title: A prospective, double-blind, randomized, controlled trial on the efficacy and cardiorenal safety of iodixanol vs. iopromide in patients with chronic kidney disease undergoing coronary angiography with or without percutaneous coronary intervention.
abstract: OBJECTIVE
  This study was undertaken to compare the renal safety as well as cardiovascular (CV) effects and diagnostic image quality of iso-osmolar iodixanol vs. low-osmolar iopromide in patients with chronic kidney disease (CKD) undergoing coronary interventions.
  
  
  BACKGROUND
  With the growing number of contrast-enhanced procedures being performed for coronary artery disease management, the safety and efficacy of iodinated contrast media (CM) have come under increased scrutiny.
  
  
  METHODS
  : Patients with CKD (CrCl < or =60 mL/min) were randomized to iodixanol (n = 106) or iopromide (n = 102). The primary endpoint was incidence of contrast-induced nephropathy (CIN), defined as an increase in serum creatinine (SCr) > or =25% or 0.5 mg/dL within 72 hr of CM administration. Secondary endpoints were mean SCr increase, a composite of CV events in-hospital and 30 days postdischarge, and diagnostic image quality.
  
  
  RESULTS
  : CIN incidence was significantly lower with iodixanol than iopromide (5.7% vs. 16.7%; P = 0.011). Baseline SCr (OR 2.21, 95% CI: 1.25-3.47; P = 0.031), iopromide use (OR 2.56, 95% CI: 1.18-5.76; P = 0.024), and CM volume (OR 2.01, 95% CI: 1.01-3.21; P = 0.038) were identified as independent risk factors for CIN. Cardiovascular events were reduced with iodixanol (1.9% vs. 8.8%; P = 0.025); diagnostic image quality was similar for both CM (P = 0.353).
  
  
  CONCLUSIONS
  : Consistent with several previous trials comparing iso-osmolar iodixanol and low-osmolar comparator CM, iodixanol was associated with a lower incidence of CIN and fewer CV events than iopromide.
authors.affiliation: Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, People's Republic of China.
authors.forename: Bin
authors.initials: B
authors.lastname: Nie
authors.forename: Wan-Jun
authors.initials: WJ
authors.lastname: Cheng
authors.forename: Yan-Fang
authors.initials: YF
authors.lastname: Li
authors.forename: Zheng
authors.initials: Z
authors.lastname: Cao
authors.forename: Qing
authors.initials: Q
authors.lastname: Yang
authors.forename: Ying-Xin
authors.initials: YX
authors.lastname: Zhao
authors.forename: Yong-He
authors.initials: YH
authors.lastname: Guo
authors.forename: Yu-Jie
authors.initials: YJ
authors.lastname: Zhou
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000503:physiopathology / Q000628:therapy; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects*; D003324:Coronary Artery Disease / Q000150:complications / Q000000981:diagnostic imaging* / Q000628:therapy; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives*; D007674:Kidney Diseases / Q000150:complications* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011857:Radiographic Image Interpretation, Computer-Assisted; D006435:Renal Dialysis; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014283:Triiodobenzoic Acids / Q000009:adverse effects*
chemical_list: D003287:Contrast Media; D014283:Triiodobenzoic Acids; D007472:Iohexol; C038192:iopromide; D003404:Creatinine; C044834:iodixanol