RESUMO
PURPOSE: Restenosis remains a major problem in percutaneous transluminal angioplasty (PTA) of peripheral arteries. The aim of this feasibility study was to evaluate the technical feasibility and safety of a new endovascular brachytherapy (EVBT) device with Rhenium-188 in restenosis prophylaxis of infrainguinal arteries. MATERIALS AND METHODS: From March 2006 to April 2009, 52 patients with 71 infrainguinal arterial lesions were treated with Re-188 to prevent restenosis after PTA. 40 patients with 53 lesions (24 de-novo lesions and 29 restenoses) were reexamined (clinic, color-coded duplex ultrasound) after a mean follow-up period of 12.7 months (2.6 to 25.1 months). The liquid beta-emitter Re-188 was introduced to the target lesion via an EVBT certified PTA balloon and a tungsten applicator. After the calculated irradiation time, Re-188 was aspirated back into the tungsten applicator. A dose of 13 Gy was applied at a depth of 2 mm into the vessel wall. RESULTS: After a mean follow-up of 12.7 months, the overall restenosis rate after Re-PTA was 15.1 % (8 / 53 lesions). The restenosis rate for de-novo lesions was 20.8 % (5 / 24) and 10.3 % for restenoses (3 / 29). In 4 patients reintervention was necessary (3 PTAs and 2 major amputations). No periprocedural complications were observed. No elevated radiation dose for the patient or the interventionalist was measured. CONCLUSION: EVBT with a Re-188 filled balloon catheter was technically feasible and safe after PTA of infrainguinal arterial lesions with restenosis rates lower than expected compared to published results. Treatment of restenoses seems to be more effective than de-novo lesions.
