Treatment of diffuse in-stent restenosis with drug-eluting stents vs. intracoronary beta-radiation therapy: INDEED Study.
BACKGROUND
We compared sirolimus-eluting stent (SES) implantation and intracoronary brachytherapy (ICBT) for diffuse bare metal in-stent restenosis (ISR) to identify more effective treatment modality.


METHODS
Patients (n=129) with diffuse ISR (lesion length > or = 10 mm) were randomly assigned to either SES implantation (n=65, group I) or beta-radiation with 188Re-MAG(3)-filled balloon (n=64, group II). The radiation dose was 20 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was late loss in analysis segment at 6 months. The secondary end points were 6-month angiographic restenosis and 1-year major adverse cardiac events (MACE) including myocardial infarction (MI), cardiac death, and target lesion revascularization (TLR).


RESULTS
Baseline characteristics were similar between two groups. The lesion length was 27.52+/-13.98 mm in group I and 27.75+/-14.25 mm in group II (p=0.927). Late loss in analysis segment at 6 months was smaller in group I than in group II (0.15+/-0.62 vs. 0.55+/-0.69 mm, p=0.003). Angiographic restenosis for analysis segment at 6 months was 8.0% (4/50) in group I and 30.2% (16/53) in group II (p=0.006). One MI and two deaths (all from group I) occurred during follow-up. TLR (4.6% vs. 18.8%, p=0.014) and MACEs (7.7% vs. 18.8%, p=0.073) were lower in group I than group II at 1 year.


CONCLUSIONS
Compared to ICBT, SES implantation for diffuse bare metal ISR showed less late loss, lower restenosis, and a trend toward lower 1-year MACEs. SES implantation appears to be superior to ICBT for treating diffuse ISR.
Park
Seong-Wook
SW
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Poongnap-dong, Songpa-gu, Seoul, 138-736, Republic of Korea. sjpark@amc.seoul.kr
Lee
Seung-Whan
SW
Koo
Bon Kwon
BK
Park
Duk-Woo
DW
Lee
Se-Whan
SW
Kim
Young-Hak
YH
Lee
Cheol Whan
CW
Hong
Myeong-Ki
MK
Kim
Jae-Joong
JJ
Mori
Ken
K
Lansky
Alexandra J
AJ
Mintz
Gary S
GS
Lee
Myoung-Mook
MM
Park
Seung-Jung
SJ
D000368:Aged; D001918:Brachytherapy / Q000009:adverse effects / Q000639:trends*; D023903:Coronary Restenosis / Q000209:etiology / Q000532:radiotherapy* / Q000601:surgery*; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage
D020123:Sirolimus