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Previous Volume 336:1697-1703 June 12, 1997 Number 24 Next

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ABSTRACT

Background In animal models of coronary restenosis, intracoronary radiotherapy has been shown to reduce the intimal hyperplasia that is a part of restenosis. We studied the safety and efficacy of catheter-based intracoronary gamma radiation plus stenting to reduce coronary restenosis in patients with previous restenosis.

Methods Patients with restenosis underwent coronary stenting, as required, and balloon dilation and were then randomly assigned to receive catheter-based irradiation with iridium-192 or placebo. Clinical follow-up was performed, with quantitative coronary angiographic and intravascular ultrasonographic measurements at six months.

Results Fifty-five patients were enrolled; 26 were assigned to the iridium-192 group and 29 to the placebo group. Angiographic studies were performed in 53 patients (96 percent) at a mean (±SD) of 6.7±2.2 months. The mean minimal luminal diameter at follow-up was larger in the iridium-192 group than in the placebo group (2.43±0.78 mm vs. 1.85±0.89 mm, P = 0.02). Late luminal loss was significantly lower in the iridium-192 group than in the placebo group (0.38±1.06 mm vs. 1.03±0.97 mm, P = 0.03). Angiographically identified restenosis (stenosis of 50 percent or more of the luminal diameter at follow-up) occurred in 17 percent of the patients in the iridium-192 group, as compared with 54 percent of those in the placebo group (P = 0.01). There were no apparent complications of the treatment.

Conclusions In this preliminary, short-term study of patients with previous coronary restenosis, coronary stenting followed by catheter-based intracoronary radiotherapy substantially reduced the rate of subsequent restenosis.

Source Information

From the Divisions of Cardiovascular Diseases and Radiation Oncology, Scripps Clinic and Research Foundation, La Jolla, Calif. (P.S.T., V.M. S.J., R.J.R., R.A.S., E.M.G., S.S., N.B.M., P.T.); and the Division of Cardiology, Washington Hospital Center, Washington, D.C. (J.J.P., G.S.M., M.B.L.).

Address reprint requests to Dr. Teirstein at the Division of Cardiovascular Diseases, SW-206, Scripps Clinic and Research Foundation, 10666 N. Torrey Pines Rd., La Jolla, CA 92037.

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