Kozuma Kayoko, Shinozaki Tomohiro, Kozuma Ken, Kashiwabara Kosuke, Oba Koji, Aoki Jiro, Awata Masaki, Nanasato Mamoru, Shiode Nobuo, Tanabe Kengo, Yamaguchi Junichi, Kimura Takeshi, Matsuyama Yutaka
Department of Biostatistics, Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo.
Division of Cardiology, Teikyo University School of Medicine.
Int Heart J. 2019 Sep 27;60(5):1050-1060. doi: 10.1536/ihj.18-717. Epub 2019 Sep 4.
Edge restenosis has gained attention as a main cause of restenosis after first-generation drug-eluting stent (DES) implantation. The aim of this study was to assess the incidence of edge restenosis and identify the predictors of edge restenosis after second-generation DES implantation. Data were obtained from several postmarketing surveillance (PMS) studies on a cobalt-chromium everolimus-eluting stent (CoCr-EES; Xience V/PROMUS, Xience Prime, Xience Prime SV, and Xience Expedition SV), a second-generation DES, in Japan. Angiographic analysis was conducted at the baseline and after eight months on the following subsegments: in-stent region, proximal edge, and distal edge. Restenosis was defined as ≥ 50% diameter stenosis (DS) at follow-up. We used multivariate logistic regression (with lesions as a random effect) to compare the instances of restenosis between the proximal and the distal edges. Univariate and multivariate analyses of the risk factors for restenosis were performed for each subsegment. We analyzed 1,966 lesions in 1,687 patients. The restenosis rates at the in-stent region, proximal edge, and distal edge were 4.4%, 3.0%, and 1.1%, respectively. The risk of restenosis at the distal edge was significantly lower than that at the proximal edge, when adjusted for 13 variables. The predictors of restenosis were postprocedural % diameter stenosis (%DS), postprocedural reference diameter, ≥ 45° bending, stent overlap at the proximal edge, and postprocedural %DS at the distal edge. Our analysis of eight-month angiographic outcomes from CoCr-EES PMS demonstrated that postprocedural %DS is a major predictor of edge restenosis. Edge restenosis is more likely attributable to postprocedural angiographic results than to the patient's background.
边缘再狭窄已成为第一代药物洗脱支架（DES）植入术后再狭窄的主要原因，受到广泛关注。本研究旨在评估第二代DES植入术后边缘再狭窄的发生率，并确定边缘再狭窄的预测因素。数据来自日本几项关于第二代DES——钴铬依维莫司洗脱支架（CoCr-EES；Xience V/PROMUS、Xience Prime、Xience Prime SV和Xience Expedition SV）的上市后监测（PMS）研究。在基线和八个月后，对以下亚节段进行血管造影分析：支架内区域、近端边缘和远端边缘。再狭窄定义为随访时直径狭窄（DS）≥50%。我们使用多变量逻辑回归（将病变作为随机效应）比较近端和远端边缘的再狭窄情况。对每个亚节段的再狭窄危险因素进行单变量和多变量分析。我们分析了1687例患者的1966个病变。支架内区域、近端边缘和远端边缘的再狭窄率分别为4.4%、3.0%和1.1%。在对13个变量进行调整后，远端边缘的再狭窄风险显著低于近端边缘。再狭窄的预测因素包括术后直径狭窄百分比（%DS）、术后参考直径、≥45°弯曲、近端边缘的支架重叠以及远端边缘的术后%DS。我们对CoCr-EES PMS八个月血管造影结果的分析表明，术后%DS是边缘再狭窄的主要预测因素。边缘再狭窄更可能归因于术后血管造影结果，而非患者背景。
