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Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study.

Pokrajac B, Pötter R, Wolfram RM, Budinsky AC, Kirisits C, Lileg B, Mendel H, Sabeti S, Schmid R, Minar E

Department of Radiotherapy and Radiobiology, Vienna General Hospital, Medical University of Vienna, Waehringer Guertel 18-20, Vienna, Austria.

BACKGROUND AND PURPOSE: The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty. PATIENTS AND METHODS: Between Oct, 1998 and Jul, 2001 a total of 134 patients have been randomized after successful angioplasty to brachytherapy or sham irradiation in a prospective, randomized, multicenter, double blind controlled trial. Patients with de novo lesion of at least 5 cm or recurrent lesion of any length after prior angioplasty have been enrolled. Brachytherapy was performed with 7F centering catheter. Mean lesion length was 9.1cm (1.5-25 cm) and mean intervention length 13.6 cm (4-27.5 cm) in brachytherapy cohort. RESULTS: In placebo cohort mean lesion length was 10.3 cm (2-25 cm) and mean intervention length 14.1 cm (2-29 cm). A dose of 18 Gy was prescribed 2 mm from the surface of centering balloons. Analyzed (based on angiography) on intention to treat basis the binary restenosis rate at 12 months was 41.7% (28/67) in brachytherapy cohort and 67.1% (45/67) in placebo cohort (chi2 test, P<0.05). Corresponding data for as treated analysis (A total of 38 patients was excluded from analysis due to lack of follow-up, early recurrence within 30 days and >30% residual stenosis after angioplasty) have been 23.4% in the brachytherapy and 53.3% in the placebo group (P<0.05), respectively. The cumulative patency rates after 24 months on intention to treat analysis were 54% in the brachytherapy and 27% in the placebo group (P<0.005). Corresponding data for as treated analysis were 77% in the brachytherapy and 39% in the placebo group (P<0.001). Late thrombosis was not seen. CONCLUSIONS: Significant reduction of restenosis rate was obtained with endovascular gamma brachytherapy after femoropopliteal angioplasty.

Published 1 February 2005 in Radiother Oncol, 74(1): 3-9.
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