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Beta radiation Trial To Eliminate Restenosis - BETTER
Description:
International multicenter feasibility study of the RDX P32-impregnated balloon for de novo and restenotic lesions.
Hypothesis:
Intracoronary brachytherapy using the RDX system can be performed effectively. Potential advantages of system include reliable dosimetry and ease of use.
Study Design
Study Design:
Patients Enrolled: 83
Mean Follow Up: 6 months
Patient Populations:
83 patients were treated with intracoronary radiation in de novo lesions, 30 of them via balloon angioplasty and 53 via stent.
Primary Endpoints:
Death, MI, TLR, CABG, MACE
Drug/Procedures Used:
Patients with de novo and restenotic lesions will undergo angioplasty using the RDX P-32 impregnated angioplasty balloon catheters.
Principal Findings:
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%
Interpretation:
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%.
References:
ESC 2001
Keywords: Feasibility Studies, Coronary Restenosis, Angioplasty, Balloon, Coronary, Brachytherapy, Stents
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