Abstract

Background

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.

Objectives

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.

Search methods

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).

Selection criteria

Randomised trials comparing angioplasty alone versus angioplasty with endovascular stents in patients with intermittent claudication.

Data collection and analysis

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 Only published trial data were used but unpublished data were sought for the update.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.

Main results

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.

Authors' conclusions

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.

Author(s)

Paul Bachoo, P A Thorpe, Heather Maxwell, Karen Welch

Abstract

Plain language summary

Endovascular stents for intermittent claudication

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.

Author(s)

Paul Bachoo, P A Thorpe, Heather Maxwell, Karen Welch

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Despite the different perspectives from which the use of endovascular stents could be assessed (patient‐orientated, clinical, physiological, anatomical, or radiological), this review failed to convincingly demonstrate that the use of stents in intermittent claudication improved outcome, from any perspective. There is no clear scientific evidence to recommend the use of angioplasty and stenting in preference to angioplasty alone in patients with intermittent claudication in either the aorto‐iliac or femoro‐popliteal segments. We have been unable to challenge our hypothesis that angioplasty alone is inferior to angioplasty with endovascular stenting in any part of the arterial tree. We are unable to recommend any specific stent as superior to any other. Although it is appreciated that endovascular stents present important economic considerations, our review cannot present any economic data.

Implications for research 

Future trials should be designed to improve upon many of the methodological flaws identified. These include the following.

• Analysis of results is performed separately for aorto‐iliac and femoro‐popliteal disease.
• All target lesions are classified using a standardised system, the Trans‐Atlantic Inter Society Consensus (TASC) classification.
• All participants in the trial have similar pre and post‐intervention pharmacotherapy.
• All participants in the trial have equal management of known risk factors and receive similar advice regarding lifestyle changes.
• Outcome measures must be relevant and include quality of life assessments, standardised walking tests, disease‐specific health status questionnaires, economic analysis, adverse events and objective measurements of arterial patency.
• Consideration should be given to a multicentre study for the purpose of recruiting sufficient numbers of participants to answer the research question and ensure the generalisability of the study findings.
• It may be interesting to investigate whether patency rates in the superficial femoral artery could be improved in response to a strategy of selectively stenting either a suboptimal angioplasty or a lesion with specific pre‐defined morphological or anatomical characteristics.

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