Key result
Balloon-delivered P-32 beta-radiation for in-stent restenosis yields a ~3% MACE rate at six months.
Why the study?
Does a P-32 beta-balloon radiation source delivering 20 Gy reduce restenosis and major adverse cardiac events in patients with in-stent restenosis?
Does a P-32 beta-balloon radiation source delivering 20 Gy reduce restenosis and major adverse cardiac events in patients with in-stent restenosis?
A new P-32 beta-balloon radiation source delivering 20 Gy is safe and highly effective at preventing recurrent in-stent restenosis at 6 months.
Low MACE rates support safety of P-32 beta-balloon radiation in in-stent restenosis; leaves open efficacy versus standard care in randomized trials.
Catheter-based intracoronary radiation therapy demonstrated reduction of the recurrence rate of in-stent restenosis by 35%-50% when compared to conventional therapy. The objectives of this study were to determine the safety and feasibility of a new balloon-shaped source design and a higher applied dose to reduce the restenosis rates. Thirty-two patients with in-stent restenosis who met study eligibility criteria were successfully treated with standard PCI techniques. Following a successful intervention, a P-32 beta-balloon source was positioned to cover the angioplasty site and a dose of a 20 Gy at 1 mm from the surface of the source was administered. The primary endpoint was a composite of major adverse cardiac events (any death, MI, emergent CABG, or repeat target vessel revascularization) during 6 months of follow-up. At 6 months, only one patient underwent repeat PTCA to the target vessel (3%). There were no instances of death, emergency surgery, late thrombosis, total occlusions, or MI. Binary restenosis measured by QCA at the stented segment was 0% and for the whole analysis vessel was 7.5%. Beta-radiation delivered with a balloon P-32 source design for patients with in-stent restenosis results in lower than expected rate of angiographic and clinical restenosis and the absence of late complications.
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Waksman et al. (2002) studied In-stent restenosis (n=32). P-32 beta-balloon source radiation therapy was evaluated on Composite of major adverse cardiac events (any death, MI, emergent CABG, or repeat target vessel revascularization). Beta-radiation delivered with a balloon P-32 source for in-stent restenosis resulted in a 3% rate of major adverse cardiac events at 6 months.
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