Document Detail


Treatment of diffuse in-stent restenosis with drug-eluting stents vs. intracoronary beta-radiation therapy: INDEED Study.
MedLine Citation:
PMID:  18190986     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. CONCLUSION: 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.
Authors:
Seong-Wook Park; Seung-Whan Lee; Bon Kwon Koo; Duk-Woo Park; Se-Whan Lee; Young-Hak Kim; Cheol Whan Lee; Myeong-Ki Hong; Jae-Joong Kim; Ken Mori; Alexandra J Lansky; Gary S Mintz; Myoung-Mook Lee; Seung-Jung Park
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2008-01-10
Journal Detail:
Title:  International journal of cardiology     Volume:  131     ISSN:  1874-1754     ISO Abbreviation:  Int. J. Cardiol.     Publication Date:  2008 Dec 
Date Detail:
Created Date:  2008-11-28     Completed Date:  2009-08-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8200291     Medline TA:  Int J Cardiol     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  70-7     Citation Subset:  IM    
Affiliation:
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
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MeSH Terms
Descriptor/Qualifier:
Aged
Brachytherapy / adverse effects,  trends*
Coronary Restenosis / etiology,  radiotherapy*,  surgery*
Drug-Eluting Stents / adverse effects,  trends*
Female
Follow-Up Studies
Humans
Male
Middle Aged
Sirolimus / administration & dosage
Chemical
Reg. No./Substance:
53123-88-9/Sirolimus

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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