Design and rationale of the TRI-stent adjudication study (TRIAS) program.

Background: 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.

Methods: 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.

Implication: 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).