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

Abstract

ABSTRACTBACKGROUNDAcute 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.METHODSIn 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 DyeVertTMsystem. 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.RESULTSThere were 412/550 (74.5%) participants with ST-elevation myocardial infarction (201/274 [73.3%] in theControl groupand 211/276 [76.4%] in theCVR group). Mean glomerular filtration rate was 84±32 mL/min/1.73 m2in theControl groupand in 85±34 mL/min/1.73 m2in theCVR group(p = 0.78). CM volume was higher in theControl group(160 ± 23 mL versus 95 ± 30 mL; p < 0.001). Seven participants (6 in theControl groupand one in theCVR group) did not have post-procedural sCr values. AKI occurred in 65/268 (24.3%) participants in theControl groupand in 44/275 (16%) participants in theCVR group(RR = 0.66; 95% confidence interval 0.47-0.93; p = 0.018).CONCLUSIONSCM volume reduction obtained by the DyeVertTMsystem is effective to prevent AKI in ACS patients undergoing invasive procedure.Trial RegistrationThe study is registered withwww.clinicaltrial.gov(NCT04714736)Clinical PerspectiveWhat Is New?Contrast media volume reduction obtained by the DyeVertTMsystem 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.