Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Division of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Int J Cardiol. 2019 May 1;282:17-23. doi: 10.1016/j.ijcard.2019.01.108. Epub 2019 Feb 2.
Stent parameters (length and diameter) are well-known risk factors for adverse outcomes after percutaneous coronary intervention (PCI) with stenting. This study aimed to investigate the differential cutoff criteria and clinical impact of the length and diameter of various drug-eluting stents (DES) for predicting major cardiovascular events.
Using patient-level data from seven stent-specific, prospective DES registries, we evaluated 17,068 patients who underwent PCI with either various contemporary DES or first-generation DES between July 2007 and July 2015: 3053 treated with cobalt-chromium everolimus-eluting stents (CoCr-EES), 2976 with platinum-chromium EES (PtCr-EES), 2888 with Resolute zotarolimus-eluting stents (Re-ZES), 782 with Biomatrix biolimus-eluting stents (Bi-BES), 1868 with Nobori BES (No-BES), 1934 with Xience Prime cobalt-chromium EES (Pr-CoCr-EES), and 3567 with first-generation sirolimus-eluting stents (SES). Two clinical outcomes were assessed: target-vessel failure (TVF; a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization [TVR]) and TVR.
Stent length and stent diameter were important factors for predicting TVF or TVR in the entire cohort and in each DES cohort. For TVF risk prediction, the Youden index-based cutoff of stent length was highest with Bi-BES (45.0 mm) and lowest with No-BES (29.0 mm), and the cutoff of stent diameter was smallest with Pr-CoCr-EES (2.78 mm) and largest with No-BES (3.20 mm). For TVR risk prediction, the cutoff of stent length was the highest with PtCr-EES (48.0 mm) and the lowest with No-BES (29.0 mm), and the cutoff of stent diameter was smallest with CoCr-EES (2.72 mm) and largest with first-generation SES (3.30 mm). The 3-year TVF and TVR rates were substantially different according to the presence or absence of long lesions and small vessels determined using these cutoff points.
For contemporary PCI practice involving diverse types of DES, we identified differential cutoff points of stent length and diameter for predicting adverse clinical outcomes. The clinical impact of these stent parameters on outcomes and its magnitude varied according to different DES. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186133.
支架参数（长度和直径）是经皮冠状动脉介入治疗（PCI）后发生不良结局的已知危险因素。本研究旨在探讨不同药物洗脱支架（DES）的长度和直径的临界值标准及其对预测主要心血管事件的临床影响。
我们使用来自七个支架特异性前瞻性 DES 注册研究的患者水平数据，评估了 2007 年 7 月至 2015 年 7 月期间接受各种当代 DES 或第一代 DES 行 PCI 的 17068 例患者：3053 例接受钴铬依维莫司洗脱支架（CoCr-EES）治疗，2976 例接受铂铬依维莫司洗脱支架（PtCr-EES）治疗，2888 例接受 Resolute 佐他莫司洗脱支架（Re-ZES）治疗，782 例接受 Biomatrix 比莫司洗脱支架（Bi-BES）治疗，1868 例接受 Nobori BES（No-BES）治疗，1934 例接受 Xience Prime 钴铬依维莫司洗脱支架（Pr-CoCr-EES）治疗，3567 例接受第一代西罗莫司洗脱支架（SES）治疗。评估了两种临床结局：靶血管失败（TVF；包括心脏死亡、靶血管心肌梗死和靶血管血运重建[TVR]）和 TVR。
支架长度和支架直径是整个队列和每个 DES 队列中预测 TVF 或 TVR 的重要因素。对于 TVF 风险预测，Bi-BES 的支架长度基于 Youden 指数的临界值最高（45.0mm），No-BES 的最低（29.0mm），支架直径的临界值最小的是 Pr-CoCr-EES（2.78mm），最大的是 No-BES（3.20mm）。对于 TVR 风险预测，PtCr-EES 的支架长度临界值最高（48.0mm），No-BES 的最低（29.0mm），CoCr-EES 的支架直径临界值最小（2.72mm），第一代 SES 的最大（3.30mm）。根据这些临界值，使用长病变和小血管的存在与否，确定了不同的支架长度和直径临界值，从而导致 3 年 TVF 和 TVR 率存在显著差异。
对于涉及多种类型 DES 的当代 PCI 实践，我们确定了预测不良临床结局的支架长度和直径的差异临界值。这些支架参数对不同 DES 结局的影响及其程度存在差异。临床试验注册网址：http://www.clinicaltrials.gov。唯一标识符：NCT01186133。
