title: Improved quality of life after 1 year with an invasive versus a noninvasive treatment strategy in claudicants: one-year results of the Invasive Revascularization or Not in Intermittent Claudication (IRONIC) Trial.
abstract: BACKGROUND
  The quality of evidence for invasive revascularization in intermittent claudication is low or very low. This prospective, randomized, controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication.
  
  
  RESULTS
  After clinical and duplex ultrasound assessment, unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive (n=79) or noninvasive (n=79) treatment groups. Primary end point was health-related quality of life after 1 year, assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire, and secondary end points included walking distances on a graded treadmill. The Medical Outcomes Study Short Form 36 version 1 physical component summary (P<0.001) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improved significantly more in the invasive versus the noninvasive treatment group. Overall, Vascular Quality of Life Questionnaire score (P<0.01) and 3 of 5 domain scores improved significantly more in the invasive versus the noninvasive treatment group. Intermittent claudication distance improved significantly in the invasive (+124 m) versus the noninvasive (+50 m) group (P=0.003), whereas the change in maximum walking distance was not significantly different between groups.
  
  
  CONCLUSIONS
  An invasive treatment strategy improves health-related quality of life and intermittent claudication distance after 1 year in patients with stable lifestyle-limiting claudication receiving current medical management. Long-term follow-up data and health-economic assessments are warranted to further establish the role for revascularization in intermittent claudication.
authors.affiliation: From the Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy (J.N., M.H., A.P., K.O., L.J.); and Health and Care Sciences and Gothenburg University Center for Person-Centered Care, Gothenburg University (C.T.), Gothenburg, Sweden. joakim.nordanstig@vgregion.se.
authors.forename: Joakim
authors.initials: J
authors.lastname: Nordanstig
authors.affiliation: From the Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy (J.N., M.H., A.P., K.O., L.J.); and Health and Care Sciences and Gothenburg University Center for Person-Centered Care, Gothenburg University (C.T.), Gothenburg, Sweden.
authors.forename: Charles
authors.initials: C
authors.lastname: Taft
authors.affiliation: From the Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy (J.N., M.H., A.P., K.O., L.J.); and Health and Care Sciences and Gothenburg University Center for Person-Centered Care, Gothenburg University (C.T.), Gothenburg, Sweden.
authors.forename: Marlene
authors.initials: M
authors.lastname: Hensäter
authors.affiliation: From the Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy (J.N., M.H., A.P., K.O., L.J.); and Health and Care Sciences and Gothenburg University Center for Person-Centered Care, Gothenburg University (C.T.), Gothenburg, Sweden.
authors.forename: Angelica
authors.initials: A
authors.lastname: Perlander
authors.affiliation: From the Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy (J.N., M.H., A.P., K.O., L.J.); and Health and Care Sciences and Gothenburg University Center for Person-Centered Care, Gothenburg University (C.T.), Gothenburg, Sweden.
authors.forename: Klas
authors.initials: K
authors.lastname: Osterberg
authors.affiliation: From the Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy (J.N., M.H., A.P., K.O., L.J.); and Health and Care Sciences and Gothenburg University Center for Person-Centered Care, Gothenburg University (C.T.), Gothenburg, Sweden.
authors.forename: Lennart
authors.initials: L
authors.lastname: Jivegård
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires
keywords: intermittent claudication; peripheral arterial disease; quality of life; revascularization