CONTRAST MEDIA VOLUME CONTROL FOR LIMITING ACUTE KIDNEY IN ACUTE CORONARY SYNDROME: THE REMEDIAL IV RANDOMIZED CLINICAL TRIAL

ABSTRACT BACKGROUND Acute kidney injury (AKI) is a common complication in patients suffering from acute coronary syndromes (ACS) and treated by percutaneous coronary intervention (PCI). Contrast media (CM) volume minimization has been advocated to prevent AKI. The DyeVert™ system (Osprey Medical Inc., Minnetonka, MN, USA) is a device designed to reduce CM volume during coronary procedures, while maintaining fluoroscopic image quality. METHODS In this is study a randomized, single-blind, investigator-driven clinical trial conducted in 4 italian interventional cardiology centers from February 4, 2020 to September 13, 2022, 550 ACS participants were randomly assigned in 1:1 ratio to 1) Control group (n = 274), in which a conventional manual or automatic injection syringe was used, and 2) Contrast Volume Reduction (CVR) group (n = 276), in which CM injection was handled by the DyeVert TM system. The primary endpoints were 1) CM volume, and 2) the rate of AKI, defined as a serum creatinine (sCr) increase ≥0.3 mg/dL within 48 hours after CM exposure. RESULTS There were 412/550 (74.5%) participants with ST-elevation myocardial infarction (201/274 [73.3%] in the Control group and 211/276 [76.4%] in the CVR group ). Mean glomerular filtration rate was 84±32 mL/min/1.73 m 2 in the Control group and in 85±34 mL/min/1.73 m 2 in the CVR group (p = 0.78). CM volume was higher in the Control group (160 ± 23 mL versus 95 ± 30 mL; p < 0.001). Seven participants (6 in the Control group and one in the CVR group ) did not have post-procedural sCr values. AKI occurred in 65/268 (24.3%) participants in the Control group and in 44/275 (16%) participants in the CVR group (RR = 0.66; 95% confidence interval 0.47-0.93; p = 0.018). CONCLUSIONS CM volume reduction obtained by the DyeVert TM system is effective to prevent AKI in ACS patients undergoing invasive procedure. Trial Registration The study is registered with www.clinicaltrial.gov ( NCT04714736 ) Clinical Perspective What Is New? Contrast media volume reduction obtained by the DyeVert TM system is effective to prevent acute kidney injury in acute coronary syndrome patients undergoing invasive procedure. What Are the Clinical Implications? Contrast media volume minimization is of outmost important in the attempt to prevent acute kidney injury. The DyeVert™ system is an “operator-independent” tool contributing to the contrast media-sparing approach.