Enrique María San Norberto1, Cintia M Flota2, Liliana Fidalgo-Domingos2, James H Taylor3, Carlos Vaquero2. 1. Department of Vascular Surgery, Valladolid University Hospital, Valladolid, Spain. Electronic address: esannorberto@hotmail.com. 2. Department of Vascular Surgery, Valladolid University Hospital, Valladolid, Spain. 3. Department of Cardiac Surgery, Valencia General University Hospital, Valencia, Spain.
Abstract
BACKGROUND: Reports our experience for the first 50 cases of use of Supera stent for popliteal atherosclerotic lesions treatment. METHODS: This prospective single-arm trial enrolled the first 50 limbs (46 patients) treated in our center with a Supera stent for symptomatic atherosclerotic disease of the popliteal artery. Also, a follow-up of 36 months is reported. RESULTS: The mean preoperative ankle-brachial index increased from 0.38 ± 0.37 before intervention to 0.63 ± 0.46 postoperatively at 12 months (P = 0.014), 0.66 ± 0.39 at 24 months (P = 0.023), and 0.74 ± 0.46 at 36 months (P = 0.029). Primary patency at 12, 24, and 36 months were 89.6%, 72.3%, and 70.2%, and primary assisted patency was 93.8%, 87.2%, and 85.1%, respectively, by Kaplan-Meier estimates. After 3 years of follow-up, age <75 years (P = 0.034) and Trans-Atlantic Inter-Society Consensus (TASC)-II D lesions (P = 0.041) constituted risk factors for stent occlusion. During the follow-up of the patients, none of them developed stent fracture as evidenced on plain radiographs during follow-up. Implantation defects did not constitute a risk factor for stent restenosis. CONCLUSIONS: Based on the results of this study, Supera stent has shown an excellent 3-year patency in this difficult-to-treat anatomic segment. In our experience, younger patients and complex lesions (TASC-II type D) were positive significant predictors for restenosis. In our cohort, post deployment stent conformation did not influence patency. Nevertheless, further investigations, including randomized studies comparing the Supera stent with other stent platforms, drug eluting angioplasty, or atherectomy devices, are mandatory.
BACKGROUND: Reports our experience for the first 50 cases of use of Supera stent for popliteal atherosclerotic lesions treatment. METHODS: This prospective single-arm trial enrolled the first 50 limbs (46 patients) treated in our center with a Supera stent for symptomatic atherosclerotic disease of the popliteal artery. Also, a follow-up of 36 months is reported. RESULTS: The mean preoperative ankle-brachial index increased from 0.38 ± 0.37 before intervention to 0.63 ± 0.46 postoperatively at 12 months (P = 0.014), 0.66 ± 0.39 at 24 months (P = 0.023), and 0.74 ± 0.46 at 36 months (P = 0.029). Primary patency at 12, 24, and 36 months were 89.6%, 72.3%, and 70.2%, and primary assisted patency was 93.8%, 87.2%, and 85.1%, respectively, by Kaplan-Meier estimates. After 3 years of follow-up, age <75 years (P = 0.034) and Trans-Atlantic Inter-Society Consensus (TASC)-II D lesions (P = 0.041) constituted risk factors for stent occlusion. During the follow-up of the patients, none of them developed stent fracture as evidenced on plain radiographs during follow-up. Implantation defects did not constitute a risk factor for stent restenosis. CONCLUSIONS: Based on the results of this study, Supera stent has shown an excellent 3-year patency in this difficult-to-treat anatomic segment. In our experience, younger patients and complex lesions (TASC-II type D) were positive significant predictors for restenosis. In our cohort, post deployment stent conformation did not influence patency. Nevertheless, further investigations, including randomized studies comparing the Supera stent with other stent platforms, drug eluting angioplasty, or atherectomy devices, are mandatory.
Authors: Michael D Dake; Fabrizio Fanelli; Aaron E Lottes; Erin E O'Leary; Heidi Reichert; Xiaohui Jiang; Weiguo Fu; Osamu Iida; Kan Zen; Marc Schermerhorn; Thomas Zeller; Gary M Ansel Journal: Cardiovasc Intervent Radiol Date: 2020-10-06 Impact factor: 2.740