[Intravascular brachytherapy for peripheral arterial occlusive disease: systematic review of medical efficacy and health economic modelling]

Abstract

Context: Percutaneous transluminal angioplasties (PTA) using balloon dilatation with or without stenting are performed to treat peripheral arterial occlusive disease (PAOD). Intravascular brachytherapy (IB) after PTA promises to reduce the restenosis rates. The present article addresses questions concerning medical efficacy and cost-effectiveness of IB in PAOD patients.

Methods: A systematic literature search for randomized controlled studies evaluating IB in PAOD was conducted in August 2007. Information synthesis was conducted using meta-analysis. Health economic modelling was performed on the basis of clinical assumptions derived from the meta-analysis and economical assumptions derived from the German Diagnosis Related Groups (G-DRG) 2007.

Results: Twelve publications covering seven studies about IB vs. no IB were included in the evaluation. IB after successful balloon dilatation showed a significant reduction in the rate of restenosis at six and/or twelve months (relative risk 0.62; 95% confidence interval: 0.46 to 0.84) and a significant delay in the time to recurrence of restenosis (17.5 vs. 7.4 months, p < 0.01). IB after stenting did not lead to significant results regarding the restenosis rates, but was more often associated with early and late occlusive thromboses. The incremental cost-effectiveness ratio per restenosis avoided for IB vs. no IB after successful balloon dilatation was--depending on the G-DRG used-Euro 8,484 and Euro 9,058, respectively. In the comparison of IB vs. no IB after stenting IB was demonstrated to be inferior to no IB.

Conclusions: IB after successful balloon dilatation in PAOD can be recommended from a medical point of view. From the health economic perspective the answer is not yet clear. IB after stenting in PAOD cannot be recommended.