3T 外周动脉疾病磁共振血管造影：钆特酸葡甲胺与钆布醇的随机前瞻性比较。

MR Angiography at 3 T of Peripheral Arterial Disease: A Randomized Prospective Comparison of Gadoterate Meglumine and Gadobutrol.

机构信息

1 Section of Cardiovascular and Interventional Radiology, Department of Bioimaging and Image-Guided Therapy, Medical University of Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria.

出版信息

AJR Am J Roentgenol. 2015 Jun;204(6):1311-21. doi: 10.2214/AJR.14.12604.

DOI:10.2214/AJR.14.12604

PMID:26001243

Abstract

OBJECTIVE

This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography (MRA) using digital subtraction angiography (DSA) as the reference standard in patients with peripheral arterial occlusive disease (PAOD).

SUBJECTS AND METHODS

In this prospective international randomized double-blind phase IV trial, 189 patients were enrolled. Of them, 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings. Subjects underwent peripheral MRA, after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol, and DSA within 30 days. The diagnostic accuracy was evaluated and compared using a noninferiority analysis. Secondary endpoints included sensitivity, specificity, diagnostic confidence, contrast-to-noise ratio, and signal-to-noise ratio evaluations.

RESULTS

The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups (mean ± SD, 80.6% ± 16.1% with gadoterate meglumine vs 77.1% ± 19.6% with gadobutrol; 3.5% difference), and the same was true for off-site readings (73.9% ± 16.9% with gadoterate meglumine vs 75.1% ± 13.8% with gadobutrol; 1.1% difference). The noninferiority of gadoterate meglumine to gadobutrol was shown for both on- and off-site readings. Sensitivity in detecting significant stenosis (> 50%) was 72.3% for gadoterate meglumine versus 70.6% for gadobutrol, whereas specificity (92.6% vs 92.3%), diagnostic confidence (87.0% vs 86.0%), signal-to-noise ratio (165.5 vs 161.0), and contrast-to-noise ratio (159.5 vs 155.3) did not differ statistically significantly between the two groups.

CONCLUSION

Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA. No statistically significant differences were detected between the two MRA groups.

摘要

目的

本大规模随机研究旨在显示在使用数字减影血管造影（DSA）作为参考标准的外周动脉闭塞性疾病（PAOD）患者中，钆特酸葡胺增强与钆布醇增强 3T MR 血管成像（MRA）的诊断性能方面，钆特酸葡胺增强不劣于钆布醇增强。

方法

在这项前瞻性国际随机 IV 期试验中，纳入了 189 名患者。其中，156 名患者可纳入现场评估的方案人群，154 名患者可纳入远程评估的方案人群。受试者在 30 天内接受外周 MRA 检查，分别静脉注射 0.1mmol/kg 的钆特酸葡胺或钆布醇后进行检查。使用非劣效性分析评估和比较诊断准确性。次要终点包括敏感性、特异性、诊断置信度、对比噪声比和信噪比评估。

结果

在现场阅读时，两组患者 MRA 和 DSA 检测狭窄的百分比一致性相似（平均±标准差，钆特酸葡胺组为 80.6%±16.1%，钆布醇组为 77.1%±19.6%；3.5%的差异），在远程阅读时也如此（钆特酸葡胺组为 73.9%±16.9%，钆布醇组为 75.1%±13.8%；1.1%的差异）。在现场和远程阅读时，钆特酸葡胺均显示不劣于钆布醇。检测到有意义的狭窄（>50%）的敏感性，钆特酸葡胺组为 72.3%，钆布醇组为 70.6%，而特异性（92.6%对 92.3%）、诊断置信度（87.0%对 86.0%）、信噪比（165.5 对 161.0）和对比噪声比（159.5 对 155.3）在两组之间无统计学差异。