Vascular brachytherapy with 192Ir after femoropopliteal stent implantation in high-risk patients:: Twelve-month follow-up results from the Vienna-5 trial

PURPOSE: To prospectively evaluate the effectiveness of endovascular brachytherapy in the prevention of restenosis after femoropopliteal stent implantation in high-risk patients. MATERIALS AND METHODS: Patients provided written informed consent to participate in this study, which was approved by the ethics committee. A total of 88 patients (mean age, 67.7 years +/- 10.1; 57 men [65%], 31 women [35%]) with femoropopliteal lesions (mean treatment length, 16.8 cm +/- 7.3) were included. Patients underwent percutaneous transluminal angioplasty (PTA) and stent implantation and were randomized in a double-blind fashion to undergo either gamma brachytherapy with an iridium 192 source or treatment with nonradioactive seeds. A 14-Gy dose of iridium 192 was prescribed at 2 mm into the arterial wall (target depth equals vessel radius plus 2 mm). The primary end point of the study was angiographic binary restenosis of more than 50% at 6-month follow-up. Secondary end point was either percutaneous or surgical target lesion revascularization after 6 months. Continuous data are presented as mean +/- standard deviation. Categorical data are expressed as percentages. Student t test was used to compare continuous data; X-2 test was used to compare categorical values. Survival function was calculated with the Kaplan-Meier method. Multivariate Cox proportional hazard regression analysis was performed to enable evaluation of multivariate predictors of recurrence at 6- and 12-month follow-up. Variables included brachytherapy, clinical stage, lesion length, de novo and recurrent lesion, vessel run off, prior stenosis or occlusion, diabetes mellitus, and stent model. RESULTS: Revascularization and brachytherapy were accomplished successfully in all patients. The overall 6-month recurrence rate was 35% in patients who underwent only stent implantation and 33% in patients who underwent both stent implantation and brachytherapy (P = .89). Nine (10%) patients developed early reocclusion in the segment treated with a stent (two patients [4%] in the stent group and seven [17%] in the stent and brachytherapy group); of these patients, three in the stent and brachytherapy group experienced reocclusion within 24 hours of the intervention. Late (> 30 days after intervention) thrombotic occlusion was observed in three patients (7%) in the stent and brachytherapy group. CONCLUSION: Brachytherapy does not improve 6-month patency after femoropopliteal stent implantation in high-risk patients because of a high incidence of early and late thrombotic occlusion. ((c)) RSNA, 2005.