Department of Biostatistics, Division of Health Sciences and Nursing Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.
Cardiovasc Interv Ther. 2021 Apr;36(2):190-197. doi: 10.1007/s12928-020-00666-2. Epub 2020 Apr 18.
Edge restenosis has still been reported after second-generation drug-eluting stent (DES) implantation. It was more likely attributable to post-procedural angiographic results than to the patient's background. The aim of this study was to develop and internally validate a prediction model for restenosis in proximal edge after 2nd-generation DES stent implantation using angiographic data. Data were obtained from several post-marketing surveillance (PMS) studies of the cobalt-chromium everolimus-eluting stent (CoCr-EES) and platinum-chromium everolimus-eluting stent (PtCr-EES), second-generation DES, in Japan. Angiographic analysis was conducted at baseline and after 8 or 12 months. We focused on the proximal edge of angiographic analysis. The main outcome was restenosis defined as ≥ 50% diameter stenosis at follow-up. The predictive performance of the prediction model based on multivariable logistic regression was assessed in terms of discrimination and calibration, which were internally validated by the bootstrap method. We also performed decision curve analysis to assess threshold of predicted probability of restenosis at which additional intervention was considered. Among 2053 lesions in 1860 patients, restenosis rates in proximal edge was 2.8%. The final model was constructed with % post-procedural diameter stenosis (DS) and post-procedural reference diameter (RD) as strong predictors for edge restenosis. Discrimination and calibration were satisfactory with optimism-corrected C-statistics 0.75. Predicted probability between 0.03 and 0.24 was preferable threshold for restenosis treatments. Our prediction model can be used to obtain valid prediction for restenosis in proximal edge, assisting to know complete stent coverage of lesion.
第二代药物洗脱支架（DES）植入后仍有边缘再狭窄的报道。它更可能归因于术后血管造影结果，而不是患者的背景。本研究的目的是利用血管造影数据为第二代 DES 支架植入后近端边缘再狭窄开发和内部验证一个预测模型。该数据来自日本钴铬依维莫司洗脱支架（CoCr-EES）和铂铬依维莫司洗脱支架（PtCr-EES），第二代 DES 的几项上市后监测（PMS）研究。在基线和 8 或 12 个月后进行血管造影分析。我们专注于血管造影分析的近端边缘。主要结局是在随访时定义为≥50%直径狭窄的再狭窄。通过 bootstrap 方法内部验证了基于多变量逻辑回归的预测模型的预测性能，评估了区分度和校准度。我们还进行了决策曲线分析，以评估考虑额外干预的预测再狭窄概率阈值。在 1860 名患者的 2053 个病变中，近端边缘的再狭窄率为 2.8%。最终模型由术后%直径狭窄（DS）和术后参考直径（RD）构建，作为边缘再狭窄的强预测因子。校正后的乐观 C 统计量为 0.75，区分度和校准度均令人满意。预测概率在 0.03 到 0.24 之间是再狭窄治疗的优选阈值。我们的预测模型可用于获得近端边缘再狭窄的有效预测，有助于了解病变的完全支架覆盖。
