Editor's Choice – Comparative Analysis of Three Year Results of Two Paclitaxel Related Stents for the Management of Femoropopliteal Disease in a Real World Setting

IF 6.8 1区医学 Q1 PERIPHERAL VASCULAR DISEASE European Journal of Vascular and Endovascular Surgery Pub Date : 2025-06-01 DOI:10.1016/j.ejvs.2025.03.010

Tsuyoshi Shibata , Yutaka Iba , Masami Shingaki , Osamu Yamashita , Yoshinori Tsubakimoto , Fumiaki Kimura , Atsutoshi Hatada , Fuminori Kasashima , Kyohei Ueno , Nobuyoshi Kawaharada

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Abstract

Objective

Randomised clinical trials have demonstrated superiority of the Eluvia stent over Zilver PTX for femoropopliteal artery disease in terms of one and two year clinical outcomes, but comparative real world data beyond two years are not available. This study aimed to compare Zilver PTX and Eluvia stents and to report three year primary patency, patient outcomes, and safety results from the REALDES study.

Methods

The REALDES study was a prospective, multicentre, observational study that enrolled adult patients with symptomatic femoropopliteal disease scheduled for treatment with either Zilver PTX or Eluvia. The study included patients with native femoropopliteal artery disease treated with Zilver PTX (n = 96 limbs) or Eluvia (n = 104 limbs). The primary outcome was three year primary patency, and secondary outcomes included freedom from clinically driven target lesion revascularisation (TLR) and Tosaka classification.

Results

The baseline characteristics were comparable between the Zilver PTX and Eluvia groups, apart for greater lesion lengths in the Zilver PTX group. At three years, the primary patency rates were 70.0% for Zilver PTX and 65.2% for Eluvia, with no statistically significant difference (p = .74). Furthermore, there were no statistically significant differences between the two stents at one and two years. Freedom from TLR rates were 79.4% for Zilver PTX and 76.3% for Eluvia, with no statistically significant difference (p = .27). The incidence of Tosaka class III was 7.3% in the Zilver PTX group and 14.4% in the Eluvia group at three years (p = .10). Among patients with re-stenosis, the incidence of in stent occlusion was statistically significantly higher with Eluvia (57.7%) than with Zilver PTX (29.2%) (p = .041). No baseline characteristics were associated with the three year re-stenosis risk.

Conclusion

The Zilver PTX and Eluvia stents demonstrated comparable primary patency and freedom from clinically driven TLR after three years in real world femoropopliteal artery interventions. In routine clinical practice, Eluvia should be used judiciously in backgrounds with a high risk of re-stenosis.

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两种紫杉醇相关支架治疗股腘动脉疾病3年疗效对比分析

目的：随机临床试验已经证明Eluvia支架在治疗股腘动脉疾病的1年和2年临床结果方面优于Zilver PTX，但没有超过2年的比较真实世界数据。该研究旨在比较Zilver PTX和Eluvia支架，并报告REALDES研究的三年初步通畅、患者预后和安全性结果。方法：REALDES研究是一项前瞻性、多中心、观察性研究，纳入了计划用Zilver PTX或Eluvia治疗的有症状股腘动脉疾病的成年患者。本研究纳入了用Zilver PTX （n = 96个肢体）或Eluvia （n = 104个肢体）治疗的先天性股腘动脉疾病患者。主要结局是三年的原发性通畅，次要结局包括无临床驱动的靶病变血运重建（TLR）和to坂分类。结果：基线特征在Zilver PTX组和Eluvia组之间具有可比性，除了Zilver PTX组的病变长度更长。三年时，Zilver PTX的初级通畅率为70.0%，Eluvia的初级通畅率为65.2%，两者无显著差异（p = 0.74）。此外，两种支架在1年和2年没有显著差异。Zilver PTX的TLR解脱率为79.4%，Eluvia为76.3%，无显著差异（p = 0.27）。三年时，Zilver PTX组to阪III级发生率为7.3%，Eluvia组为14.4% （p = 0.10）。在再狭窄患者中，Eluvia支架内闭塞发生率（57.7%）明显高于Zilver PTX (29.2%) （p = 0.041）。没有基线特征与三年再狭窄风险相关。结论：在现实世界的股腘动脉介入治疗中，Zilver PTX和Eluvia支架在三年后显示出相当的原发性通畅和临床驱动的TLR自由。在常规临床实践中，对于再狭窄风险高的患者应谨慎使用艾路维。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Vascular and Endovascular Surgery 医学-外科

CiteScore

6.80

自引率

15.80%

发文量

471

审稿时长

66 days

期刊介绍： The European Journal of Vascular and Endovascular Surgery is aimed primarily at vascular surgeons dealing with patients with arterial, venous and lymphatic diseases. Contributions are included on the diagnosis, investigation and management of these vascular disorders. Papers that consider the technical aspects of vascular surgery are encouraged, and the journal includes invited state-of-the-art articles. Reflecting the increasing importance of endovascular techniques in the management of vascular diseases and the value of closer collaboration between the vascular surgeon and the vascular radiologist, the journal has now extended its scope to encompass the growing number of contributions from this exciting field. Articles describing endovascular method and their critical evaluation are included, as well as reports on the emerging technology associated with this field.