BACKGROUND: The use of safe iodinated contrast media (CM) to prevent contrast-induced nephropathy (CIN) is an important consideration among renally impaired diabetic patients during coronary angiography. HYPOTHESIS: Diabetic patients with normal or mild renal dysfunction are less likely to receive renal protective measures during angiography, yet they may also be at risk for CIN. We compared the renal effects of iopamidol and iodixanol in diabetic patients who were referred for angiography. METHODS:Diabetic patients (N=122) with a serum creatinine (SCr) level of < or = 2 mg/dl were double-blind randomized to receive nonionic CM: iopamidol-370 (low osmolar, monomeric) or iodixanol-320 (iso-osmolar, dimeric). Renal stability was evaluated at baseline and at Days 1, 3, and 7 post-angiography. The primary endpoint was a > or = 25% increase in SCr. RESULTS: Seventeen (10 iopamidol, 7 iodixanol; P=NS) patients had an increase in SCr > or = 25% over baseline. Over all days, analysis revealed nonsignificant differences in the incidence of CIN between the two study groups regardless of how CIN was defined. CONCLUSIONS:Diabetic patients with normal or mild renal dysfunction are at risk for CIN. No significant difference in renal response was observed for these CM in this at-risk population.
RCT Entities:
BACKGROUND: The use of safe iodinated contrast media (CM) to prevent contrast-induced nephropathy (CIN) is an important consideration among renally impaired diabeticpatients during coronary angiography. HYPOTHESIS: Diabeticpatients with normal or mild renal dysfunction are less likely to receive renal protective measures during angiography, yet they may also be at risk for CIN. We compared the renal effects of iopamidol and iodixanol in diabeticpatients who were referred for angiography. METHODS:Diabeticpatients (N=122) with a serum creatinine (SCr) level of < or = 2 mg/dl were double-blind randomized to receive nonionic CM: iopamidol-370 (low osmolar, monomeric) or iodixanol-320 (iso-osmolar, dimeric). Renal stability was evaluated at baseline and at Days 1, 3, and 7 post-angiography. The primary endpoint was a > or = 25% increase in SCr. RESULTS: Seventeen (10 iopamidol, 7 iodixanol; P=NS) patients had an increase in SCr > or = 25% over baseline. Over all days, analysis revealed nonsignificant differences in the incidence of CIN between the two study groups regardless of how CIN was defined. CONCLUSIONS:Diabeticpatients with normal or mild renal dysfunction are at risk for CIN. No significant difference in renal response was observed for these CM in this at-risk population.
Authors: Fulvio Stacul; Aart J van der Molen; Peter Reimer; Judith A W Webb; Henrik S Thomsen; Sameh K Morcos; Torsten Almén; Peter Aspelin; Marie-France Bellin; Olivier Clement; Gertraud Heinz-Peer Journal: Eur Radiol Date: 2011-08-25 Impact factor: 5.315