(Circulation. 2000;101:360.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Three-Year Clinical and Angiographic Follow-Up After Intracoronary Radiation
Results of a Randomized Clinical Trial
From the Division of Cardiovascular Diseases (P.S.T., R.J.R., R.A.S., E.M.G., S.S., K.S., D.A.C.) and Division of Radiation Oncology (V.M., S.J., P.T.), Scripps Clinic, La Jolla, Calif; Division of Cardiology, Brigham and Women’s Hospital (J.J.P.), Boston, Mass; and Division of Cardiology, Washington Hospital Center (M.B.L.), Washington, DC.
Background—Although several early trials indicate treatment of restenosis with radiation therapy is safe and effective, the long-term impact of this new technology has been questioned. The objective of this report is to document angiographic and clinical outcome 3 years after treatment of restenotic stented coronary arteries with catheter-based 192Ir.
Methods and Results—A double-blind, randomized trial compared 192Ir with placebo sources in patients with previous restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to 192Ir and 29 to placebo. At 3-year follow-up, target-lesion revascularization was significantly lower in the 192Ir group (15.4% versus 48.3%; P<0.01). The dichotomous restenosis rate at 3-year follow-up was also significantly lower in 192Ir patients (33% versus 64%; P<0.05). In a subgroup of patients with 3-year angiographic follow-up not subjected to target-lesion revascularization by the 6-month angiogram, the mean minimal luminal diameter between 6 months and 3 years decreased from 2.49±0.81 to 2.12±0.73 mm in 192Ir patients but was unchanged in placebo patients.
Conclusions—The early clinical benefits observed after treatment of coronary restenosis with 192Ir appear durable at late follow-up. Angiographic restenosis continues to be significantly reduced in 192Ir-treated patients, but a small amount of late loss was observed between the 6-month and 3-year follow-up time points. No events occurred in the 192Ir group to suggest major untoward effects of vascular radiotherapy. At 3-year follow-up, vascular radiotherapy continues to be a promising new treatment for restenosis.
Key Words: radioisotopes • radiotherapy • stents • coronary disease • restenosis
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A. E. Raizner, S. N. Oesterle, R. Waksman, P. W. Serruys, A. Colombo, Y.-L. Lim, A. C. Yeung, W. J. van der Giessen, L. Vandertie, J. K. Chiu, et al. Inhibition of Restenosis With {beta}-Emitting Radiotherapy : Report of the Proliferation Reduction With Vascular Energy Trial (PREVENT) Circulation, August 29, 2000; 102(9): 951 - 958. [Abstract] [Full Text] [PDF]
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R. E. Kuntz and D. S. Baim Prevention of Coronary Restenosis : The Evolving Evidence Base for Radiation Therapy Circulation, May 9, 2000; 101(18): 2130 - 2133. [Full Text] [PDF]
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D. O. Williams and B. L. Sharaf Intracoronary Radiation : It Keeps on Glowing Circulation, February 1, 2000; 101(4): 350 - 351. [Full Text] [PDF]
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S. Scott, M. O'Sullivan, S. Hafizi, L. M. Shapiro, and M. R. Bennett Human Vascular Smooth Muscle Cells From Restenosis or In-Stent Stenosis Sites Demonstrate Enhanced Responses to p53: Implications for Brachytherapy and Drug Treatment for Restenosis Circ. Res., March 8, 2002; 90(4): 398 - 404. [Abstract] [Full Text] [PDF]
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