Deutsches Herzzentrum and 1 Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Circ Cardiovasc Interv. 2009 Oct;2(5):430-7. doi: 10.1161/CIRCINTERVENTIONS.109.874933. Epub 2009 Sep 22.
No clinical trial has yet focused on contrast-mediated nephrotoxicity in patients with chronic renal failure exclusively undergoing percutaneous coronary intervention (PCI). Therefore, the aim of this study was to compare the effect of contemporary contrast media on nephrotoxicity in this high-risk patient population.
This prospective, randomized, double-blind, comparative clinical trial randomly selected 939 patients with chronic renal failure undergoing coronary angiography with potential PCI to receive either the iso-osmolar contrast medium iodixanol or the low-osmolar contrast medium iomeprol. Of those 939 patients, 615 received diagnostic angiography only and were not included in the primary study analysis, but were followed up in a registry. Three hundred twenty-four patients underwent PCI, of which one-half received iodixanol or iomeprol, respectively, and were included in the primary study analysis. The primary end point was the peak increase in S-creatinine during hospitalization for PCI. Maximum increase in S-creatinine after PCI was lower than expected and thus impaired the power of the study. It was not significantly different between the 2 contrast groups (0.19+/-0.40 mg/dL for iodixanol and 0.21+/-0.34 mg/dL for iomeprol; P=0.53). Albeit contrast media-induced nephropathy rates were lower with iodixanol (22.2% compared with 27.8% for iomeprol), this difference was not statistically different (P=0.25). Subgroup analysis suggested a favorable outcome regarding nephrotoxicity in patients who received higher contrast volumes (>340 mL) in the iodixanol group (P(interaction)=0.016).
Routine use of iso-osmolar contrast medium is not associated with a significant reduction of nephrotoxicity compared with low-osmolar contrast medium in patients with chronic renal failure undergoing PCI. However, a positive effect was seen in the iso-osmolar contrast group for patients receiving high amounts of contrast medium, which awaits confirmation of a specifically designed randomized clinical trial. Clinical Trial Registration- clinicaltrials.gov Identifier: NCT00390585.
目前尚无临床试验专门针对慢性肾衰竭患者行经皮冠状动脉介入治疗（PCI）时的对比剂相关肾毒性。因此，本研究旨在比较在这一高危人群中，应用现代对比剂对肾毒性的影响。
这是一项前瞻性、随机、双盲、对照临床试验，共入选 939 例行冠状动脉造影术且有行 PCI 适应证的慢性肾衰竭患者，随机接受等渗对比剂碘克沙醇或低渗对比剂碘美普尔。其中 615 例患者仅行诊断性冠状动脉造影，未纳入主要研究分析，但在登记处进行了随访。324 例患者行 PCI，其中 162 例分别接受碘克沙醇或碘美普尔治疗，纳入主要研究分析。主要终点是 PCI 住院期间血清肌酐（Scr）峰值升高。PCI 后 Scr 最大升高值低于预期，削弱了研究的效能。两组间无显著差异（碘克沙醇组为 0.19+/-0.40mg/dL，碘美普尔组为 0.21+/-0.34mg/dL；P=0.53）。虽然碘克沙醇组对比剂肾病发生率较低（22.2%比 27.8%，碘美普尔组），但差异无统计学意义（P=0.25）。亚组分析提示，在接受碘克沙醇治疗且对比剂用量较高（>340mL）的患者中，碘克沙醇在肾毒性方面具有更好的结局（P（交互）=0.016）。
与低渗对比剂相比，在接受 PCI 的慢性肾衰竭患者中，常规应用等渗对比剂并未显著降低肾毒性。然而，对于接受大量对比剂的患者，等渗对比剂组显示出积极的效果，这有待专门设计的随机临床试验进一步证实。
ClinicalTrials.gov 标识符：NCT00390585。
