title: Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: five-year follow-up--prospective randomized study.
abstract: 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.
authors.affiliation: Department of Angiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria. rmwolfram@hotmail.com
authors.forename: Roswitha M
authors.initials: RM
authors.lastname: Wolfram
authors.forename: Alexandra C
authors.initials: AC
authors.lastname: Budinsky
authors.forename: Boris
authors.initials: B
authors.lastname: Pokrajac
authors.forename: Richard
authors.initials: R
authors.lastname: Potter
authors.forename: Erich
authors.initials: E
authors.lastname: Minar
mesh_terms: 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