Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: five-year follow-up--prospective randomized study.
OBJECTIVE
To report the 5-year results from the prospective randomized Vienna-2 trial, which was designed to evaluate the safety and effectiveness of adjunctive endovascular brachytherapy (EBT) compared with no further treatment after successful revascularization in patients with long-segment femoropopliteal lesions.


METHODS
Each patient gave written informed consent to participate in the study, which was approved by the hospital's ethics committee. One hundred two patients (men, 53.9%; mean age, 72.1 years +/- 8.7 [standard deviation]; lesion length, 8.1 cm +/- 4.9) underwent percutaneous transluminal angioplasty (PTA) without further stent implantation. Patients were then assigned to either receive EBT (n = 51) by using an iridium 192 source, with a prescribed dose of 12 Gy at 3 mm from the source axis, or no further treatment (n = 51). Radiation was delivered without a centering catheter. Data were analyzed by using a Student t test for continuous values and a chi(2) test to compare categorical values. A Cox proportional hazards regression analysis was performed to evaluate predictors of recurrence at follow-up.


RESULTS
After 6 months, the restenosis rate for the 102 patients with completed 5-year follow-up was significantly reduced for the PTA plus EBT group versus the PTA alone group (29.4% vs 56.9%, P < .05). During follow-up we observed a late catch-up phenomenon, and after 5 years the recurrence rate was comparable in both groups (72.5% vs 72.5%, P > .99). Time to recurrence, however, was significantly delayed in the PTA plus EBT group (17.5 months +/- 14.7 vs 7.4 months +/- 6.8 for the PTA alone group, P < .05).


CONCLUSIONS
At 5-year follow-up, PTA followed by gamma radiation EBT with a dose of 12 Gy resulted in a delay but not an inhibition of restenosis when compared with that of PTA alone.
Wolfram
Roswitha M
RM
Department of Angiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria. rmwolfram@hotmail.com
Budinsky
Alexandra C
AC
Pokrajac
Boris
B
Potter
Richard
R
Minar
Erich
E
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty; D001157:Arterial Occlusive Diseases / Q000517:prevention & control / Q000628:therapy*; D001918:Brachytherapy / Q000379:methods*; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D011446:Prospective Studies; D012008:Recurrence; D013997:Time Factors