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Washington Radiation for In-Stent restenosis Trial - BETA WRIST
Description:
Use of beta-radiation to prevent recurrent in-stent restenosis after angioplasty.
Hypothesis:
Intracoronary gamma-radiation therapy reduces recurrent in-stent restenosis (ISR). This study was designed to examine the efficacy and safety of the beta-emitter 90-yttrium for the prevention of recurrent ISR.
Study Design
Study Design:
Patients Screened: 50
Patients Enrolled: 50
Mean Follow Up: 6 months
Mean Patient Age: 60 +/- 10 years
Female: 40
Patient Populations:
Diameter stenosis >50% Vessels 2.5 to 4.0 mm in diameter Lesion length <47 mm Successful primary treatment (<30% residual stenosis without complications) .
Exclusions:
Recent (<72 hours) acute myocardial infarction (MI) Ejection fraction <20% Angiographic thrombus Multiple lesions in the same vessel.
Primary Endpoints:
Cumulative composite clinical outcome (major adverse clinical events [MACE]) of death, MI, and repeat target lesion revascularization at 6 months.
Secondary Endpoints:
Restenosis Late loss (in millimeters Loss index (late loss/acute gain).
Drug/Procedures Used:
Beta-radiation using a Yttrium-90 source wire through a centering catheter with a prescribed dose of 20.6 Gray at 1.0 mm.
Principal Findings:
At 6 months, the binary angiographic restenosis rate was 22%, the target lesion revascularization rate was 26%, and the target vessel revascularization rate was 34%; all rates were significantly lower than those of the placebo group of [gamma]-WRIST.
Interpretation:
Beta radiation with a 90-yttrium source used as adjunct therapy for patients with in stent restenosis results in a lower-than-expected rate of angiographic and clinical restenosis.
References:
Circulation (Online). 101(16):1895-8, 2000 Apr 25
Keywords: Beta Particles, Coronary Restenosis, Constriction, Pathologic, Angioplasty, Stents
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