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MR-IMPACT II 试验:磁共振成像评估冠心病心肌灌注——磁共振灌注与单光子发射计算机断层成像用于冠心病检测的比较:一项多中心、多厂家的比较研究。

MR-IMPACT II: Magnetic Resonance Imaging for Myocardial Perfusion Assessment in Coronary artery disease Trial: perfusion-cardiac magnetic resonance vs. single-photon emission computed tomography for the detection of coronary artery disease: a comparative multicentre, multivendor trial.

机构信息

University Hospital Lausanne, Rue de Bugnon 46, CH-1011 Lausanne, Switzerland.

出版信息

Eur Heart J. 2013 Mar;34(10):775-81. doi: 10.1093/eurheartj/ehs022. Epub 2012 Mar 4.

DOI:10.1093/eurheartj/ehs022
PMID:22390914
Abstract

AIMS

Perfusion-cardiac magnetic resonance (CMR) has emerged as a potential alternative to single-photon emission computed tomography (SPECT) to assess myocardial ischaemia non-invasively. The goal was to compare the diagnostic performance of perfusion-CMR and SPECT for the detection of coronary artery disease (CAD) using conventional X-ray coronary angiography (CXA) as the reference standard.

METHODS AND RESULTS

In this multivendor trial, 533 patients, eligible for CXA or SPECT, were enrolled in 33 centres (USA and Europe) with 515 patients receiving MR contrast medium. Single-photon emission computed tomography and CXA were performed within 4 weeks before or after CMR in all patients. The prevalence of CAD in the sample was 49%. Drop-out rates for CMR and SPECT were 5.6 and 3.7%, respectively (P = 0.21). The primary endpoint was non-inferiority of CMR vs. SPECT for both sensitivity and specificity for the detection of CAD. Readers were blinded vs. clinical data, CXA, and imaging results. As a secondary endpoint, the safety profile of the CMR examination was evaluated. For CMR and SPECT, the sensitivity scores were 0.67 and 0.59, respectively, with the lower confidence level for the difference of +0.02, indicating superiority of CMR over SPECT. The specificity scores for CMR and SPECT were 0.61 and 0.72, respectively (lower confidence level for the difference: -0.17), indicating inferiority of CMR vs. SPECT. No severe adverse events occurred in the 515 patients.

CONCLUSION

In this large multicentre, multivendor study, the sensitivity of perfusion-CMR to detect CAD was superior to SPECT, while its specificity was inferior to SPECT. Cardiac magnetic resonance is a safe alternative to SPECT to detect perfusion deficits in CAD.

摘要

目的

灌注心脏磁共振(CMR)已成为一种潜在的替代单光子发射计算机断层扫描(SPECT)的方法,可无创性评估心肌缺血。本研究旨在通过常规 X 射线冠状动脉造影(CXA)作为参考标准,比较灌注 CMR 和 SPECT 检测冠状动脉疾病(CAD)的诊断性能。

方法和结果

在这项多中心试验中,533 名适合 CXA 或 SPECT 的患者在 33 个中心(美国和欧洲)入组,其中 515 名患者接受了磁共振对比剂。所有患者均在 CMR 前或后 4 周内接受 SPECT 和 CXA 检查。该样本中 CAD 的患病率为 49%。CMR 和 SPECT 的脱落率分别为 5.6%和 3.7%(P = 0.21)。主要终点是 CMR 与 SPECT 检测 CAD 的敏感性和特异性的非劣效性。读者对临床数据、CXA 和影像学结果均设盲。作为次要终点,评估了 CMR 检查的安全性。对于 CMR 和 SPECT,敏感性评分分别为 0.67 和 0.59,差异的置信下限为+0.02,表明 CMR 优于 SPECT。CMR 和 SPECT 的特异性评分分别为 0.61 和 0.72(置信下限差值为-0.17),表明 CMR 劣于 SPECT。在 515 名患者中未发生严重不良事件。

结论

在这项大型多中心、多供应商研究中,灌注 CMR 检测 CAD 的敏感性优于 SPECT,但其特异性劣于 SPECT。心脏磁共振是 SPECT 的安全替代方法,可用于检测 CAD 中的灌注缺陷。

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