In the largest study of its kind, the Avert device from Osprey Medical has been found to significantly reduce the volume of radiographic dye without decreasing image quality in patients who are at risk of developing acute kidney injury (AKI) after undergoing a coronary angiography or percutaneous coronary intervention (PCI). The device did not, however, reduce contrast-induced AKI (CI-AKI).
The Avert results were presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions in Orlando, USA.
“Physicians are extremely careful about the volume of dye they administer to patients; the greater the volume, the more problems a physician can encounter,” says Roxana Mehran, director of interventional cardiovascular research and clinical trials at the Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (New York City, USA), and the study’s lead author.
The Avert device is designed to allow the operator to control the volume of dye used during an interventional procedure. Once the appropriate amount of dye has been injected into the coronary, the remaining dye goes into a reservoir, rather than into the aorta.
The prospective, randomised multicentre study enrolled 578 patients, at 39 sites, who were considered to be at risk of CI-AKI while undergoing coronary angiography with or without PCI. The treatment group (n=292) included hydration and Avert; the control group (n=286) received hydration only. The study’s objectives were to assess total CMV used and determine the incidence of CI-AKI, which was defined as a 0.3mg/dl increase in serum creatinine within 72 hours post-procedure.
Of the 568 patients with CI-AKI, PCI was performed on 239 (42.2%). The use of Avert resulted in a 15.5% relative reduction in CMV in all patients (86±51 ml vs. 101±71 ml, p=0.002) and a 22.8% relative reduction in CMV for PCI patients (114ml±55 vs. 147±81ml, p=0.001). There were no significant differences in CI-AKI (27% vs. 26.2%, p=0.72) or adverse event rates between the two groups.
“The bottom line is the Avert system is safe, easy to use and reduces contrast media volume without sacrificing image quality,” says Mehran. “While the use of this device did not result in a significant reduction of CI-AKI, there was one exception. A post-hoc analysis showed that in certain groups—patients with a GFR between 40 and 60—CI-AKI was significantly reduced. The next step would be to study patients with moderate chronic kidney disease in a prospective randomised trial.”