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

Abstract: Purpose: 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.

Methods: Patients with a single de novo 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).

Results: 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 (p < 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 (p < 0.001). Clinical improvement of at least 1 Rutherford class was achieved in 142 of 174 patients (81.6%).

Conclusion: This study showed promising short-term results for the treatment of SFA lesions with Zilver PTX DES in Chinese patients.

Unique identifier: ClinicalTrials.gov, identifier: NCT02171962

Object Details

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch
• Notes: Frontiers in cardiovascular medicine. - 9 (2022) , 877578, ISSN: 2297-055X

Contributors, Places and Time

• Event: Veröffentlichung
• (where): Freiburg
• (who): Universität
• (when): 2022
• Creator: 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.

Further information

• DOI: 10.3389/fcvm.2022.877578
• URN: urn:nbn:de:bsz:25-freidok-2308161
• Rights: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Last update: 15.08.2025, 7:23 AM CEST