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(Circulation. 2000;102:3117.)
© 2000 American Heart Association, Inc.

Basic Science Reports

Effects of ß^–-Emitting ¹⁸⁸Re Balloon in Stented Porcine Coronary Arteries

An Angiographic, Intravascular Ultrasound, and Histomorphometric Study

Raj Makkar, MD; James Whiting, PhD; Alex Li, PhD; Hidehiko Honda, MD; Michael C. Fishbein, MD; F.F. (Russ) Knapp, PhD; Jörg Hausleiter, MD; Frank Litvack, MD; Neal L. Eigler, MD

From the Division of Cardiology and the Research Institute at Cedars-Sinai Medical Center and the UCLA School of Medicine (R.M., H.H., J.H., F.L., N.L.E.), the Division of Medical Physics at Cedars-Sinai Medical Center (J.W., A.L.), and the Department of Pathology at UCLA School of Medicine (M.C.F.), Los Angeles, Calif, and the Oak Ridge National Laboratory (F.F.K.), Oak Ridge, Tenn.

Correspondence to Neal Eigler, MD, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Los Angeles, CA 90048. E-mail IB1surfdoc{at}aol.com

Background—Restenosis within stents may be prevented by ionizing radiation from an intravascular source.

Methods and Results—A liquid ß^- radiation (¹⁸⁸Re) balloon was evaluated in a randomized and blinded porcine coronary model of stent restenosis. Group A pigs (n=17) received 0,16, 22, or 29 Gy at 0.5-mm depth, followed by stenting. Restenosis was quantified by angiography, ultrasound, and histomorphometry at 30 days. Group B (n=7) was stented first and then treated with 0 or 29 Gy with follow-up at 60 days. There was a measurable effect at 16 Gy, which improved with increasing doses. At 29 Gy, the histological stenotic area was reduced by 67% (22% versus 66% in controls, P<0.001). Radiation after stenting was equally effective; the stenotic area was reduced (21% versus 65%, P<0.001). At 16 Gy, the vessel just distal to the stent was significantly smaller than control vessels because of intimal thickening (P=0.003). Radiated vessels had distinctive histology consisting of neointimal fibrin and reduced smooth muscle cells and matrix (P<0.0001).

Conclusions—¹⁸⁸Re balloon brachytherapy in porcine coronary arteries results in dose-dependent and injury-independent inhibition of stent restenosis for up to 60 days. Restenosis at the borders of the irradiated zone is a potential limitation and may be related to underdosing. Brachytherapy with the ¹⁸⁸Re balloon appears to be safe and feasible for clinical studies.

Key Words: balloon • restenosis • angioplasty • stents

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