Beta Radiation to reduce In-stent resTEnosis - BRITE

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

Description:

Randomized safety and efficacy trial of the RDX P-32 impregnated angioplasty balloon for in-stent restenosis

Hypothesis:

Use of the RDX P-32 beta-radiation balloon catheter is safe and effective for the treatment of in-stent restenosis.

Study Design

Study Design:

Patients Enrolled: 98

Primary Endpoints:

Death, MI, MACE, TLR, TVR, angiographic restenosis

Drug/Procedures Used:

Use of the RDX angioplasty balloon versus conventional therapy for the treatment of in-stent restenosis

Principal Findings:

30 day outcomes: death 0%, MI 0%, TVR 1%, TLR 1%, CABG 0%, MACE 1%. 6 month outcomes: death 0%, MI 1.1%, TVR 11.7%, TLR 10.6%, CABG 1.1%, MACE 11.7%, restenosis (in-stent) 8.4%

Interpretation:

Intracoronary radiation wth the Radiance Radiation System appears to be safe. There is no direct control group available for comparison making it difficult to judge efficacy of the device. Compared to historical controls, an 8.4% in stent rate of restenosis appears low, but restenosis may have also occurred outside of the stented and radiated region. This is evidenced by the fact that the rates of target vessel revascularization exceded the rate of in stent restenosis.

References:

AHA 2000 ESC 2001

Keywords: Beta Particles, Coronary Disease, Stents


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