Randomized blinded clinical trial of intracoronary brachytherapy with 90Sr/Y beta-radiation for the prevention of restenosis after stent implantation in native coronary arteries in diabetic patients.
BACKGROUND
We report a double-blind, randomized clinical trial of intracoronary beta-radiation for prevention of restenosis after stent implantation in native coronary de novo lesions in diabetic patients.


METHODS
After successful stent implantation in native coronary de novo lesions, 106 lesions in 89 diabetic patients were randomly allocated to treatment with beta-radiation with 18 Gy at 1 mm vessel depth (n = 53) or placebo treatment (n = 53).


RESULTS
Angiographic analysis at 9 month follow-up revealed a late lumen loss of 0.7+/-0.9 mm in the radiotherapy group versus 1.2+/-0.8 mm in the control group at the injured segment (P = 0.006), 0.9+/-1.0 versus 1.3+/-0.7 mm at the radiated segment (P = 0.02), and 0.9+/-1.0 versus 1.3+/-0.7 mm at the target segment (P = 0.04) (defined as active source length plus 5mm on proximal and distal sites). Binary restenosis rates were significantly lower in the radiation group in all subsegments (injured segment: 10.9 versus 37.3%, P = 0.003; radiated segment: 21.7 versus 49.0%, P = 0.005; target segment: 23.9 versus 49.0%, P = 0.01). Target lesion revascularization for restenosis was required in nine lesions (17.6%) in the radiotherapy group versus 18 (34.0%) in the placebo group (P = 0.05). Late thrombosis occurred in four radiated patients (after premature discontinuation of antiplatelet therapy in all), resulting in a major adverse clinical event rate of 37.2% in the brachytherapy group versus 38.6% in the placebo group (P = ns).


CONCLUSIONS
In diabetic patients with de novo coronary lesions, intracoronary radiation after stent implantation significantly reduced restenosis. However, this clinical benefit was reduced by the frequent occurrence of late thrombosis.
Syeda
Bonni
B
Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria. bonni.syeda@meduniwien.ac.at
Schukro
Christoph
C
Kirisits
Christian
C
Lang
Irene
I
Siostrzonek
Peter
P
Gottsauner-Wolf
Michael
M
Pokrajac
Boris
B
Schmid
Rainer
R
Yahya
Nabil
N
Pötter
Richard
R
Glogar
Dietmar
D
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001610:Beta Particles / Q000627:therapeutic use; D001918:Brachytherapy / Q000009:adverse effects; D003327:Coronary Disease / Q000150:complications / Q000532:radiotherapy* / Q000628:therapy; D023903:Coronary Restenosis / Q000517:prevention & control*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D040201:Platelet Membrane Glycoprotein IIb / Q000627:therapeutic use; D011446:Prospective Studies; D012044:Regression Analysis; D015607:Stents; D013326:Strontium Radioisotopes / Q000627:therapeutic use; D016896:Treatment Outcome; D015019:Yttrium / Q000627:therapeutic use
D040201:Platelet Membrane Glycoprotein IIb; D013326:Strontium Radioisotopes; D015019:Yttrium