Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study

Background: Even though many types of stents have been tested in superficial femoral artery (SFA) and popliteal artery (PA), the vast majority of these devices have provided an unsatisfactory outcome, probably due their unsuitable anatomical and physiological characteristics. The Supera peripheral s...

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Main Authors: Giuseppe Guzzardi, Angelo Spinazzola, Gianluca Cangiano, Massimiliano Natrella, Andrea Paladini, Carla Porta, Luca Boccalon, Davide Negroni, Giovanni Leati, Domenico Laganà, Riccardo Guglielmi, Alessandro Carriero
Format: Article
Language:English
Published: SAGE Publishing 2021-09-01
Series:Journal of Public Health Research
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Online Access:https://www.jphres.org/index.php/jphres/article/view/2360
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author Giuseppe Guzzardi
Angelo Spinazzola
Gianluca Cangiano
Massimiliano Natrella
Andrea Paladini
Carla Porta
Luca Boccalon
Davide Negroni
Giovanni Leati
Domenico Laganà
Riccardo Guglielmi
Alessandro Carriero
author_facet Giuseppe Guzzardi
Angelo Spinazzola
Gianluca Cangiano
Massimiliano Natrella
Andrea Paladini
Carla Porta
Luca Boccalon
Davide Negroni
Giovanni Leati
Domenico Laganà
Riccardo Guglielmi
Alessandro Carriero
author_sort Giuseppe Guzzardi
collection DOAJ
description Background: Even though many types of stents have been tested in superficial femoral artery (SFA) and popliteal artery (PA), the vast majority of these devices have provided an unsatisfactory outcome, probably due their unsuitable anatomical and physiological characteristics. The Supera peripheral stent (Abbott Vascular, Santa Rosa, CA, USA) is a braided interwoven nitinol device specifically designed for treating atherosclerotic lesions of the femoro-popliteal segment. The aim of this multicenter retrospective study was to describe the effectiveness of Supera stents in the management of femoral-popliteal atherosclerotic lesions and to critically analyze our findings in the context of current and past literature. Design and Methods: In this study we enrolled only patients who satisfied the inclusion criteria: 1) patients affected by chronic obstructive arterial disease (COAD) grade II, as per Rutherford classification; 2) patients treated with endovascular revascularization and Supera stent implantation in the femoro-popliteal axis. We retrospectively analyzed the Doppler Ultra-sound (US) follow-up at 12-24 and 36 month in order to detect the vascular occlusions. The primary patency, primary patency assisted and TLR were described statistically analyzed by survival analysis and the demographic data, clinical data, device safety following stenting were described as frequency and mean value. Results: 105 endovascular procedures on 99 patients for femoro-popliteal stenting with Supera were performed in four Italian hospitals. The median follow-up was 39 months (range 6-72), with primary patency rate of 83.1%, 74.3% and 69.5% at 12, 24 and 36 months after the procedure. The primary patency assisted was 89.9%, 76.8% and 73.4% in the same period, while the freedom from TLR values were 92.7%, 91.5% and 89.5% at 12, 24 and 36 months after the procedure, respectively. The mortality rate recorded at 12 months from the Supera implantation was 2.8% (3 out of 99 patients enrolled). Conclusions: Our data were in agreement with the current literature, showing the non-inferiority Supera stent in relation to the other stent available. Supera stent showed an excellent safety, effectiveness profile and high durability for the treatment of PAD patients with femoro-popliteal artery disease.
