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European Heart Journal 2002 23(17):1351-1359; doi:10.1053/euhj.2001.3153
Copyright © 2002 by the European Society of Cardiology.
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Intracoronary ß-radiation to reduce restenosis after balloon angioplasty and stenting. The Beta Radiation In Europe (BRIE) study

P.W. Serruysa,f1, G. Sianosa, W. van der Giessena, H.J.R.M. Bonnierb, P. Urbanc, W. Wijnsd, E. Benite, M. Vandormaelf, R. Dörrg, C. Discoh, N. Debbasi and S. Silberj

a Thoraxcenter, Heartcenter, Rotterdam, Academisch Ziekenhuis Dijkzigt Rotterdam, The Netherlands
b Catharina Ziekenhuis, Eindhoven, The Netherlands
c Centre Hospitalier Vaudois, Lausanne, Switzerland
d Onze Lieve Vrouw Ziekenhuis—Cardiovascular Center, Aalst, Belgium
e UZ Virga Jesse Ziekenhuis, Hasselt, Belgium
f Clinique St. Jean, Brussels, Belgium
g Klinik Weisser Hirsch, Dresden, Germany
h Cardialysis, Rotterdam, The Netherlands
i Clinique Universitaire de Saint-Luc, Brussels, Belgium
j Internistische Klinik, Munchen, Germany

revised December 3, 2001; accepted December 5, 2001

Abstract

Aims The BRIE trial is a registry evaluating the safety and performance of90 Sr delivered locally (Beta-Cath TM system of Novoste) to de-novo and restenotic lesions in patients with up to two discrete lesions in different vessels.

Methods and Results In total, 149 patients (175 lesions) were enrolled; 62 treated with balloons and 113 with stents. The restenosis rate, the minimal luminal diameter and the late loss were determined in three regions of interest: (a) in a subsegment of 5mm containing the original minimal luminal diameter pre-intervention termed target segment; (b) the irradiated segment, 28mm in length, and (c) the entire analysed segment, 42mm in length, termed the vessel segment. Binary restenosis was 9·9% for the target segment, 28·9% for the irradiated segment, and 33·6% for the vessel segment. These angiographic results include 5·3% total occlusions. Excluding total occlusions binary restenosis was 4·9%, 25% and 29·9%, respectively. At 1 year the incidence of major adverse cardiac events placed in a hierarchical ranking were: death 2%, myocardial infarction 10·1%, CABG 2%, and target vessel revascularization 20·1%. The event-free survival rate was 65·8%. Non-appropriate coverage of the injured segment by the radioactive source termed geographical miss affected 67·9% of the vessels, and increased edge restenosis significantly (16·3% vs 4·3%, P=0·004). It accounted for 40% of the treatment failures.

Conclusion The results of this registry reflect the learning process of the practitioner. The full therapeutic potential of this new technology is reflected by the restenosis rate at the site of the target segment. It can only be unravelled once the incidence of late vessel occlusion and geographical miss has been eliminated by the prolonged use of thienopyridine, the appropriate training of the operator applying this new treatment for restenosis prevention, and the use of longer sources. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.

Key Words: Radiation therapy, balloon angioplasty, stents, restenosis

f1 Correspondence: Prof. P. W. Serruys, MD, PhD, Head of Department of Interventional Cardiology, Heartcenter, Erasmus Medical Center, Thoraxcenter, Bd. 404, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.

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