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

Area of Science:

• Cardiovascular Medicine
• Biomaterials Science
• Interventional Cardiology

Background:

• Drug-eluting stents (DES) use cytotoxic drugs, but a
• The endothelial progenitor cell (EPC) capturing stent promotes accelerated endothelial coverage, showing promise in observational studies for preventing in-stent restenosis and late stent thrombosis.
• Randomized trials are needed to evaluate the efficacy of EPC capturing stents compared to existing technologies.

Purpose of the Study:

• To evaluate the safety and efficacy of an EPC capturing stent in patients with coronary artery disease.
• To compare the EPC capturing stent against bare metal stents in low-risk patients for target lesion failure (TLF).
• To assess the noninferiority of the EPC capturing stent versus DES in high-risk patients for TLF.

Main Methods:

• The TRIAS program is a multicenter, randomized, controlled trial enrolling 2560 patients.
• TRIAS Low Risk trial: 1300 patients randomized between EPC capturing stent and bare metal stent.
• TRIAS High Risk trial: 1260 patients randomized between EPC capturing stent and DES, with 5-year follow-up.

Main Results:

• Data on target lesion failure (TLF) at 1 year will be collected for both low and high-risk trials.
• Angiographic follow-up at 13 months will be performed as part of an ancillary study.
• The study is designed to provide robust evidence on the performance of the novel stent technology.

Conclusions:

• The TRIAS Program will offer crucial data on a broad spectrum of coronary artery lesions.
• Results will guide the clinical application of EPC capturing stents in interventional cardiology.
• The study addresses the need for randomized evidence on advanced stent technologies.