Radioactive stents.

Abstract

Intracoronary stenting has improved catheter-based revascularization of obstructive coronary artery disease. Despite the improved outcomes with stenting, restenosis still occurs at an unacceptable rate, particularly in smaller vessels and in longer lesions. In this article, we review the concept of using a stent implanted with low activities of radioisotope as a means to inhibit the proliferative process that is believed to initiate in-stent restenosis. This approach has been shown to be effective in certain animal models of restenosis. The initial clinical results with the phase-1 safety trials are summarized. The early clinical results with more than 200 implants of low activity 32P Palmaz-Schatz and BX radioactive stents have demonstrated excellent procedural and 30-day event-free survival. Further dose-finding safety trials are anticipated in 1998 and 1999. A large scale randomized clinical trial will commence if and when early safety and efficacy data suggest a therapeutic effect from this technology.