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, 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

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.

Keywords: drug-eluting stent; paclitaxel-eluting stent; peripheral artery disease; peripheral vascular disease; superficial femoral artery.

Conflict of interest statement

AEL and MDD are paid consultants for Cook Medical. EEO'L is a paid employee of Cook Medical. TZ has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore and Associates, Medtronic, Philips-Spectranetics, and Shockwave; consulted for Boston Scientific Corp., Gore and Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, and Vesper Medical; received (institution) research, clinical trial, or drug study funds from 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Efemoral, Cook Medical, Gore and Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, and B. Braun; and has common stock in QT Medical. This study was sponsored by Cook Medical. The funder had the following involvement with the study: study design, collection of data, analysis and interpretation of data, decision to publish the data, and writing the publication. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Ye, Böhme, Fu, Liu, Zhang, Liu, Zhang, Zou, Lu, Lottes, O'Leary, Zeller and Dake.

Figures

Figure 1
Figure 1
Patient flow diagram.
Figure 2
Figure 2
Primary patency. The Kaplan–Meier curve shows an 81.9% rate of primary patency through 1-year for patients treated with DES. The life table is included. DES, drug-eluting stent.
Figure 3
Figure 3
Event-free survival. The Kaplan–Meier curve shows a 94.9% rate of event-free survival (EFS) through 1-year for patients treated with DES. The life table is included. DES, drug-eluting stent; EFS, event-free survival.
Figure 4
Figure 4
Freedom from TLR. The Kaplan–Meier curve shows a 95.5% rate of freedom from TLR through 1-year for patients treated with DES. The life table is included. DES, drug-eluting stent; TLR, target lesion revascularization.
Figure 5
Figure 5
Rutherford classification. Rutherford classification significantly improved through 1-year compared to pre-procedure (p < 0.001).

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