title: Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication: A Randomized Clinical Trial.
abstract: OBJECTIVE
  Supervised exercise is recommended as a first-line treatment for intermittent claudication. Combination therapy of endovascular revascularization plus supervised exercise may be more promising but few data comparing the 2 therapies are available.
  
  
  OBJECTIVE
  To assess the effectiveness of endovascular revascularization plus supervised exercise for intermittent claudication compared with supervised exercise only.
  
  
  METHODS
  Randomized clinical trial of 212 patients allocated to either endovascular revascularization plus supervised exercise or supervised exercise only. Data were collected between May 17, 2010, and February 16, 2013, in the Netherlands at 10 sites. Patients were followed up for 12 months and the data were analyzed according to the intention-to-treat principle.
  
  
  METHODS
  A combination of endovascular revascularization (selective stenting) plus supervised exercise (n = 106) or supervised exercise only (n = 106).
  
  
  METHODS
  The primary end point was the difference in maximum treadmill walking distance at 12 months between the groups. Secondary end points included treadmill pain-free walking distance, vascular quality of life (VascuQol) score (1 [worst outcome] to 7 [best outcome]), and 36-item Short-Form Health Survey (SF-36) domain scores for physical functioning, physical role functioning, bodily pain, and general health perceptions (0 [severe limitation] to 100 [no limitation]).
  
  
  RESULTS
  Endovascular revascularization plus supervised exercise (combination therapy) was associated with significantly greater improvement in maximum walking distance (from 264 m to 1501 m for an improvement of 1237 m) compared with the supervised exercise only group (from 285 m to 1240 m for improvement of 955 m) (mean difference between groups, 282 m; 99% CI, 60-505 m) and in pain-free walking distance (from 117 m to 1237 m for an improvement of 1120 m vs from 135 m to 847 m for improvement of 712 m, respectively) (mean difference, 408 m; 99% CI, 195-622 m). Similarly, the combination therapy group demonstrated significantly greater improvement in the disease-specific VascuQol score (1.34 [99% CI, 1.04-1.64] in the combination therapy group vs 0.73 [99% CI, 0.43-1.03] in the exercise group; mean difference, 0.62 [99% CI, 0.20-1.03]) and in the score for the SF-36 physical functioning (22.4 [99% CI, 16.3-28.5] vs 12.6 [99% CI, 6.3-18.9], respectively; mean difference, 9.8 [99% CI, 1.4-18.2]). No significant differences were found for the SF-36 domains of physical role functioning, bodily pain, and general health perceptions.
  
  
  CONCLUSIONS
  Among patients with intermittent claudication after 1 year of follow-up, a combination therapy of endovascular revascularization followed by supervised exercise resulted in significantly greater improvement in walking distances and health-related quality-of-life scores compared with supervised exercise only.
  
  
  BACKGROUND
  Netherlands Trial Registry Identifier: NTR2249.
authors.affiliation: Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands2Department of Radiology, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Farzin
authors.initials: F
authors.lastname: Fakhry
authors.affiliation: Department of Research and Innovation, Dutch Health Care Inspectorate, Utrecht, the Netherlands.
authors.forename: Sandra
authors.initials: S
authors.lastname: Spronk
authors.affiliation: Department of Vascular Surgery, Amphia Hospital, Breda, the Netherlands.
authors.forename: Lijckle
authors.initials: L
authors.lastname: van der Laan
authors.affiliation: Departments of Vascular Surgery and Interventional Radiology, Haga Hospital, The Hague, the Netherlands.
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Wever
authors.affiliation: Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands.
authors.forename: Joep A W
authors.initials: JA
authors.lastname: Teijink
authors.affiliation: Department of Vascular Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.
authors.forename: Wolter H
authors.initials: WH
authors.lastname: Hoffmann
authors.affiliation: Department of Vascular Surgery, Bernhoven Hospital, Uden, the Netherlands.
authors.forename: Taco M
authors.initials: TM
authors.lastname: Smits
authors.affiliation: Department of Vascular Surgery, Sint Franciscus Hospital, Rotterdam, the Netherlands.
authors.forename: Jerome P
authors.initials: JP
authors.lastname: van Brussel
authors.affiliation: Department of Vascular Surgery, Elkerliek Hospital, Helmond, the Netherlands.
authors.forename: Guido N M
authors.initials: GN
authors.lastname: Stultiens
authors.affiliation: Department of Vascular Surgery, Zorgsaam Hospital, Terneuzen, the Netherlands.
authors.forename: Alex
authors.initials: A
authors.lastname: Derom
authors.affiliation: Department of Vascular Surgery, Ikazia Hospital, Rotterdam, the Netherlands.
authors.forename: P Ted
authors.initials: PT
authors.lastname: den Hoed
authors.affiliation: Department of Vascular Surgery, Amphia Hospital, Breda, the Netherlands.
authors.forename: Gwan H
authors.initials: GH
authors.lastname: Ho
authors.affiliation: Departments of Vascular Surgery and Interventional Radiology, Haga Hospital, The Hague, the Netherlands.
authors.forename: Lukas C
authors.initials: LC
authors.lastname: van Dijk
authors.affiliation: Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands.
authors.forename: Nicole
authors.initials: N
authors.lastname: Verhofstad
authors.affiliation: Department of Vascular Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.
authors.forename: Mariella
authors.initials: M
authors.lastname: Orsini
authors.affiliation: Department of Vascular Surgery, Bernhoven Hospital, Uden, the Netherlands.
authors.forename: Andre
authors.initials: A
authors.lastname: van Petersen
authors.affiliation: Department of Vascular Surgery, Sint Franciscus Hospital, Rotterdam, the Netherlands.
authors.forename: Kristel
authors.initials: K
authors.lastname: Woltman
authors.affiliation: Departments of Vascular Surgery and Interventional Radiology, Haga Hospital, The Hague, the Netherlands.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Hulst
authors.affiliation: Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands.
authors.forename: Marc R H M
authors.initials: MR
authors.lastname: van Sambeek
authors.affiliation: Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Rizopoulos
authors.affiliation: Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Ellen V
authors.initials: EV
authors.lastname: Rouwet
authors.affiliation: Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands2Department of Radiology, Erasmus University Medical Center, Rotterdam, the Netherlands15Department of Health Policy and Management, Harvard T. H. Chan School of Publ.
authors.forename: M G Myriam
authors.initials: MG
authors.lastname: Hunink
mesh_terms: D000368:Aged; D003131:Combined Modality Therapy / Q000379:methods; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006304:Health Status; D006801:Humans; D057194:Intention to Treat Analysis; D007383:Intermittent Claudication / Q000628:therapy*; D008297:Male; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000379:methods*; D016138:Walking