• DOI:10.1161/01.CIR.101.4.360
• Corpus ID: 2294203

Three-year clinical and angiographic follow-up after intracoronary radiation : results of a randomized clinical trial.

@article{Teirstein2000ThreeyearCA,
  title={Three-year clinical and angiographic follow-up after intracoronary radiation : results of a randomized clinical trial.},
  author={Paul S. Teirstein and Vincent Massullo and Shirish K. Jani and Jeffrey J. Popma and Robert J. Russo and Richard Schatz and Erminia M. Guarneri and Stephen Steuterman and Kathleen Sirkin and David A. Cloutier and Martin B. Leon and Prabhakar Tripuraneni},
  journal={Circulation},
  year={2000},
  volume={101 4},
  pages={
          360-5
        }
}

• P. Teirstein, V. Massullo, +9 authors P. Tripuraneni
• Published 1 February 2000
• Medicine
• Circulation

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.