Texas A & M University College of Medicine, Baylor Dallas Campus, Dallas, Texas, USA.
University of Texas M.D., Anderson Cancer Center, Houston, Texas, USA.
Cardiorenal Med. 2021;11(4):193-199. doi: 10.1159/000517884. Epub 2021 Aug 12.
Several clinical studies and meta-analyses have demonstrated lower incidence of adverse renal and cardiovascular outcomes associated with the use of iso-osmolar contrast media (IOCM) than low-osmolar contrast media (LOCM) in patients with variable risk profiles undergoing intra-arterial interventional procedures. However, the association of contrast-type and major adverse renal and cardiovascular events (MARCE) has not been studied via comprehensive and robust real-world data analyses in patients with comorbid conditions considered at risk for post-procedural acute kidney injury (AKI). The objective of this study was therefore to retrospectively assess the MARCE rates comparing IOCM with LOCM in at-risk patients receiving iodinated intra-arterial contrast media using a real-world inpatient data source.
Patients who underwent a diagnostic or treatment procedure with intra-arterial IOCM or LOCM administration were identified using the Premier Healthcare Database. Patient subgroups including those with diabetes, heart failure, chronic kidney disease (CKD) stages 1-4, CKD 3-4, or diagnosis of chronic total occlusion (CTO) were formed. Subgroups with combinations of diabetes and CKD 3-4 with and without CTO were also investigated. We compared the primary endpoint of MARCE (composite of AKI, AKI requiring dialysis, acute myocardial infarction, stroke/transient ischemic attack, stent occlusion/thrombosis, or death) after IOCM versus LOCM administration via adjusted multivariable regression analyses.
A total of 536,013 inpatient visits met the primary inclusion and exclusion criteria (IOCM = 133,192; LOCM = 402,821). After multivariable modeling, the use of IOCM was associated with a significantly lower incidence of MARCE than LOCM in patients with CKD 1-4, CKD 3-4, diabetes, or heart failure, with greatest absolute risk reduction (ARR) of 2.4% (p < 0.0001) in CKD 3-4 patients (relative risk reduction [RRR] = 13.8%, number needed to treat [NNT] = 43). Additionally, ARR associated with IOCM increased to 3.5% (p < 0.0001) in patients with combined comorbidities of diabetes and CKD 3-4 (RRR = 19.1%, NNT = 29). Statistically significant risk reduction was also found for the use of IOCM among patients who underwent revascularization for CTO (ARR = 1.6% [p < 0.0001], RRR = 22.3%, NNT = 62).
Intra-arterial administration using IOCM in at-risk patients is associated with lower rates of MARCE than the use of LOCM. This difference is especially apparent in patients with a combination of CKD 3-4 and diabetes and in patients with CTO, providing real-world data validation with meaningful NNT in favor of IOCM.
几项临床研究和荟萃分析表明，与低渗透压对比剂（LOCM）相比，在接受经动脉介入治疗的具有不同风险特征的患者中，使用等渗对比剂（IOCM）与不良肾脏和心血管结局的发生率较低。然而，在考虑有术后急性肾损伤（AKI）风险的合并症的患者中，尚未通过综合而稳健的真实世界数据分析来研究对比剂类型与主要不良肾脏和心血管事件（MARCE）之间的关联。因此，本研究的目的是使用真实世界的住院患者数据源，回顾性评估风险患者中 IOCM 与 LOCM 相比的 MARCE 发生率。
使用 Premier Healthcare Database 确定接受经动脉 IOCM 或 LOCM 给药的诊断或治疗程序的患者。形成了包括糖尿病、心力衰竭、慢性肾脏病（CKD）1-4 期、CKD 3-4 期或慢性完全闭塞（CTO）诊断在内的患者亚组。还研究了糖尿病和 CKD 3-4 期与 CTO 组合以及无 CTO 的亚组。我们通过调整后的多变量回归分析比较了 IOCM 与 LOCM 给药后 MARCE（AKI、需要透析的 AKI、急性心肌梗死、卒中和短暂性脑缺血发作、支架闭塞/血栓形成或死亡的复合）的主要终点。
共有 536,013 例住院患者符合主要纳入和排除标准（IOCM = 133,192；LOCM = 402,821）。多变量建模后，与 LOCM 相比，CKD 1-4、CKD 3-4、糖尿病或心力衰竭患者使用 IOCM 与 MARCE 的发生率显著降低，CKD 3-4 患者的绝对风险降低（ARR）最大为 2.4%（p < 0.0001）（RRR = 13.8%，需要治疗的人数 [NNT] = 43）。此外，在合并糖尿病和 CKD 3-4 两种合并症的患者中，与 IOCM 相关的 ARR 增加至 3.5%（p < 0.0001）（RRR = 19.1%，NNT = 29）。在接受 CTO 血运重建的患者中，使用 IOCM 也可显著降低风险（ARR = 1.6%[p < 0.0001]，RRR = 22.3%，NNT = 62）。
在风险患者中，使用 IOCM 进行经动脉给药与 MARCE 发生率低于 LOCM 相关。在 CKD 3-4 与糖尿病合并症患者和 CTO 患者中，这种差异尤其明显，为 IOCM 提供了有意义的 NNT 的真实世界数据验证。
