• Doo Sun Sim, Kyung Hoon Cho, Dae Young Hyun, Dae Sung Park, Jun-Kyu Park, Dae-Heung Byeon, Won-Il Jo, Sang-Wook Kim, Joon Ho Ahn, Seung Hun Lee, Min Chul Kim, Young Joon Hong, Ju Han Kim, Youngkeun Ahn, and Myung Ho Jeong.
• Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea.
• J. Korean Med. Sci. 2024 Aug 26; 39 (33): e234e234.

BackgroundIn patients with coronary artery disease treated with permanent polymer-coated 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.MethodsA 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.ResultsTwenty 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.ConclusionThe new polymer-free EES was safe and effective with low LLL and excellent strut coverage at 8 months of follow-up.Trial RegistrationTrial Registration: Clinical Research Information Service Identifier: KCT0005699.© 2024 The Korean Academy of Medical Sciences.

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