Balloon-based radiation therapy for treatment of in-stent restenosis in human coronary arteries: results from the BRITE I study.
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.
Waksman
Ron
R
Cardiovascular Brachytherapy Institute, Washington Hospital Center, Washington, DC 20010, USA. ron.waksman@medstar.net
Buchbinder
Maurice
M
Reisman
Mark
M
Lansky
Alexandra J
AJ
Trauthen
Brett
B
Whiting
James
J
Li
Alexander
A
D000368:Aged; D001158:Arteries / Q000473:pathology* / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D002404:Catheterization; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000453:epidemiology / Q000209:etiology* / Q000628:therapy*; D004307:Dose-Response Relationship, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011881:Radiotherapy, Computer-Assisted; D012086:Reoperation; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome