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.

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.

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

• Journal Article Type: Article
• Online Publication Date: Sep 17, 2009
• 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
• DOI: https://doi.org/10.1016/j.avsg.2009.07.005
• Keywords: Surgery; Cardiology and Cardiovascular Medicine; General Medicine
• Public URL: https://hull-repository.worktribe.com/output/391570