TCD-17187 药物涂层球囊治疗股浅动脉和腘动脉近段粥样硬化病变的 24 个月安全性和有效性。
Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.
机构信息
Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.
Division of Cardiology, Cardiovascular Center, Osaka Police Hospital, Osaka, Japan.
出版信息
Cardiovasc Intervent Radiol. 2024 Jun;47(6):730-740. doi: 10.1007/s00270-024-03747-4. Epub 2024 May 30.
PURPOSE
In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients.
METHODS
This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate.
RESULTS
Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD.
CONCLUSION
This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months.
LEVEL OF EVIDENCE
Level 3, Cohort study.
CLINICAL TRIAL REGISTRATION
URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.
目的
在本试验中，评估了 TCD-17187 药物涂层球囊（DCB）在治疗股浅动脉（SFA）和腘动脉近端（PA）动脉粥样硬化病变中的 24 个月安全性和有效性。
方法
这是一项前瞻性、多中心、核心实验室评估的单臂试验。2019 年至 2020 年，共纳入 121 例有症状的外周动脉疾病患者。主要有效性终点为一期通畅率。安全性终点为主要不良事件（MAE）发生率。
结果
患者年龄为 74.5±7.3 岁，其中 67.5%患有糖尿病。病变长度和参考血管直径（RVD）分别为 106.0±52.6mm 和 5.2±0.8mm。慢性完全闭塞（CTO）和双侧钙化率（外周动脉钙评分系统（PACSS）分级 3 级和 4 级）分别为 17.5%和 50.8%。24 个月时，超声双功能检查的一期通畅率为 71.3%，无临床驱动的靶病变血运重建（CD-TLR）率为 87.0%。MAE 发生率为 13.2%，所有事件均为 CD-TLR。在 24 个月内，无器械相关或手术相关死亡或大截肢事件。多变量 Cox 比例风险回归分析显示，与一期通畅率丧失相关的显著差异与 CTO、再狭窄病变和 RVD 有关。
结论
本试验证实了 TCD-17187 DCB 治疗股浅动脉和/或腘动脉近端动脉粥样硬化病变的安全性和有效性，最长可达 24 个月。
证据水平
3 级，队列研究。
临床试验注册
网址：https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J：注册 ID：UMIN000034122。注册日期：2018 年 9 月 13 日。
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