• Ann Vasc Surg · Jan 2010

    Randomized Controlled Trial Comparative Study

    Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication.

    • F A K Mazari, S Gulati, M N A Rahman, H L D Lee, T A Mehta, P T McCollum, and I C Chetter.
    • 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
    • Ann Vasc Surg. 2010 Jan 1; 24 (1): 69-79.

    BackgroundTo compare angioplasty (PTA), supervised exercise (SEP) and PTA + SEP in the treatment of intermittent claudication (IC) due to femoropopliteal disease.MethodsOver 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.ResultsAll 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).ConclusionSEP should be the primary treatment for the patients with claudication and PTA should be supplemented by an SEP.Copyright 2010 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.

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