Nephrogenic Systemic Fibrosis in Patients with Advanced Renal Dysfunction Following Gadolinium-based Contrast Agents

Background The risk of nephrogenic systemic fibrosis (NSF) following administration of contemporary gadolinium-based contrast agents (GBCAs) in patients with advanced chronic kidney disease (CKD) or end-stage renal disease (ESRD) is thought to be low; however, existing reports have involved relatively few participants compared with the number of patients who might benefit from contrast-enhanced MRI in the United States. Purpose To estimate the risk of NSF with contemporary GBCAs in real-world practice in patients with advanced CKD or ESRD. Materials and Methods Adult patients with preexisting diagnoses of stage 4 or 5 CKD or ESRD who received GBCAs between January 2010 and January 2025 were identified retrospectively from the TriNetX U.S. Network. Propensity score matching (PSM) with a control group regarding demographic characteristics and comorbidities was performed to reduce confounding. The primary endpoint (possible NSF [International Statistical Classification of Diseases and Related Health Problems, 10th Revision, code L90.8]) and secondary endpoint (possible NSF confounders) were assessed within 1 year. Risk ratios (RRs) were calculated to assess the occurrence and mortality rates of possible NSF, and the Kaplan-Meier log-rank test was used to compare cumulative occurrence rates. Results A total of 73 022 adults (mean age, 64.1 years ± 15.1 [SD]; 39 359 [53.9%] male) with advanced CKD or ESRD who received GBCAs were identified. After PSM, 36 (0.05%) and 542 (0.74%) patients with advanced CKD or ESRD with possible NSF and NSF confounder codes, respectively, were retained, compared with 36 (0.05%) and 518 (0.71%) in controls, respectively (RR, 1.00 [95% CI: 0.63, 1.59] [<i>P</i> > .99] and 1.05 [95% CI: 0.93, 1.18] [<i>P</i> = .46]). Diagnostic code rates were similar for patients who received American College of Radiology group II GBCAs and macrocyclic GBCAs, with no evidence of a difference from those of the controls without advanced CKD or ESRD. Conclusion In this real-world database analysis, the probability of a diagnostic code for possible NSF following contemporary GBCA administration in patients with advanced CKD or ESRD was exceedingly low and not significantly greater than that of matched controls without renal dysfunction. © The Authors 2025. Published by the Radiological Society of North America under a CC BY 4.0 license. <i>Supplemental material is available for this article.</i> See also the editorial by Li in this issue.