title: Feasibility and 1-Year outcomes of subintimal revascularization with supera®stenting of long femoropopliteal occlusions in critical limb ischemia: The "Supersub" Study.
abstract: BACKGROUND
  Stent-based revascularization of long femoro-popliteal (FP) lesions has been mainly studied in claudicants and compromised by restenosis and stent fractures. The Supera®stent's biomimetic design allows enhanced fracture resistance. Data for Supera®stenting to treat long chronic total occlusions (CTOs) in patients with critical limb ischemia (CLI), are scarce.
  
  
  OBJECTIVE
  To assess long-term outcomes of subintimal revascularization with Supera®stenting, for long FP CTOs in patients with CLI.
  
  
  METHODS
  Prospective, single-center, single-arm study of 34 consecutive CLI patients with FP TASC C and D CTOs, who underwent Supera®stenting after subintimal crossing. Primary efficacy endpoint was 1-year patency and freedom from target lesion revascularization (TLR). Primary safety endpoint was the composite rate of freedom from death from any cause, major amputations, and TLR at a year. Secondary endpoints were stent integrity, clinical improvement, amputation free-survival, quality of life, and cost-efficiency.
  
  
  RESULTS
  Mean lesion length was 27.9 ± 10.2 cm. Acute technical success was 100%. Primary patency was 94.1%. Freedom from TLR was 97.1%. Limb salvage was 100%. Clinical improvement was observed in 100% of patients: TCPO2increased from 12.7 ± 6.2 to 54.8 ± 8.4 mm Hg (p < 0,0001); and 100% of patients experienced a shift in Rutherford to class 0 (p < 0.0001). There were no stents fractures. Amputation free-survival was 82.4%.
  
  
  CONCLUSIONS
  Subintimal revascularization with Supera®stenting in CLI patients with long FP occlusions, is feasible and superior to validated efficacy performance goals. Larger multicenter studies are needed to validate the safety and efficacy of this novel alternative approach. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Interventional Radiology Unit, Foot & Ankle clinic, Policlinico Abano Terme - Abano Terme (PD), Italy.
authors.forename: Luis M
authors.initials: LM
authors.lastname: Palena
authors.affiliation: Department of Internal Medicine, Division of Cardiovascular Medicine, Metro Health Hospital, Michigan State University, Wyoming, Michigan.
authors.forename: Larry J
authors.initials: LJ
authors.lastname: Diaz-Sandoval
authors.affiliation: Interventional Radiology Unit, Foot & Ankle clinic, Policlinico Abano Terme - Abano Terme (PD), Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Sultato
authors.affiliation: Interventional Radiology Unit, Foot & Ankle clinic, Policlinico Abano Terme - Abano Terme (PD), Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Brigato
authors.affiliation: Interventional Radiology Unit, Foot & Ankle clinic, Policlinico Abano Terme - Abano Terme (PD), Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Candeo
authors.affiliation: Interventional Radiology Unit, Foot & Ankle clinic, Policlinico Abano Terme - Abano Terme (PD), Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Brocco
authors.affiliation: Interventional Radiology Unit, Foot & Ankle clinic, Policlinico Abano Terme - Abano Terme (PD), Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Manzi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D057510:Endovascular Procedures / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex
keywords: biomimetic; cost-effectiveness; peripheral artery disease; stenting