Key result
Polymer-free TIGERevolutioN stent yields ~0.7 mm late lumen loss and complete strut coverage.
Why the study?
Permanent polymers on DES may delay arterial healing, whereas thin strut polymer-free DES could improve clinical outcomes and reduce DAPT duration.
Does a polymer-free everolimus-eluting stent using a titanium dioxide film improve angiographic outcomes in patients with de novo coronary lesions?
Does a polymer-free everolimus-eluting stent using a titanium dioxide film improve angiographic outcomes in patients with de novo coronary lesions?
A novel polymer-free everolimus-eluting stent using a titanium dioxide film demonstrated favorable safety and surrogate efficacy outcomes at 8 months in a first-in-human study.
Hypothesis-generating for this novel polymer-free stent; leaves open confirmation of clinical benefit in randomized trials.
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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Sim et al. (2024) studied de novo coronary lesions (stable or unstable angina) (n=20). TIGERevolutioN polymer-free everolimus-eluting stent was evaluated on angiographic in-stent late lumen loss (LLL) at 8 months. The TIGERevolutioN polymer-free everolimus-eluting stent resulted in an angiographic in-stent late lumen loss of 0.7 ± 0.4 mm at 8 months, with complete strut coverage and no adverse events.
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