{"id":5839,"date":"2023-03-28T15:04:44","date_gmt":"2023-03-28T13:04:44","guid":{"rendered":"https:\/\/www.jphres.org\/?p=5839"},"modified":"2023-04-02T14:06:38","modified_gmt":"2023-04-02T12:06:38","slug":"endovascular-treatment-of-femoro-popliteal-disease-with-the-supera-stent-results-of-a-multicenter-study","status":"publish","type":"page","link":"https:\/\/www.jphres.us.com\/index.php\/jphres\/article\/view\/2360\/","title":{"rendered":"Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study"},"content":{"rendered":"<div class=\"item doi\"><span class=\"value\"><a href=\"https:\/\/doi.org\/10.4081\/jphr.2021.2360\">https:\/\/doi.org\/10.4081\/jphr.2021.2360<\/a><\/span><\/div>\n<ul class=\"item authors\">\n<li><span class=\"name\"><strong>Giuseppe Guzzardi<\/strong><br \/>\n<\/span><span class=\"affiliation\">Department of Radiology, Unit of Interventional Radiology, \u201cMaggiore della Carit\u00e0\u201d University Hospital, Novara, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Angelo Spinazzola<\/strong><br \/>\n<\/span><span class=\"affiliation\">Unit of Interventional Radiology, ASST-Crema, Crema, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Gianluca Cangiano<\/strong><br \/>\n<\/span><span class=\"affiliation\">Unit of Interventional Radiology, \u201cA. Cardarelli\u201d Hospital, Naples, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Massimiliano Natrella<\/strong><br \/>\n<\/span><span class=\"affiliation\">Department of Radiology, \u201cG. Parini\u201d Hospital, Aosta, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Andrea Paladini<\/strong><br \/>\n<\/span><span class=\"affiliation\">Department of Radiology, Unit of Interventional Radiology, \u201cMaggiore della Carit\u00e0\u201d University Hospital, Novara, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Carla Porta<\/strong><br \/>\n<\/span><span class=\"affiliation\">Division of Vascular Surgery, \u201cMaggiore della Carit\u00e0\u201d University Hospital, Novara, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Luca Boccalon<\/strong><br \/>\n<\/span><span class=\"affiliation\">Division of Vascular Surgery, ASST-Crema, Crema, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Davide Negroni<\/strong><br \/>\n<\/span><span class=\"affiliation\">Department of Radiology, Unit of Interventional Radiology, \u201cMaggiore della Carit\u00e0\u201d University Hospital, Novara, Italy.<\/span><span class=\"orcid\"><a href=\"https:\/\/orcid.org\/0000-0002-1570-3695\" target=\"_blank\" rel=\"noopener\">\u00a0https:\/\/orcid.org\/0000-0002-1570-3695<\/a><\/span><\/li>\n<li><span class=\"name\"><strong>Giovanni Leati<\/strong><br \/>\n<\/span><span class=\"affiliation\">Unit of Interventional Radiology, ASST-Crema, Crema, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Domenico Lagan\u00e0<\/strong><br \/>\n<\/span><span class=\"affiliation\">Department of Experimental and Clinical Medicine, \u201cMagna Graecia\u201d University, Catanzaro, Italy.<\/span><\/li>\n<li><span class=\"name\"><strong>Riccardo Guglielmi<\/strong><br \/>\n<\/span><span class=\"affiliation\">Istitute of Radiology, Spital Thurgau AG, Kantonsspital M\u00fcnsterlingen, Switzerland.<\/span><\/li>\n<li><span class=\"name\"><strong>Alessandro Carriero<\/strong><br \/>\n<\/span><span class=\"affiliation\">Department of Radiology, Unit of Interventional Radiology, \u201cMaggiore della Carit\u00e0\u201d University Hospital, Novara, Italy.<\/span><\/li>\n<\/ul>\n<h3 class=\"label\">ABSTRACT<\/h3>\n<p><strong>Background:\u00a0<\/strong>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.<br \/>\n<strong><br \/>\nDesign and Methods:<\/strong>\u00a0In this study we enrolled only patients who satisfied the inclusion criteria: 1) patients affected by chronic obstructive arterial disease (COAD) grade II, as\u00a0<em>per<\/em>\u00a0Rutherford 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.<br \/>\n<strong><br \/>\nResults:\u00a0<\/strong>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).<br \/>\n<strong><br \/>\nConclusions:<\/strong>\u00a0Our 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.<\/p>\n<h3 class=\"label\">REFERENCES<\/h3>\n<div class=\"value\">1. Zeller T. Current state of endovascular treatment of femoro-popliteal artery disease. Vasc Med. 2007;12(3):223\u201334.