Contact: Amanda Jekowsky, ajekowsk@acc.org, 202-731-3069

NEW FLUID MANAGEMENT SYSTEM SUPERIOR TO CONVENTIONAL HYDRATION FOR IMPROVING SAFETY OF IMAGE-GUIDED PROCEDURES

REMEDIAL II Trial Shows RenalGuard Therapy® Leads to Fewer Cases of Contrast-Induced Acute Kidney Injury for High-Risk Patients

New Orleans, LA – Treating patients with the RenalGuard System™ (PLC Medical Systems, Inc.) instead of conventional hydration treatment improves the safety of image-guided cardiology procedures, leading to fewer cases of contrast-induced acute kidney injury (CI-AKI), according to research presented today at the American College of Cardiology’s 60th Annual Scientific Session. ACC.11 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further advances in cardiovascular medicine.

The findings of the REMEDIAL II trial will help patients at high risk of kidney failure who undergo image-guided cardiology procedures, such as coronary angiography and angioplasty. The dye used in these procedures is toxic to the kidneys, and patients with pre-existing impaired kidney function can experience acute kidney failure during or after a procedure.

While previous studies have shown that a combination of N-acetylcysteine (NAC) and sodium bicarbonate solution improves outcomes for low-to-medium-risk patients, the rate of CI-AKI remains high for high-risk patients. The REMEDIAL II team tested the hypothesis that the RenalGuard System™ may help these high-risk patients by providing a more controlled and monitored form of hydration and forced diuresis.
“Data from the PRINCE study indicate that increasing the urine flow rate reduces the toxic effect of contrast media by diluting the dye and flushing it out of the body more quickly,” said Carlo Briguori, M.D., Ph.D., lead study author and director of the Laboratory of Interventional Cardiology at the Clinica Mediterranea in Naples, Italy. “However, at present, a forced diuresis regimen is usually achieved by a high dose of furosemide, which may be deleterious due to a negative fluid balance. This risk may be overcome by the RenalGuard System™ and its matched fluid replacement capability.”

The RenalGuard System™ includes a closed-loop fluid management system that pumps in an amount of hydrating solution that corresponds to urine output. According to Briguori, this feature maintains intravascular blood volume and minimizes the risk of over- or under-hydration.

The study was conducted at four interventional cardiology centers in Italy, and the REMEDIAL II research team enrolled 292 patients with chronic kidney disease who were scheduled from January 2009 to December 2010 for coronary and/or peripheral angiography and/or angioplasty. The team randomized study patients in a 1:1 ratio to receive either: a) conventional hydration; a combination of NAC and sodium bicarbonate solution, or b) hydration with normal saline plus NAC and low-dose furosemide controlled by the RenalGuard System™.

The team measured certain biomarkers of kidney function, including serum creatinine (sCr) and cystatin C (sCyC), the day before the procedure and up to one week post-procedure. The study’s primary outcome measure was development of CI-AKI. Secondary outcome measures included specific changes in the concentration of sCr and sCyC, the rate of acute renal failure requiring dialysis, and the rate of adverse events that occurred in the hospital and one month post-procedure.

The data showed that nearly twice as many patients in the conventional hydration group compared to the RenalGuard System™ group experienced CI-AKI at 20.5 percent and 11 percent respectively (p = 0.025; Odds Ratio [OR] = 0.47; 95 percent CI = 0.25-0.92). In addition, more severe damage from the CI-AKI occurred in the conventional hydration group, with 23 percent of the patients experiencing stage 2 or 3 damage, compared to 6 percent of patients in the RenalGuard System™ group (p = 0.14).

For the secondary outcomes, the conventional hydration group had a higher rate of in-hospital renal failure requiring dialysis, at 4.1 percent, compared to 0.7 percent in the RenalGuard System™ group (p = 0.056; OR = 0.16; 95 percent CI = 0.02-1.13). While length of in-hospital stay was similar in the two groups, the conventional hydration group also showed a higher one-month rate of major adverse events (9.6 percent compared to 6.8 percent; p = 0.52), such as death and acute pulmonary edema (accumulation of fluid in the lungs). The conventional hydration group also showed sCyC levels that increased significantly more than in the RenalGuard System™ group, indicating reduced kidney function.

“According to the results of the REMEDIAL II trial, RenalGuard Therapy®, including hydration with normal saline plus a high dose of NAC and a limited dose of furosemide, should be the considered as the prophylactic strategy for patients at high risk for CI-AKI,” Briguori said.

The study was funded by PLC Medical Systems, Inc. and Briguori had no disclosures.

Dr. Briguori will be available to the media on Monday, April 4, at 12:30 p.m. CDT in Room.338/339.
Dr. Briguori will present the study “Renal Insufficiency Following Contrast Media Administration Trial II: RenalGuard System in High-Risk Patients for Contrast-Induced Acute Kidney Injury” on Monday, April 4, at 10:45 a.m. CDT in the Joint Main Tent: La Nouvelle.

The American College of Cardiology (www.cardiosource.org) represents the majority of board certified cardiovascular care professionals through education, research, promotion, development and application of standards and guidelines – and to influence health care policy. ACC.11 is the largest cardiovascular meeting, bringing together cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.
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