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Review
. 2014 Jan 8;2014(1):CD003504.
doi: 10.1002/14651858.CD003504.pub2.

Intravascular brachytherapy for peripheral vascular disease

Alina Andras  1 , Monica Hansrani, Marlene Stewart, Gerard Stansby
Affiliations
Review

Intravascular brachytherapy for peripheral vascular disease

Alina Andras et al. Cochrane Database Syst Rev. .

Abstract

Background: Interventional treatment of arteries that are narrowed and obstructed by atherosclerosis involves either bypassing the blockage using a graft; widening the artery from the inside with a balloon, a procedure known as percutaneous transluminal angioplasty (PTA); or providing a strut to hold the vessel open, known as a stent. All of these treatments are, however, limited by the high numbers that fail within a year. Intravascular brachytherapy is the application of radiation directly to the site of vessel narrowing. It is known to inhibit the processes that lead to restenosis (narrowing) of vessels and grafts after treatment. This is an update of a review first published in 2002.

Objectives: To assess the efficacy of, and complications associated with, intravascular brachytherapy (IVBT) for maintaining patency after angioplasty or stent insertion in native vessels or bypass grafts of the iliac or infrainguinal arteries.

Search methods: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched their Specialised Register (last searched August 2013) and CENTRAL (2013, Issue 7).

Selection criteria: Randomised controlled trials of the use of brachytherapy as an adjunct to the endovascular treatment of people with peripheral arterial disease (PAD) or stenosed bypass grafts of the iliac or infrainguinal arteries versus the procedure without brachytherapy.

Data collection and analysis: Two review authors independently assessed trial quality and two other review authors independently extracted the data. Adverse event information was collected from the trials.

Main results: Eight trials with a combined total of 1090 participants were included in this review. All included studies used the femoropopliteal artery. We did not identify any studies that used the iliac arteries. All studies compared PTA with or without stenting plus IVBT versus PTA with or without stenting alone. No trials were found comparing IVBT to technologies such as drug eluting stents or balloons, or cryoplasty. Follow-up ranged from six months to five years. The quality of the included trials was moderate with our concerns relating to the difficulty of blinding due to the nature of the procedures and the small sample sizes for some studies. Primary outcomes (patency or restenosis and need for re-intervention) were reported in the majority of the trials, but reporting at various time points and the use of multiple definitions of the outcomes by the included studies meant that not all data were available for pooling. The secondary outcomes were not reported in many of the included studies.For brachytherapy, cumulative patency was higher at 24 months (odds ratio (OR) 2.36, 95% confidence interval (CI) 1.36 to 4.10, n = 222, P = 0.002). A statistically significant difference was found for restenosis at six months (OR 0.27, 95% CI 0.11 to 0.66, n = 562, P = 0.004), 12 months (OR 0.44, 95% CI 0.28 to 0.68, n = 375, P = 0.0002) and 24 months (OR 0.41, 95% CI 0.21 to 0.78, n = 164, P = 0.007) in favour of IVBT. No difference was found after five years as measured in one study. The need for re-interventions was reported in six studies. Target lesion revascularisation was significantly reduced in trial participants treated with IVBT compared with angioplasty alone (OR 0.51, 95% CI 0.27 to 0.97, P = 0.04) at six months after the interventions. No statistically significant difference was found between the procedures on the need for re-intervention at 12 and 24 months after the procedures.A statistically significant lower number of occlusions was found in the control group at more than three months (OR 11.46, 95% CI 1.44 to 90.96, n = 363, P = 0.02) but no differences were found at less than one month nor at 12 months after the procedures making the clinical significance uncertain. Ankle brachial index was statistically significantly better for IVBT at the 12 month follow-up (mean difference 0.08, 95% CI 0.02 to 0.14, n = 100, P = 0.02) but no statistically significant differences were found at 24 hours and at six months.Quality of life, complications, limb loss, cardiovascular deaths, death from all causes, pain free walking distance and maximum walking distance on a treadmill were similar for the two arms of the trials with no statistically significant difference found between the treatment groups.

Authors' conclusions: The evidence for using peripheral artery brachytherapy as an adjunct to percutaneous transluminal angioplasty to maintain patency and for the prevention of restenosis in people with peripheral vascular disease is limited, mainly due to the inconsistency of assessment and reporting of clinically relevant outcomes. More data are needed on clinically relevant outcomes such as health related quality of life (HRQOL) or limb salvage and longer-term outcomes, together with comparisons with other techniques such as drug eluting balloons and stents. Adequately powered randomised controlled trials, health economics and cost-effectiveness data are required before the procedure could be recommended for widespread use.

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Conflict of interest statement

None known

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 1 Clinical patency.
1.2
1.2. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 2 Cumulative patency.
1.3
1.3. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 3 Restenosis.
1.4
1.4. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 4 Need for re‐intervention at 6 months.
1.5
1.5. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 5 Need for re‐intervention at 12 months.
1.6
1.6. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 6 Need for re‐intervention at 24 months.
1.7
1.7. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 7 Need for re‐intervention at 60 months.
1.8
1.8. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 8 Occlusion.
1.9
1.9. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 9 Limb loss.
1.10
1.10. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 10 Cardiovascular death.
1.11
1.11. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 11 Death from all causes.
1.12
1.12. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 12 Complications.
1.13
1.13. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 13 ABI.
1.14
1.14. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 14 Pain free walking distance.
1.15
1.15. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 15 Maximum walking distance.
1.16
1.16. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 16 Quality of life (scores).
1.17
1.17. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 17 De novo restenosis.
1.18
1.18. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 18 Binary restenosis.
1.19
1.19. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 19 Peak velocity ratio.
1.20
1.20. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 20 Lumen.
1.21
1.21. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 21 Vessel wall area.
1.22
1.22. Analysis
Comparison 1 Brachytherapy versus no brachytherapy, Outcome 22 Plaque area.
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References

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Boselli 2002 {published data only}
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