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自膨式编织镍钛合金支架治疗严重股腘动脉病变。Supera 外周血管支架系统的真实世界研究结果。

Self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease. Real life results of the Supera Peripheral Stent System.

机构信息

University Hospitals Leuven, Leuven, Belgium.

Department of Vascular Surgery, AZ Klina, Brasschaat, Belgium.

出版信息

Acta Chir Belg. 2023 Oct;123(5):463-472. doi: 10.1080/00015458.2022.2072457. Epub 2022 May 10.

DOI:10.1080/00015458.2022.2072457
PMID:35485637
Abstract

PURPOSE

The excellent performance of the Supera Peripheral Stent System by Abbott Vascular in femoropopliteal interventions has already been proven through several trials. This retrospective study aims to evaluate the durability and long-term patency of the Supera stent for the treatment of severe femoropopliteal lesions in a real-world population.

METHODS

A retrospective analysis was conducted of 136 consecutive limbs from 128 patients with atherosclerotic disease in the femoropopliteal region, treated with Supera stents between September 2010 and September 2017. As primary endpoints patency rates and freedom from target lesion revascularization (TLR) were calculated and presented using Kaplan-Meier analysis.

RESULTS

Fifty-five percent were treated for claudication (IC), 45% for chronical limb threatening ischemia (CLTI). The mean treated lesion length was 143 mm (±77.8). The majority of lesions (63%) were Trans-Atlantic Inter-Society Consensus Criteria II (TASC II) C/D lesions. The overall primary patency rates at 12 and 24 months of follow-up were 72.6% and 60.8% respectively. The primary patency at 12 and 24 months for TASC II A/B lesions was respectively 86% and 75.4%. For TASC II C/D lesions primary patency at 12 and 24 months was 64% and 51.1% respectively ( = 0.001). Overall freedom from TLR after 12 and 24 months was 73.8% and 62.8% respectively. No significant patency differences were observed based on calcification rate.

CONCLUSION

Endovascular treatment of femoropopliteal disease with Supera Stent is safe, even in extensive, highly calcified lesions. Patency rates and freedom from TLR are acceptable in a real-life population.

摘要

目的

雅培血管的 Supera 外周支架系统在股腘介入治疗中的优异表现已经通过多项试验得到证实。本回顾性研究旨在评估 Supera 支架治疗股腘动脉严重病变的耐久性和长期通畅率。

方法

对 2010 年 9 月至 2017 年 9 月期间接受 Supera 支架治疗的 128 例股腘动脉粥样硬化患者的 136 条肢体进行回顾性分析。主要终点为通畅率和免于靶病变血运重建(TLR)的比例,采用 Kaplan-Meier 分析进行计算和呈现。

结果

55%的患者因跛行(IC)接受治疗,45%因慢性肢体威胁性缺血(CLTI)接受治疗。平均治疗病变长度为 143mm(±77.8)。大多数病变(63%)为跨大西洋内科学会共识分类 II(TASC II)C/D 病变。12 个月和 24 个月的总体主要通畅率分别为 72.6%和 60.8%。TASC II A/B 病变的 12 个月和 24 个月主要通畅率分别为 86%和 75.4%。TASC II C/D 病变的 12 个月和 24 个月主要通畅率分别为 64%和 51.1%( = 0.001)。12 个月和 24 个月时的总体 TLR 无复发率分别为 73.8%和 62.8%。基于钙化率,未观察到明显的通畅率差异。

结论

在真实世界人群中,Supera 支架治疗股腘动脉疾病是安全的,即使在广泛的、高度钙化的病变中也是如此。通畅率和 TLR 无复发率在真实人群中是可以接受的。

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