2012
DOI: 10.1111/sdi.12000
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From Basic Biology to Randomized Clinical Trial: The Beta Radiation for ArterioVenous Graft Outflow Stenosis (BRAVO II)

Abstract: The BRAVO-II study was a randomized controlled study of endovascular radiation therapy as compared to sham radiation therapy, following angioplasty of a thrombosed PRFE graft. The results did not show a benefit of endovascular radiation therapy, albeit in the context of an early termination of the study at less than 50% enrollment due to business reasons. Emphasis is laid on the fact that there may still be a role for radiation therapy in specific clinical settings associated with dialysis vascular access dysf… Show more

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Cited by 11 publications
(7 citation statements)
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References 31 publications
(25 reference statements)
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“…Waksman et al treated 18 grafts with restenosis with 11 sites remaining patent at 44 weeks [218]. The BRAVO 2 trial aimed to randomize patients into brachytherapy or sham treatment after the promising results of the BRAVO pilot, but this trial was halted preliminarily [219, 220]. …”
Section: Future Approaches To Treatmentmentioning
confidence: 99%
“…Waksman et al treated 18 grafts with restenosis with 11 sites remaining patent at 44 weeks [218]. The BRAVO 2 trial aimed to randomize patients into brachytherapy or sham treatment after the promising results of the BRAVO pilot, but this trial was halted preliminarily [219, 220]. …”
Section: Future Approaches To Treatmentmentioning
confidence: 99%
“…Brachytherapy applied to areas of angioplasty is potentially promising. A randomized study was halted prematurely due to financial issues and although initial results were no different to POBA, long-term follow-up was not possible (16). Perivascular delivery of drugs to modulate development of intimal hyperplasia is also a future area of study.…”
Section: Other Devicesmentioning
confidence: 99%
“…A 3-month primary patency rate of 51.7% was achieved in the radiation group, which did not significantly differ from 50% primary patency in the placebo group (p=1.00). Despite the disappointing results, the authors of the study believe that there may still be potentials in endovascular brachytherapy in the setting of dialysis vascular access stenosis when combined with other anti-stenotic means such as local drug, cell, or gene therapy (45).…”
Section: The Combat Against Restenosismentioning
confidence: 99%