Beta radiation Trial To Eliminate Restenosis - BETTER

May 16, 2002
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Date Updated:
05/16/2002
Original Posted Date:
05/16/2002
References

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

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Feasibility Studies, Coronary Restenosis, Angioplasty, Balloon, Coronary, Brachytherapy, Stents


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