BRAVO I: A pilot study of vascular brachytherapy in polytetrafluoroethylene dialysis access grafts

BRAVO I: A pilot study of vascular brachytherapy in polytetrafluoroethylene dialysis access grafts

Hemodialysis vascular access dysfunction owing to stenosis and thrombosis in polytetrafluoroethylene dialysis access grafts is a huge clinical problem for which there are currently no long lasting durable therapies. Vascular brachytherapy has been used successfully for the prevention of coronary res...

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Bibliographic Details
Published in:Kidney international Vol. 70; no. 11; pp. 2006 - 2013
Main Authors: Misra, S., Bonan, R., Pflederer, T., Roy-Chaudhury, P., for the BRAVO I Investigators
Format: Journal Article
Language:English
Published: New York, NY Elsevier Inc 01-12-2006
Nature Publishing
Elsevier Limited
Subjects:
Aged
Biological and medical sciences
Brachytherapy - adverse effects
Brachytherapy - methods
Catheters, Indwelling - adverse effects
dialysis access stenosis
Female
Graft Occlusion, Vascular - radiotherapy
Humans
Male
Medical sciences
Middle Aged
Nephrology. Urinary tract diseases
Pilot Projects
Polytetrafluoroethylene
Regional Blood Flow
Renal Dialysis - adverse effects
safety
thrombosis
Treatment Outcome
vascular brachytherapy
thrombosis
safety
vascular brachytherapy
dialysis access stenosis
Venous access
Nephrology
Accessibility
Toxicity
Stenosis
Cardiovascular disease
Injection site
Radiotherapy
Thrombosis
Urology
Vascular disease
Treatment
Blood vessel
Graft
Dialysis
Circulatory system
Curietherapy
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Description
Summary:Hemodialysis vascular access dysfunction owing to stenosis and thrombosis in polytetrafluoroethylene dialysis access grafts is a huge clinical problem for which there are currently no long lasting durable therapies. Vascular brachytherapy has been used successfully for the prevention of coronary restenosis following angioplasty and stent placement. The Beta Radiation for Treatment of Arterial-Venous Graft Outflow I study was a pilot study of vascular brachytherapy in hemodialysis patients with patent but dysfunctional grafts. Twenty-five patients were randomized to receive either radiation therapy (a single dose of 18.4Gy) or sham radiation, following angioplasty. The primary efficacy end point of the study was target lesion primary patency at 6 months. The primary safety end point was a composite of death, emergency surgery on the graft, venous rupture, or aneurysm formation. Forty-two percent of the radiated grafts achieved the target lesion primary patency end point at 6 months as compared to 0% of the control group (P=0.015), but this did not translate into an improvement in secondary patency at either 6 or 12 months. Radiation therapy was found to be safe in the setting of hemodialysis vascular access dysfunction. Our results suggest that vascular brachytherapy is an intervention that is worthy of further examination in the setting of non-thrombosed dialysis access grafts.
ISSN:0085-2538
1523-1755
DOI:10.1038/sj.ki.5001869