title: A Real-World Experience With the Supera Interwoven Nitinol Stent in Femoropopliteal Arteries: Midterm Patency Results and Failure Analysis.
abstract: OBJECTIVE
  To evaluate the safety and midterm patency of the Supera interwoven nitinol stent in a real-world population and determine deployment and patient-related factors that may predispose to loss of patency.
  
  
  METHODS
  A retrospective analysis was conducted of 111 consecutive limbs from 97 patients (mean age 75.3 years; 68 men) with severe atherosclerotic disease of the superficial femoral and popliteal arteries that were treated with Supera stents between June 2012 and October 2014. Half the patients had claudication (56%); the remainder had rest pain (19%) and tissue loss (26%). Forty-eight (43%) lesions were chronic total occlusions, and more than half were classified as TransAtlantic Inter-Society Consensus C (22%) or D (30%).
  
  
  RESULTS
  All 146 Supera stents (1.32 stents per limb) were deployed successfully, extending over a mean length of 175.5±130.5 mm to treat lesions averaging 151.5±127.1 mm long. At 30 days, Kaplan-Meier estimated freedom from death, target lesion revascularization, and amputation was 97.3%. Primary patency and freedom from clinically driven target lesion revascularization rates were 87.1% and 95.0% at 6 months, respectively, and 78.9% and 87.6% at 12 months, respectively. Four distinct mechanisms for failure were identified in the 13 limbs in which patency was lost; stent intussusception (n=4), compromised inflow or outflow (n=2), gross oversizing (n=1), and neoplastic thrombophilia (n=1); the cause of 5 occlusions could not be identified.
  
  
  CONCLUSIONS
  In this heterogeneous group that included long and complex atheromatous femoropopliteal lesions, the Supera stent achieved excellent clinical and patency results at 1 year. Further improvement may be achieved through careful patient selection and the avoidance of deployment pitfalls.
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Myint
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia Department of Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.
authors.forename: Olaf
authors.initials: O
authors.lastname: Schouten
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia The Vascular Institute, Prince of Wales, Sydney, Australia.
authors.forename: Victor
authors.initials: V
authors.lastname: Bourke
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia The Vascular Institute, Prince of Wales, Sydney, Australia Faculty of Medicine, University of New South Wales, Sydney, Australia.
authors.forename: Shannon D
authors.initials: SD
authors.lastname: Thomas
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia The Vascular Institute, Prince of Wales, Sydney, Australia.
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Lennox
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia The Vascular Institute, Prince of Wales, Sydney, Australia Faculty of Medicine, University of New South Wales, Sydney, Australia.
authors.forename: Ramon L
authors.initials: RL
authors.lastname: Varcoe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000671:Amputation, Surgical; D015901:Angiography, Digital Subtraction; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology*; D006801:Humans; D007383:Intermittent Claudication / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D009517:New South Wales; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology*; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D017211:Treatment Failure; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol
keywords: angioplasty; femoropopliteal segment; ischemia; occlusion; patency; peripheral artery disease; popliteal artery; stenosis; stents; superficial femoral artery