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64层及以上计算机断层扫描血管造影术作为冠状动脉疾病检查中侵入性冠状动脉造影替代方法的临床有效性和成本效益的系统评价。

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.

作者信息

Mowatt G, Cummins E, Waugh N, Walker S, Cook J, Jia X, Hillis G S, Fraser C

机构信息

Health Services Research Unit, Institute of Applied Health Sciences, University of Aberdeen, UK.

出版信息

Health Technol Assess. 2008 May;12(17):iii-iv, ix-143. doi: 10.3310/hta12170.

Abstract

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.

摘要

目的

评估对于疑似冠心病(CAD)患者的诊断以及已知CAD患者的评估,使用64层或更高层螺旋计算机断层扫描(CT)血管造影而非有创冠状动脉造影(CA)在不同患者群体中的临床有效性和成本效益。

数据来源

检索了2002年至2006年12月的电子数据库。

综述方法

将纳入研究制成表格,并计算敏感度、特异度、阳性预测值和阴性预测值。使用分层汇总接受者操作特征曲线拟合Meta分析模型。报告每个模型的汇总敏感度、特异度、阳性和阴性似然比以及诊断比值比,以中位数和95%可信区间(CrI)表示。还检索了关于64层CT评估CAD成本效益的研究。

结果

诊断准确性和预后研究分别纳入了超过2500人和1700人。研究的总体质量相当好。在汇总估计中,64层CT血管造影对于基于患者的显著CAD(定义为狭窄50%或更高)检测具有高度敏感性(99%,95%CrI 97%至99%),而在各项研究中,阴性预测值(NPV)非常高(中位数100%,范围86%至100%)。在节段水平分析中,与基于患者的检测相比,敏感度较低(90%,95%CrI 85%至94%,而基于患者检测时为99%,95%CrI 97%至99%),特异度较高(97%,95%CrI 95%至98%,而基于患者检测时为89%,95%CrI 83%至94%),而在各项研究中,中位数NPV相似(99%,范围95%至100%,而基于患者检测时为100%,范围86%至100%)。在单支冠状动脉水平,汇总估计的敏感度范围从左旋支(LCX)动脉的85%到左主干动脉的95%,特异度范围从左前降支(LAD)动脉和LCX的96%到左主干动脉的100%,而在各项研究中,阳性预测值(PPV)范围从LCX的81%到左主干动脉的100%,NPV非常高,范围从LAD(范围95%至100%)、LCX(范围93%至100%)和右冠状动脉(RCA)(范围94%至100%)的98%到左主干动脉的100%。搭桥血管分析的汇总估计敏感度为99%(95%CrI 95%至100%),特异度为96%(95%CrI 86%至99%),各项研究的中位数PPV和NPV值分别为93%(范围90%至95%)和99%(范围98%至100%)。相比之下,支架分析的汇总敏感度为89%(95%CrI 68%至97%),特异度为94%(95%CrI 83%至98%),各项研究的中位数PPV和NPV值分别为77%(范围33%至100%)和96%(范围71%至100%)。在检测真阳性方面,64层CT几乎与有创CA一样好。然而,其假阳性率略高。似乎涉及64层CT的诊断策略仍需要对CT检测阳性者进行有创CA检查,部分原因是为了识别CT假阳性,还因为CA能提供CT目前无法提供的其他信息,特别是可能的冠状动脉搭桥术(CABG)的插入部位和远端血流细节。6层CT的高敏感度避免了对那些接受检查但无CAD的人进行不必要的CA检查的费用。鉴于可能存在的(尽管很小)相关死亡率,通过使用64层CT避免这些不必要的CA检查可能也会带来微小的即时生存优势。这本身可能足以超过涉及64层CT的策略在检测真阳性方面略低的比率。通过使用64层CT避免不必要的CA检查似乎也可能导致诊断途径的总体成本节省。只有当CA的成本相对较低且就诊人群中CAD的患病率相对较高(以至于大多数患者将继续接受CA检查)时,使用64层CT才可能导致每位患者的总体诊断成本更高。

结论

目前64层CT的主要价值可能在于排除显著CAD。在评估患者血运重建时,它不太可能取代CA,特别是因为血管造影和血管成形术通常在同一次进行。需要进一步研究256层机器与64层CT相比的边际优势和成本、64层CT在疑似急性冠状动脉综合征患者中的效用、多层螺旋计算机断层扫描检查斑块形态的潜力、CT在识别适合CABG患者中的作用,以及对重复使用或在年轻个体或育龄妇女中使用64层或更高层CT血管造影所引发的担忧。

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