Kardiologie I, Zentrum für Kardiologie, University Medical Center Mainz and Deutsches Zentrum für Herz und Kreislauf Forschung, Standort Rhein-Main, Germany; Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro, Italy.
Kardiologie I, Zentrum für Kardiologie, University Medical Center Mainz and Deutsches Zentrum für Herz und Kreislauf Forschung, Standort Rhein-Main, Germany.
JACC Cardiovasc Interv. 2017 Sep 25;10(18):1819-1827. doi: 10.1016/j.jcin.2017.07.034.
The aim of this study was to describe the incidence and clinical characteristics, including intracoronary imaging features, of clinical restenosis in bioresorbable coronary scaffolds (BRS). Further, the authors searched for clinical and procedural predictors of scaffold restenosis (ScR) and report on the clinical outcomes after treatment of ScR in a cohort of consecutive all-comer patients.
Data from randomized controlled trials demonstrate a higher rate of target lesion failure in patients treated with BRS as compared with those treated with metal drug-eluting stents. Although in-scaffold thrombosis has been thoroughly investigated, there are little data available on the incidence and characteristics of ScR.
A total of 657 consecutive patients (age 63 ± 12 years, 79% men, 21% diabetics, 67% acute coronary syndrome) who received a total of 883 BRS for the treatment of coronary artery stenoses between May 2012 and January 2015 were enrolled in a retrospective registry.
During the median follow-up of 1,076 days (interquartile range: 762 to 1,206 days), a total of 49 cases of ScR were found in 41 patients (Kaplan-Meier incidence: 2.4%, 6.0%, and 9.0% at 12-, 24-, and 36-month follow-up, respectively). ScR presented as stable angina or as incidental finding in 73% of the cases. The angiographic pattern was complex (type II to IV) in 55% of the ScR lesions. The neointima was homogeneous with high signal intensity in all but 3 cases at optical coherence tomography. Prior revascularization (hazard ratio [HR]: 2.7; 95% confidence interval [CI]: 1.5 to 5.1; p = 0.002), diabetes (HR: 2.9; 95%CI: 1.5 to 5.4; p = 0.001), lesion types B2 or C (HR: 2.8; 95% CI: 1.5 to 5.4; p = 0.002), and implantation technique (HR: 0.3; 95% CI: 0.1 to 0.6; p = 0.001) emerged as independent predictors of ScR. Oversizing (HR: 6.29; 95% CI: 2.4 to 16.4), undersizing (HR: 5.15; 95% CI: 1.99 to 13.30), and a residual stenosis >27% (HR: 8.9; 95% CI: 3.6 to 21.8) were associated with an increased ScR risk.
The 3-year incidence of ScR was similar to that observed in similar settings with newer-generation drug-eluting stents. It is often associated with a benign presentation and a complex angiographic pattern. Predictors of ScR match those of metallic stent restenosis, and the implantation technique used at index appears to play an important role.
本研究旨在描述生物可吸收支架（BRS）临床再狭窄的发生率和临床特征，包括冠状动脉内影像学特征。进一步，作者寻找支架内再狭窄（ScR）的临床和手术预测因素，并报告在连续所有患者队列中对 ScR 进行治疗后的临床结局。
随机对照试验的数据表明，接受 BRS 治疗的患者比接受金属药物洗脱支架治疗的患者靶病变失败的发生率更高。尽管支架内血栓形成已得到充分研究，但关于 ScR 的发生率和特征的数据很少。
2012 年 5 月至 2015 年 1 月期间，共有 657 例连续患者（年龄 63±12 岁，79%男性，21%糖尿病患者，67%急性冠状动脉综合征）接受了总共 883 个 BRS 治疗冠状动脉狭窄，纳入了一项回顾性注册研究。
在中位数为 1076 天的随访期间（四分位距：762 至 1206 天），41 例患者中有 49 例（Kaplan-Meier 发生率：12、24 和 36 个月时分别为 2.4%、6.0%和 9.0%）发现 ScR。ScR 表现为稳定型心绞痛或偶发发现，占 73%。病变的血管造影模式为复杂型（II 至 IV 型），占 55%。在所有但 3 例病例中，光学相干断层扫描（OCT）显示新生内膜呈均匀高信号。预先进行血运重建（危险比 [HR]：2.7；95%置信区间 [CI]：1.5 至 5.1；p=0.002）、糖尿病（HR：2.9；95%CI：1.5 至 5.4；p=0.001）、B2 或 C 型病变（HR：2.8；95%CI：1.5 至 5.4；p=0.002）和植入技术（HR：0.3；95%CI：0.1 至 0.6；p=0.001）是 ScR 的独立预测因素。支架过大（HR：6.29；95%CI：2.4 至 16.4）、支架过小（HR：5.15；95%CI：1.99 至 13.30）和残余狭窄>27%（HR：8.9；95%CI：3.6 至 21.8）与 ScR 风险增加相关。
3 年 ScR 的发生率与类似环境中新一代药物洗脱支架观察到的相似。它通常与良性表现和复杂的血管造影模式相关。ScR 的预测因素与金属支架再狭窄的预测因素相同，指数植入技术似乎发挥了重要作用。
