Intracoronary beta-radiation to reduce restenosis after balloon angioplasty and stenting; the Beta Radiation In Europe (BRIE) study.
OBJECTIVE
The BRIE trial is a registry evaluating the safety and performance of (90)Sr delivered locally (Beta-Cath TM system of Novoste) to de-novo and restenotic lesions in patients with up to two discrete lesions in different vessels.


RESULTS
In total, 149 patients (175 lesions) were enrolled; 62 treated with balloons and 113 with stents. The restenosis rate, the minimal luminal diameter and the late loss were determined in three regions of interest: (a) in a subsegment of 5mm containing the original minimal luminal diameter pre-intervention termed target segment; (b) the irradiated segment, 28 mm in length, and (c) the entire analysed segment, 42 mm in length, termed the vessel segment. Binary restenosis was 9.9% for the target segment, 28.9% for the irradiated segment, and 33.6% for the vessel segment. These angiographic results include 5.3% total occlusions. Excluding total occlusions binary restenosis was 4.9%, 25% and 29.9%, respectively. At 1 year the incidence of major adverse cardiac events placed in a hierarchical ranking were: death 2%, myocardial infarction 10.1%, CABG 2%, and target vessel revascularization 20.1%. The event-free survival rate was 65.8%. Non-appropriate coverage of the injured segment by the radioactive source termed geographical miss affected 67.9% of the vessels, and increased edge restenosis significantly (16.3% vs 4.3%, P=0.004). It accounted for 40% of the treatment failures.


CONCLUSIONS
The results of this registry reflect the learning process of the practitioner. The full therapeutic potential of this new technology is reflected by the restenosis rate at the site of the target segment. It can only be unravelled once the incidence of late vessel occlusion and geographical miss has been eliminated by the prolonged use of thienopyridine, the appropriate training of the operator applying this new treatment for restenosis prevention, and the use of longer sources.
Serruys
P W
PW
Department of Interventional Cardiology, Thoraxcenter, Heartcenter, Erasmus Medical Center, Academisch Ziekenhuis Dijkzigt Rotterdam, The Netherlands.
Sianos
G
G
van der Giessen
W
W
Bonnier
H J R M
HJ
Urban
P
P
Wijns
W
W
Benit
E
E
Vandormael
M
M
Dörr
R
R
Disco
C
C
Debbas
N
N
Silber
S
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D003324:Coronary Artery Disease / Q000532:radiotherapy*; D023903:Coronary Restenosis / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015607:Stents; D013326:Strontium Radioisotopes / Q000627:therapeutic use; D016019:Survival Analysis; D016896:Treatment Outcome; D015021:Yttrium Radioisotopes / Q000627:therapeutic use
D013326:Strontium Radioisotopes; D015021:Yttrium Radioisotopes