title: Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial.
abstract: OBJECTIVE
  To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments.
  
  
  OBJECTIVE
  To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications.
  
  
  METHODS
  ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus.
  
  
  METHODS
  Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire.
  
  
  RESULTS
  The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%).
  
  
  CONCLUSIONS
  Providing level 1 evidence, ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01602159.
authors.affiliation: Department of Surgery, The Johns Hopkins University, Baltimore, Maryland2Department of Surgery, Johns Hopkins Bayview Medical Center, Baltimore, Maryland.
authors.forename: Mahmoud B
authors.initials: MB
authors.lastname: Malas
authors.affiliation: Department of Surgery, The Johns Hopkins University, Baltimore, Maryland.
authors.forename: Umair
authors.initials: U
authors.lastname: Qazi
authors.affiliation: Department of Surgery, The Johns Hopkins University, Baltimore, Maryland.
authors.forename: Natalia
authors.initials: N
authors.lastname: Glebova
authors.affiliation: Department of Surgery, The Johns Hopkins University, Baltimore, Maryland.
authors.forename: Isibor
authors.initials: I
authors.lastname: Arhuidese
authors.affiliation: Department of Surgery, The Johns Hopkins University, Baltimore, Maryland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Reifsnyder
authors.affiliation: Department of Surgery, The Johns Hopkins University, Baltimore, Maryland.
authors.forename: James
authors.initials: J
authors.lastname: Black
authors.affiliation: Department of Surgery, The Johns Hopkins University, Baltimore, Maryland.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Perler
authors.affiliation: Department of Surgery, The Johns Hopkins University, Baltimore, Maryland3Editor, JAMA Surgery.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Freischlag
mesh_terms: D000328:Adult; D000368:Aged; D017130:Angioplasty; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007383:Intermittent Claudication / Q000601:surgery*; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008396:Maryland / Q000453:epidemiology; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D015607:Stents; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000379:methods*