Klomp Margo, Beijk Marcel A M, Verouden Niels J W, Tijssen Jan G P, de Winter Robbert J
Department of Cardiology, Academic Medical Center, University of Amsterdam, the Netherlands.
Am Heart J. 2009 Oct;158(4):527-532.e1. doi: 10.1016/j.ahj.2009.07.022.
In the treatment of coronary artery disease, a "pro-healing" approach for prevention of in-stent restenosis and late stent thrombosis is intuitively favored over the use of cytotoxic or cytostatic drugs released from a drug-eluting stent (DES). Promoting accelerated endothelial coverage of the stent surface, the endothelial progenitor cell (EPC) capturing stent has shown its safety and efficacy in the HEALING observational studies; however, randomized trials evaluating the device are lacking.
The multicenter, randomized, controlled, 2-armed TRIAS program aims to include a total of 2560 patients. In the TRIAS Low Risk trial, a total of 1300 patients with lesions carrying a low risk of restenosis are randomized between the EPC capturing stent and a bare metal stent, assuming superiority in the incidence of target lesion failure (TLF) at 1 year. In the TRIAS High Risk trial, 1260 patients with lesions carrying a high risk of restenosis are randomized, assuming the noninferiority in TLF at 1 year of the EPC capturing stent as compared to DES. TLF is defined as the composite of cardiac death, myocardial infarction, and clinically driven target lesion revascularization. In addition, the duration of clinical follow-up is extended to 5 years to capture late events. Angiographic follow-up at 13 months is performed as part of the TRIAS Program ancillary study.
The results of the TRIAS Program will provide information on a relevant patient population with coronary artery lesions, comprising the full spectrum of low risk and high risk of restenosis treated with a novel stent technology in a randomized, controlled manner (TRIAS Low Risk trial: ISRCTN 47701105 and TRIAS High Risk trial: ISRCTN 74297220).
在冠心病治疗中，相较于药物洗脱支架（DES）释放的细胞毒性或细胞抑制药物，一种“促进愈合”的方法用于预防支架内再狭窄和晚期支架血栓形成在直观上更受青睐。内皮祖细胞（EPC）捕获支架可促进支架表面内皮覆盖加速，在HEALING观察性研究中已显示出其安全性和有效性；然而，缺乏评估该装置的随机试验。
多中心、随机、对照、双臂TRIAS项目旨在共纳入2560例患者。在TRIAS低风险试验中，共1300例再狭窄风险低的病变患者被随机分配至EPC捕获支架组和裸金属支架组，假设1年时靶病变失败（TLF）发生率具有优越性。在TRIAS高风险试验中，1260例再狭窄风险高的病变患者被随机分组，假设EPC捕获支架在1年时的TLF不劣于DES。TLF定义为心源性死亡、心肌梗死和临床驱动的靶病变血运重建的复合终点。此外，临床随访时间延长至5年以捕捉晚期事件。作为TRIAS项目辅助研究的一部分，在13个月时进行血管造影随访。
TRIAS项目的结果将为患有冠状动脉病变的相关患者群体提供信息，该群体包括以随机、对照方式接受新型支架技术治疗的再狭窄低风险和高风险的全谱患者（TRIAS低风险试验：ISRCTN 47701105；TRIAS高风险试验：ISRCTN 74297220）。
