J Korean Med Sci.  2024 Aug;39(33):e234. 10.3346/jkms.2024.39.e234.

First-in-Human Evaluation of a Polymer-Free Everolimus-Eluting Stent Using a Titanium Dioxide Film

• Sim DS
• Cho KH
• Hyun DY
• Park DS
• Park JK
• Byeon DH
• Jo WI
• Kim SW
• Ahn JH
• Lee SH
• Kim MC
• Hong YJ
• Kim JH
• Ahn Y
• Jeong MH

• KMID: 2559226
• DOI: http://doi.org/10.3346/jkms.2024.39.e234

Abstract

Background
In patients with coronary artery disease treated with permanent polymercoated drug-eluting stents (DES), the persistent presence of a less biocompatible polymer might delay arterial healing. Thin strut polymer-free DES have the potential to improve clinical outcomes and reduce the duration of dual antiplatelet therapy (DAPT). The purpose of this first-in-human study was to assess the safety and effectiveness of a novel polymer-free DES in patients with de novo coronary lesions. The TIGERevolutioN^® stent (CG Bio Co., Ltd., Seoul, Korea) consists of a cobalt chromium platform with a strut thickness of 70 μm and a surface treated with titanium dioxide onto which everolimus-eluting stent (EES) is applied abluminally (6 µg/mm of stent length) without utilization of a polymer.
Methods
A total of 20 patients were enrolled, with de novo coronary lesions (stable or unstable angina) and > 50% diameter stenosis in a vessel 2.25 to 4.00 mm in diameter and ≤ 40 mm in length for angiographic, optical coherence tomography (OCT), and clinical assessment at 8 months. All patients received DAPT after stent implantation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at 8 months.
Results
Twenty patients with 20 lesions were treated with TIGERevolutioN^® . At 8 months, in-stent LLL was 0.7 ± 0.4 mm. On OCT, percent area stenosis was 29.2 ± 9.4% and stent strut coverage was complete in all lesions. No adverse cardiovascular event occurred at 8 months.
Conclusion
The new polymer-free EES was safe and effective with low LLL and excellent strut coverage at 8 months of follow-up.

Keyword

Drug-Eluting Stents; Titanium Dioxide; Polymers

Figure

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  Fig. 1 Construction and properties of the TIGERevolutioN® polymer-free stent.TiO2 = titanium dioxide, Co-Cr = cobalt chromium.

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  Fig. 2 In vitro release kinetics of everolimus from the TIGERevolutioN® stent (courtesy of CG Bio Co., Ltd., Seoul, Korea).

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