Reduces the incidence of CIN in patients with baseline impairment in renal function
PLC Systems has presented the results from the Mythos investigator-sponsored clinical trial of RenalGuard at the American Heart Association (AHA) Scientific Sessions 2009, on November 15, 2009 in Orlando, Florida.
Giancarlo Marenzi, chief of intensive cardiac care unit at Centro Cardiologico Monzino-University of Milan (CCM), presented a poster reflecting the updated interim results covering 105 patients for the investigator-sponsored clinical trial. Earlier results presented this fall reflected completion of 90 patients.
In the results presented at AHA, the trial had enrolled 105 chronic kidney disease (CKD) patients undergoing elective or urgent percutaneous coronary interventions (PCI).
Approximately 14% of the patients in the control group were determined to have acquired contrast-induced nephropathy (CIN), whereas only 4% of those who were treated with RenalGuard acquired CIN.
Dr Marenzi also reported that the incidence of in-hospital complications in the control group was 18%, compared to only 6% in the RenalGuard group, a statistically significant difference (p=0.05) that was consistent with results revealed earlier this fall.
The Mythos data continues to indicate that patients who were at high risk for renal failure, treated with RenalGuard while undergoing certain imaging procedures, acquired CIN at a significantly lower rate than those who were treated beforehand with overnight hydration. Acquiring CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function.
The investigators for the trial are Dr Antonio Bartorelli, director of interventional cardiology, CCM, and professor of cardiology at University of Milan, and Dr Marenzi.
The Mythos trial is a randomised clinical trial designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy utilising RenalGuard, compared to standard overnight hydration, in reducing the incidence of CIN in patients with baseline impairment in renal function undergoing cardiac catheterisation procedures and percutaneous coronary interventions.