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.)
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