Feasibility pilot study of the use of ultra-low dose iodinated contrast agent for endovascular procedures in patients with chronic limb-threatening ischemia and renal impairment: the ULTRA-LOW study.

内容摘要

To evaluate the feasibility and safety of an ultra-low-dose iodinated contrast media (CM) protocol during peripheral endovascular procedures in patients with chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI). This prospective, two-center, observational study included consecutive patients with CLTI and renal dysfunction (eGFR&#x2009;<&#x2009;60&#xa0;mL/min/1.73m2, stages 2-4) undergoing infrainguinal revascularization over a 1-year period. The protocol utilized 1:9 or 2:8 CM-to-saline dilutions to minimize iodine exposure. Primary endpoints were technical success (revascularization using&#x2009;&#x2264;&#x2009;15&#xa0;mL CM) and the incidence of Contrast-Associated Acute Kidney Injury (CI-AKI), defined as a 25% increase from baseline or a 0.5&#xa0;mg/dL increase in absolute sCr value, within 72&#xa0;h. Secondary endpoints included procedural success, limb salvage, and freedom from clinically driven target lesion revascularization (TLR) at 6&#xa0;months. Eighteen patients were enrolled, presenting advanced (Rutherford 6: 38.9%; occlusions: 38.8%) and complex infrainguinal disease (both femoropopliteal and infrapopliteal disease 27.7%; occlusions 38.8%). Technical success was 94.5%, with a mean CM volume of 10.3&#x2009;&#xb1;&#x2009;3.5&#xa0;mL (range: 5-17&#xa0;mL). Procedural success was 100%. No cases of CI-AKI occurred; one patient (5.5%) required dialysis 3 months post-procedure due to disease progression. Mean sCr and eGFR significantly improved at 72&#xa0;h compared to baseline (p&#x2009;<&#x2009;0.0001). At 6&#xa0;months, limb salvage was 94.4%, TLR-free rate was 81.3% and survival was 83.3%. Ultra-low-dose iodinated CM protocol in complex CLTI endovascular treatment of CKD patients is safe and effective, achieving high technical success without evidence of renal function deterioration. Level 4, Case Series.