A double-blind study comparing the safety, tolerability, and efficacy of ioversol-350 and iohexol-350 in coronary arteriography with left ventriculography.
A multicenter, double-blind, randomized study was performed to compare the efficacy, patient tolerability and safety of ioversol-350 with that of iohexol-350 in patients undergoing selective coronary arteriography with left ventriculography. Demographic parameters with the exception of age were comparable between the contrast media groups.  Ioversol-350 patients (mean 60.9 years) were significantly older than iohexol-350 patients (mean = 56.1 years) (p=0.0007).  The treatment groups were comparable with respect to all measures of contrast media dose.  All coronary arteriography procedures in both contrast media groups were rated as diagnostic by the investigators.  Seventy-four of 80 (92.5%) ioversol-350 procedures were rated excellent or good in overall quality.  The contrast media groups did not differ significantly with respect to heat associated with left ventricular (LV), left coronary artery (LCA), or right coronary artery (RCA) injections or with respect to pain associated with LCA or RCA injections.  However, pain associated with LV injections was significantly greater in the iohexol-350 group compared with the ioversol-350 group (p=0.0087).  The contrast media groups did not differ with respect to changes in ECG or hemodynamic parameters from baseline.  Results of this study demonstrate that ioversol-350 is diagnostically effective, well tolerated and safe when used for selective coronary arteriography with left ventriculography.
Mercy Hospital, Des Moines, Iowa.
M D
MD
McGaughey
M S
MS
Remetz
E
E
Sharf-Bornhofen
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D017023:Coronary Angiography / Q000009:adverse effects / Q000379:methods; D004311:Double-Blind Method; D004869:Equipment Safety; D005260:Female; D006801:Humans; D007472:Iohexol / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D015646:Ventriculography, First-Pass / Q000009:adverse effects / Q000379:methods