Application of intravascular brachytherapy: utilization of beta-irradiation source delivery systems within a...

There are numerous clinical studies ongoing to assess the outcome, physics, and radiobiology of intravascular brachytherapy and its effect on the reduction of the rate of restenosis after balloon angioplasty procedures. The present study reports on the experience of two different delivery systems as utilized in the community hospital setting.

Patients were enrolled into one of four ongoing trials at our institution: the Novoste Beta-Cath trial, the Novoste Stents and Radiation Therapy trial (START), the Novoste START 40/20 trial, and the Guidant Intimal Hyperplasia Inhibition with Beta In-stent Trial (INHIBIT). The Novoste studies utilized the Novoste Beta-Cath System with 90Sr/Y, and the Guidant INHIBIT trial used 32P. Enrollments into the various trials were determined by inclusion and exclusion criteria specified by each protocol. Randomization was conducted per criteria as determined by the participating study protocol.

Forty-two patients were enrolled in total. Thirty-four were included in the Novoste trials and eight in the Guidant study, according to availability of the trial. Assessment of practicality of treatment was dependent primarily on treatment duration and extension of time of catheterization procedures by the addition of intravascular radiation. Average dwell time within the Novoste trials was 3 min 40 s, and 7 min 46 s for patients in the Guidant study. No acute complications were observed in any of the trials.

Intravascular brachytherapy can be performed in the community hospital setting without compromising the efficiency of balloon angioplasty procedures. Pending long-term outcome data and FDA approval for specific delivery systems, endovascular brachytherapy in community hospital cardiac catheterization laboratories can be realized in an efficient and timely manner.