[Comparison of iodixanol (Visipaque) and ioxaglate (Hexabrix) in coronary angiography and ventriculography: a double-blind randomized study].
OBJECTIVE
To evaluate and compare in a double-blinded and prospective study the incidence of adverse reactions between two contrast agents used for coronary angiography and ventriculography. The first agent was the non-ionic, dimeric, isotonic contrast medium iodixanol (Visipaque), the other was the ionic dimeric contrast medium ioxaglate (Hexabrix).


METHODS
A total of 110 consecutive patients were randomized and received either iodixanol 320 mgl/ml or ioxaglate 320 mgl/ml. The efficacy, safety, tolerability and specific cardiovascular effects were evaluated. Adverse reactions were recorded during the procedure and during the first 24 hours after the examination. Hemodynamic and electrophysiological parameters were recorded before and after the ventricular injection and the first injections into the left and right coronary artery, respectively.


RESULTS
The incidence of clinical adverse reactions was significantly different between iodixanol and ioxaglate (3% vs 28%, p = 0.0004). 24 patients (16 iodixanol; 8 ioxaglate) experienced no discomfort (sensation of warmth, coldness or pain), and the intensity of discomfort experienced by the remainder was similar for the two groups. No patient reported pain. During the 3 minutes after injection of contrast medium, the LV end-diastolic pressure increased but, apart from one reading, the increases with iodixanol were always significantly different (p < 0.05), and less than those for ioxaglate. During the same time period, heart rate was increased to a greater extent by ioxaglate (p < 0.05). QT interval was significantly (p < 0.05) prolonged with both ioxaglate and iodixanol, but the changes were less marked after iodixanol. The angiographic studies were of diagnostic quality for all patients and optimal diagnostic information was achieved in 92% of both groups.


CONCLUSIONS
This randomized study shows that iodixanol and ioxaglate are of comparable diagnostic efficacy in coronary angiography and ventriculography, but that iodixanol is better tolerated by patients and results in less marked hemodynamic and eletrophysiological changes than does ioxaglate.
Roriz
R
R
Département de Radiologie et d'Hémodynamique, Hôpital Cardio-vasculaire et Pneumologique, Lyon, France.
de Gevigney
G
G
Finet
G
G
Nantois-Collet
C
C
Borch
K W
KW
Amiel
M
M
Beaune
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000379:methods*; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000209:etiology; D016903:Drug Monitoring; D004562:Electrocardiography / Q000187:drug effects; D006352:Heart Ventricles / Q000000981:diagnostic imaging*; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007485:Ioxaglic Acid / Q000009:adverse effects*; D007827:Laryngitis / Q000139:chemically induced; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011446:Prospective Studies; D014283:Triiodobenzoic Acids / Q000009:adverse effects*
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol; D007485:Ioxaglic Acid
Comparaison de l'iodixanol (Visipaque) et de l'ioxaglate (Hexabrix) en coronaro-ventriculographie: une étude randomisée en double aveugle.