title: Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication.
abstract: BACKGROUND
  To compare angioplasty (PTA), supervised exercise (SEP) and PTA + SEP in the treatment of intermittent claudication (IC) due to femoropopliteal disease.
  
  
  METHODS
  Over a 6-year period, 178 patients (108 men; median age, 70 years) with femoropopliteal lesions suitable for angioplasty were randomized to PTA, SEP, or PTA + SEP. Patients were assessed prior to and at 1 and 3 months post treatment. ISCVS outcome criteria (ankle pressures, treadmill walking distances) and quality of life (QoL) questionnaires (SF-36 and VascuQoL) were analyzed.
  
  
  RESULTS
  All groups were well matched at baseline. Twenty-one patients withdrew. Results are as follows: Intragroup analysis: All groups demonstrated significant clinical and QoL improvements (Friedman test, p < 0.05). SEP (60 patients, 8 withdrew)-62.7% of patients (n = 32) improved following treatment [20 mild, 9 moderate, 3 marked], 27.4% (n = 14) demonstrated no improvement, and 9.8% (n = 5) deteriorated. PTA (60 patients, 3 withdrew)-66.6% patients (n = 38) improved following treatment [19 mild, 10 moderate, 9 marked], 22.8% (n = 13) demonstrated no improvement, and 10.5% (n = 6) deteriorated. PTA + SEP (58 patients, 10 withdrew)-81.6% of patients (n = 40) improved following treatment [10 mild, 17 moderate, 3 marked], 14.2% (n = 7) demonstrated no improvement, and 4.0% (n = 2) deteriorated. Intergroup analysis: PTA + SEP produce a much greater improvement in clinical outcome measures than PTA or SEP alone, but there was no significant QoL advantage (Kruskal-Wallis test, p > 0.05).
  
  
  CONCLUSIONS
  SEP should be the primary treatment for the patients with claudication and PTA should be supplemented by an SEP.
authors.affiliation: Academic Vascular Surgery Unit, University of Hull, Vascular Laboratory, Alderson House, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ, United Kingdom. fayyaz.mazari@hey.nhs.uk
authors.forename: F A K
authors.initials: FA
authors.lastname: Mazari
authors.forename: S
authors.initials: S
authors.lastname: Gulati
authors.forename: M N A
authors.initials: MN
authors.lastname: Rahman
authors.forename: H L D
authors.initials: HL
authors.lastname: Lee
authors.forename: T A
authors.initials: TA
authors.lastname: Mehta
authors.forename: P T
authors.initials: PT
authors.lastname: McCollum
authors.forename: I C
authors.initials: IC
authors.lastname: Chetter
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D000842:Ankle / Q000098:blood supply; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D001794:Blood Pressure; D003131:Combined Modality Therapy; D005080:Exercise Test; D005081:Exercise Therapy; D017079:Exercise Tolerance; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking