Byrne Robert A, Banai Shmuel, Colleran Roisin, Colombo Antonio
German Heart Centre Munich, Technical University of MunichMunich, Germany.
Tel Aviv Medical CenterIsrael.
Interv Cardiol. 2018 Jan;13(1):40-44. doi: 10.15420/icr.2017:27:1.
Patients with diabetes have poorer outcomes after percutaneous coronary intervention than patients without diabetes. The Cre8™ EVO drug-eluting stent (DES) has design features that aim to improve clinical outcomes in patients with diabetes. These include Abluminal Reservoir Technology - a proprietary polymer-free drug-release system consisting of reservoirs on the abluminal surface of the stent that control drug release and direct the drug exclusively towards the vessel wall - and the Amphilimus™ drug formulation, which enables enhanced drug-tissue permeation utilising fatty acid transport pathways. The latter is particularly advantageous in patients with diabetes, whose cell metabolism favours increased cellular uptake of fatty acid. Furthermore, evidence suggests that mTOR inhibitors (-limus drugs) utilised in conventional DES are less effective in diabetic cells. The new stent architecture provides high device deliverability and conformability, facilitating clinical use in complex disease patterns and high-risk lesion morphologies. Clinical evidence for the efficacy and safety of the Cre8™ DES in patients with diabetes has been demonstrated in a number of clinical trials and observational registries. These data are reviewed herein, along with an overview of on-going randomised trials.
与非糖尿病患者相比,糖尿病患者经皮冠状动脉介入治疗后的预后较差。Cre8™ EVO药物洗脱支架(DES)具有旨在改善糖尿病患者临床预后的设计特点。这些特点包括无载体储库技术——一种无聚合物的专有药物释放系统,由支架外表面的储库组成,可控制药物释放并将药物仅导向血管壁——以及Amphilimus™药物制剂,该制剂可利用脂肪酸转运途径增强药物对组织的渗透。后者对糖尿病患者尤其有利,因为糖尿病患者的细胞代谢有利于增加细胞对脂肪酸的摄取。此外,有证据表明,传统DES中使用的mTOR抑制剂(-雷帕霉素类药物)在糖尿病细胞中的效果较差。新的支架结构具有高度的器械输送性和顺应性,便于在复杂疾病模式和高危病变形态中临床应用。Cre8™ DES在糖尿病患者中的疗效和安全性的临床证据已在多项临床试验和观察性登记研究中得到证实。本文将对这些数据进行综述,并概述正在进行的随机试验。