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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 steps—the 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.

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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