Department of Cardiovascular Medicine, Chonnam National University Hospital, Chonnam National University School of Medicine, Gwangju, Korea.
Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea.
J Korean Med Sci. 2024 Aug 26;39(33):e234. doi: 10.3346/jkms.2024.39.e234.
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.
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.
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.
The new polymer-free EES was safe and effective with low LLL and excellent strut coverage at 8 months of follow-up.
Trial Registration: Clinical Research Information Service Identifier: KCT0005699.
在接受永久性聚合物涂层药物洗脱支架（DES）治疗的冠状动脉疾病患者中，持续存在生物相容性较差的聚合物可能会延迟动脉愈合。薄壁支架无聚合物的 DES 有可能改善临床结果并减少双联抗血小板治疗（DAPT）的持续时间。这项首例人体研究的目的是评估新型无聚合物 DES 在新发冠状动脉病变患者中的安全性和有效性。TIGERevolutioN®支架（CG Bio Co.，Ltd.，韩国首尔）由钴铬平台组成，厚度为 70μm，表面经过处理，涂有二氧化钛，然后将依维莫司洗脱支架（EES）无聚合物地涂覆于支架的内膜（支架长度为 6μg/mm）。
共纳入 20 例患者，其冠状动脉病变为新发病变（稳定型或不稳定型心绞痛），血管直径为 2.25 至 4.00mm，长度≤40mm，用于血管造影、光学相干断层扫描（OCT）和 8 个月时的临床评估，所有患者在支架植入后均接受 DAPT。主要终点为 8 个月时的支架内晚期管腔丢失（LLL）。
20 例患者的 20 处病变接受了 TIGERevolutioN®治疗。8 个月时，支架内 LLL 为 0.7±0.4mm。OCT 显示，病变处的百分比狭窄为 29.2±9.4%，所有病变的支架梁均完全覆盖。8 个月时未发生不良心血管事件。
新型无聚合物 EES 在 8 个月的随访中具有较低的 LLL 和出色的支架梁覆盖率，是安全有效的。
临床试验注册信息服务标识符：KCT0005699。
