Beta Radiation in Europe - BRIE

May 16, 2002
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Date Presented:
01/01/2002
Date Published:
01/01/2002
Date Updated:
05/16/2002
Original Posted Date:
05/16/2002
References

Description:

Safety and efficacy registry using Novoste Beta-Cath system after balloon angioplasty/stenting

Hypothesis:

Beta radiation is effective at reducing restenosis after angioplasty/stenting. Edge restenosis may limit the effectiveness of this treatment.

Study Design

Study Design:

Patients Enrolled: 150
Mean Patient Age: 35-85 (mean 59)
Female: 27%

Patient Populations:

Angina Objective signs of ischemia Significant de novo native coronary lesion

Primary Endpoints:

MACE at 30 days, 6 months, and 1 year Restenosis, late loss, and MLD at 1 year

Drug/Procedures Used:

European registry of patients who underwent treatment with the Novoste Betacath system (30-mm source) after angioplasty/stenting for de novo lesions.

Principal Findings:

Angiographic restenosis: 33.6% Target vessel revasc (TVR): 15.4% MACE: 28.2% Geographic miss occured in 41% of the patients and led to increased rates of restenosis (16.3% vs. 4.3%). Geographic miss of stent-injured segments resulted in increased restenosis rates. Geographic miss of balloon-injured segments did not statistically increase restenosis.

Interpretation:

Geographic miss increases the risk of restenosis at the edges of the treated area, particularly when a stent has been deployed.

References:

Journal of the American College of Cardiology. 38(2):415-20, 2001 Aug. P.W. Serruys, J. Bonnier, P. Urban, W. Wijns, M. Vandormael, R. Doerr, S. Silber, G. Sianos. B. Burette, W. Dries Safety and Performance of 90-Strontium for Treatment of De Novo and Restenotic Lesions. The BRIE Trial (Beta Radiation in Europe). Circulation, 102: II-750 (2000)

Keywords: Beta Particles, Coronary Disease, Angioplasty, Balloon, Coronary, Hirudins, Stents


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