Document Detail

Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: five-year follow-up--prospective randomized study.
MedLine Citation:
PMID:  16926331     Owner:  NLM     Status:  MEDLINE    
PURPOSE: 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. MATERIALS AND 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). CONCLUSION: 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.
Roswitha M Wolfram; Alexandra C Budinsky; Boris Pokrajac; Richard Potter; Erich Minar
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Radiology     Volume:  240     ISSN:  0033-8419     ISO Abbreviation:  Radiology     Publication Date:  2006 Sep 
Date Detail:
Created Date:  2006-08-23     Completed Date:  2006-09-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0401260     Medline TA:  Radiology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  878-84     Citation Subset:  AIM; IM    
Copyright Information:
(c) RSNA, 2006.
Department of Angiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria.
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MeSH Terms
Aged, 80 and over
Arterial Occlusive Diseases / prevention & control,  therapy*
Brachytherapy / methods*
Femoral Artery*
Follow-Up Studies
Middle Aged
Popliteal Artery*
Prospective Studies
Time Factors

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