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

The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty. 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 7 F centering catheter. Mean lesion length was 9.1 cm (1.5–25 cm) and mean intervention length 13.6 cm (4–27.5 cm) in brachytherapy cohort. 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 ( χ 2 test, P30% residual stenosis after angioplasty) have been 23.4% in the brachytherapy and 53.3% in the placebo group ( P