Intracoronary brachytherapy for the prevention of restenosis after percutaneous coronary revascularization

The purpose of this article is to review the current literature pertaining to intracoronary brachytherapy for the prevention of restenosis after percutaneous coronary revascularization (PCR).

English-language articles were identified through a MEDLINE search (January 1984 to January 2003) using the keywords brachytherapy, radioactive stents, and coronary arteries. In addition, pertinent reference citations from relevant articles were reviewed.

Restenosis after PCR is a complex process, thought to be due to a combination of vessel wall remodeling and neointimal proliferation. To date, catheter-based delivery of intracoronary brachytherapy has been found to prevent vessel wall remodeling and causes a reduction in the proliferation of the neointima. Neointimal proliferation, as measured by mean neointimal area, was reduced in all animal studies (range 26%-91%). In contrast, animal studies examining radioactive stents demonstrated an increase in neointimal proliferation, suggesting that they may not be helpful at preventing post-PCR restenosis. All human studies using catheter-based intracoronary brachytherapy for in-stent restenosis have employed either beta (beta) or gamma (gamma) radiation sources with variable doses of radiation (range 7-56 Grays [Gy]). Restenosis occurred in 12% to 40% of patients in nonrandomized studies, and clinical events occurred in 13% to 50% of patients. To date, there have been 7 published randomized trials in humans comparing catheter-based intracoronary brachytherapy to placebo, with a total of 1047 patients. The dose of radiation in the trials ranged from 14 Gy to 30 Gy. During follow-up, 8% to 33% of patients who received brachytherapy had restenosis versus 39% to 64% of patients receiving placebo. Clinical events occurred in 19% to 50% among patients who received brachytherapy versus 29% to 79% among patients receiving placebo. The majority of human studies examining radioactive stents do not demonstrate a reduction in restenosis in patients post-PCR. There are no randomized trials examining radioactive stents in humans.

Nonrandomized studies of radioactive stents suggest they are not effective at preventing in-stent restenosis. In contrast, data from animal and human studies suggest that catheter-based intracoronary brachytherapy can prevent in-stent restenosis and reduce clinical events post-PCR.