Authors' objectives:

This report is intended to assist physicians in finding answers to the following questions pertaining to intracoronary radiation therapy:

- How safe (short-term, long-term) is intracoronary radiation therapy? - Do catheter-based g- or b-radiation effectively reduce restenosis rates following angioplasty and stenting? Do radioactive stents reduce in-stent restenosis rates?

Authors' recommendations: Catheter-based g-brachytherapy in patients with de novo or non-stented restenotic lesions is not yet supported due to absence of data from well-designed longitudinal randomized clinical studies and because of lack of sufficiently strong, long-term scientific and clinical data. Catheter-based b-brachytherapy for the treatment of native coronary arteries to prevent restenosis in de novo lesions is an evolving technology that shows considerable promise; however, more scientific and clinical evidence needs to be published to support this technology as safe and efficacious in this patient population. Radioactive stents for the treatment of de novo or restenotic lesions due to high incidence of late luminal losses, proximal and distal to the stent edges, should currently be considered investigational treatments that require further technological adaptations of current radioactive stent platforms and more evidence from well-designed, randomized controlled trials. Application of brachytherapy has been proposed as a treatment and for the prevention of coronary artery restenosis. Research on the effectiveness and long-term outcomes of intracoronary brachytherapy is lacking at this time. The best current evidence is for the short-term safety and efficacy of the, FDA approved, catheter-based g-brachytherapy for the treatment of restenosis following conventional therapy. The FDA has also approved catheter-based b-brachytherapy. While it is tempting to endorse these treatments due to the seriousness of the disease and the recent FDA approval of the technology, a strong recommendation would be premature. Fundamental questions remain to be answered concerning patient selection criteria, optimal radiation dose, effectiveness outside the research setting, and long-term outcomes. It is recommended that physicians discuss the potential risks and short-term benefits of these treatments with the patients. At the present time, both catheter-based g and b - brachytherapy should be used only in controlled settings that generate data on the intervention's safety and efficacy. The use of radioactive stents is restricted to clinical trials, and the FDA has not approved their use. Results of trials using radioactive stents have been limited to single-arm studies with small sample sizes and short outcome horizons. Therefore, the use of radioactive stenting cannot be recommended outside of clinical trials. Current evidence does not support the recommendation of either catheter or stent-delivered intracoronary brachytherapy for the prevention of restenosis of primary (de novo or non-stented) coronary artery stenosis.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.health.state.mn.us/htac/brachydr.htm

Year Published: 2001

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: Health Technology Advisory Committee

Contact Address: Queries should be referred to the Minnesota Department of Health (http://www.health.state.mn.us/)

Copyright: Health Technology Advisory Committee