J Korean Radiol Soc 2003;48:141-145 Paired Comparison of Iopamidol and Iopromide in Hepatic Arteriography1 Young Ho Choi, M.D.2, Jin Wook Chung, M.D., Guk Myung Choi, M.D., Chang Jin Yoon, M.D., Keon Ha Kim, M.D., Seung Gyu Moon, M.D., Hyo-cheol Kim, M.D., Jae Hyung Park, M.D. Purpose: To compare the clinical efficacy of iopamidol 370 and iopromide 370, as used in hepatic arteriography, in terms of their safety, patient tolerance, and image quality. Materials and Methods: Between February and April 2001, 30 patients (M:F=27:3; mean age, 57 years) with hepatocellular carcinoma underwent hepatic angiography in which iopamidol 370 was used for transcatheter arterial chemoembolization (TAE). Sensations of heat or pain following contrast injection, a patient’s distress or discom- fort levels, and any side effects of the contrast media were monitored, and afterwards patients were asked whether they were aware of any differences between iopamidol 370 and iopromide 370, which had been used in hepatic angiography for previous TAE prior to February 2001. Three experienced independent radiologists assessed the diag- nostic efficacy of the contrast media in terms of overall image quality, which was sta- tistically analysed using Wilcoxon’s signed ranks test. Results: No patient experienced sensations of heat or pain during angiography, or showed any objective distress or discomfort, though two suffered mild nausea during angiography with iopamidol 370. None was aware of any difference between iopro- mide 370 and iopamidol 370. In terms of overall image quality, the diagnostic efficacy of contrast media in all patients was‘ good’to‘ excellent’, with no significant differ- ence between iopromide 370 and iopamidol 370 (p>0.05). Conclusion: In hepatic arteriography, the clinical efficacy of iopamidol 370 is compa- rable with that of another nonionic contrast medium, iopromide 370, in terms of safe- ty, tolerance, and image quality. Iopamidol 370 is thus a useful alternative medium. Index words : Contrast media, efficacy study Contrast media, comparative studies Contrast media, angiography The development of contrast media for angiography creased tolerance and good radio-opacity. Since the first has always been directed toward substances with in- nonionic contrast agent was developed in 1969 to over- come the limitations of ionic contrast media that caused 1Department of Radiology, Seoul National University College of Medicine and the Institute of Radiation Medicine, SNUMRC more intense sensations of heat and pain, and cardiac 2 Department of Radiology, Boramae Municipal Hospital toxicity due to high osmolarity (1, 2), ongoing efforts Received March 7, 2002 ; Accepted September 24, 2002 Address reprint requests to : Jin Wook Chung, M.D., Department of have been made to develop media with fewer side ef- Radiology, Seoul National University College of Medicine and the Institute of Radiation Medicine, SNUMRC fects. 28, Yongon-dong, Chongno-gu, Seoul 110-744, Korea. Iopamidol is one of the most widely used nonionic Tel. 82-2-760-2584 Fax. 82-2-743-6385 E-mail: [email protected] contrast media with low osmolarity. To date, many clin- ─ 141 ─ Young Ho Choi, et al : Paired Comparison of Iopamidol and Iopromide in Hepatic Arteri ography ical studies involving its use in aortography (3, 4), pe- unstable or pregnant; had moderate to severe cardiac, ripheral angiography (5-7), cardiac angiography (8- hepatic, or renal failure; suffered from paraproteinemia, 10), cerebral angiography (11, 12), and visceral arteriog- multiple myeloma, thrombocytopenia, or sickle cell raphy (13) have been performed, but to our knowledge, anaemia; had an allergic or hypersensitive condition for none have examined its use in hepatic arteriography. In which a drug had been prescribed; or had received any conjunction with Dong Kook Pharmaceuticals, we other contrast medium within the previous 48 hours, therefore conducted the present investigation. were excluded from the study. In this study, the clinical efficacy of two nonionic con- trast media, iopamidol 370 (PamirayⓇ; Dong Kook, Procedures Seoul, Korea) and iopromide 370 (Ultravist(r); Shering, Before chemoembolization, patients underwent an- Seoul, Korea) was compared in terms of safety, patient giography to determine the location and extent of the tu- tolerance, and image quality (Fig. 1). Iopromide 370 is mor. Local anesthesia with 1% lidocaine was performed one of the nonionic contrast media most widely used in prior to femoral arterial puncture for insertion of an ar- angiographic procedures such as abdominal aortogra- terial sheath. A 5-Fr RH catheter (Cook, Bloomington, phy and visceral arteriography, and its osmolarity and U.S.) was inserted into the aorta and its branches under viscosity are similar to those of iopamidol 370 (Table 1). fluoroscopic guidance, and angiography of the celiac In our study, the two media were used serially during trunk was performed. The amount of contrast medium transcatheter arterial chemoembolizations (TAE) under- used ranged from 42 to 48 mL and the injection rate was gone by each of the patients involved. 