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

Mazari, F.A.K.; Gulati, S.; Rahman, M.N.A.; Lee, H.L.D.; Mehta, T.A.; McCollum, P.T.; Chetter, I.C.

Authors

F.A.K. Mazari

S. Gulati

M.N.A. Rahman

H.L.D. Lee

T.A. Mehta

P.T. McCollum

I.C. Chetter I.Chetter@hull.ac.uk



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).

Conclusion
SEP should be the primary treatment for the patients with claudication and PTA should be supplemented by an SEP.

Journal Article Type Article
Publication Date 2010-01
Journal ANNALS OF VASCULAR SURGERY
Print ISSN 0890-5096
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 24
Issue 1
Pages 69-79
APA6 Citation Mazari, F., Gulati, S., Rahman, M., Lee, H., Mehta, T., McCollum, P., & Chetter, I. (2010). Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication. Annals of vascular surgery, 24(1), 69-79. https://doi.org/10.1016/j.avsg.2009.07.005
DOI https://doi.org/10.1016/j.avsg.2009.07.005
Keywords Surgery; Cardiology and Cardiovascular Medicine; General Medicine
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