1. Hexabrix Key Clinical Review Mehran, 2009
Mid-Year Sales Meeting
Bloomington, IN
July 13th – 17th

2. Hexabrix Key Clinical Review
Title:
Ionic Low-Osmolar Versus Nonionic Iso-Osmolar Contrast Media to Obviate Worsening Nephropathy After Angioplasty in Chronic Renal Failure Patients (ICON)
Main Author:
Dr. Roxana Mehran
Publication:
JACC: Cardiovascular Interventions
Date:
2009

3. Hexabrix Key Clinical Review
Study Objective(s):
Compare the nephrotoxicity of Visipaque versus Hexabrix in patients with chronic renal insufficiency undergoing coronary angiograpahy.

4. Hexabrix Key Clinical Review
Patient Population Details:
146 Total – Visipaque (72) & Hexabrix (74)
High risk patients undergoing coronary angiographic procedures.
Stable renal insufficiency defined as having 2 consecutive serum creatinine levels greater than 1.5mg/dl and less than 3.0 mg/dl.
Baseline charactoristics were not significantly different.

5. Hexabrix Key Clinical Review
Primary & Secondary Endpoints:
Primary: The median peak increase of serum creatinine from day 0 to day 3 after angiography.
Secondary:
Proportion of patients with a peak serum creatinine increase > 0.5 mg/dl
Proportion of patients with a peak serum creatinine increase > 1.0 mg/dl
Proportion of patients with a peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through 3

6. Hexabrix Key Clinical Review
Outcomes & Results:
The peak increase in serum creatinine levels over time did not differ significantly between the 2 groups.
No significant differences of any of the secondary endpoints occurred between the 2 groups.
The incidences of adverse events in terms of death, myocardial infarction, and repeat revascularization did not differ between the 2 groups.

7. Hexabrix Key Clinical Review

8. Hexabrix Key Clinical Review
Other Important Notes:
Randomized, prospective, controlled, double blind study completed at 7 centers with the US & Canada.
N-Acetylcysteine administered at the discretion of the investigator.
Authors state that the study was underpowered & that a larger randomized study is warranted.

9. Hexabrix Key Clinical Review
Role Play (15 min)
Pairs of 3 (MCP, MD & Observer)
Each MCP detail the paper to group
Be sure to summarize the key points

10. Hexabrix Key Clinical Review
Examples of use in the field?