Department of Cardiovascular Medicine, Ome Municipal General Hospital, Tokyo, Japan.
Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Catheter Cardiovasc Interv. 2019 Jul 1;94(1):E9-E16. doi: 10.1002/ccd.28070. Epub 2019 Feb 4.
The aim of the study was to investigate the impact of chronic kidney disease (CKD) on the 5-year clinical outcomes of everolimus-eluting stent (EES) implantation.
Recent studies have demonstrated the safety and efficacy of EES. However, limited information exists on the long-term clinical outcomes associated with CKD.
The Tokyo-MD PCI study is a multi-center observational study designed to describe the clinical outcomes of unselected patients after EES implantation. In this subanalysis, patients on maintenance hemodialysis were excluded, and patients with (n = 316) or without (n = 1,424) CKD were evaluated for their 5-year incidence rates of major adverse cardiac events (MACEs), defined as death, non-fatal myocardial infarction, ischemia driven target lesion revascularization (ID-TLR), and stent thrombosis (ST).
The mean and median follow-up duration were 1,391 ± 557 days and 1,769 days (interquartile range, 1,012-1,800 days), respectively. Although the incidence of ID-TLR and ST was similar between patients with and without CKD (4.9% vs. 3.7%, P = 0.26, 0.5% vs. 1.0%, P = 0.20, respectively), cardiac death and MACE were significantly higher in patients with CKD than in those without CKD (6.5% vs. 2.9%, P = 0.007, 26.9% vs. 14.0%, P < 0.001, respectively). In multivariate analysis, CKD was an independent predictor of MACE (hazard ratio 1.22 [95% confidence interval 1.04-1.43], P = 0.01).
Patients with CKD had similar ID-TLR and ST rates as those without CKD at 5 years after EES implantation. The risk of long-term MACEs appeared to be associated with CKD.
本研究旨在探讨慢性肾脏病（CKD）对依维莫司洗脱支架（EES）植入后 5 年临床结局的影响。
最近的研究已经证实了 EES 的安全性和有效性。然而，关于与 CKD 相关的长期临床结局的信息有限。
东京-MD PCI 研究是一项多中心观察性研究，旨在描述 EES 植入后未经选择的患者的临床结局。在这项亚分析中，排除了维持性血液透析患者，并评估了 316 例有 CKD 患者和 1424 例无 CKD 患者的 5 年主要不良心脏事件（MACE）发生率，MACE 定义为死亡、非致死性心肌梗死、缺血驱动的靶病变血运重建（ID-TLR）和支架血栓形成（ST）。
平均和中位随访时间分别为 1391±557 天和 1769 天（四分位距 1012-1800 天）。尽管 CKD 患者和无 CKD 患者的 ID-TLR 和 ST 发生率相似（4.9%比 3.7%，P=0.26，0.5%比 1.0%，P=0.20），但 CKD 患者的心脏死亡和 MACE 发生率明显高于无 CKD 患者（6.5%比 2.9%，P=0.007，26.9%比 14.0%，P<0.001）。多变量分析显示，CKD 是 MACE 的独立预测因素（危险比 1.22[95%置信区间 1.04-1.43]，P=0.01）。
EES 植入后 5 年，CKD 患者的 ID-TLR 和 ST 发生率与无 CKD 患者相似。长期 MACE 的风险似乎与 CKD 相关。
