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)

• Published in: Journal of the American College of Cardiology 2004-08, Vol.44 (3), p.528-540
• Main Authors: SERRUYS, Patrick W, WIJNS, William, VONHAUSEN, Heike, OTTO-TERLOUW, Patricia C, VAN DER GIESSEN, Wim J, WAKSMAN, Ron, SIANOS, Georgios, DE SCHEERDER, Ivan, VAN DEN HEUVEL, Paul A, RUTSCH, Wolfgang, GLOGAR, Helmut D, MACAYA, Carlos, MATERNE, Pierre H, VELDHOF, Susan
• Format: Article
• Language: English
• Subjects: Aged; Angina pectoris; Angioplasty; Aspirin - therapeutic use; Biological and medical sciences; Brachytherapy - methods; Cardiology; Coronary Angiography; Coronary Restenosis - complications; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - prevention & control; Coronary vessels; Diseases of the cardiovascular system; Europe; Female; Heart attacks; Humans; Hyperplasia - prevention & control; Male; Medical sciences; Middle Aged; Phosphorus Radioisotopes - therapeutic use; Platelet Aggregation Inhibitors - therapeutic use; Primary Prevention - methods; Radiation Dosage; Radiation therapy; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Stents; Ticlopidine - analogs & derivatives; Ticlopidine - therapeutic use; Tunica Intima - pathology; Ultrasonography, Interventional; Veins & arteries
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2004.03.077

We sought to assess the efficacy of vascular brachytherapy (VBT) combined with stenting for the primary prevention of restenosis. 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/IIa 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. 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. 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). 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.