AI Article Synopsis
- * Twenty patients were enrolled, and results after 8 months showed minimal in-stent late lumen loss (0.7 mm) and complete stent strut coverage, indicating successful healing.
- * There were no adverse cardiovascular events reported within the same period, suggesting that the new stent design is safe and effective in treating coronary artery disease.
Article Abstract
Background: In 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.
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.
Trial Registration: Trial Registration: Clinical Research Information Service Identifier: KCT0005699.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347186 | PMC |
| http://dx.doi.org/10.3346/jkms.2024.39.e234 | DOI Listing |
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