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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

View larger version (48K): [in a new window]   Figure 1 A schematic diagram of the tandem positioning of the 32P radiation source and an irradiated coronary artery with the anatomical and dose-based sub-segment definition. BRM = balloon radiopaque marker; CB = centering balloon; CBRM = centering balloon radiopaque marker; EIRL = effective irradiation length; EIRS = effective irradiated segment; INS = injured segment; IRL = irradiation length; IRS = irradiated segment; SB = side branch; SL = stent length; SrL = source length; SrRM = source radiopaque marker; VS = vessel segment.

View larger version (21K): [in a new window]   Figure 4 Event-free survival curves (Kaplan-Meier) at one year for the control and irradiated patients. MACE = major adverse cardiac and cerebrovascular events; p(FE) = p value Fisher exact test; p(LR) = p value log rank test; RR = relative risk.

View larger version (72K): [in a new window]   Figure 2 An example of quantitative coronary angiography depicting the automatic assessment of the anatomic relationship between the obstructed (A), the injured (B), and the irradiated (C) sub-segments, which allows the quantitative assessment of the length of the geographical miss, 8.73 mm at the proximal edge in this case.

View larger version (24K): [in a new window]   Figure 3 Location of the minimal luminal diameter at six months follow-up (±4 weeks) in patients with >50% diameter stenoses in relation to the dose-based sub-segments. Four instances of late total occlusion (LTO) were documented at the time of the angiographic follow-up, and two occurred later. EIRS = effective irradiated segment; IRS = irradiated segment; VS = vessel segment.