Intravascular brachytherapy for peripheral vascular disease.

BACKGROUND

International treatment of atherosclerotic narrowed and blocked arteries involves either bypassing the blockage using a graft, widening it 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 (IVBT) 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.

OBJECTIVES

The objective of this review was to assess the efficacy and complications of intravascular brachytherapy on maintaining patency after angioplasty or stent insertion in native vessels or bypass grafts of the iliac or infrainguinal arteries.

SEARCH STRATEGY

The reviewers searched the Cochrane Peripheral Vascular Diseases Group Trials Register (last searched 5 July 2002), the Cochrane Controlled Trials Register (last searched Issue 2, 2002), MEDLINE, EMBASE and reference lists of relevant articles.

SELECTION CRITERIA

Randomised trials of the use of brachytherapy as an adjunct to the treatment of patients with peripheral arterial diseases (PAD) or stenosed bypass grafts of the iliac or infrainguinal arteries arteries versus the procedure without brachytherapy.

DATA COLLECTION AND ANALYSIS

Two reviewers independently assessed trial quality and extracted data. Adverse events information was collected from the trials.

MAIN RESULTS

One trial was identified which met the inclusion criteria, involving 117 patients, mean age 71 years (43-89). The trial compared PTA versus PTA and IVBT in patients with long-segment de novo or restenotic lesions or occlusions of any length in the femoropopliteal artery. Results were provided at six month follow up in 107 patients (54 PTA alone, 53 PTA+IVBT). The results favoured adjuvant IVBT in preventing restenosis/occlusion with an odds ratio (OR) of 0.35 (95% CI 0.24 to 0.53). Analysis of subgroups showed a significant benefit of IVBT in non-diabetics, OR 0.22 (95% CI 0.07 to 0.69), in those undergoing IVBT in restenotic lesions, OR 0.32 (95% CI 0.10 to 1.01), occlusive lesions, OR 0.19 (95% CI 0.06 to 0.62) and lesions in which the PTA length was greater than 10cm, OR 0.24 (95% CI 0.09 to 0.62).

REVIEWER'S CONCLUSIONS: Results from the only trial available would suggest that IVBT is effective at improving the patency of femoropopliteal arteries undergoing PTA in the short-term, particularly in non-diabetics with long occlusions (>10cm).