Less iodine injected for the same diagnostic performances: comparison of two low-osmolar contrast agents (iobitridol 350 and iopamidol 370) in coronary angiography and ventriculography: a randomized double-blind clinical study.

Abstract:

OBJECTIVE:Mild reductions in iodine concentration could reduce acute side effects after intraarterial contrast media administration without affecting the quality of coronary artery images. This study was designed to show the equivalence in terms of image quality of two nonionic low-osmolar monomers, iobitridol 350 and iopamidol 370, and to compare their clinical safety in coronary angiography and ventriculography. METHODS AND RESULTS:In this multicentre, double-blind clinical trial, 98 adult patients were randomized to receive either iobitridol 350 or iopamidol 370. The image quality (primary evaluation criterion) of the whole examination was assessed using a 5-point scale (poor, fair, moderate, good, excellent). Secondary endpoints were the image quality per territory, diagnostic efficacy, practical comfort (5-point scale: impossible to evaluate, not practical, moderately practical, practical, very practical to use) and clinical safety (adverse events and vital signs). The proportions of examinations presenting with good or excellent global image quality was similar with both contrast media: 87.8% with iobitridol 350 vs. 89.8% with iopamidol 370. Similar results were observed when considering the image quality specifically for each major coronary artery and left ventricle. No difference between groups was found with respect to other secondary criteria. Adverse events occurred in 7 patients with iobitridol 350 (14.3%) and in 10 patients with iopamidol 370 (20.4%). CONCLUSIONS:This study showed that, with regard to image quality and diagnostic efficacy and using a lower iodine concentration, iobitridol 350 was comparable to iopamidol 370 in adult patients requiring coronary angiography and ventriculography for diagnostic indications.

journal_name

Acta Cardiol

journal_title

Acta cardiologica

authors

Velázquez MT,Albarrán A,Hernández F,García Tejada J,Zueco J,Andreu J,De la Torre JM,Figueroa A,Sainz F,Tascón J

doi

10.2143/AC.65.4.2053896

subject

Has Abstract

pub_date

2010-08-01 00:00:00

pages

387-94

issue

4

eissn

0001-5385

issn

1784-973X

journal_volume

65

pub_type

杂志文章,多中心研究,随机对照试验
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    pub_type: 临床试验,杂志文章,随机对照试验

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