Andalusian HTA agency 129 published a <strong>report</strong> on MSCT coronary<br />

angiography including a meta-analysis of 16-SCT or more coronary angiography and an<br />

economic model based on a decision tree. The input parameters were drawn from <strong>the</strong><br />

meta-analysis of studies using “patients” as units of analysis. The model was populated<br />

with patients with a suspected coronary stenosis (>50% vessel diameter). The three<br />

following strategies were compared:<br />

• direct CCA,<br />

• 16-SCT coronary angiography followed by CCA when positive,<br />

• 64-SCT coronary angiography followed by CCA when positive<br />

The prevalence of significant coronary stenosis was assumed to be 40%. The sensitivity<br />

and specificity of 16-SCT were 94% and 77.9% respectively. Those of 64-SCT were<br />

98.4% and 93.7% respectively. Complications due to CCA occurred in 2.2% of <strong>the</strong><br />

procedures and lead to death in 5% of <strong>the</strong> complicated procedures, AMI in 45% and<br />

urgent surgery in <strong>the</strong> remaining 50%.<br />

The perspective was that of <strong>the</strong> Andalusian public health system. Costs included direct<br />

costs of equipment, consumables (including pharmaceuticals), procedures (including<br />

ECG and blood tests in <strong>the</strong> three arms), and costs of personnel. Procedure costs and<br />

costs of complications were obtained from <strong>the</strong> public tariffs of <strong>the</strong> SSPA (Sistema<br />

Sanitario Público Andaluz). For <strong>the</strong> equipment cost, an average per patient was<br />

calculated based on <strong>the</strong> purchasing price, <strong>the</strong> throughput and <strong>the</strong> lifetime of <strong>the</strong><br />

equipment. Costs of personnel were calculated as <strong>the</strong> legal hourly wage cost per<br />

professional qualification multiplied by <strong>the</strong> time per test, based on a 2004 Spanish paper<br />

comparing CCA to 16-SCT coronary angiography. Costs drawn from <strong>the</strong> literature<br />

were validated by a radiologist and a nurse of <strong>the</strong> radiology department of two<br />

Andalusian hospitals. The time spent by <strong>the</strong> radiologist, <strong>the</strong> technician and <strong>the</strong> nursing<br />

auxiliary in <strong>the</strong> case of a 16-SCT coronary angiography was 45 minutes against 12<br />

minutes for a 64-SCT coronary angiography. Total costs per patient of following <strong>the</strong><br />

three paths were respectively €203.96 for <strong>the</strong> 64-SCT path, €259.06 for <strong>the</strong> 16-SCT<br />

path and €307.85 for direct CCA.<br />

The ICER was calculated comparing CCA and 16-SCT to 64-SCT. Two denominators,<br />

i.e. effectiveness parameters, were used: (1) number of cases correctly diagnosed with<br />

stenosis (true positives) and (2) number of effective cases, defined as <strong>the</strong> number of<br />

true positives minus <strong>the</strong> number of false negatives. In both methods, <strong>the</strong> 16-SCT<br />

strategy was dominated by <strong>the</strong> 64-SCT strategy. In <strong>the</strong> CCA arm more patients were<br />

correctly diagnosed (0.64%) than in <strong>the</strong> 64-SCT arm, but CCA was also more expensive<br />

(€103.89 more). The ICER of CCA relative to 64-SCT was €16 596 per correctly<br />

diagnosed case and €8 206 per ‘effective case’.

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