Systematic review of the clinical effectiveness and cost-effectiveness of 64-slice or higher computed tomography angiography as an alternative to invasive coronary angiography in the investigation of coronary artery disease.
Mowatt G., Cummins E., Waugh N., Walker S., Cook J., Jia X., Hillis GS., Fraser C.
OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness, in different patient groups, of the use of 64-slice or higher computed tomography (CT) angiography, instead of invasive coronary angiography (CA), for diagnosing people with suspected coronary artery disease (CAD) and assessing people with known CAD. DATA SOURCES: Electronic databases were searched from 2002 to December 2006. REVIEW METHODS: Included studies were tabulated and sensitivity, specificity, positive and negative predictive values calculated. Meta-analysis models were fitted using hierarchical summary receiver operating characteristic curves. Summary sensitivity, specificity, positive and negative likelihood ratios and diagnostic odds ratios for each model were reported as a median and 95% credible interval (CrI). Searches were also carried out for studies on the cost-effectiveness of 64-slice CT in the assessment of CAD. RESULTS: The diagnostic accuracy and prognostic studies enrolled over 2500 and 1700 people, respectively. The overall quality of the studies was reasonably good. In the pooled estimates, 64-slice CT angiography was highly sensitive (99%, 95% CrI 97 to 99%) for patient-based detection of significant CAD (defined as 50% or more stenosis), while across studies the negative predictive value (NPV) was very high (median 100%, range 86 to 100%). In segment-level analysis compared with patient-based detection, sensitivity was lower (90%, 95% CrI 85 to 94%, versus 99%, 95% CrI 97 to 99%) and specificity higher (97%, 95% CrI 95 to 98%, versus 89%, 95% CrI 83 to 94%), while across studies the median NPV was similar (99%, range 95 to 100%, versus 100%, range 86 to 100%). At individual coronary artery level the pooled estimates for sensitivity ranged from 85% for the left circumflex (LCX) artery to 95% for the left main artery, specificity ranged from 96% for both the left anterior descending (LAD) artery and LCX to 100% for the left main artery, while across studies the positive predictive value (PPV) ranged from 81% for the LCX to 100% for the left main artery and NPV was very high, ranging from 98% for the LAD (range 95 to 100%), LCX (range 93 to 100%) and right coronary artery (RCA) (range 94 to 100%) to 100% for the left main artery. The pooled estimates for bypass graft analysis were 99% (95% CrI 95 to 100%) sensitivity, 96% (95% CrI 86 to 99%) specificity, with median PPV and NPV values across studies of 93% (range 90 to 95%) and 99% (range 98 to 100%), respectively. This compares with, for stent analysis, a pooled sensitivity of 89% (95% CrI 68 to 97%), specificity 94% (95% CrI 83 to 98%), and median PPV and NPV values across studies of 77% (range 33 to 100%) and 96% (range 71 to 100%), respectively. Sixty-four-slice CT is almost as good as invasive CA in terms of detecting true positives. However, it is somewhat poorer in its rate of false positives. It seems likely that diagnostic strategies involving 64-slice CT will still require invasive CA for CT test positives, partly to identify CT false positives, but also because CA provides other information that CT currently does not, notably details of insertion site and distal run-off for possible coronary artery bypass graft (CABG). The high sensitivity of 64-slice CT avoids the costs of unnecessary CA in those referred for investigation but who do not have CAD. Given the possible, although small, associated death rate, avoiding these unnecessary CAs through the use of 64-slice CT may also confer a small immediate survival advantage. This in itself may be sufficient to outweigh the very marginally inferior rates of detection of true positives by strategies involving 64-slice CT. The avoidance of unnecessary CA through the use of 64-slice CT also appears likely to result in overall cost savings in the diagnostic pathway. Only if both the cost of CA is relatively low and the prevalence of CAD in the presenting population is relatively high (so that most patients will go on to CA) will the use of 64-slice CT be likely to result in a higher overall diagnostic cost per patient. CONCLUSIONS: The main value of 64-slice CT may at present be to rule out significant CAD. It is unlikely to replace CA in assessment for revascularisation of patients, particularly as angiography and angioplasty are often done on the same occasion. Further research is needed into the marginal advantages and costs of 256-slice machines compared with 64-slice CT, the usefulness of 64-slice CT in people with suspected acute coronary syndrome, the potential of multislice computed tomography to examine plaque morphology, the role of CT in identifying patients suitable for CABG, and the concerns raised about repetitive use, or use of 64-slice or higher CT angiography in younger individuals or women of childbearing age.