Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study.
BACKGROUND
Inasmuch as endovascular brachytherapy (BT) has gained recent interest because of its inhibitory effect on mechanisms leading to restenosis after percutaneous transluminal angioplasty (PTA), we performed this randomized study to determine its efficacy for prophylaxis of restenosis after femoropopliteal PTA.


RESULTS
One hundred thirteen patients (63 men, 50 women; mean age 71 years) with de novo or recurrent femoropopliteal lesions were included in this randomized trial comparing the restenosis rate after PTA plus BT (57 patients, PTA+BT group) versus PTA (56 patients, PTA group) without stent implantation. The mean treated length was 16.7 cm (PTA+BT group) versus 14.8 cm (PTA group). In patients randomized to PTA plus BT, a dose of 12 Gy was applied by an (192)Ir source 3 mm from the source axis. Follow-up examinations included measurement of the ankle-brachial index, color-flow duplex sonography, and angiography. The primary end point of the study was patency after 6 months. The overall recurrence rate after 6 months was 15 (28.3%) of 53 in the PTA+BT group versus 29 (53.7%) of 54 in the PTA group (chi(2) test, P<0.05). The cumulative patency rates at 12 months of follow-up were 63.6% in the PTA+BT group and 35.3% in the PTA group (log-rank test, P<0.005).


CONCLUSIONS
This is the first randomized study to demonstrate the efficacy of endovascular BT for prophylaxis of restenosis after femoropopliteal PTA. The value of this approach should now be improved by modification of the BT procedure and by combination with stent implantation.
Minar
E
E
Department of Angiology, University of Vienna, General Hospital Vienna, Vienna, Austria. erich.minar@akh-wien.ac.at
Pokrajac
B
B
Maca
T
T
Ahmadi
R
R
Fellner
C
C
Mittlböck
M
M
Seitz
W
W
Wolfram
R
R
Pötter
R
R
D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001918:Brachytherapy / Q000379:methods*; D003251:Constriction, Pathologic / Q000517:prevention & control; D005260:Female; D005263:Femoral Artery / Q000473:pathology / Q000528:radiation effects*; D005500:Follow-Up Studies; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000473:pathology / Q000528:radiation effects*; D055502:Secondary Prevention; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome