Intracoronary beta-irradiation with liquid rhenium-188 to prevent restenosis following pure balloon angioplasty: results from the TRIPPER-1 study.
BACKGROUND
Patients who receive percutaneous transluminal coronary angioplasty (PTCA) are often haunted by restenosis of the target vessel within 6 months. Intracoronary irradiation has been shown to alter the luminal narrowing response after balloon angioplasty.


METHODS
The Taiwan Radiation in Prevention of Post-Pure Balloon Angioplasty Restenosis-I (TRIPPER-I) study evaluated the feasibility, safety, and 6-month angiographic restenosis with intracoronary irradiation after pure balloon angioplasty (POBA) of de novo and post-POBA restenotic lesions in native coronary arteries using a self-centering beta-emitter rhenium-188 (Re-188)-filled balloon.


RESULTS
Forty patients received 14 Gy at a 0.5-mm tissue depth with a Re-188 solution-filled perfusion balloon catheter, and 25 control patients received 5-min inflation with a perfusion balloon catheter. There were no procedural complications or in-hospital or 30-day major adverse cardiac events. Six-month angiographic follow-up was performed on 39 Re-188 (97.5%) and 25 control patients (100%). The restenosis rate was 49% in the Re-188 and 56% in the control groups (p=0.62). The composite end-points of death, myocardial infarction, and target-vessel revascularization were 40% in the Re-188 group and 36% in the control group (p=0.80).


CONCLUSIONS
Catheter-based radiotherapy after POBA of de novo and post-POBA restenotic lesions with a Re-188-filled balloon is feasible but was ineffective in reducing target lesion restenosis with a dose of 14 Gy delivered at a 0.5-mm tissue depth in this study.
Hang
Chi-Ling
CL
Section of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan, ROC.
Fu
Morgan
M
Hsieh
Bor-Tsung
BT
Leung
Stephen Wan
SW
Wu
Chiung-Jen
CJ
Ting
Gann
G
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001610:Beta Particles / Q000627:therapeutic use*; D001918:Brachytherapy / Q000379:methods*; D023903:Coronary Restenosis / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011868:Radioisotopes / Q000627:therapeutic use*; D012211:Rhenium / Q000627:therapeutic use*
D011868:Radioisotopes; D012211:Rhenium