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Title: Targeted Renal Therapy May Reduce Contrast-Induced Nephropathy in High-Risk Patients: Presented at SIR

"Targeted Renal Therapy May Reduce Contrast-Induced Nephropathy in High-Risk Patients: Presented at SIR"

By Bonnie Darves SEATTLE, WA -- March 7, 2007 -- Patients who would benefit from cardiac catheterisation or other procedures but whose pre-existing renal impairment puts them at high risk for contrast-induced nephropathy (CIN) may benefit from targeted renal therapy (TRT) using the relatively new Benephit(R) CV infusion system that delivers vasodilator therapies such as fenoldopam directly into the renal arteries. A new study, reported here on March 4[^th at the Society of Interventional Radiology's Annual Scientific Meeting (SIR), shows that the incidence of CIN may drop dramatically, from the predicted incidence of 29% to approximately 9%, when the system is used.

Early data from the BeRITe! Registry -- with results of 150 patients at high risk for CIN out of 268 enrolled -- indicate that TRT may reduce CIN by 65%, potentially enabling patients to undergo procedures that would have been contraindicated because of renal impairment.

"This registry -- at least our early experience -- is very encouraging, in that it has shown that there is a benefit to delivering intra-renal (IR) fenoldopam in reducing CIN incidence compared to the validated predictive model," said lead author Bret Wiechmann, MD, interventional radiologist, Vascular & Interventional Physicians, and clinical associate professor of radiology, University of Florida, Gainseville, Florida, United States.

He added that because of "specific mechanisms with fenoldopam related to the renal vascular bed, if it is delivered locally you have fewer systemic side effects and can deliver the drug where it can be most used most effectively, and at higher concentrations."

The Benephit system is approved by the U.S. Food and Drug Administration for direct administration of drugs through an infusion catheter into the renal arteries, Dr. Wiechmann said. The system has received no specific approval for CIN prevention.

In the study, 135 (91%) of patients received IR fenoldopam and 15 (6%) received IR sodium bicarbonate; 94% of patients had pre-existing renal impairment. Mean infusion time was 162 minutes for all patients. Complications occurred in 4 patients and were minor, Dr. Wiechmann noted.

The registry results on TRT, if confirmed through long-term experience, may shed light on what has been a confusing issue for interventional radiologists, Dr. Wiechmann explained -- the lack of a standard of care for preventing or reducing CIN. Studies have produced conflicting results on various CIN prophylaxis approaches -- intra-renal sodium bicarbonate, n-acetylcysteine (Mucomyst), IV fenoldopam and even Vitamin C.

"Because of the existing, conflicting data with regards to other regimens for CIN prophylaxis, no standard of care has emerged. Mostly what we're doing is using things that might be intuitive but don't have a lot of science behind them," he said. "It's early, but certainly the registry data is very encouraging with regard to CIN incidence using TRT."

He acknowledged the inherent limitations of any observational-type study that is reliant on registry data, but noted that a randomised trial comparing bicarbonate infusion to TRT plus bicarbonate infusion is underway, and that the SIR Foundation is pursuing development of a large-scale trial of TRT.

[Presentation title: Targeted Renal Therapy (TRT) for Prevention of Contrast-Induced Nephropathy: Results of the BeRITe! Registry. Abstract 160]

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