A Cochrane review [Abstract] 1 included 8 studies with total of 1 090 subjects. All included studies used the femoropopliteal artery; no studies using the iliac arteries were identified. All studies compared percutaneous transluminal angioplasty (PTA) with or without stenting plus intravascular brachytherapy (IVBT) versus PTA with or without stenting alone. No studies were found comparing IVBT to technologies such as drug eluting stents or balloons, or cryoplasty. Follow-up ranged from 6 months to 5 years.
For brachytherapy, cumulative patency was higher at 24 months (table T1). A statistically significant difference was found for restenosis at 6 months, 12 months and 24 months in favour of IVBT. No difference was found after 5 years as measured in one study. The need for re-interventions was reported in 6 studies. Target lesion revascularisation was significantly reduced in trial participants treated with IVBT compared with angioplasty alone at 6 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.
| Outcome and follow-up time | OR (95% CI) | Participants (studies) |
|---|---|---|
| Patency | ||
| 6 months | 0.79 (0.31 to 1.99) | 88 (1) |
| 12 months | 1.36 (0.58 to 3.20) | 88 (1) |
| Cumulative patency 24 months | 2.36 (1.36 to 4.10) | 222 (2) |
| Restenosis or reocclusions | ||
| 6 months | 0.27 (0.11 to 0.66) | 562 (5) |
| 12 months | 0.44 (0.28 to 0.68) | 375 (5) |
| 24 months | 0.41 (0.21 to 0.78) | 164 (2) |
| 60 months | 1.00 (0.42 to 2.39) | 102 (1) |
| Target lesion revascularisation | ||
| 6 months | 0.51 (0.27 to 0.97) | 220 (3) |
| 12 months | 0.44 (0.19 to 1.02) | 215 (3) |
| 24 months | 0.46 (0.04 to 5.75) | 30 (1) |
| 60 months | 0.92 (0.41 to 2.06) | 102 (1) |
| Target vessel revascularisation | ||
| 6 months | 0.55 (0.30 to 1.01) | 393 (3) |
| 12 months | 5.43 (0.61 to 48.25) | 164 (2) |
| 24 months | 2.36 (0.36 to 15.45) | 30 (1) |
| 60 months | 0.91 (0.38 to 2.15) | 102 (1) |
| Occlusion | ||
| Less then 1 month | 2.18 (0.76 to 6.32) | 275 (3) |
| More than 3 months | 11.46 (1.44 to 90.96) | 363 (2) |
| 12 months | 0.84 (0.13 to 5.27) | 100 (1) |
A statistically significant lower number of occlusions was found in the control group at more than 3 months but no differences were found at less than one month nor at 12 months after the procedures making the clinical significance uncertain (table T1). Ankle brachial index was statistically significantly better for IVBT at the 12 month follow-up (MD 0.08, 95% CI 0.02 to 0.14, n = 100) but no statistically significant differences were found at 24 hours and at 6 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 studies with no statistically significant difference found between the treatment groups.
Comment: The quality of evidence is downgraded by imprecise results (few patients and wide confidence intervals).
Primary/Secondary Keywords