Intermittent claudication is a cramping leg pain that develops when walking and is relieved with rest. It is caused by inadequate blood flow to the leg muscles because of atherosclerosis (fatty deposits on the walls of the arteries blocking blood flow). People with mild-to-moderate claudication are advised to keep walking, stop smoking and reduce cardiovascular risk factors. Possible treatments include exercise, drugs, bypass surgery or angioplasty. Angioplasty involves expanding the narrowed artery. This can be done by inflating a 'balloon' inside the artery. Sometimes stents (thin metal sleeves) are inserted to keep the artery open.
The review authors identified two controlled studies in which a total of 104 participants (68 male and 36 female) with intermittent claudication were randomised to receive the same type of endovascular stent (Palmaz) or balloon angioplasty alone. This review found that there is not enough evidence from randomised controlled trials about the effects of using stents with angioplasty over angioplasty alone to treat intermittent claudication.
The small number of relevant studies identified together with the small sample sizes and methodological weaknesses severely limit the usefulness of this review in guiding practice. The results from larger multicentre trials are needed.
Endovascular stents have been suggested as a means to improve the patency of arteries after angioplasty in patients with intermittent claudication. This is an update of a Cochrane review published in 2002.
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.
For this update the Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched August 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (last searched 2009, Issue 3).
Randomised trials comparing angioplasty alone versus angioplasty with endovascular stents in patients with intermittent claudication.
Two authors independently assessed trial quality and extracted the data. Only published trial data were used but unpublished data were sought for the update. Effectiveness was measured by the pre-defined primary outcome measures restenosis or reocclusion rates and maximum walking distance.
Two studies were included involving a total of 104 participants. Both studies included only individuals with femoro-popliteal disease. They 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 were detected in either study.