Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study.
OBJECTIVE
The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty.


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.
Pokrajac
Boris
B
Department of Radiotherapy and Radiobiology, Vienna General Hospital, Medical University of Vienna, Waehringer Guertel 18-20, Vienna, Austria.
Pötter
Richard
R
Wolfram
Roswitha M
RM
Budinsky
Alexandra C
AC
Kirisits
Christian
C
Lileg
Brigitte
B
Mendel
Helmuth
H
Sabeti
Schila
S
Schmid
Rainer
R
Minar
Erich
E
D000368:Aged; D000800:Angioplasty, Balloon; D001918:Brachytherapy / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005263:Femoral Artery / Q000473:pathology* / Q000601:surgery*; D006083:Graft Occlusion, Vascular / Q000517:prevention & control* / Q000532:radiotherapy*; D006801:Humans; D007496:Iridium Radioisotopes / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011150:Popliteal Artery / Q000473:pathology* / Q000601:surgery*; D016896:Treatment Outcome
D007496:Iridium Radioisotopes; D010919:Placebos