Filippo Cademartiri MD, PhD, Presenter: Speakers Bureau, Bracco Group Consultant, Guerbet SA Speakers Bureau, Guerbet SA

Jean-Francois Paul MD, PhD, Abstract Co-Author: Investigator, F. Hoffmann-La Roche Ltd

Francois H. Laurent MD, Abstract Co-Author: Nothing to Disclose

Hans-Christoph Richard F. Becker MD, PhD, Abstract Co-Author: Speaker, Bracco Group Speaker, Bayer AG Speaker, Guerbet SA Speaker, Siemens AG Consultant, Amgen Inc

Andrea Laghi MD, Abstract Co-Author: Speaker, Bracco Group Speaker, Bayer AG Speaker, General Electric Company Speaker, Koninklijke Philips NV

Stephan Achenbach MD, Abstract Co-Author: Research Grant, Siemens AG Research Grant, Bayer AG Research Grant, Abbott Laboratories Speaker, Guerbet SA Speaker, Siemens AG Speaker, Bayer AG Speaker, AstraZeneca PLC Speaker, Berlin-Chemie AG Speaker, Abbott Laboratories Speaker, Edwards Lifesciences Corporation

To demonstrate the non-inferiority in diagnostic efficacy of iobitridol (Xenetix® 350) compared to iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) when used for coronary CT scans.

Multi-center, randomized, double blind, prospective, non-inferiority phase IV trial including 468 patients with suspected coronary artery disease (CAD) and scheduled for coronary CT angiography. The primary endpoint was the CT scan evaluability for CAD diagnosis in terms of quality and interpretability of images. It was based on the full evaluation by 2 off-site independent readers of 18 coronary segments for each patient. Secondary endpoints comprised both efficacy assessment (mainly image quality, stenosis assessment, and signal quantification) as well as safety assessment, in terms of clinical and electrographic tolerance.

Out of the 452 patients completed for the primary analysis, the totality of 18 coronary segments were evaluable in 92.1% of patients from the iobitridol group, versus 94.6 and 95.4% in the iomeprol and iopromide groups respectively. The non-inferiority of iobitridol for the CT evaluation of CAD was statistically demonstrated (p<0.05). Mean image quality was good to excellent for each of the 3 contrast media. No relevant differences were observed for other secondary endpoints between the 3 groups, despite the fact that the amount of iodine (in g) injected was significantly different between the 3 groups: 27.8±3.4 (iobitridol), 29.3±3.8 (iopromide) and 31.7±3.8 (iomeprol), p<0.001. Eventually, the good general safety profile of products was confirmed.

Coronary CT angiography using Xenetix® 350 is non-inferior to more concentrated contrast agents regarding image quality and evaluability while the amount of iodine required can be significantly reduced.

Coronary CT angiography using Xenetix® 350 is non-inferior to more concentrated contrast agents regarding image quality and evaluability while the amount of iodine required can be significantly reduced.

Cademartiri, F, Paul, J, Laurent, F, Becker, H, Laghi, A, Achenbach, S, Comparative Assessment of Image Quality for Coronary CT Angiography Using 3 Iodinated Contrast Agents with Different Iodine Concentrations: A Randomized European Multicenter Trial.  Radiological Society of North America 2014 Scientific Assembly and Annual Meeting, - ,Chicago IL. http://archive.rsna.org/2014/14012947.html