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REMEDIAL II: Contrast-induced acute kidney injury lowered with RenalGuard System

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American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Compared with conventional hydration treatment, use of the RenalGuard System in patients with chronic kidney disease improved the safety of image-guided cardiology procedures, which led to fewer cases of contrast-induced acute kidney injury, according to findings presented here.

“This trial demonstrates that the RenalGuard System [PLC Medical Systems] is very good device to prevent contrast-induced acute kidney injury in high-risk patients,” said Carlo Briguori, MD, PhD, lead study author and director, Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples, in a press conference.

The Italy-based study was conducted at four interventional cardiology centers and included 292 patients with chronic kidney disease. Patients were scheduled for coronary and/or peripheral angiography and/or angioplasty between January 2009 and December 2010. They were randomized to receive either conventional hydration that included a combination of N-acetylcysteine (NAC) and sodium bicarbonate solution or hydration with normal saline plus NAC and low-dose furosemide controlled by the RenalGuard System. Biomarkers such as serum creatinine (sCr) and cystatin C were assessed the day before and up to 1 week following the procedure.

The researchers reported that the primary endpoint of the development of contrast-induced acute kidney injury CI-AKI (sCr increase ≥0.3 mg/dL at 48 hours) was nearly two times higher in the conventional treatment group (20.5% vs. 11%; P=.025). Non-statistically significant more patients experienced stage 2 or 3 damage in the conventional arm (23% vs. 6%; P=.14) as well.

Additional analysis revealed that a lower rate of in-hospital renal failure requiring dialysis occurred in the RenalGuard System group (0.7% vs. 4.1%; P=0.056), although rates of in-hospital stay and major adverse events were similar between groups.

For Briguori, the rate of dialysis was the most important clinical finding, because it shows the possibility to prevent this very improbable complication. – by Brian Ellis

Disclosure: Dr. Briguori reports no relevant financial disclosures.

For more information:

• Briguori C. LBCT III, Session 3014. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

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