Endovascular beta-radiation to reduce restenosis after coronary balloon angioplasty: results of the beta energy restenosis trial (BERT).
BACKGROUND
In the porcine overstretch injury model of restenosis, endovascular beta-radiation reduces neointima formation. To determine whether this therapy could be applied to patients with coronary artery disease, a special device was developed to allow delivery of 12 encapsulated 90Sr/Y sources, measuring a total of 30 mm, to various sites within the coronary arterial tree. This study was designed to evaluate the feasibility of the delivery of 12, 14, or 16 Gy at 2 mm after balloon angioplasty of stenoses of native coronary vessels.


RESULTS
Delivery of beta-radiation was attempted in 23 patients after successful balloon angioplasty. Source delivery was successful in 21 of the 23 patients (91%). There was no in-hospital or 30-day morbidity or mortality. Follow-up quantitative coronary arteriography in 20 patients demonstrated a late loss of 0.05 mm, a late loss index of 4%, and a restenosis rate of 15%. The use of the beta-emitter 90Sr/Y significantly reduced treatment time and operator exposure compared with previous trials with the gamma-emitter 192Ir.


CONCLUSIONS
In this study, the administration of endovascular beta-radiation after angioplasty was safe and feasible and substantially altered the postangioplasty late lumen loss, resulting in a lower-than-expected rate of restenosis. On the basis of these encouraging results, a multicenter, randomized trial with operators and patients blinded to treatment assignment is planned.
King
S B
SB
Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Emory University School of Medicine, Atlanta, GA, USA. sking01@emory.edu
Williams
D O
DO
Chougule
P
P
Klein
J L
JL
Waksman
R
R
Hilstead
R
R
Macdonald
J
J
Anderberg
K
K
Crocker
I R
IR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D001610:Beta Particles; D001918:Brachytherapy; D003327:Coronary Disease / Q000517:prevention & control*; D003331:Coronary Vessels / Q000528:radiation effects*; D006801:Humans; D008875:Middle Aged; D012008:Recurrence