Endovascular stents for intermittent claudication.

Abstract

Endovascular stents have been suggested as a means to improve the patency of arteries after angioplasty in patients with intermittent claudication. The null hypothesis to be tested by this review is that for individuals with claudication, the use of an endovascular stent in addition to percutaneous transluminal angioplasty, does not improve symptoms of life-style limiting claudication, when compared to percutaneous angioplasty alone. We searched the Specialised Register of the Cochrane Peripheral Vascular Disease Group, (last searched October 2002), and the Cochrane Central Register of Controlled Trials (CENTRAL), (last searched Issue 3, 2002). We also searched MEDLINE and EMBASE (up to and including January 2001); bibliographies of published data, and hand searched the Journal of Vascular Interventional Radiology (1990-2001). Enquiries were made to stent manufacturers for unpublished trial data. Randomised trials comparing angioplasty alone, versus angioplasty with endovascular stents, in subjects with intermittent claudication. Both reviewers independently assessed trial quality and extracted the data. Only published trial data were used. Effectiveness was measured by pre-defined primary outcome measures: restenosis / reocclusion rates and maximum walking distance. Two trials were included with a total sample size of 104 subjects. Both trials included only individuals with femoro-popliteal disease and compared angioplasty and stenting with the Palmaz stent against angioplasty alone. Although one study showed a slight statistical advantage in arterial patency after angioplasty alone, this was not found when the two studies were combined. No differences in the secondary outcomes in either study were detected. The small number of relevant trials identified, together with the small sample sizes and methodological weaknesses, severely limit the usefulness of this review in guiding practice. Larger multicentre trials are needed.