Randomized comparison between intracoronary β-radiation brachytherapy and implantation of paclitaxel-eluting stents for the treatment of diffuse in-stent restenosis

Background and purpose: Intracoronary brachytherapy was the primary therapeutic option for the treatment of instent restenosis (ISR) during the last years. Especially for the treatment of diffuse ISR (lesions > 10mm), beta-source brachytherapy was significantly superior to singular balloon angioplasty. Despite lacking clinical database, the implantation of drug eluting stents recently became a common procedure for the treatment of ISR. This randomized trial aimed to compare the efficacy of beta-brachytherapy with beta-radioisotopes Sr-90/Y-90 and paclitaxel-eluting stent implantation for the treatment of diffuse ISR. Material and methods: Thirty-seven patients with diffuse ISR were randomly assigned to beta-brachytherapy after balloon angioplasty (Beta-Cath (TM) in 17 patients) or paclitaxel-eluting stent implantation (Taxus-Express2 (TM) in 20 patients). Six-month clinical follow-up was obtained for all patients, while angiographic follow-up was available for 30 patients. Results: Binary ISR (restenosis > 50%) within target segment was observed in three patients treated with Beta-CathT (TM), of which one needed target segment revascularisation for recurrent ISR, whereas no significant restenosis occurred in the patients treated with Taxus-Express2 (TM) (P = 0.037). No further major adverse cardiac (target segment revascularisation, myocardial infarction, death) was found in either group (P = INS). Stent implantation was the more time-saving (31 +/- 11 min versus 60 +/- 23 min, P < 0.001) procedure. Conclusions: Although this trial revealed a significant reduction of binary restenosis in the Taxus-Express2 (TM) arm, we found no difference in clinical outcome after implantation of paclitaxel-eluting stents for the treatment of diffuse I-SIR when compared to beta-brachytherapy. (c) 2006 Elsevier Ireland Ltd. All rights reserved.