title: SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not.
  
  
  METHODS
  Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications.
  
  
  CONCLUSIONS
  The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications.
  
  
  BACKGROUND
  Clinicaltrials: NCT01220245.
authors.affiliation: Rijnstate Hospital, Department of Surgery, Arnhem, The Netherlands.
authors.forename: Mare M A
authors.initials: MM
authors.lastname: Lensvelt
authors.forename: Suzanne
authors.initials: S
authors.lastname: Holewijn
authors.forename: Wilbert M
authors.initials: WM
authors.lastname: Fritschy
authors.forename: Otmar R M
authors.initials: OR
authors.lastname: Wikkeling
authors.forename: Laurens A
authors.initials: LA
authors.lastname: van Walraven
authors.forename: Bas M
authors.initials: BM
authors.lastname: Wallis de Vries
authors.forename: Clark J
authors.initials: CJ
authors.lastname: Zeebregts
authors.forename: Michel M P J
authors.initials: MM
authors.lastname: Reijnen
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005263:Femoral Artery / Q000503:physiopathology / Q000601:surgery*; D006493:Heparin / Q000008:administration & dosage*; D006784:Hospitals, Teaching; D006801:Humans; D009426:Netherlands; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology / Q000601:surgery*; D011474:Prosthesis Design; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D006493:Heparin