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

Wei Ye, Tanja Böhme, Weiguo Fu, Changwei Liu, Xiaoming Zhang, Peng Liu, Jiwei Zhang, Yinghua Zou, Xinwu Lu, Aaron E. Lottes, Erin E. O'Leary, Thomas Zeller, Michael D. Dake

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number877578
JournalFrontiers in Cardiovascular Medicine
Volume9
DOIs
StatePublished - Sep 27 2022
Externally publishedYes

Keywords

  • drug-eluting stent
  • paclitaxel-eluting stent
  • peripheral artery disease
  • peripheral vascular disease
  • superficial femoral artery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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