Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study) |
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Authors: | Gilbert Deray Olivier Rouviere Lorenzo Bacigalupo Bart Maes Thierry Hannedouche François Vrtovsnik Claire Rigothier Jean-Marie Billiouw Paolo Campioni Joaquin Ferreiros Daniel Devos Daniel Alison François Glowacki Jean-Jacques Boffa Luis Marti-Bonmati |
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Affiliation: | 1. Department of Nephrology, Pitié Salpétrière Hospital, Bat G. Cordier, 47-83 Bd de l’h?pital, 75651, Paris cedex 13, France 2. Hospices Civils de Lyon, Department of Urinary and Vascular Imaging, H?pital E. Herriot, Université de Lyon, Lyon, France 3. Université Lyon 1, faculté de médecine Lyon Est, Lyon, France 5. Radiology Department, E.O. Ospedali Galliera, Genova, Italy 6. Department of Nephrology, Heilig Hartziekenhuis Roeselare, Roeselare, Belgium 7. Department of Nephrology, University Hospitals, Strasbourg, France 8. Department of Nephrology, Bichat Hospital, Paris, France 9. Department of Nephrology Transplantation Dialysis, Pellegrin Hospital, Bordeaux, France 10. Department of Nephrology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium 11. Azienda Ospedaliero-Universitaria Sant’Anna, Ferrara, Italy 12. Servicio de Radiodiagnostico, Hospital Clinico de San Carlos, Madrid, Spain 13. Department of Radiology, Gent University Hospital, Gent, Belgium 14. Department of Radiology, Trousseau Hospital, Tours, France 15. Department of Nephrology, University Hospitals, Lille, France 16. Department of Nephrology and Dialysis, Tenon Hospital, Paris, France 17. Department of Radiology, University of Valencia, Valencia, Spain
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Abstract: | Objective To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients. Methods Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72?±?24 h after the MRI procedure, by at least 25 % or 44.2 μmol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at ?15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72?±?24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up. Results Among the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [Δ?=??1.4 %, 95%CI = (?7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P?=?0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted. Conclusion Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD. Key points ? Contrast-induced nephropathy (CIN) is a potential problem following gadolinium administration for MRI. ? Meglumine gadoterate (Gd-DOTA) appears safe, even in patients with chronic kidney disease. ? Gd-DOTA only caused a temporary creatinine level increase in 1/70 such patients. ? No case or sign of NSF was detected at 3-month follow-up. |
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