First-in-Human Evaluation of a Polymer-Free Everolimus-Eluting Stent Using a Titanium Dioxide Film
10.3346/jkms.2024.39.e234
- Author:
Doo Sun SIM
1
;
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
;
Myung Ho JEONG
Author Information
1. Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea
- Publication Type:Original Article
- From:Journal of Korean Medical Science
2024;39(33):e234-
- CountryRepublic of Korea
- Language:English
-
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.
