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).
OBJECTIVE
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/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.


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.
Serruys
Patrick W
PW
Erasmus Medical Center, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
Wijns
William
W
Sianos
Georgios
G
de Scheerder
Ivan
I
van den Heuvel
Paul A
PA
Rutsch
Wolfgang
W
Glogar
Helmut D
HD
Macaya
Carlos
C
Materne
Pierre H
PH
Veldhof
Susan
S
Vonhausen
Heike
H
Otto-Terlouw
Patricia C
PC
van der Giessen
Wim J
WJ
D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D001918:Brachytherapy / Q000379:methods*; D000077144:Clopidogrel; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000517:prevention & control*; D005060:Europe; D005260:Female; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010761:Phosphorus Radioisotopes / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011322:Primary Prevention / Q000379:methods; D011829:Radiation Dosage; D015607:Stents; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017539:Tunica Intima / Q000473:pathology; D018084:Ultrasonography, Interventional
D010761:Phosphorus Radioisotopes; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin