Endovascular brachytherapy for the prevention of restenosis after femoropopliteal angioplasty. Results of the VARA Trial.
OBJECTIVE
Endovascular brachytherapy (EBT) has been proposed as a method to prevent restenosis. We performed a prospective randomised multicenter study to determine its efficacy for prophylaxis of restenosis after femoropopliteal percutaneous transluminal angioplasty (PTA).


METHODS
Patients with symptomatic stenotic or totally occluding lesions in the femoropopliteal artery were randomised to be treated with PTA plus EBT or PTA alone. In case of EBT, 14 Gy was applied by an 192Ir source to the vessel wall. Clinical examination, ankle-brachial pressure index (ABPI) and duplex ultrasound were planned after 6 and 12 months. The primary endpoint was significant restenosis of the treated segment at duplex ultrasound after 12 months.


RESULTS
Fifty-three of the 60 patients who eventually met the inclusion criteria could be studied. After 12 months, restenosis rates were 44% (12/27) in the PTA group versus 35% (8/23) in the PTA + EBT group (c2 test, P=0.51). There was no difference in mandatory reintervention between the 2 groups. Overall, EBT resulted in an absolute risk reduction of significant restenosis of 9%, yet in patients with totally occlusive disease this reduction was 32%.


CONCLUSIONS
This study suggests an effect of EBT on the occurrence of restenosis only after PTA of occluded femoropopliteal lesions. Due to a too small number of patients analysed this difference is not statistically significant.
van Tongeren
R B
RB
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. R.B.M.van_Tongeren@LUMC.nl
van Sambeek
M R H M
MR
van Overhagen
H
H
Coen
V L
VL
Schmitz
P I
PI
Gescher
F M
FM
Wittens
C H
CH
Vernhout
R M
RM
van Urk
H
H
Levendag
P C
PC
Bruijninckx
C M
CM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects*; D017546:Angioscopy; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000532:radiotherapy* / Q000601:surgery; D001918:Brachytherapy / Q000379:methods*; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D012189:Retrospective Studies; D012307:Risk Factors; D055502:Secondary Prevention; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex