Steffen Desch1, Georg Fuernau2, Janine Pöss2, Roza Meyer-Saraei2, Mohammed Saad2, Ingo Eitel2, Holger Thiele3, Suzanne de Waha2. 1. Heart Centre Leipzig, Department of Internal Medicine/Cardiology, University of Leipzig, Leipzig, Germany; University Heart Centre Luebeck, Department of Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Luebeck, Germany; German Centre for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Luebeck, Luebeck, Germany. Electronic address: steffen.desch@medizin.uni-leipzig.de. 2. University Heart Centre Luebeck, Department of Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Luebeck, Germany; German Centre for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Luebeck, Luebeck, Germany. 3. Heart Centre Leipzig, Department of Internal Medicine/Cardiology, University of Leipzig, Leipzig, Germany.
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.
RCT Entities:
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.
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