Patients at risk for contrast-induced acute kidney injury while undergoing coronary angiography had a 15.5 percent relative reduction in contrast media volume when using the Avert system (Osprey Medical), according to a prospective, multicenter, randomized trial.
However, patients who received the Avert system had similar rates of acute kidney injury compared with patients who only received hydration.
Lead researcher Roxana Mehran, MD, FSCAI, of the Icahn School of Medicine at Mount Sinai in New York City, presented the results of the study during a late-breaking clinical trial session at the Society for Cardiovascular Angiography and Interventions scientific sessions on May 4 in Orlando.
“Contrast media volume is a very, very important factor in reducing acute kidney injury,” Mehran said at a news conference.
Mehran said the Avert system is a contrast modulation device outside of the body and is connected to the manifold injector that physicians use for contrast media to fill and visualize the coronary arteries.
“[The Avert system] is measuring and balancing the pressure that you’re exerting,” she said. “The physician could monitor that and change it. It takes as much volume of the contrast media needed into the coronary artery and then the excess, which is usually wasted into the aorta, before it’s injected it actually is diverted away from the patient into a reservoir and then re-injected at the next injection.”
The study enrolled 578 patients from 39 U.S. centers who underwent coronary angiography with or without PCI and were at risk for contrast-induced acute kidney injury. They were randomized in a 1:1 ratio to receive hydration plus the Avert system (n=292) or hydration only (n=286). Patients had their blood drawn within the first days after undergoing the procedure.
The researchers defined acute kidney injury as a 0.3 mg/dL increase in serum creatinine within 72 hours of the procedure.
At baseline, the groups were well balanced with a mean serum creatinine of 1.6 mg/dL. In addition, 42.2 percent underwent PCI and 64.9 percent had diabetes.
The mean contrast media volume was 86 ml in the Avert group and 101 in the hydration group, which represented a statistically significant 15.5 percent relative reduction. For patients undergoing PCI, the mean contrast media volume was 114 ml and 147 ml, respectively, corresponding to a statistically significant 22.8 percent relative reduction.
The rates of contrast-induced acute kidney injury were 27.0 percent in the Avert group and 26.2 percent in the hydration group. However, a post-hoc subgroup analysis of 470 patients with an eGFR between 40 and 60 ml/min found there was a statistically significant 49.5 percent relative reduction in contrast-induced acute kidney injury in patients who received the Avert system.
The rates of adverse events were similar between the groups, according to the researchers.
“The Avert system was not associated with any safety issues,” Mehran said. “The quality of the image was actually quite good. The physicians felt comfortable looking at the data.”