Canyiğit Murat, Beşler Muhammed Said
Yıldırım Beyazıt University Faculty of Medicine, Department of Radiology, Ankara, Türkiye.
Kahramanmaraş Necip Fazıl City Hospital, Clinic of Radiology, Kahramanmaraş, Türkiye.
Diagn Interv Radiol. 2025 Jan 1;31(1):52-57. doi: 10.4274/dir.2024.242868. Epub 2024 Aug 19.
To describe the short-term follow-up results of the recently introduced iCover balloon-expandable covered stents for iliac artery lesions.
All consecutive patients treated with iCover balloon-expandable covered stents between March 2022 and August 2023 were retrospectively reviewed. The primary endpoint was target lesion revascularization (TLR) at 6 months. Secondary endpoints included major adverse events, freedom from TLR throughout the follow-up period, primary and secondary patency, and clinical and technical success.
In the study population of 40 adult patients (87.5% men, mean age: 63.5 ± 11 years), the mean follow-up period was 6.2 ± 2.8 months. A total of 98 stents of various sizes were implanted. The technical success rate was 100%. Freedom from TLR was 95.8% [95%, confidence interval (CI): 95%- 96.6%], the primary patency rate was 91.7% (95%, CI: 89.8%-93.6%), and the secondary patency rate was 95.8% (95%, CI: 95%-96.6%) at 6 months. The all-cause mortality rate was 5%.
These real-world data demonstrate a high technical and clinical success rate, a high 6-month primary patency rate, and a low requirement for TLR. These are promising indicators for the safety and efficacy of iCover stents.
Balloon-expandable covered stents are frequently used in iliac artery atherosclerotic disease. This study shows that the short-term follow-up results of the new iCover stent are satisfactory, indicating its safety and efficacy.
描述近期推出的用于髂动脉病变的iCover球囊扩张式覆膜支架的短期随访结果。
对2022年3月至2023年8月期间接受iCover球囊扩张式覆膜支架治疗的所有连续患者进行回顾性研究。主要终点是6个月时的靶病变血运重建（TLR）。次要终点包括主要不良事件、随访期间无TLR、原发性和继发性通畅率以及临床和技术成功率。
在40例成年患者（87.5%为男性，平均年龄：63.5±11岁）的研究人群中，平均随访期为6.2±2.8个月。共植入了98枚不同尺寸的支架。技术成功率为100%。6个月时无TLR率为95.8%[95%，置信区间（CI）：95%-96.6%]，原发性通畅率为91.7%（95%，CI：89.8%-93.6%），继发性通畅率为95.8%（95%，CI：95%-96.6%）。全因死亡率为5%。
这些真实世界的数据显示出较高的技术和临床成功率、较高的6个月原发性通畅率以及较低的TLR需求。这些都是iCover支架安全性和有效性的有前景的指标。
球囊扩张式覆膜支架常用于髂动脉粥样硬化疾病。本研究表明，新型iCover支架的短期随访结果令人满意，表明其安全性和有效性。
