Intracoronary beta-irradiation with liquid rhenium-188 to prevent restenosis following pure balloon angioplasty: results from the TRIPPER-1 study
Hang, C-Ling.; Fu, M.; Hsieh, B-Tsung.; Leung, S.Wan.; Wu, C-Jen.; Ting, G.
Chang Gung Medical Journal 26(2): 98-106
2003
ISSN/ISBN: 2072-0939 PMID: 12718386 Document Number: 558858
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. 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. 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). 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.