Ye Wei, Böhme Tanja, Fu Weiguo, Liu Changwei, Zhang Xiaoming, Liu Peng, Zhang Jiwei, Zou Yinghua, Lu Xinwu, Lottes Aaron E, O'Leary Erin E, Zeller Thomas, Dake Michael D
Vascular Surgical Department, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, China.
Department of Angiology, Universitaets-Herz-Zentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Front Cardiovasc Med. 2022 Sep 27;9:877578. doi: 10.3389/fcvm.2022.877578. eCollection 2022.
The benefit of using the Zilver PTX drug-eluting stent (DES) in superficial femoral artery (SFA) lesions has been demonstrated in multiple clinical studies. This prospective, multicenter study evaluated the 1-year safety and effectiveness of the DES for the treatment of femoropopliteal lesions in a Chinese patient population.
Patients with a single or restenotic SFA lesion ≤140 mm and a Rutherford classification of 2 to 4 were treated with the DES. The primary endpoint was primary patency assessed by duplex ultrasound at 1-year. Secondary endpoints included adverse events, event-free survival (EFS), and freedom from target lesion revascularization (TLR). Clinical outcomes included Rutherford classification, ankle-brachial index (ABI), and the walking impairment questionnaire (WIQ).
In this study, 178 patients with symptomatic peripheral artery disease were enrolled at nine institutions in China. The average lesion length was 79.0 ± 48.6 mm (range 14.8-245.4 mm) and 50.0% of lesions were total occlusions. The 1-year primary patency rate was 81.9%. Covariate analysis revealed that lesion length ( < 0.01) was the only significant factor for patency. No paclitaxel-related adverse events or amputations were reported. The 1-year rate for EFS was 94.9% and freedom from TLR was 95.5%. Through 1-year, treatment with the DES resulted in statistically significant improvement in ABI and WIQ scores compared with pre-procedure ( < 0.001). Clinical improvement of at least 1 Rutherford class was achieved in 142 of 174 patients (81.6%).
This study showed promising short-term results for the treatment of SFA lesions with Zilver PTX DES in Chinese patients.
ClinicalTrials.gov, identifier: NCT02171962.
多项临床研究已证实使用Zilver PTX药物洗脱支架（DES）治疗股浅动脉（SFA）病变的益处。这项前瞻性、多中心研究评估了DES在中国患者人群中治疗股腘动脉病变的1年安全性和有效性。
对单一或再狭窄的SFA病变长度≤140 mm且Rutherford分级为2至4级的患者使用DES进行治疗。主要终点是1年时通过双功超声评估的主要通畅率。次要终点包括不良事件、无事件生存期（EFS）和无靶病变血运重建（TLR）。临床结果包括Rutherford分级、踝肱指数（ABI）和步行障碍问卷（WIQ）。
本研究在中国的9家机构纳入了178例有症状的外周动脉疾病患者。平均病变长度为79.0±48.6 mm（范围14.8 - 245.4 mm），50.0%的病变为完全闭塞。1年主要通畅率为81.9%。协变量分析显示病变长度（<0.01）是通畅的唯一显著因素。未报告与紫杉醇相关的不良事件或截肢情况。1年EFS率为94.9%，无TLR率为95.5%。在1年期间，与术前相比，DES治疗使ABI和WIQ评分有统计学意义的改善（<0.001）。174例患者中有142例（81.6%）临床改善至少1个Rutherford分级。
本研究显示Zilver PTX DES治疗中国患者SFA病变的短期结果良好。
ClinicalTrials.gov，标识符：NCT02171962。
