title: Impact of iso-osmolar versus low-osmolar contrast agents on contrast-induced nephropathy and tissue reperfusion in unselected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the Contrast Media and Nephrotoxicity Following Primary Angioplasty for Acute Myocardial Infarction [CONTRAST-AMI] Trial).
abstract: Conflicting data have been reported on the effects of low-osmolar and iso-osmolar contrast media on contrast-induced acute kidney injury (CI-AKI). In particular, no clinical trial has yet focused on the effect of contemporary contrast media on CI-AKI, epicardial flow, and microcirculatory function in patients with ST-segment elevation acute myocardial infarction who undergo primary percutaneous coronary intervention. The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty for Acute Myocardial Infarction (CONTRAST-AMI) trial is a prospective, randomized, single-blind, parallel-group, noninferiority study aiming to evaluate the effects of the low-osmolar contrast medium iopromide compared to the iso-osmolar agent iodixanol on CI-AKI and tissue-level perfusion in patients with ST-segment elevation acute myocardial infarction. Four hundred seventy-five consecutive, unselected patients who underwent primary percutaneous coronary intervention were randomized to iopromide (n = 239) or iodixanol (n = 236). All patients received high-dose N-acetylcysteine and hydration. The primary end point was the proportion of patients with serum creatinine (sCr) increases ≥25% from baseline to 72 hours. Secondary end points were Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade, increase in sCr ≥50%, increase in sCr ≥0.5 or ≥1 mg/dl, and 1-month major adverse cardiac events. The primary end point occurred in 10% of the iopromide group and in 13% of the iodixanol group (95% confidence interval -9% to 3%, p for noninferiority = 0.0002). A TIMI myocardial perfusion grade of 0 or 1 was present in 14% of patients in the 2 groups. No differences between the 2 groups were found in any of the secondary analyses of sCr increase. No significant difference in 1-month major adverse cardiac events was found (8% vs 6%, p = 0.37). In conclusion, in a population of unselected patients with ST-segment elevation acute myocardial infarction who underwent primary percutaneous coronary intervention, iopromide was not inferior to iodixanol in the occurrence of CI-AKI; no significant differences were found in terms of tissue-level reperfusion and major adverse cardiac events between the 2 contrast agents.
authors.affiliation: Department of Cardiovascular Diseases, San Donato Hospital, Arezzo, Italy. leonardobolognese@hotmail.com
authors.forename: Leonardo
authors.initials: L
authors.lastname: Bolognese
authors.forename: Giovanni
authors.initials: G
authors.lastname: Falsini
authors.forename: Carsten
authors.initials: C
authors.lastname: Schwenke
authors.forename: Simone
authors.initials: S
authors.lastname: Grotti
authors.forename: Ugo
authors.initials: U
authors.lastname: Limbruno
authors.forename: Francesco
authors.initials: F
authors.lastname: Liistro
authors.forename: Arcangelo
authors.initials: A
authors.lastname: Carrera
authors.forename: Paolo
authors.initials: P
authors.lastname: Angioli
authors.forename: Andrea
authors.initials: A
authors.lastname: Picchi
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ducci
authors.forename: Carlo
authors.initials: C
authors.lastname: Pierli
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects* / Q000379:methods; D003326:Coronary Circulation / Q000187:drug effects; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D015994:Incidence; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives; D007558:Italy / Q000453:epidemiology; D008297:Male; D009203:Myocardial Infarction / Q000000981:diagnostic imaging* / Q000503:physiopathology / Q000628:therapy; D015428:Myocardial Reperfusion Injury / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D016037:Single-Blind Method; D014283:Triiodobenzoic Acids / Q000009:adverse effects
chemical_list: D003287:Contrast Media; D014283:Triiodobenzoic Acids; D007472:Iohexol; C038192:iopromide; C044834:iodixanol