Service de Chirurgie Vasculaire, l'institut du Thorax, CHU Nantes, Nantes, France.
Service de Chirurgie Vasculaire, Clinique Océane, Vannes, France.
J Endovasc Ther. 2023 Feb;30(1):98-105. doi: 10.1177/15266028221075227. Epub 2022 Feb 3.
The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD).
The STELLA SUPERA (STEnting Long de L'Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2-6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months.
Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months.
The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.
通过短病变和相对较低闭塞比例的试验，已经证明自膨式编织镍钛诺支架（Supera）在股腘介入治疗中的性能。在长病变中，Supera 支架的证据有限。本研究旨在评估 Supera 支架在有症状的外周动脉疾病（PAD）患者中治疗长股腘段病变（跨大西洋血管内学会共识 [TASC] C/D）的临床安全性和疗效。
STELLA SUPERA（STEnting Long de L'Artère fémorale superficielle par le stent métallique Supera）是一项前瞻性、2 中心、单臂研究。采用 Supera 支架治疗有症状（Rutherford 分期 2-6）的股腘段新发和 TASC C/D 病变的患者。主要终点是 12 个月时的主要持续临床改善。随访包括临床检查、双功能超声检查和双平面 X 射线检查，最长随访时间为 24 个月。
2016 年 12 月至 2018 年 10 月，48 例有症状的患者（49 条股腘病变，TASC D=32，65%）接受了治疗。平均病变长度为 234±123mm，78%为完全闭塞。平均支架内病变长度为 273±127mm。12 个月和 24 个月时，主要持续临床改善率分别为 87.2%和 79.7%。与基线相比，24 个月时 Rutherford 分类评估显著改善（p=0.02）。24 个月时，主要通畅率和免于靶病变血运重建（TLR）率分别为 77.9%和 86.9%。踝肱压指数从基线时的 0.62±0.15 增加到 24 个月时的 0.93±0.15（p<0.0001）。24 个月时无支架断裂。
在长病变（TASC C/D）中使用 Supera 支架是一种安全有效的血管内替代治疗方法。这些结果强调需要进行随机临床试验来评估编织支架在长股腘病变中的价值。
