title: Two-year results from a randomized clinical trial of revascularization in patients with intermittent claudication.
abstract: BACKGROUND
  Intermittent claudication is associated with significant impairment of health-related quality of life. The use of revascularization techniques to improve health-related quality of life remains controversial.
  
  
  METHODS
  Patients with intermittent claudication due to iliac or femoropopliteal peripheral artery disease were enrolled in the IRONIC trial. They were randomized to either best medical therapy (BMT), including a structured, non-supervised exercise programme, or revascularization with either endovascular or open techniques in addition to BMT. The primary outcome was health-related quality of life at 2 years assessed using the Short Form 36 (SF-36(®) ) questionnaire. Secondary outcomes included VascuQoL questionnaire results, treadmill walking distances and achievement of patient-specified treatment goals.
  
  
  RESULTS
  Both randomized groups had improved health-related quality of life and treadmill walking distance at 2-year follow-up. Overall SF-36(®) physical component summary score, three SF-36(®) physical domain scores, overall VascuQoL score, and three of five VascuQoL domain scores showed significantly greater improvement in the group that also received invasive treatment. Intermittent claudication distance on a graded treadmill improved more in the revascularization + BMT group (117 versus 55 m; P = 0·003) whereas maximum walking distance and 6-min walk test distance were similar. Some 44 per cent of patients in the revascularization + BMT group reported they had fully achieved their treatment goal versus 10 per cent in the BMT group.
  
  
  CONCLUSIONS
  A revascularization strategy with unsupervised exercise improved health-related quality of life and intermittent claudication distance more than standard BMT and an unsupervised exercise programme in patients with lifestyle-limiting claudication.
  
  
  BACKGROUND
  NCT01219842 (http://www.clinicaltrials.gov).
authors.affiliation: Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy, Gothenburg, Sweden.
authors.forename: J
authors.initials: J
authors.lastname: Nordanstig
authors.affiliation: Health and Care Sciences, Gothenburg University Centre for Person-centred Care, Gothenburg University, Gothenburg, Sweden.|Gothenburg University Centre for Person-centred Care, Gothenburg University, Gothenburg, Sweden.
authors.forename: C
authors.initials: C
authors.lastname: Taft
authors.affiliation: Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy, Gothenburg, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Hensäter
authors.affiliation: Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy, Gothenburg, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Perlander
authors.affiliation: Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy, Gothenburg, Sweden.
authors.forename: K
authors.initials: K
authors.lastname: Österberg
authors.affiliation: Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy, Gothenburg, Sweden.|Health Technology Assessment Centre, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
authors.forename: L
authors.initials: L
authors.lastname: Jivegård
mesh_terms: D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D057510:Endovascular Procedures; D005080:Exercise Test; D005081:Exercise Therapy; D005260:Female; D005500:Follow-Up Studies; D006305:Health Status Indicators; D006801:Humans; D007383:Intermittent Claudication / Q000601:surgery* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome