Safety and feasibility of intracoronary brachytherapy with the Novoste (TM) system within international multicenter studies

Clinical trials are increasingly investigating the effects of intracoronary radiation for the treatment of de-novo lesions, restenosis (without stents ), and in-stent restenosis. As the first group in Germany, we had the oppor tunity to use the Novoste(TM) system within the international multicenter s tudies BETA-CATH, START and BRIE and report our preliminary experience rega rding safety and feasibility of intracoronary brachytherapy with this after loader. A total of 95 patients were enrolled. The Novoste(TM) system was us ed in 92 patients (104 lesions). Ischemic complications were not observed; therefore, radiation was performed as planned. The mean applied dose was 16 +/- 2 Gy (14-20 Gy, at 2 mm distance) and mean exposure time was 202 +/- 2 7 s (165-261 s). The addition of brachytherapy increased the total duration of the intervention for 17 +/- s min. At the body surface of the patients, the following dose rates were measured: left chest wall: 99 +/- 52 mu Sv/h ; groin 3 +/- 3 mu Sv/h. All patients received ASS 300 mg/d o.d. Patients w ith stent implantation in the same session received 250 mg b.i.d. Ticlopidi n or 75 mg Clopidogrel o.d. for at least three months. Total mortality and infarct rate was 0. There was no acute, subacute or late stent thrombosis. Conclusion: Our first experience with the Novoste(TM) Beta-Cath(TM) system showed that intracoronary brachytherapy can be safely and simply performed in the cath lab. There were no acute complications. To avoid the possible r isk of late stent thrombosis, Ticlopidin or Clopidogrel must be administere d for at least three months.