CLINICAL RESEARCH
Direct stenting versus direct stenting followed by centered beta-radiation with intravascular ultrasound-guided dosimetry and long-term anti-platelet treatment
Results of a randomized trial: Beta-radiation Investigation with Direct stenting and Galileo in Europe (BRIDGE)
Patrick W. Serruys, MD, PhD, FACC*,*,
William Wijns, MD ,
Georgios Sianos, MD, PhD*,
Ivan de Scheerder, MD ,
Paul A. van den Heuvel, MD ,
Wolfgang Rutsch, MD||,
Helmut D. Glogar, MD¶,
Carlos Macaya, MD#,
Pierre H. Materne, MD**,
Susan Veldhof, RN ,
Heike Vonhausen, PhD ,
Patricia C. Otto-Terlouw, MSc and
Wim J. van der Giessen, MD, PhD*
* Erasmus Medical Center, Rotterdam, The Netherlands
Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
UZ Gasthuisberg, Leuven, Belgium
Academisch Ziekenhuis Middelheim, Antwerpen, Belgium
|| Universitätsklinik Charité, Berlin, Germany
¶ Allgemeines Krankenhaus der Stadt, Wien, Austria
# Hospital Clínico San Carlos, Madrid, Spain
** CHR de la Citadelle, Liege, Belgium
 Guidant, Diegem, Belgium
 Cardialysis BV, Rotterdam, The Netherlands
Manuscript received November 21, 2003;
revised manuscript received March 1, 2004,
accepted March 2, 2004.
* Reprint requests and correspondence: Professor Patrick W. Serruys, Erasmus Medical Center, Thoraxcenter, Bd-406, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. p.w.j.c.serruys{at}erasmusmc.nl
OBJECTIVES: We sought to assess the efficacy of vascular brachytherapy (VBT) combined with stenting for the primary prevention of restenosis.
BACKGROUND: Intravascular brachytherapy after stent implantation for de novo lesions has been abandoned for the present. We revisited this procedure by optimizing all procedural stepsthe use of glycoprotein IIb/IIIa blockers, direct stenting, adequate radiation coverage, avoidance of edge damage, source centering, intravascular ultrasound-guided dosimetry, and continuation of a dual anti-platelet regimen for one year.
METHODS: The Beta-Radiation Investigation with Direct stenting and Galileo in Europe (BRIDGE) study is a multicenter, randomized controlled trial evaluating the long-term efficacy of VBT with P-32 (20 Gy at 1 mm in the coronary wall) after direct stenting. The primary end point was angiographic intra-stent late loss; secondary end points were six months binary restenosis and neo-intimal hyperplasia. Patients (n = 112) with de novo lesions (2.5 to 4.0 mm in diameter up to 15 mm long) were randomized to either VBT or no-VBT.
RESULTS: At six months, intra-stent loss was 0.43 and 0.84 mm (p < 0.001) in the irradiated and control groups, respectively. Intra-stent neo-intimal volume was reduced from 36 mm3 to 10 mm3. However, in the irradiated group there were six late occlusions as well as eight restenoses outside the stented and peri-stented area at the fall-off dose edges of the irradiated area. Accordingly, the target vessel revascularization and major adverse cardiac and cerebrovascular events rates at one year in the VBT group (20.4% and 25.9%, respectively) were higher than in the control group (12.1% and 17.2%, respectively).
CONCLUSIONS: Despite the optimization of pre-, peri-, and post-procedural factors and despite the relative efficacy of the brachytherapy for the prevention of the intra-stent neo-intimal hyperplasia, the clinical outcome of the irradiated group was less favorable than that of the control group.
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Abbreviations and Acronyms
| | EIRS | = effective irradiated segment | | GM | = geographical miss | | IVUS | = intravascular ultrasound | | MACCE | = major adverse cardiac and cerebrovascular events | | MI | = myocardial infarction | | MLD | = minimal luminal diameter | | QCA | = quantitative coronary angiography | | VBT | = vascular brachytherapy |
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