[Safety and feasibility of intracoronary brachytherapy with the Novoste system within the scope of 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 opportunity to use the Novoste system within the international multicenter studies BETA-CATH, START and BRIE and report our preliminary experience regarding safety and feasibility of intracoronary brachytherapy with this afterloader. A total of 95 patients were enrolled. The Novoste system was used 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 +/- 27 s (165-261 s). The addition of brachytherapy increased the total duration of the intervention for 17 +/- 8 min. At the body surface of the patients, the following dose rates were measured: left chest wall: 99 +/- 52 microSv/h; groin 3 +/- 3 microSv/h. All patients received ASS 300 mg/d o.d. Patients with stent implantation in the same session received 250 mg b.i.d. Ticlopidin 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.


CONCLUSIONS
Our first experience with the Novoste Beta-Cath system showed that intracoronary brachytherapy can be safely and simply performed in the cath lab. There were no acute complications. To avoid the possible risk of late stent thrombosis, Ticlopidin or Clopidogrel must be administered for at least three months.
Silber
S
S
Kardiologischen Gemeinschaftspraxis in der Klinik Dr. Müller, München. ssilber@med.de
von Rottkay
P
P
Lössl
P
P
Schneider
A
A
Seidel
N
N
Tourlakidou
S
S
Krischke
I
I
Gessler
B
B
Naser
K
K
Bauer
A
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D001918:Brachytherapy / Q000295:instrumentation*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000532:radiotherapy*; D004307:Dose-Response Relationship, Radiation; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010043:Outcome and Process Assessment, Health Care; D012008:Recurrence
Sicherheit und Durchführbarkeit der intrakoronaren Brachytherapie mit dem Novoste-System im Rahmen von internationalen Multicenter-Studien.