Mount Sinai Journal of Medicine - Volume 68, Number 3, Page 192

Volume 68 Number 3
May 2001 back to contents

Radiation Therapy to Inhibit Restenosis: Early Clinical Results 192-196

Paul S. Teirstein, M.D., Vincent Massullo, M.D., Shirish Jani, Ph.D., and Prabhakar Tripuraneni, M.D.

Address correspondence to Paul S. Teirstein, M.D., Division of Cardiovascular Diseases, SW206, Scripps Clinic, 10666 North Torrey Pines Road, La Jolla, CA 92037.
ABSTRACT
BACKGROUND: Although several early trials indicate that 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 restenosis of stented coronary arteries with catheter-based iridium-192 (192Ir).
METHODS: 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.
RESULTS: At 3-year follow-up, target-lesion revascularization was significantly lower in the 192Ir group (15.4% vs. 48.3%; p < 0.01). The dichotomous restenosis rate at 3-year follow-up was also significantly lower in 192Ir patients (33% vs. 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 ą 0.81 mm to 2.12 ą 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
Coronary artery angioplasty, restenosis, radiation therapy, clinical trials.

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