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1 Comparison of contrast-induced discomfort between Visipaque (Iodixanol) injection 320 mg I/mL and Isovue (Iopamidol) 370 mg I/mL in patients undergoing peripheral arteriography Poster No.: C-1976 Congress: ECR 2014 Type: Scientific Exhibit Authors: C. Rosenberg 1, J. J. Martínez Rodrigo 2, E. L. Vicent 2, J. M. Fernández 3, T. Todoran 4 ; 1 Greifswald/DE, 2 Valencia/ES, 3 Barcelona/ES, 4 Charleston, SC/US Keywords: DOI: Contrast agents, Arteries / Aorta, Interventional vascular, Catheter arteriography, Contrast agent-other, Safety, Diagnostic procedure, Arteriosclerosis /ecr2014/C-1976 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Page 1 of 8

2 Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. Page 2 of 8

3 Aims and objectives To compare contrast-induced patient discomfort (sensation of heat, pain or coldness) following administration of an iso-osmolar contrast medium, VISIPAQUE (iodixanol) Injection 320 mg I/mL or a low osmolar contrast medium, ISOVUE -370 (iopamidol Injection 76%) in patients undergoing peripheral arteriography as part of routine medical care. Methods and materials This was a prospective, multi-center, randomized double-blind, parallel group comparative study of VISIPAQUE-320 and ISOVUE-370 in patients undergoing upper or lower extremity or carotid arteriograms. The study was conducted at 13 sites across Europe and US. The peripheral arteriography was performed at each site following their routine procedural protocol. The CM volume and injection rate were determined by patient needs and the parameters of the specific arteriographic procedure performed. The presence or absence of contrast-induced discomfort in terms of sensation of coldness or heat and injection-associated pain were assessed immediately (#10 minutes) following each contrast administration and recorded using the pain assessment tool described by Jensen (2008). If a patient reported any of the patient discomforts being studied (i.e., sensations of coldness, heat or pain), he or she was further questioned on the intensity and location. The intensity of pain was rated verbally by the patient on a scale of 0 (none) to 10 (the most intense sensation imaginable) (see Figure 1). Raw score for each sensation was then converted to 4 different intensity categories: 0 = none, 1-3 = mild, 4-7= moderate, and 8-10= severe. Because multiple contrast injections were made during each procedure, the patient discomfort (the highest score of any category), heat or pain and coldness were compared for the first and overall injections between the two contrast groups (Figure 2). Images for this section: Page 3 of 8

4 Fig. 1: Evaluation of Discomfort Intensity (Adopted from Jensen 2008). Fig. 2: Patient Discomfort Evaluation Process Page 4 of 8

5 Results VISIPAQUE Injection 320 mg I/mL was administered in 127 patients (mean age 62 years, 61% male) and ISOVUE-370 in 126 (mean age 63 years, 64% male). Of these, 125 in VISIPAQUE group and 124 in ISOVUE group completed discomfort assessments. The Key results are presented in Figure 3. Subjects who received VISIPAQUE administration has statistically significantly less moderate/severe maximum discomfort (p=0.0028), primarily driven by significantly less moderate/severe pain (p< ) for the overall injections. Similarly, subjects in the VISIPAQUE group experienced statistically significantly less severe discomfort (p<0.0001), less severe heat (p=0.0002) and less severe pain (p<0.0001). In the analysis of patient discomfort scores, a statistically significant lower score for the VISIPAQUE group compared to the ISOVUE group was recorded (2.8 vs. 5.1, p<0.0001). Logistical regression analysis demonstrated that contrast administration was a significant independent risk factor for moderate/severe patient discomfort and pain with VISIPAQUE contributing less moderate/severe patient discomfort compared to ISOVUE (p< for discomfort and p< for pain). No difference of other safety profile was observed between the two contrast groups. Images for this section: Fig. 2: Patient Discomfort Evaluation Process Page 5 of 8

6 Fig. 3: Comparison of Discomfort, Heat or Pain between the Two Contrast Groups. Page 6 of 8

7 Conclusion Peripheral arteriography is the basic technique for interventional vascular procedures and remains the gold standard diagnostic procedures in spite of alternative noninvasive techniques for imaging blood vessels. Sensations of pain, heat/warmth, or coldness associated with contrast administration are frequent and important discomfort experiences for patients undergoing peripheral arteriography. Multiple previous studies performed in 1990s demonstrated that patients who received the iso-osmolar contrast medium, VISIPAQUE, experienced significantly lower incidence and intensity of discomfort when compared to various low osmolar contrast media [Manke et al. 2003] [Verow et al. 1995] [Justesen et al. 1997] [Pugh et al. 1993] [Tveit et al. 1994] [Palmers et al. 1993]. But it is questionable whether these data obtained more than 10 years ago are still relevant to today's clinical practice. In this prospective, multi-center, double-blind, parallel group, comparative study, we achieved similar results as those reported in the literature. These clinical data reaffirm the general aggreement that the higher the osmotic pressure, the poorer patient tolerance [American Academy of Radiology 2010]. In conclusion, VISIPAQUE injection 320 mg I/mL induced significantly less moderate/ severe and severe patient discomfort, heat or pain than did ISOVUE-370. The results of this comparative study suggest that VISIPAQUE is a preferable contrast agent for use in peripheral arteriography. Personal information References American Academy of Radiology. Manual on Contrast Media, version 7, Jensen MP. Chapter 5: Pain assessment in clinical trials and Appendix 5.1: Pain quality assessment scale (PQAS).In: Wittink HM, Carr DB (eds). Pain Research and Clinical Management. Pain Management: Evidence, Outcomes and Quality of Life, A Sourcebook. London: Elsevier, Page 7 of 8

8 Manke C, Marcus C, Page A, et al. Pain in Femoral Arteriography: A double-blind, randomized, clinical study comparing safety and efficacy of the iso-osmolar iodixanol 270 mgi/ml and the low osmolar iomeprol 300 mgi/ml in 9 European centers. Acta Radiol 2003;44: Palmers Y, De Greef D, Grynne BH, et al. A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mg I/mL and ioxaglate 320 mg I/mL in cerebral arteriography. Eur. J. Radiol 1993;17: Pugh ND, Sissons GRJ, Ruttley MST, et al. Iodixanol in Femoral Arteriography (phase III): a comparative double-blind parallel trial between iodixanol and iopromide. Clinical Radiology 1993;47:96-99 Tveit K, Bolz KD, Bolstad B, et al. Iodixanol in cardioangiography: a double-blind parallel comparison between iodixanol 320 mg I/mL and ioxaglate 320 mg I/mL. Acta Radiologica 1994;35: Verow P, Oystein Nossen J, Sheppick A, and Kjaersgaard P. A comparison of iodixanol with iopamidol in aorta-femoral angiography. Br. J. Radiol. 1995;68: Page 8 of 8