Angioplasty versus bare metal stenting for superficial femoral artery lesions

Mohammed M Chowdhury, Alexander D McLain, Christopher P Twine, Mohammed M Chowdhury, Alexander D McLain, Christopher P Twine

Abstract

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 or even critical ischaemia, which may be treated by balloon angioplasty with or without stenting. This is the first update of a review published in 2009.

Objectives: The primary aim was to determine the effect of percutaneous transluminal angioplasty (PTA) compared with PTA with bare metal stenting for superficial femoral artery (SFA) stenoses on vessel patency in people with symptomatic (Rutherford categories1 to 6; Fontaine stages II to IV) lower limb peripheral vascular disease.In addition, we assessed the efficacy of PTA and stenting in improving quality of life, ankle brachial index and treadmill walking distance.

Search methods: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched August 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 6).

Selection criteria: Randomised trials of angioplasty alone versus angioplasty with bare metal stenting for the treatment of superficial femoral artery stenoses.

Data collection and analysis: Two review authors (MC, CT) independently selected suitable trials, assessed trial quality and extracted data. Furthermore, these two review authors performed assessments of methodological quality and wrote the final manuscript. The third review author (ADM) cross-checked all stages of the review process.

Main results: We include three new studies in this update, making a total of 11 included trials with 1387 participants. The average age was 69 years and all trials included men and women. Participants were followed for up to two years. There was an improvement in primary duplex patency at six and 12 months in participants treated with PTA plus stent over lesions treated with PTA alone (six months: odds ratio (OR) 2.90, 95% confidence interval (CI) 1.17 to 7.18, P = 0.02, six studies, 578 participants; 12 months: OR 1.78, 95% CI 1.02 to 3.10, P = 0.04, nine studies, 858 participants). This was lost by 24 months (P = 0.06). There was a significant angiographic patency benefit at six months (OR 2.49, 95% CI 1.49 to 4.17, P = 0.0005, four studies, 329 participants) which was lost by 12 months (OR 1.30, 95% CI 0.84 to 2.00, P = 0.24, five studies, 384 participants). Ankle brachial index (ABI) and treadmill walking distance showed no improvement at 12 months (P = 0.49 and P = 0.57 respectively) between participants treated with PTA alone or PTA with stent insertion. Three trials (660 participants) reported quality of life, which showed no significant difference between participants treated with PTA alone or PTA with stent insertion at any time interval. Antiplatelet therapy protocols and inclusion criteria regarding affected arteries between trials showed marked heterogeneity.

Authors' conclusions: Although there was a short-term gain in primary patency there was no sustained benefit from primary stenting of lesions of the superficial femoral artery in addition to angioplasty. Future trials should focus on quality of life for claudication and limb salvage for critical ischaemia.

Conflict of interest statement

MMC: none known ADM: I act as a consultant to LeMaitre vascular and have presented at their sales meetings. This is compliant with US legislation. LeMaitre vascular makes grafts for bypass surgery. The aortic intervention division of Cook Medical supported my attendance at the Veith meeting in November 2013 by paying for flights, accommodation and meeting fee. I am the examinations director and a member of the executive committee of UEMS Section and Board of Vascular Surgery. They have paid my travel expenses to committee meetings and to run the European Exam in vascular surgery (FEBVS). CPT: none known

Figures

1
1
Study flow diagram.
2
2
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
3
3
Forest plot of comparison: 1 Angioplasty versus stenting at 6 months, outcome: 1.1 Duplex patency.
4
4
Forest plot of comparison: 1 Angioplasty versus stenting at 6 months, outcome: 1.2 Angiographic patency.
5
5
Forest plot of comparison: 2 Angioplasty versus stenting at 12 months, outcome: 2.1 Duplex patency.
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6
Forest plot of comparison: 2 Angioplasty versus stenting at 12 months, outcome: 2.2 Angiographic patency.
7
7
Funnel plot of comparison: 2 Angioplasty versus stenting at 12 months, outcome: 2.1 Duplex patency.
1.1. Analysis
1.1. Analysis
Comparison 1 Angioplasty versus stenting at 6 months, Outcome 1 Duplex patency.
1.2. Analysis
1.2. Analysis
Comparison 1 Angioplasty versus stenting at 6 months, Outcome 2 Angiographic patency.
1.3. Analysis
1.3. Analysis
Comparison 1 Angioplasty versus stenting at 6 months, Outcome 3 Ankle brachial index.
1.4. Analysis
1.4. Analysis
Comparison 1 Angioplasty versus stenting at 6 months, Outcome 4 Treadmill walking distance.
1.5. Analysis
1.5. Analysis
Comparison 1 Angioplasty versus stenting at 6 months, Outcome 5 Quality of life.
2.1. Analysis
2.1. Analysis
Comparison 2 Angioplasty versus stenting at 12 months, Outcome 1 Duplex patency.
2.2. Analysis
2.2. Analysis
Comparison 2 Angioplasty versus stenting at 12 months, Outcome 2 Angiographic patency.
2.3. Analysis
2.3. Analysis
Comparison 2 Angioplasty versus stenting at 12 months, Outcome 3 Ankle brachial index.
2.4. Analysis
2.4. Analysis
Comparison 2 Angioplasty versus stenting at 12 months, Outcome 4 Treadmill walking distance.
2.5. Analysis
2.5. Analysis
Comparison 2 Angioplasty versus stenting at 12 months, Outcome 5 Quality of life.
3.1. Analysis
3.1. Analysis
Comparison 3 Angioplasty versus stenting at 24 months, Outcome 1 Duplex patency.
3.2. Analysis
3.2. Analysis
Comparison 3 Angioplasty versus stenting at 24 months, Outcome 2 Angiographic patency.
3.3. Analysis
3.3. Analysis
Comparison 3 Angioplasty versus stenting at 24 months, Outcome 3 Ankle brachial index.
3.4. Analysis
3.4. Analysis
Comparison 3 Angioplasty versus stenting at 24 months, Outcome 4 Treadmill walking distance.

References

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Duda 2006 {published data only}
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Saxon 2003 {published data only}
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VascuCoil Trial {published data only}
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Osprey {published data only}
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