<br \/>\n2. de Boer SW, van den Heuvel DAF, de Vries-Werson DAB, Vos JA, Fioole B, Vroegindeweij D, et al. Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions. 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Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: Twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3(3):267\u201376.<br \/>\n11. Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg [Internet]. 2013;58(2):386-395.e4. Available from: http:\/\/dx.doi.org\/10.1016\/j.jvs.2013.01.050<br \/>\n12. San Norberto EM, Fuente R, Flota CM, Taylor JH, Vaquero C. Impact of Implantation Defects on Intermediate Outcome of Supera Stent for Popliteal Artery Stenosis. Ann Vasc Surg [Internet]. 2017;41:186\u201395. Available from: http:\/\/dx.doi.org\/10.1016\/j.avsg.2016.09.021<br \/>\n13. Maleckis K, Deegan P, Poulson W, Sievers C, Desyatova A, MacTaggart J, et al. Comparison of femoropopliteal artery stents under axial and radial compression, axial tension, bending, and torsion deformations. J Mech Behav Biomed Mater [Internet]. 2017;75(July):160\u20138. Available from: http:\/\/dx.doi.org\/10.1016\/j.jmbbm.2017.07.017<br \/>\n14. Jude S. Summary of Safety and Effectiveness Data ( Ssed ). US Food Drug Adm. 2016;39:1\u201330.<br \/>\n15. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, et al. 2016 AHA\/ACC guideline on the management of patients with lower extremity peripheral artery disease: A report of the American college of cardiology\/American Heart Association Task Force on Clinical Practice Guidelines. Vol. 135, Circulation. 2017. 726\u2013779 p.<br \/>\n16. Brevetti G, Bucur R, Balbarini A, Melillo E, Novo S, Muratori I, et al. Women and peripheral arterial disease: Same disease, different issues. J Cardiovasc Med. 2008;9(4):382\u20138.<br \/>\n17. Sigvant B, Wiberg-Hedman K, Bergqvist D, Rolandsson O, Andersson B, Persson E, et al. A population-based study of peripheral arterial disease prevalence with special focus on critical limb ischemia and sex differences. J Vasc Surg. 2007;45(6):1185\u201391.<br \/>\n18. Poulson W, Kamenskiy A, Seas A, Deegan P, Lomneth C, MacTaggart J. Limb flexion-induced axial compression and bending in human femoropopliteal artery segments. J Vasc Surg [Internet]. 2018;67(2):607\u201313. Available from: http:\/\/dx.doi.org\/10.1016\/j.jvs.2017.01.071<br \/>\n19. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, et al. 2011 ACCF\/AHA Focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): A Report of the American College of Cardiology Foundation\/American Heart Association Task Force on Practice Guidelines &#8211; Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology. J Vasc Surg [Internet]. 2011;54(5):e32\u201358. Available from: http:\/\/dx.doi.org\/10.1016\/j.jvs.2011.09.001<br \/>\n20. G\u00f6kg\u00f6l C, Schumann S, Diehm N, Zheng G, B\u00fcchler P. In Vivo Quantification of the Deformations of the Femoropopliteal Segment. J Endovasc Ther. 2017;24(1):27\u201334.<br \/>\n21. Patel SD, Zymvragoudakis V, Sheehan L, Lea T, Modarai B, Katsanos K, et al. Atherosclerotic Plaque Analysis: A Pilot Study to Assess a Novel Tool to Predict Outcome Following Lower Limb Endovascular Intervention. Eur J Vasc Endovasc Surg [Internet]. 2015;50(4):487\u201393. Available from: http:\/\/dx.doi.org\/10.1016\/j.ejvs.2015.05.006<br \/>\n22. Bhatt H, Kovach R, Janzer S, George JC. SUPERA stent outcomes in Above-The-Knee IntervEntions: Effects of COMPression and ELongation (SAKE-COMPEL) Sub-study. Cardiovasc Revascularization Med [Internet]. 2018;19(5):512\u20135. Available from: https:\/\/doi.org\/10.1016\/j.carrev.2017.11.007<br \/>\n23. Garcia LA, Rosenfield KR, Metzger CD, Zidar F, Pershad A, Popma JJ, et al. SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent. Catheter Cardiovasc Interv. 2017;89(7):1259\u201367.<br \/>\n24. Sib\u00e9 M, Kaladji A, Boirat C, Cardon A, Chaufour X, Bossavy JP, et al. French multicenter experience with the GORE TIGRIS Vascular Stent in superficial femoral and popliteal arteries. J Vasc Surg [Internet]. 2017;65(5):1329\u201335. Available from: http:\/\/dx.doi.org\/10.1016\/j.jvs.2016.11.056<br \/>\n25. Garcia L, Jaff MR, Metzger C, Sedillo G, Pershad A, Zidar F, et al. Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial. Circ Cardiovasc Interv. 