Abstract:
HTML
Purpose: To describe the technique and early results of a prospective,
triple-masked, multi-center, randomized placebo-controlled trial to evaluate
the safety and effectiveness of the NovosteTMCoronaTMsystem
in the treatment of venous outflow stenoses in patients with hemodialysis
grafts.
Methods and Materials: Twenty-five patients were randomized in the BRAVO (Beta
Radiation for Arterio-Venous Graft Outflow Stenosis) study. All subjects had
polytetrafluoroethylene grafts with significant focal stenoses (more than 50%)
at the venous anastomosis who underwent successful angioplasty. They were then
either treated with 18.4 Gy of intravascular beta-radiation with Strontium-90
delivered through a specially designed catheter, or given placebo. Follow-up is
via repeat angiography and assessment of intragraft blood flow.
Results: Analysis of adverse event profiles, the number of repeat interventions
and the number of thrombotic episodes does not appear to be any different from
those expected after standard angioplasty at the venous anastomosis. In each
case, the source train was deployed at the intended site. Four subjects (16%)
were terminated in the first three months because their grafts either
thrombosed or the stenosis recurred. Continued follow-up for all other patients
through six months is in progress.
Conclusion: Endovascular radiation therapy represents a novel approach to
reduce the significant clinical morbidity and economic costs associated with
hemodialysis vascular access dysfunction. The CoronaTMsystem has an
acceptable safety profile and will continue to be studied as additional
patients are recruited into the BRAVO trial. (P.R., S.M., are consultants for and
have received honoraria from Novoste Corporation.)
Questions about this event email: zuckerda@healthall.com
Zuckerman MD, D,
Endovascular Radiation Therapy for Venous Stenosis in Dialysis Grafts: Initial Experience with the BRAVO Study. Radiological Society of North America 2003 Scientific Assembly and Annual Meeting, November 30 - December 5, 2003 ,Chicago IL.
http://archive.rsna.org/2003/3108599.html
