AUTHOR=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. 

TITLE=First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=9

YEAR=2022

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.877578

DOI=10.3389/fcvm.2022.877578

ISSN=2297-055X

ABSTRACT=<sec><title>Purpose</title><p>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.</p></sec><sec><title>Methods</title><p>Patients with a single <italic>de novo</italic> 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).</p></sec><sec><title>Results</title><p>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 (<italic>p</italic> &lt; 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 (<italic>p</italic> &lt; 0.001). Clinical improvement of at least 1 Rutherford class was achieved in 142 of 174 patients (81.6%).</p></sec><sec><title>Conclusion</title><p>This study showed promising short-term results for the treatment of SFA lesions with Zilver PTX DES in Chinese patients.</p></sec><sec><title>Unique identifier</title><p><ext-link ext-link-type="uri" xlink:href="https://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link>, identifier: NCT02171962.</p></sec>