Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial. 2023

Bahaa Nasr, and Flora Gouailler, and Olivier Marret, and Marie Guillou, and Philippe Chaillou, and Béatrice Guyomarc'h, and Blandine Maurel, and Yann Gouëffic
Service de Chirurgie Vasculaire, l'institut du Thorax, CHU Nantes, Nantes, France.

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.

UI MeSH Term Description Entries
D011150 Popliteal Artery The continuation of the femoral artery coursing through the popliteal fossa; it divides into the anterior and posterior tibial arteries. Arteria Poplitea,Artery, Popliteal,Popliteal Arteries
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D011474 Prosthesis Design The plan and delineation of prostheses in general or a specific prosthesis. Design, Prosthesis,Designs, Prosthesis,Prosthesis Designs
D005263 Femoral Artery The main artery of the thigh, a continuation of the external iliac artery. Common Femoral Artery,Arteries, Common Femoral,Arteries, Femoral,Artery, Common Femoral,Artery, Femoral,Common Femoral Arteries,Femoral Arteries,Femoral Arteries, Common,Femoral Artery, Common
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014654 Vascular Patency The degree to which BLOOD VESSELS are not blocked or obstructed. Patency, Vascular,Patencies, Vascular,Vascular Patencies
D015607 Stents Devices that provide support for tubular structures that are being anastomosed or for body cavities during skin grafting. Stent
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D058729 Peripheral Arterial Disease Lack of perfusion in the EXTREMITIES resulting from atherosclerosis. It is characterized by INTERMITTENT CLAUDICATION, and an ANKLE BRACHIAL INDEX of 0.9 or less. Peripheral Arterial Diseases,Peripheral Artery Disease,Arterial Disease, Peripheral,Arterial Diseases, Peripheral,Artery Disease, Peripheral,Artery Diseases, Peripheral,Disease, Peripheral Arterial,Disease, Peripheral Artery,Diseases, Peripheral Arterial,Diseases, Peripheral Artery,Peripheral Artery Diseases

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