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.

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 192 Ir. Methods and Results —A double-blind, randomized trial compared 192 Ir with placebo sources in patients with previous restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to 192 Ir and 29 to placebo. At 3-year follow-up, target-lesion revascularization was significantly lower in the 192 Ir group (15.4% versus 48.3%; P <0.01). The dichotomous restenosis rate at 3-year follow-up was also significantly lower in 192 Ir 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 192 Ir patients but was unchanged in placebo patients. Conclusions —The early clinical benefits observed after treatment of coronary restenosis with 192 Ir appear durable at late follow-up. Angiographic restenosis continues to be significantly reduced in 192 Ir-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 192 Ir 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.