Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Division of Biostatistics, Center for Medical Research and Information, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
J Am Coll Cardiol. 2018 Feb 27;71(8):832-841. doi: 10.1016/j.jacc.2017.12.032.
Limited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD).
This study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice.
Among 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents] registry, the IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization] registry, and the PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease] study) treated between July 2007 and July 2015, the authors identified 2,692 patients with significant LMCAD who received second-generation DES; 1,254 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 232 with biodegradable polymer biolimus-eluting stents (BP-BES), 616 with platinum-chromium EES (PtCr-EES), and 590 with Resolute zotarolimus-eluting stent (Re-ZES). The primary outcome was target-vessel failure.
The observed 3-year rates of target-vessel failure were not significantly different for the different types of DES (16.7% for the CoCr-EES, 13.2% for the BP-BES, 18.7% for the PtCr-EES, and 14.7% for the Re-ZES; p = 0.15). In multiple treatment propensity score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were similar in between-group comparisons of the different DES, except for the PtCr-EES versus the BP-BES (reference; HR: 1.60; 95% confidence interval: 1.01 to 2.54; p = 0.046). There were no significant differences in risk of composite of all-cause death, any myocardial infarction, or any revascularization and its individual components according to the different types of DES. Although the 3-year incidence of stent thrombosis was considerably low (≤1.0%) for all types of DES, between-group differences were observed, generally favoring the EES platforms.
In this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).
关于不同类型的药物洗脱支架（DES）治疗左主干冠状动脉阻塞性病变（LMCAD）的相对疗效，数据有限。
本研究旨在比较真实世界临床实践中各种第二代 DES 治疗 LMCAD 的有效性和安全性。
在 3 项多中心前瞻性注册研究（IRIS-DES[介入心脏病学研究协会-药物洗脱支架]注册研究、IRIS-MAIN[介入心脏病学研究协会-左主干血运重建]注册研究和 PRECOMBAT[左主干冠状动脉疾病患者使用药物洗脱支架行旁路手术与血管成形术的随机比较的 PREmier 研究]）中，共纳入 4470 例患者，于 2007 年 7 月至 2015 年 7 月期间接受治疗，其中 2692 例 LMCAD 患者接受了第二代 DES 治疗，包括 1254 例钴铬依维莫司洗脱支架（CoCr-EES）、232 例生物可降解聚合物雷帕霉素洗脱支架（BP-BES）、616 例铂铬依维莫司洗脱支架（PtCr-EES）和 590 例 Resolute 佐他莫司洗脱支架（Re-ZES）。主要终点为靶血管失败。
不同类型 DES 的 3 年靶血管失败率无显著差异（CoCr-EES 为 16.7%，BP-BES 为 13.2%，PtCr-EES 为 18.7%，Re-ZES 为 14.7%；p=0.15）。在多因素治疗倾向评分分析中，不同 DES 组间比较的靶血管失败调整后的风险比（HR）相似，除了 PtCr-EES 与 BP-BES 之间（参照；HR：1.60；95%置信区间：1.01 至 2.54；p=0.046）。根据不同类型 DES，全因死亡、任何心肌梗死或任何血运重建及其各个组成部分的复合风险均无显著差异。虽然所有类型 DES 的支架血栓形成发生率均较低（≤1.0%），但仍观察到组间差异，普遍有利于 EES 平台。
在这项涉及 LMCAD 中各种第二代 DES 不受限制使用的 3 项前瞻性注册研究的汇总分析中，我们发现 3 年靶血管失败风险在不同组间无显著差异，除了 PtCr-EES 与 BP-BES 相比，主要结局的风险较高。（常规临床实践中第一代、第二代和新型药物洗脱支架的评估[IRIS-DES]；NCT01186133）。
