Document Detail


Clinical and angiographic outcomes with sirolimus-eluting stents in total coronary occlusions: the ACROSS/TOSCA-4 (Approaches to Chronic Occlusions With Sirolimus-Eluting Stents/Total Occlusion Study of Coronary Arteries-4) trial.
MedLine Citation:
PMID:  19463409     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We sought to examine angiographic and clinical outcomes with sirolimus-eluting stents (SES) in total coronary occlusion (TCO) revascularization.
BACKGROUND: Despite evaluation of drug-eluting stents beyond approved indications, few studies have evaluated their clinical benefit in TCO revascularization.
METHODS: Among 15 centers in North America, 200 consecutive TCO patients (78.8% >6 weeks TCO age) were enrolled for treatment with SES. The primary end point was 6-month angiographic binary restenosis within the treated segment.
RESULTS: Patient characteristics included: diabetes, 24.5%; prior infarction, 33.5%; and stent length, 45.9 mm median (quartile 1, 30.2 mm; quartile 2, 62.1 mm). A total of 199 patients (99.5%) were treated with SES, and procedural success was 98.0%. The 6-month binary restenosis rates were 9.5% in-stent, 12.4% in-segment, and 22.6% in-"working length" representing the entire treatment segment. Rates of 1-year target lesion revascularization, myocardial infarction, and target vessel failure were 9.8%, 1.0%, and 10.9%, respectively. Stent thrombosis occurred in 2 patients (1.0%). Using logistic regression modeling with propensity score adjustment, the absolute reduction in binary restenosis with SES compared with a historical bare-metal stent control was 37.7% (95% confidence interval [CI]: 27.2% to 48.3%, p < 0.001; odds ratio: 0.17, 95% CI: 0.09 to 0.30, p < 0.0001). Among 32 patients (16%) identified with stent fracture, target lesion revascularization was more common than patients without fracture (25.0% vs. 6.7%, p = 0.005).
CONCLUSIONS: Despite greater lesion complexity than prior TCO trials, percutaneous revascularization with SES appears safe and results in substantial reductions in angiographic restenosis and failed patency and a low rate of repeat revascularization. These findings support the use of SES in TCO revascularization. (The ACROSS/TOSCA Trial; NCT00378612).
Authors:
David E Kandzari; Sunil V Rao; Jeffrey W Moses; Vladimir Dzavik; Bradley H Strauss; Michael J Kutryk; Charles A Simonton; Jyotsna Garg; Yuliya Lokhnygina; G B John Mancini; Eunice Yeoh; Christopher E Buller;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  2     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-05-25     Completed Date:  2010-09-29     Revised Date:  2012-08-29    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  97-106     Citation Subset:  IM    
Affiliation:
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA. kandzari.david@scrippshealth.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00378612
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MeSH Terms
Descriptor/Qualifier:
Aged
Confidence Intervals
Coronary Angiography
Coronary Artery Disease / drug therapy,  metabolism,  therapy
Coronary Restenosis / drug therapy,  therapy*
Coronary Vessels / drug effects*,  pathology
Drug-Eluting Stents*
Female
Health Status Indicators
Humans
Immunosuppressive Agents / therapeutic use*
Logistic Models
Male
Middle Aged
Odds Ratio
Prospective Studies
Sirolimus / therapeutic use*
Vascular Patency
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 53123-88-9/Sirolimus

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


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