7 to 8 mL/second. If it was suspected that an aberrant hepatic artery originated from the superior mesenteric Materials and Methods artery, this was examined angiographically after the in- jection of contrast media at a rate of 6-8 mL/second. Patients Using a 3-Fr microcatheter, if necessary, selective an- Between February and April 2001, 30 patients [M:F = giography of the right or left hepatic, or inferior phrenic 27:3; age, 40-74 (mean, 57) years] in whom hepatocel- artery was performed to determine the exact location of lular carcinoma had been diagnosed prior to February 2001 underwent TAE once using iopamidol 370 after Table 1. written consent to its use had been obtained. Prior to Iopamidol 370 Iopromide 370 February 2001, TAE was performed at least once, using Iodine concentration (mg/mL) 370 370 iopromide 370. Osmolarity (mOsm/kg H2O) 796 780 All patients except one (Patient 28) were in relatively Molecular weight 770 791 good general condition. Any one who were medically Viscocity at 37°C (centipoises) 9.5 9.5 A B Fig. 1. Molecular structure of iopamidol and iopromide. Iopamidol (A) and iopromide (B) have a tri-iodinated benzene ring and three highly hydrophilic side chains. They are stable in solu- tion. ─ 142 ─ J Korean Radiol Soc 2003;48:141-145 the tumor and to clarify the site of its feeding artery. The side effects for at least 24 hours after the completion of amount of contrast media used ranged from 3 to 14 mL, procedures. injected at 0.5-2 mL/second according to the size of the After the conclusion of angiography, patients were vessel. asked whether they were aware of any differences be- The respective amounts of iopromide 370 and iopami- tween iopamidol 370 and iopromide 370, which had dol 370 used were 42-105 (mean, 70.2) and 42-105 been used in hepatic angiography before February 2001. (mean, 68.6) mL, with no statistically significant differ- The safety of iopromide 370 was analysed on the basis ence between the mean volumes. of the answers and the patients’medical records. Angiographic images were obtained using a Siemens Image quality was assessed by three experienced inde- Polytron S-Plus DSA System in conjunction with a pendent radiologists blinded to a patient’s identity and Siemens Angiostar Table equipped with a 13-inch inten- clinical profile and to the contrast media used. In addi- sifier. tion, each was unware of the other radiologists’assess- ment. Using original images, the diagnostic efficacy of Safety and Efficacy Analysis contrast media in terms of overall image quality was as- During hepatic angiography performed using iopami- sessed according to a five-point scale, as follows: 1, poor dol 370 between February and April 2001, patients were opacification; 2, insufficient opacification; 3, sufficient told that sensations of heat or pain might occur after opacification; 4, good opacification; 5, excellent opacifi- contrast injection, and were asked to grade these sensa- cation.“ Poor”indicated that image quality did not per- tions after the whole procedure as ‘none’, ‘mild’, mit diagnosis, and“ excellent”that vessel detail was visi- ‘moderate’or‘ severe’. Investigators used a four-point ble. For statistical analysis of image quality, Wilcoxon’s scale, as follows, to assess the degree of a patient’s dis- signed ranks test was used. Two-sided probability (p) tress or discomfort: 0, no evidence of distress; 1, slight values of <0.05 were considered statistically significant. movement and/or vocal complaint; 2, moderate move- The reproducibility of the three observers’assessment ment and/or vocal complaint; 3, forcible movement of image quality was assigned a ĸ (kappa) value. and/or loud cries. Side effects during the procedures were determined Results by direct questioning and observation. The severity of any side effect was graded as‘ none’,‘ mild’(disappear- No patient experienced sensations of heat or pain dur- ing spontaneously, or no need for therapy),‘ moderate’ ing angiography with either iopromide 370 or iopamidol (necessitating therapy but responding immediately) or 370, or showed any objective distress or discomfort. ‘severe’(alarming or life-threatening, responding poor- Two patients complained that the use of iopamidol 370 ly or slowly to therapy). All patients were monitored for led to mild nausea, though none were aware of any dif- A B Fig. 2. Image quality of hepatic angiography. Two hepatic angiograms were evaluated as“ good opacification”(A) and“ exellent opacification”(B) by all three radiologists. ─ 143 ─ Young Ho Choi, et al : Paired Comparison of Iopamidol and Iopromide in Hepatic Arteri ography ferences between the two media. were collected from just 30 patients, which may have With regard to the reproducibility of observors’as- induced bias. To determine whether iopamidol and oth- sessment of image quality, ĸ values of 0.58, 0.74, and er contrast media, including iopromide, exert different 0.64 was assigned to observers 1 and 2, 1 and 3, and 2 effects because of differences in their formulation or and 3, respectively.