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spelling doaj.art-d3df01e5cdae4f8c8311cccdc848a8c82023-01-02T04:11:14ZengSAGE PublishingJournal of Public Health Research2279-90282279-90362021-09-0110.4081/jphr.2021.2360Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter studyGiuseppe Guzzardi0Angelo Spinazzola1Gianluca Cangiano2Massimiliano Natrella3Andrea Paladini4Carla Porta5Luca Boccalon6Davide Negroni7Giovanni Leati8Domenico Laganà9Riccardo Guglielmi10Alessandro Carriero11Department of Radiology, Unit of Interventional Radiology, “Maggiore della Carità” University Hospital, NovaraUnit of Interventional Radiology, ASST-Crema, CremaUnit of Interventional Radiology, “A. Cardarelli” Hospital, NaplesDepartment of Radiology, “G. Parini” Hospital, AostaDepartment of Radiology, Unit of Interventional Radiology, “Maggiore della Carità” University Hospital, NovaraDivision of Vascular Surgery, “Maggiore della Carità” University Hospital, NovaraDivision of Vascular Surgery, ASST-Crema, CremaDepartment of Radiology, Unit of Interventional Radiology, “Maggiore della Carità” University Hospital, NovaraUnit of Interventional Radiology, ASST-Crema, CremaDepartment of Experimental and Clinical Medicine, “Magna Graecia” University, CatanzaroIstitute of Radiology, Spital Thurgau AG, Kantonsspital MünsterlingenDepartment of Radiology, Unit of Interventional Radiology, “Maggiore della Carità” University Hospital, NovaraBackground: Even though many types of stents have been tested in superficial femoral artery (SFA) and popliteal artery (PA), the vast majority of these devices have provided an unsatisfactory outcome, probably due their unsuitable anatomical and physiological characteristics. The Supera peripheral stent (Abbott Vascular, Santa Rosa, CA, USA) is a braided interwoven nitinol device specifically designed for treating atherosclerotic lesions of the femoro-popliteal segment. The aim of this multicenter retrospective study was to describe the effectiveness of Supera stents in the management of femoral-popliteal atherosclerotic lesions and to critically analyze our findings in the context of current and past literature. Design and Methods: In this study we enrolled only patients who satisfied the inclusion criteria: 1) patients affected by chronic obstructive arterial disease (COAD) grade II, as per Rutherford classification; 2) patients treated with endovascular revascularization and Supera stent implantation in the femoro-popliteal axis. We retrospectively analyzed the Doppler Ultra-sound (US) follow-up at 12-24 and 36 month in order to detect the vascular occlusions. The primary patency, primary patency assisted and TLR were described statistically analyzed by survival analysis and the demographic data, clinical data, device safety following stenting were described as frequency and mean value. Results: 105 endovascular procedures on 99 patients for femoro-popliteal stenting with Supera were performed in four Italian hospitals. The median follow-up was 39 months (range 6-72), with primary patency rate of 83.1%, 74.3% and 69.5% at 12, 24 and 36 months after the procedure. The primary patency assisted was 89.9%, 76.8% and 73.4% in the same period, while the freedom from TLR values were 92.7%, 91.5% and 89.5% at 12, 24 and 36 months after the procedure, respectively. The mortality rate recorded at 12 months from the Supera implantation was 2.8% (3 out of 99 patients enrolled). Conclusions: Our data were in agreement with the current literature, showing the non-inferiority Supera stent in relation to the other stent available. Supera stent showed an excellent safety, effectiveness profile and high durability for the treatment of PAD patients with femoro-popliteal artery disease.https://www.jphres.org/index.php/jphres/article/view/2360Peripheral artery diseaseendovascular treatmentfemoro-popliteal arterystent
spellingShingle Giuseppe Guzzardi
Angelo Spinazzola
Gianluca Cangiano
Massimiliano Natrella
Andrea Paladini
Carla Porta
Luca Boccalon
Davide Negroni
Giovanni Leati
Domenico Laganà
Riccardo Guglielmi
Alessandro Carriero
Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study
Journal of Public Health Research
Peripheral artery disease
endovascular treatment
femoro-popliteal artery
stent
title Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study
title_full Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study
title_fullStr Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study
title_full_unstemmed Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study
title_short Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study
title_sort endovascular treatment of femoro popliteal disease with the supera stent results of a multicenter study
topic Peripheral artery disease
endovascular treatment
femoro-popliteal artery
stent
url https://www.jphres.org/index.php/jphres/article/view/2360
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