Three-year clinical follow-up results of intracoronary radiation therapy using a rhenium-188-diethylene-triamine-penta-acetic-acid-filled balloon system.
BACKGROUND
Intracoronary radiation therapy (IRT) prevents recurrent in-stent restenosis, but its long-term safety and efficacy remain uncertain. In the present study, the long-term clinical outcome of IRT using the rhenium-188 ((188)Re)-filled balloon system was evaluated.


RESULTS
After successful catheter-based treatment of either a de novo or restenotic lesion, 187 patients were randomly assigned to either the radiation (N=104) or the control (N=83) group. The (188)Re-filled balloon system was designed to deliver 17.6 Gy to 1.0-mm tissue depth. Angiographic restenosis was significantly reduced with IRT at 9 months (18.9% vs 45.9%, p<0.001), but the incidence of major adverse cardiac events (MACE) including death, myocardial infarction, and target-vessel revascularization (TVR) by 3 years showed no difference. Lack of clinical benefit might be related to TVR caused by geographic miss (6/22, 28.6%), balloon-induced unhealed dissection (3/22, 13.6%) and late thrombosis (2/22, 9.1%). In the restenotic subgroup (N=39), the MACE rate within 3 years was significantly reduced with IRT (14.3% vs 54.5%, p=0.01).


CONCLUSIONS
IRT using the (188)Re -filled balloon system is safe and technically feasible. Although IRT failed to show favorable outcomes for de novo lesion, the clinical benefits for restenotic lesions seem durable for 3 years. Furthermore, preventing geographic miss and dissection might improve long-term outcomes.
Kim
Kwang-Il
KI
Cardiovascular Center, Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Korea.
Bae
Jangwhan
J
Kang
Hyun-Jae
HJ
Koo
Bon-Kwon
BK
Youn
Tae-Jin
TJ
Kim
Sang-Hyun
SH
Chae
In-Ho
IH
Kim
Hyo-Soo
HS
Sohn
Dae-Won
DW
Oh
Byung-Hee
BH
Lee
Myoung-Mook
MM
Park
Young-Bae
YB
Choi
Yun-Shik
YS
Lee
Dong-Soo
DS
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control* / Q000532:radiotherapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D004369:Pentetic Acid / Q000627:therapeutic use; D011868:Radioisotopes / Q000627:therapeutic use*; D011878:Radiotherapy / Q000295:instrumentation / Q000379:methods*; D012211:Rhenium / Q000627:therapeutic use*
D011868:Radioisotopes; D012211:Rhenium; D004369:Pentetic Acid