Angioplasty versus angioplasty and stenting for lesions of the superficial femoral artery

Twine CP, Coulston J, Shandall A, McLain AD

Published Online:

April 15, 2009

Intermittent claudication is pain in the leg that is brought on by walking and which is relieved by rest. The pain is a result of insufficient blood flow to the muscles of the leg due to narrowing of the arteries by atherosclerosis. Patients who have narrowing of the main artery in the thigh, the superficial femoral artery, and intermittent claudication which severely restricts their quality of life or causes dangerous tissue changes in the leg may undergo a procedure known as angioplasty to widen this narrowing. This procedure involves passing a balloon into the narrowed segment and inflating the balloon to push the artery open. In addition to this, a cylindrical piece of metal mesh called a stent may be inserted at the site where the artery has been pushed open with the aim of holding the narrowing open in the future. While stents work well in the arteries of the heart and other arteries, it is not clear whether adding stents following angioplasty to narrowings of the superficial femoral artery has any benefit to the patient.

The review authors identified eight randomised controlled trials with a total of 968 participants.Their average age was 67 and all trials included men and women. The participants were randomised to have either balloon angioplasty alone or balloon angioplasty with stent placement. At one year, blood flowing through the narrowing in the arteries was no greater in patients with a stent inserted when compared to those without. There was a small improvement in the distance that the patients with a stent could walk up to one year later. However, when asked about their quality of life there was no improvement, whether a stent was placed or not, up to one year later. There were differences in the included trials; in some trials patients with narrowings in other leg arteries were included. There were also differences in the blood thinning drugs given after stent placement between trials, which may change results as these agents are important in keeping stents working in other parts of the body. These factors led to the conclusion that there is a small benefit to adding a stent when performing balloon angioplasty in certain patients with superficial femoral artery narrowing. However, this could not be recommended as routine practice in all patients.

Abstract (click to read)

Background:

Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenoses or occlusions in the superficial femoral artery may result in intermittent claudication as an early consequence, which may be treated by balloon angioplasty with or without stenting.

Objectives:

The objective was to determine the effect of percutaneous transluminal angioplasty (PTA) when compared with PTA with stenting for lesions of the superficial femoral artery, for people with intermittent claudication or critical limb ischaemia.

Search strategy:

The Cochrane Peripheral Vascular Diseases (PVD) Group searched their trials register (last searched February 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2009, Issue 1) for publications describing randomised controlled trials (RCTs) of percutaneous angioplasty with or without stenting.

Selection criteria:

Randomised trials of angioplasty alone versus angioplasty with stenting for the treatment of superficial femoral artery stenoses.

Data collection and analysis:

Two authors (CT, JC) independently selected suitable trials,assessed trial quality and extracted data. A third author (AS) ranked the concealment of allocation and checked the final manuscript. The fourth author (DM) cross checked all stages of the review process.

Main results:

Eight trials with 968 participants were included. The average age was 67 and all trials included men and women. Participants were followed for up to two years.

There was a small but statistically significant improvement in primary angiographic and duplex patency at six months in patients treated with PTA plus stent over lesions treated with PTA alone (three trials and four trials, respectively). However, primary angiographic patency was non-significant 12 months (five trials, P = 0.23) and 24 months (two trials, P = 0.45). A similar but lesser effect was seen for ankle brachial pressure index (ABPI), while a more pronounced improvement in treadmill walking distance in patients with PTA plus stent insertion was observed at six and 12 (P < 0.0001), but not 24 months (P = 0.81). Only one trial reported quality of life, which showed no significant difference between patients treated with PTA alone or PTA with stent insertion at any time interval. Antiplatelet therapy protocols and inclusion criteria between trials showed marked heterogenicity.

Authors' conclusions:

There is limited benefit to stenting lesions of the superficial femoral artery in addition to angioplasty, however this cannot be recommended routinely based on the results of this analysis.

This record should be cited as:

Twine CP, Coulston J, Shandall A, McLain AD. Angioplasty versus stenting for superficial femoral artery lesions. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD006767. DOI: 10.1002/14651858.CD006767.pub2

Assessed as up to date:

February 3, 2009

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Primary Review Group:

Peripheral Vascular Diseases Group

PEARLS - Practical Evidence About Real Life Situations (click to read)

Clinical question:

How effective is percutaneous transluminal angioplasty (PTA) when compared with PTA and stenting for lesions of the superficial femoral artery (SFA), for people with intermittent claudication or critical limb ischaemia?

Bottom line:

There was a small but statistically significant improvement in primary angiographic patency (NNT* 10 [5 to 296]) and duplex patency (NNT 17 [7 to 29]) at six months, in patients treated with PTA plus stent over lesions treated with PTA alone. However, primary angiographic patency was non-significant after 12 months and 24 months. A similar but lesser effect was seen for ankle brachial pressure index, while a more pronounced improvement in treadmill walking distance in patients with PTA with stent insertion was observed at six months (mean 271 versus 183 metres) and 12 months, but not at 24 months. However, when asked about their quality of life, there was no improvement, whether a stent was placed or not, up to one year later. Therefore stenting combined with PTA cannot be recommended as routine practice. *NNT = number needed to treat to benefit one individual (95% confidence interval)

Caveat:

Protocols between trials varied, and the benefit may be limited to patients with SFA disease, subsequently treated with clopidogrel. In some trials, patients with narrowings in other leg arteries were included. There were also differences in the anticoagulants given after stent placement between trials, which may change results.

Context:

Lower limb peripheral arterial disease is a common, important manifestation of systemic atherosclerosis. It occurs in 3% to 10% of the population, increasing to 15% to 20% in people over 70 years of age.¹ Stenoses or occlusions in the SFA may result in intermittent claudication as an early consequence, which may be treated by balloon angioplasty, with or without stenting. 1. Selvin E, Erlinger TP. Circulation 2004;110:738-43

Cochrane Systematic Review:

Twine CP et al. Angioplasty versus stenting for superficial femoral artery lesions. Cochrane Reviews 2009, Issue 2. Article No. CD006767. DOI: 10.1002/14651858.CD006767.pub2. This review contains 8 studies involving 968 participants.

Authored by:

Brian R McAvoy

Cochrane Primary Health Care Field

Health topics:

Heart & circulation > Peripheral vascular disease > Critical limb ischaemia

Heart & circulation > Peripheral vascular disease > Peripheral arterial occlusive disease

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Angioplasty versus angioplasty and stenting for lesions of the superficial femoral artery

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