Comparison of a centered 32P source wire system with a noncentered 90Sr/Y brachytherapy system for intracoronary beta-radiation following PCI of diffuse in-stent restenosis.
BACKGROUND
We investigated the potential impact of differences in effective radiation dose between the centered Guidant 32P source wire system and the noncentered Novoste 90Sr/Y BetaCath system on clinical and angiographic outcomes of intracoronary brachytherapy for the prevention of in-stent restenosis.


METHODS
From 10/00 to 05/04, a total of 400 patients underwent percutaneous coronary intervention (PCI) with brachytherapy for diffuse in-stent restenosis at our institution. Following balloon dilatation, patient Group A (n=200) was treated with the centered 32P Galileo source wire system, patient Group B (n=200) was treated with the noncentered 90Sr/Y BetaCath radiation system. In Group A, the prescribed dose of 20 Gy was applied in 1-mm depth of the vessel wall. In Group B, the prescribed dose of 18.4 Gy was applied for visual reference vessel sizes >2.7 and <3.35 mm, 23 Gy for >3.36 and <4.00 mm, and 25.3 Gy for >4.00 mm, each calculated at a distance of 2 mm from the center line of the radiation source. Patients received aspirin and clopidogrel over 12 months. Primary endpoint was target lesion revascularization (TLR) at 6 months. Secondary endpoints were the binary restenosis rate and major adverse cardiac event (MACE) at 30 days and 6 months.


RESULTS
At 30 days, one patient of each group underwent PCI at a nontarget lesion (0.5%). At 6 months, MACEs were equally distributed in both groups. Target lesion revascularization at 6 months was 5.9% in Group A and 9.2% in Group B (P=.08). Binary angiographic restenosis rate at 6 months was 5.5% in Group A and 11.2% in Group B (P=.014).


CONCLUSIONS
Intracoronary beta-radiation using the centered 32P source wire system yielded a significant reduction of recurrence rate compared to the noncentered 90S/Y BetaCath system after PCI of diffuse in-stent restenosis. There was a nonsignificant trend toward reduction of TLR among patients treated with the centered 32P source wire system.
Haase
Jürgen
J
Red Cross Hospital Cardiology Center, Frankfurt/Main, Germany. j.hasse@kardiocentrum-ffm.de
von Neumann-Cosel
Peter
P
Damm
Michael
M
Hofmann
Manfred
M
Störger
Hans
H
Isner
Daniel
D
Bergmann
Michael
M
Piancatelli
Claudia
C
Schächinger
Volker
V
Schwarz
Franz
F
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D001918:Brachytherapy / Q000295:instrumentation*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000532:radiotherapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010761:Phosphorus Radioisotopes / Q000627:therapeutic use; D012189:Retrospective Studies; D013326:Strontium Radioisotopes / Q000627:therapeutic use; D016896:Treatment Outcome; D015021:Yttrium Radioisotopes / Q000627:therapeutic use
D010761:Phosphorus Radioisotopes; D013326:Strontium Radioisotopes; D015021:Yttrium Radioisotopes