Beta radiation Trial To Eliminate Restenosis - BETTER
International multicenter feasibility study of the RDX P32-impregnated balloon for de novo and restenotic lesions.
Intracoronary brachytherapy using the RDX system can be performed effectively. Potential advantages of system include reliable dosimetry and ease of use.
Patients Enrolled: 83
Mean Follow Up: 6 months
83 patients were treated with intracoronary radiation in de novo lesions, 30 of them via balloon angioplasty and 53 via stent.
Death, MI, TLR, CABG, MACE
Patients with de novo and restenotic lesions will undergo angioplasty using the RDX P-32 impregnated angioplasty balloon catheters.
30 day results: Death 0%, MI 2%, TLR 0%, CABG 0%, MACE 2%. 6 month results: Death 1.3%, MI 1.3%, TLR 22.5%, CABG 0%, MACE 24%
For de novo coronary stenoses, 6 months rates of target lesion revascularization (TLR) remained relatively high at 22.5%. Rates of angiographic restenosis are always higher than rates of TLR, and angiographic rates of restenosis would be higher than 22.5%.
Keywords: Feasibility Studies, Coronary Restenosis, Angioplasty, Balloon, Coronary, Brachytherapy, Stents
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