Anand Prasad (Department of Medicine, Division of Cardiology, University of Texas Health Science Center, San Antonio, USA) and others report in the Journal of Interventional Cardiology that the use of RenalGuard in patients undergoing interventional cardiology procedures is associated with significant reductions in all-cause mortality, the need for dialysis, and major adverse cardiovascular and cerebrovascular events (MACCE) in the both short- and long-term.
As with previous studies, the meta-analysis also showed that the device significant reduces contrast-induced acute kidney injury; it included 10 studies, four of which were randomised controlled trials. Of a total of 1,585 patients, 698 were enrolled in the four randomised trials, and 887 belonged to the remaining patient registries included in the analysis.
Results showed that use of RenalGuard was associated with a significant risk reduction for contrast-induced acute kidney injury compared with controls—7.7% vs. 23.6% respectively; p˂0.01. Patients who underwent an interventional cardiology procedure with RenalGuard also had decreased mortality (p=0.05), dialysis (p=0.01), and MACCE (P˂0.01) compared with those who did not undergo a procedure with the device.
RenalGuard chief executive officer Jim Dillon says: “We thank the authors of this study, whose detailed analysis shows that RenalGuard provides greater benefit to patients and healthcare providers than volume expansion, not only by lowering the incidence of contrast-induced acute kidney injury and reducing the need for dialysis, but improving patient outcomes by furthermore decreasing patient mortality and the incidence of costly major adverse cardiovascular events.”
The RenalGuard system is currently marketed for use in the cardiac catheterisation laboratory in markets where it is approved, including a number of countries in Europe and the Middle East. The company expects to conclude its pivotal US trial before the end of this year and file for pre-marketing approval with the FDA in 2018.