Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Department of Biostatistics, Center for Medical Research and Information, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Catheter Cardiovasc Interv. 2020 Aug;96(2):243-252. doi: 10.1002/ccd.28462. Epub 2019 Sep 3.
Whether the diabetic status differentially affects the clinical outcomes with different drug-eluting stents (DES) has been controversial.
From stent-specific, prospective DES registries, we evaluated 17,184 patients (11,428 in non-diabetics and 5,756 in diabetics) who received several contemporary DES: 3570 sirolimus-eluting stents (SES), 5,023 cobalt-chromium everolimus-eluting stents (CoCr-EES), 2,985 platinum-chromium EES (PtCr-EES), 2,913 Resolute zotarolimus-eluting stents (Re-ZES), and 2,693 biodegradable-polymer biolimus-eluting stents (BP-BES). The primary outcome was patient-oriented composite endpoint (POCE, a composite of all-cause death, any myocardial infarction, and any revascularization) at 3-year follow-up and target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 3 years was also evaluated. In non-diabetics, the rates of POCE were not significantly different (CoCr-EES 14.3%, PtCr-EES 13.0%, Re-ZES 14.3%, BP-BES 13.4%, and SES 14.6%; overall p = .39). In diabetics, similar results were revealed (CoCr-EES 18.4%, PtCr-EES 20.3%, Re-ZES 17.3%, BP-BES 17.7%, and SES 17.8%; overall p = .44). In multiple treatment propensity-score weighting analysis, regardless of the diabetic status, the hazard ratios for POCE between-individual comparison were similar. Target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) was also comparable except the higher ratio of Re-ZES than PtCr-EES (hazard ratio 1.25, 1.26, 95% confidence interval 1.00-1.55, p = .048) in patients without diabetes.
In this clinical-practice registry study, regardless the diabetic status, the 3-year rates of the primary outcome were similar among different types of DES, suggesting no differential clinical response between contemporary DES in patients with or without diabetes.
糖尿病状态是否会对不同药物洗脱支架（DES）的临床结果产生不同影响一直存在争议。
我们从支架特异性、前瞻性 DES 注册中心评估了 17184 名患者（非糖尿病患者 11428 名，糖尿病患者 5756 名），他们接受了几种当代 DES：3570 个西罗莫司洗脱支架（SES）、5023 个钴铬依维莫司洗脱支架（CoCr-EES）、2985 个铂铬依维莫司洗脱支架（PtCr-EES）、2913 个雷帕霉素洗脱支架（Re-ZES）和 2693 个生物可降解聚合物雷帕霉素洗脱支架（BP-BES）。主要终点为 3 年随访时的患者导向复合终点（POCE，全因死亡、任何心肌梗死和任何血运重建的复合终点），并评估了 3 年时的靶血管失败（包括心源性死亡、靶血管心肌梗死和靶血管血运重建的复合终点）。在非糖尿病患者中，POCE 的发生率无显著差异（CoCr-EES 为 14.3%、PtCr-EES 为 13.0%、Re-ZES 为 14.3%、BP-BES 为 13.4%和 SES 为 14.6%；整体 p =.39）。在糖尿病患者中，也得到了类似的结果（CoCr-EES 为 18.4%、PtCr-EES 为 20.3%、Re-ZES 为 17.3%、BP-BES 为 17.7%和 SES 为 17.8%；整体 p =.44）。在多次治疗倾向评分加权分析中，无论糖尿病状态如何，个体间 POCE 的风险比相似。除了糖尿病患者中 Re-ZES 与 PtCr-EES 比值较高（风险比 1.25、1.26、95%置信区间 1.00-1.55、p =.048）外，靶血管失败（心源性死亡、靶血管心肌梗死和靶血管血运重建的复合终点）也相似。
在这项临床实践注册研究中，无论糖尿病状态如何，不同类型 DES 的 3 年主要结局发生率相似，表明在有或没有糖尿病的患者中，当代 DES 的临床反应没有差异。
