碘克沙醇与碘海醇预防对比剂肾病的比较：IDPC 试验。
Ioxaglate Versus IoDixanol for the Prevention of Contrast-Induced Nephropathy: The IDPC Trial.
机构信息
Instituto Dante Pazzanese de Cardiologia, Av. Dr Dante Pazzaensse, 500, Ibirapuera, São Paulo - SP, Brazil.
出版信息
J Invasive Cardiol. 2023 Jun;35(6):E281-E290. doi: 10.25270/jic/21.00249. Epub 2023 May 16.
BACKGROUND
Despite the potential benefits of percutaneous procedures for the assessment and treatment of coronary artery disease, these interventions require the use of iodine contrast, which might lead to contrast-induced nephropathy (CIN) and increased risk of dialysis and major adverse cardiac events (MACE).
AIMS
We sought to compare two different iodine contrasts (low vs. iso-osmolar) for the prevention of CIN among high-risk patients.
METHODS
This is a single-center, randomized (1:1) trial comparing consecutive patients at high risk for CIN referred to percutaneous coronary diagnostic and/or therapeutic procedures with low (ioxaglate) vs. iso-osmolarity (iodixanol) iodine contrast. High risk was defined by the presence of at least one of the following conditions: age >70 years, diabetes mellitus, non-dialytic chronic kidney disease, chronic heart failure, cardiogenic shock, and acute coronary syndrome (ACS). The primary endpoint was the occurrence of CIN, defined as a >25% relative increase and/or >0.5 mg/dL absolute increase in creatinine (Cr) levels compared with baseline between the 2nd and 5th day after contrast media administration.
RESULTS
A total of 2,268 patients were enrolled. Mean age was 67 years. Diabetes mellitus (53%), non-dialytic chronic kidney disease (31%), and ACS (39%) were highly prevalent. The mean volume of contrast media was 89 ml ± 48.6. CIN occurred in 15% of all patients, with no significant difference regarding the type of contrast used (iso = 15.2% vs. low = 15.1%, P>.99). Differences were not observed in specific subgroups such as diabetics, elderly, and ACS patients. At 30-day follow-up, 13 patients in the iso-osmolarity group and 11 in low-osmolarity group required dialysis (P =.8). There were 37 (3.3%) deaths in the iso-osmolarity cohort vs. 29 (2.6%) in the low-osmolarity group (P =.4).
CONCLUSION
Among patients at high risk for CIN, the incidence of this complication was 15%, and independent of the use of low- or iso-osmolar contrast.
背景
尽管经皮介入术在评估和治疗冠状动脉疾病方面具有潜在的益处，但这些介入操作需要使用碘造影剂，这可能导致对比剂诱导的肾病（CIN）和透析以及主要不良心脏事件（MACE）的风险增加。
目的
我们旨在比较两种不同的碘造影剂（低渗与等渗）在高危患者中的预防 CIN 的效果。
方法
这是一项单中心、随机（1:1）试验，比较了接受经皮冠状动脉诊断和/或治疗性操作的高危 CIN 患者（低渗碘对比剂[ioxaglate]与等渗碘对比剂[iodixanol]）。高危定义为存在以下至少一种情况：年龄＞70 岁、糖尿病、非透析性慢性肾脏病、慢性心力衰竭、心源性休克和急性冠状动脉综合征（ACS）。主要终点是 CIN 的发生，定义为与造影剂给药后第 2 至第 5 天相比，肌酐（Cr）水平升高＞25%且/或绝对升高＞0.5 mg/dL。
结果
共纳入 2268 例患者。平均年龄为 67 岁。糖尿病（53%）、非透析性慢性肾脏病（31%）和 ACS（39%）的患病率较高。造影剂的平均用量为 89 ml ± 48.6。所有患者中 CIN 的发生率为 15%，但与使用的造影剂类型无关（等渗组为 15.2%，低渗组为 15.1%，P＞0.99）。在特定亚组（如糖尿病患者、老年人和 ACS 患者）中也未观察到差异。30 天随访时，等渗组中有 13 例和低渗组中有 11 例需要透析（P=0.8）。等渗组有 37 例（3.3%）死亡，低渗组有 29 例（2.6%）死亡（P=0.4）。
结论
在 CIN 高危患者中，该并发症的发生率为 15%，且与使用低渗或等渗造影剂无关。
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