From the Andreas Gruentzig Cardiovascular Center, Division of Cardiology
(S.B.K., J.L.K., R.W., K.A.), and the Department of Radiation Oncology
(I.R.C.), Emory University School of Medicine, Atlanta, Ga; the Division of
Cardiology (D.O.W.) and the Department of Radiation Oncology (P.C.), Rhode
Island Hospital, Brown University, Providence, RI; and Novoste Corp (R.H.,
J.M.), Norcross, Ga.
Correspondence to Dr Spencer B. King III, Director, Andreas Gruentzig Cardiovascular Center, Room F-606, Emory University Hospital, 1364 Clifton Rd NE, Atlanta, Ga 30322. E-mail sking01{at}emory.edu
Background—In the porcine
overstretch injury model of restenosis, endovascular
ß-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.
Methods and Results—Delivery of ß-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 ß-emitter 90Sr/Y significantly reduced
treatment time and operator exposure compared with previous trials with
the
Conclusions—In this study, the administration of endovascular
ß-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.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
Endovascular ß-Radiation to Reduce Restenosis After Coronary Balloon Angioplasty
Results of the Beta Energy Restenosis Trial (BERT)
-emitter 192Ir.
Key Words: angioplasty • coronary disease • radioisotopes • restenosis
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