Bangalore Sripal, Abhaichand Rajpal, Mullasari Ajit, Jain Rajneesh, Chand R K Prem, Arambam Priyadarshini, Kaul Upendra
New York University School of Medicine, New York, NY, USA.
Department of Cardiology, L.R.G. Naidu Cardiology Research Institute and Clinic, Kuppuswamy Naidu Memorial Hospital, Coimbatore, India.
Cardiovasc Revasc Med. 2019 Dec;20(12):1075-1080. doi: 10.1016/j.carrev.2019.02.017. Epub 2019 Feb 28.
Patients with diabetes and those with chronic kidney disease (CKD) are at increased risk of cardiovascular events. Everolimus eluting stents (EES) have been shown to be superior to paclitaxel eluting stents (PES) in patients with diabetes. However, it is not known if EES is as beneficial in diabetic patients with CKD compared with those without CKD.
Patients enrolled in the TUXEDO-India trial, which is a clinical trial of patients with diabetes and coronary artery disease (CAD) randomly assigned to EES vs. thin-strut PES (Taxus Element), with data on baseline renal function were selected. CKD was defined as an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m using the Cockcroft-Gault formula. Primary outcome was target vessel failure (TVF-defined as cardiac death, TV myocardial infarction (MI) or ischemia driven TV revascularization) at 1 year. Various secondary outcomes including stent thrombosis were evaluated. Among the 1821 patients with diabetes included in this analysis, 344 (19%) had CKD. In a propensity score adjusted analysis, patients with CKD had a significant increase in MACE (HR = 2.02; 95% CI 1.17-3.50; P = 0.01); death/MI/TVR (HR = 1.99; 95% CI 1.18-3.34; P = 0.009); death/MI (HR = 2.31; 95% CI 1.30-4.08; P = 0.004); cardiac death/MI (HR = 2.40; 95% CI 1.31-4.42; P = 0.005); death (HR = 2.88; 95% CI 1.35-6.13; P = 0.006) driven by an increase in cardiac death (HR = 3.33; 95% CI 1.42-7.83; P = 0.006) when compared with those without CKD. However, stent related events (TV-MI, TVR, TLR and stent thrombosis) were not different between CKD and non CKD groups. A significant interaction between CKD status and stent type (EES vs. PES) was noted for the outcomes of TVF (P = 0.046), MACE (P = 0.02), cardiac death or MI (P = 0.05), non-target vessel related MI (P = 0.04), non-Q-wave MI (P = 0.03) and deaths/MI/TVR (P = 0.04) such that EES was superior to PES in the non-CKD cohort but not in the CKD cohort.
In subjects with diabetes, CKD is an independent predictor of adverse cardiovascular outcomes including increased risk of death driven largely by non-stent related events. While EES was superior to PES in patients without CKD, this was not the case in those with CKD (Clinical Trials Registry-India number, CTRI/2011/06/001830).
糖尿病患者和慢性肾脏病（CKD）患者发生心血管事件的风险增加。在糖尿病患者中，依维莫司洗脱支架（EES）已被证明优于紫杉醇洗脱支架（PES）。然而，与无CKD的糖尿病患者相比，EES对合并CKD的糖尿病患者是否同样有益尚不清楚。
入选TUXEDO-India试验的患者，该试验是一项针对糖尿病和冠状动脉疾病（CAD）患者的临床试验，患者被随机分配接受EES或薄支柱PES（Taxus Element），选取有基线肾功能数据的患者。使用Cockcroft-Gault公式将CKD定义为估计肾小球滤过率（eGFR）<60ml/min/1.73m²。主要结局是1年时的靶血管失败（TVF，定义为心源性死亡、靶血管心肌梗死（MI）或缺血驱动的靶血管血运重建）。评估了包括支架血栓形成在内的各种次要结局。在该分析纳入的1821例糖尿病患者中，344例（19%）患有CKD。在倾向评分调整分析中，与无CKD的患者相比，CKD患者的主要不良心血管事件（MACE）显著增加（HR = 2.02；95%CI 1.17 - 3.50；P = 0.01）；死亡/MI/靶血管血运重建（TVR）（HR = 1.99；95%CI 1.18 - 3.34；P = 0.009）；死亡/MI（HR = 2.31；95%CI 1.30 - 4.08；P = 0.004）；心源性死亡/MI（HR = 2.40；95%CI 1.31 - 4.42；P = 0.005）；死亡（HR = 2.88；95%CI 1.35 - 6.13；P = 0.006），主要是由于心源性死亡增加（HR = 3.33；95%CI 1.42 - 7.83；P = 0.006）。然而，CKD组和非CKD组之间的支架相关事件（靶血管MI、TVR、靶病变血运重建（TLR）和支架血栓形成）并无差异。对于TVF（P = 0.046）、MACE（P = 0.02）、心源性死亡或MI（P = 0.05）、非靶血管相关MI（P = 0.04）、非Q波MI（P = 0.03）和死亡/MI/TVR（P = 0.04）的结局，注意到CKD状态与支架类型（EES与PES）之间存在显著交互作用，使得EES在非CKD队列中优于PES，但在CKD队列中并非如此。
在糖尿病患者中，CKD是不良心血管结局的独立预测因素，包括主要由非支架相关事件导致的死亡风险增加。虽然EES在无CKD的患者中优于PES，但在合并CKD的患者中并非如此（印度临床试验注册编号，CTRI/2011/06/001830）。
