Impact of a novel contrast reduction system on contrast savings in coronary angiography - The DyeVert randomised controlled trial

Abstract

Aims: The most prominent procedure-related and thus modifiable risk factor for contrast-induced acute kidney injury is contrast media (CM) volume. The DyeVert™ system has been designed to reduce the amount of CM. The primary objective of this randomised controlled trial was thus to examine whether the novel DyeVert™ contrast reduction system (Osprey Medical Inc., Minnetonka, MN, USA) leads to a reduction in CM volume in patients undergoing diagnostic coronary angiography.

Methods: Patients scheduled for a diagnostic coronary angiogram were randomised to angiography with or without the DyeVert™ system. The primary efficacy endpoint was mean CM volume. Image quality was evaluated by an independent reviewer blinded to treatment allocation.

Results: A total of 96 patients underwent randomisation. Baseline characteristics were well balanced between groups. Use of the DyeVert™ system resulted in a significant 41.0% reduction in CM volume (36.9±10.9mL versus 62.5±12.7mL, p<0.001). Image quality using the DyeVert™ system was non-inferior compared to control (p=0.03). There were no device-related adverse events.

Conclusions: The DyeVert™ system leads to significant reduction in CM volume in patients undergoing diagnostic coronary angiography, while maintaining image quality.

Keywords: Contrast media; Contrast reduction; Contrast-induced acute kidney injury; Coronary angiography.