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This article is intended for primary care clinicians, vascular surgeons, interventional radiologists, cardiologists, and other specialists who care for patients with intermittent claudication.
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February 9, 2009 — Patients with intermittent claudication, or leg pain caused by arterial disease, may be able to forego treatment of the affected artery by participating in hospital-supervised exercise, according to the results of a randomized controlled trial reported in the February issue of Radiology.
"Exercise training is recommended as an initial treatment for intermittent claudication by the TransAtlantic Inter-Society Consensus (TASC)," write Sandra Spronk, PhD, from the Vascular Laboratory, Ikazia Hospital in Rotterdam, the Netherlands, and colleagues. "Endovascular revascularization, however, is becoming more common, presumably because its immediate benefit may prevent unnecessary disability. In a randomized controlled trial, we compared clinical success, functional capacity, and quality of life [QOL] during 12 months of follow-up after endovascular revascularization or supervised hospital-based exercise training in patients with intermittent claudication."
The study sample consisted of 151 consecutive patients who presented with symptoms of intermittent claudication between September 2002 and September 2005. Of 151 patients randomly selected, 76 were assigned to undergo endovascular revascularization (angioplasty-first approach), and 75 to hospital-based supervised exercise. The main endpoints of the study were clinical success, defined as improvement in at least 1 category in the Rutherford scale above the pretreatment level; functional capacity; and QOL after 6 and 12 months.
Multivariable regression analysis adjusted outcomes for imbalances of baseline values and significance of differences between the groups were evaluated with the unpaired t test, the χ2 test, or the Mann-Whitney U test.
Clinical success immediately after the start of treatment was better in patients who underwent revascularization vs those who had supervised exercise (adjusted odds ratio [OR], 39; 99% confidence interval [CI], 11 - 131; P < .001). This difference between groups was not maintained after 6 or 12 months (6-month adjusted OR, 0.9; 99% CI, 0.3 - 2.3; P = .70; 12-month adjusted OR, 1.1; 99% CI, 0.5 - 2.8; P = .73).
Compared with patients in the exercise group, fewer patients in the revascularization group showed signs of ipsilateral symptoms at 6 months (adjusted OR, 0.4; 99% CI, 0.2 - 0.9; P < .001). However, differences were not significant at 12 months. Functional capacity and QOL scores increased after 6 and 12 months in both groups, with no significant differences between groups.
Limitations of this study are that it was a single-center study performed in the Netherlands with strict inclusion and exclusion criteria, limiting generalizability; lack of power; multiple comparisons effect; subjective nature of QOL; lack of use of a graded incline; limitations of the revascularization technique used; and bilateral effect of exercise.
"After 6 and 12 months, patients with intermittent claudication benefited equally from either endovascular revascularization or supervised exercise," the study authors write. "Improvement was, however, more immediate after revascularization."
Radiology. 2009;250:586-595.
Intermittent claudication is becoming more prevalent, varying from 3% to 6% in those aged 40 to 60 years. Exercise training is recommended as the initial treatment of intermittent claudication, and endovascular revascularization is becoming more common because of the immediate benefits conferred.
This is a randomized trial to compare the relative effectiveness of revascularization and supervised exercise in patients referred to a vascular surgery center with claudication of the lower limbs.
