Randomized comparison between intracoronary beta-radiation brachytherapy and implantation of paclitaxel-eluting stents for the treatment of diffuse in-stent restenosis.
OBJECTIVE
Intracoronary brachytherapy was the primary therapeutic option for the treatment of in-stent 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 (90)Sr/(90)Y and paclitaxel-eluting stent implantation for the treatment of diffuse ISR.


METHODS
Thirty-seven patients with diffuse ISR were randomly assigned to beta-brachytherapy after balloon angioplasty (Beta-Cath in 17 patients) or paclitaxel-eluting stent implantation (Taxus-Express2 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-Cath, of which one needed target segment revascularisation for recurrent ISR, whereas no significant restenosis occurred in the patients treated with Taxus-Express2 (P=0.037). No further major adverse cardiac (target segment revascularisation, myocardial infarction, death) was found in either group (P=NS). 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 arm, we found no difference in clinical outcome after implantation of paclitaxel-eluting stents for the treatment of diffuse ISR when compared to beta-brachytherapy.
Schukro
Christoph
C
Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria. christoph.schukro@meduniwien.ac.at
Syeda
Bonni
B
Kirisits
Christian
C
Schmid
Rainer
R
Pichler
Philipp
P
Pokrajac
Boris
B
Lang
Irene
I
Pötter
Richard
R
Glogar
Dietmar
D
D015906:Angioplasty, Balloon, Coronary; D001610:Beta Particles; D001918:Brachytherapy / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000628:therapy*; D004333:Drug Administration Routes; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome
D017239:Paclitaxel