August 23, 2011 — PLC Systems Inc. said the final results from the REMEDIAL II investigator-sponsored clinical trial have been published online in Circulation, a peer-reviewed journal of the American Heart Association. It will appear in the September 2011 issue of the publication. REMEDIAL II is an Italian trial of the company’s RenalGuard device.
Results showed RenalGuard is superior to current methods at preventing contrast-induced nephropathy (CIN) and in-hospital dialysis in high-risk patients undergoing computed tomography (CT) and angiography imaging procedures. All patients also received injections of iodine-based contrast agents.
Investigators discovered patients treated with RenalGuard and N-acetylcysteine (NAC) developed CIN, a serious and potentially fatal condition, at a much lower rate than patients in the control group. The second group was treated with an infusion of sodium bicarbonate and NAC. Sodium bicarbonate plus NAC remains the current standard-of-care for the prevention of CIN in many healthcare institutions worldwide.
The results provided strong scientific data that RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury (CI-AKI) in high-risk patients.
Carlo Briguori, M.D., Ph.D., chief of laboratory of interventional cardiology, Clinica Mediterranea, Naples, Italy, reported on data from 294 patients with chronic kidney disease (CKD). All patients also underwent elective catheterization procedures for diagnostic imaging.
The primary endpoint for the study used a definition of CIN as a rise in serum creatinine (SCr) of 0.3 mg/dl over the patient's baseline reading. The RenalGuard group had a CIN incidence rate 46 percent lower than the control group using this definition of CIN. He also reported on a number of secondary endpoints. There was a 60 percent reduction in CIN in the RenalGuard group compared to the control group when defining CIN as a 0.5 mg/dl absolute rise in SCr. There was an 80 percent reduction of CIN in the RenalGuard-treated group over the control group when defining CIN as a 25 percent rise over baseline SCr.
The development of CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function. Notably the trial also found RenalGuard therapy significantly reduced the need for in-hospital dialysis in high-risk patients. In the control group, seven (or 4.8 percent) of these patients required some level of dialysis. Only one patient (0.7 percent), or 85 percent fewer, in the RenalGuard-treated group required dialysis.
The Circulation article can be accessed at the following link: http://circ.ahajournals.org/content/early/2011/08/13/CIRCULATIONAHA.111.030759.abstract
For more information: www.plcmed.com