2015;8(5):1\u20138.<br \/>\n26. Scheinert D, Grummt L, Piorkowski M, Sax J, Scheinert S, Ulrich M, et al. A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-Month results of the SUPERA SFA registry. J Endovasc Ther. 2011;18(6):745\u201352.<br \/>\n27. Gray WA, Keirse K, Soga Y, Benko A, Babaev A, Yokoi Y, et al. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018;392(10157):1541\u201351.<br \/>\n28. Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al. Durable Clinical Effectiveness with Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation. 2016;133(15):1472\u201383.<br \/>\n29. Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: Three-year follow-up from the resilient randomized trial. J Endovasc Ther. 2012;19(1):1\u20139.<br \/>\n30. Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, et al. The United States study for evaluating endovascular treatments of lesions in the superficial femoral artery and proximal popliteal by using the prot\u00e9g\u00e9 everflex nitinol stent system II (DURABILITY II). J Vasc Surg [Internet]. 2013;58(1):73-83.e1. Available from: http:\/\/dx.doi.org\/10.1016\/j.jvs.2012.12.066<br \/>\n31. Ohki T, Kichikawa K, Yokoi H, Uematsu M, Yamaoka T, Maeda K, et al. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions. J Vasc Surg [Internet]. 2017;66(1):130-142.e1. Available from: http:\/\/dx.doi.org\/10.1016\/j.jvs.2017.01.065<br \/>\n32. Palena LM, Diaz-Sandoval LJ, Sultato E, Brigato C, Candeo A, Brocco E, et al. Feasibility and 1-Year outcomes of subintimal revascularization with supera\u00ae stenting of long femoropopliteal occlusions in critical limb ischemia: The \u201cSupersub\u201d Study. Catheter Cardiovasc Interv. 2017;89(5):910\u201320.<br \/>\n33. Armstrong EJ, Jeon-Slaughter H, Kahlon RS, Niazi KA, Shammas NW, Banerjee S. Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry. J Endovasc Ther. 2020;27(1):60\u20135.<\/div>\n","protected":false},"excerpt":{"rendered":"<p>https:\/\/doi.org\/10.4081\/jphr.2021.2360 Giuseppe Guzzardi Department of Radiology, Unit of Interventional Radiology, \u201cMaggiore della Carit\u00e0\u201d University Hospital, Novara, Italy. Angelo Spinazzola Unit of Interventional Radiology, ASST-Crema, Crema, Italy. Gianluca Cangiano Unit of Interventional Radiology, \u201cA. Cardarelli\u201d Hospital, Naples, Italy. Massimiliano Natrella Department of Radiology, \u201cG. Parini\u201d Hospital, Aosta, Italy. Andrea Paladini Department of Radiology, Unit of Interventional &#8230; <a title=\"Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study\" class=\"read-more\" href=\"https:\/\/www.jphres.us.com\/index.php\/jphres\/article\/view\/2360\/\" aria-label=\"More on Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study\">Read more<\/a><\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":{"footnotes":""},"class_list":["post-5839","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study - Journal of Public Health Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.jphres.us.com\/index.php\/jphres\/article\/view\/2360\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Endovascular treatment of femoro-popliteal disease with the Supera stent: results of a multicenter study - Journal of Public Health Research\" \/>\n<meta property=\"og:description\" content=\"https:\/\/doi.org\/10.4081\/jphr.2021.2360 Giuseppe Guzzardi Department of Radiology, Unit of Interventional Radiology, \u201cMaggiore della Carit\u00e0\u201d University Hospital, Novara, Italy. Angelo Spinazzola Unit of Interventional Radiology, ASST-Crema, Crema, Italy. Gianluca Cangiano Unit of Interventional Radiology, \u201cA. Cardarelli\u201d Hospital, Naples, Italy. Massimiliano Natrella Department of Radiology, \u201cG. Parini\u201d Hospital, Aosta, Italy. Andrea Paladini Department of Radiology, Unit of Interventional ... 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Angelo Spinazzola Unit of Interventional Radiology, ASST-Crema, Crema, Italy. Gianluca Cangiano Unit of Interventional Radiology, \u201cA. Cardarelli\u201d Hospital, Naples, Italy. Massimiliano Natrella Department of Radiology, \u201cG. Parini\u201d Hospital, Aosta, Italy. Andrea Paladini Department of Radiology, Unit of Interventional ... 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