Bracco Ppt Presentation_1

8/7/2019 Bracco Ppt Presentation_1

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Confidential & Proprietary


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Additional findings from the IMPACT Study

A Comparison of the Efficacy & Safetyof Iopamidol-370 and Iodixanol-320 inPatients Undergoing Multidetector-row

Computed Tomography

D ushyant V. Sahani, Gilles Sowlez, M D , Ke-Min Chen, M D , Luigi Lepanto, M D , Jian-Rong Xu, M D , Rendon C. Nelson, M D , Luigi Grazioli, M D , Angelo Vanzulli, M D , Jay

P. Heiken, M D , and the Investigators of the IMPACT Study


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Reminder

Data from the IMPACT Study on the comparisonof the renal tolerability assessment werepublished in Investigative Radiology last year


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Additional investigation objectives of theIMPACT Study

To prospectively compare the effects of iopamidol-370 and iodixanol-320 on: heart rate (H R) and

contrast enhancement efficacy

in renally-impaired patients undergoing contrast-enhanced, multidetector-row computed

tomography (CE-MDCT).


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Study Design

Multicenter (15 centers), double-blind, parallelgroup comparison

Patients were assigned randomly to receive

the intravenous (I.V.) injection of Iopamidol-370 or Visipaque TM 320 (iodixanol injection)

All groups and individuals associated with the

study remained blinded until the database waslocked and the data analyzed

Visipaque (iodixanol injection) is a trademark of GE Healthcare.


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Study Patients

A total of 166 patients, 18 years of age or older

with stable, pre-existing moderate-to-severe kidney disease

referred for CE-MDCT examinationof the liver or peripheral vasculature


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Contrast Injection Protocol

The total iodine dose was set at 40 gI for allpatients (equating to 108 mL of Iopamidol-370or 125 mL of Iodixanol-320)

Both contrast agents were injected via an 18-20-gauge IV angiocatheter at 4 mL/s

The injection of the contrast agents wasfollowed by a 20 mL saline flush at 4 mL/s


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Monitoring Heart Rate

Heart rate (HR) measured with patients insupine position (on CT table)

Baseline HR (bpm) was obtained within 5min before CM injection

HR was monitored continuously from start of CM injection for 5 min

Peak post-dose HR was recorded


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Measurement of Contrast Enhancement

Images from liver MDCT exams were independentlyevaluated by 2 expert radiologists: with > 1 5 years abdominal imaging experience, unaffiliated with study centers,

and fully blinded to the CM used

The blinded readers performed quantitative HounsfieldUnit (HU) measurements at 4 predefined regions of interest (ROIs):

Arterial phase: proximal abdominal aorta Portal venous phase: main portal vein, inferior vena

cava, and normal liver parenchyma


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Comparability of Study Groups

* Isovue is the Bracco trade name of Iopamidol in U.S.

*


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Contrast MediaHeart Rate Effects


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Effects on Heart Rate


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Effects on Heart Rate


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Contrast Enhancement


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RO I Reader Parameter Iopamidol370

Iodixanol320

Difference(IopamidolIodixanol )

9 5% CI p-value

Proximal Abdominal

Aorta

Reader1

N 56 5 9

Mean 30 1 .3 273.6

Lsmean 303.2 27 1 .8 3 1 .4 (6. 1 ,56. 8 )

0.02

SE 9 .2 8 .9

Reader2

N 55 5 9

Mean 300. 1 276.0

Lsmean 30 1 .9 275. 1 26. 8 (2.3,5 1 .3 )

0.03

SE 8 .9 8 .6

Arterial Phase


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RO I Reader Parameter Iopamidol370

Iodixanol320

Difference(IopamidolIodixanol )

9 5% CI p-value

LiverParenchyma

Reader1

N 55 60

Mean 11 3. 4 11 2.0

Lsmean 11 3. 4 111 .9 1 .4 (-5.5,8 .4 )

0.7

SE 2.5 2. 4

Reader2

N 56 6 1

Mean 111 .9 1 0 8 .5

Lsmean 11 2. 1 1 0 8 .3 3. 8 (-3.2,1 0.7 )

0.3

SE 2.5 2. 4

Portal Phase


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Conclusions of this study

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