Document Detail


Randomized comparison of minimally invasive direct coronary artery bypass surgery versus sirolimus-eluting stenting in isolated proximal left anterior descending coronary artery stenosis.
MedLine Citation:
PMID:  19539141     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: The purpose of this randomized study was to compare sirolimus-eluting stenting (SES) with minimally invasive direct coronary artery bypass (MIDCAB) surgery for patients with isolated proximal left anterior descending (LAD) coronary artery disease. BACKGROUND: Bare-metal stenting is inferior to MIDCAB surgery in patients with isolated proximal LAD lesions due to a higher reintervention rate with similar results for mortality and reinfarction. SES are effective in restenosis reduction. METHODS: A total of 130 patients with significant proximal LAD coronary artery disease were randomized to either SES (n = 65) or MIDCAB surgery (n = 65). The primary clinical end point was noninferiority in freedom from major adverse cardiac events (MACE), such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months. RESULTS: Follow-up was completed for all patients. MACE occurred in 7.7% of patients after stenting, as compared with 7.7% after surgery (p = 0.03 for noninferiority). The individual components of the combined end point revealed mixed results. Although noninferiority was revealed for the difference in death and myocardial infarction (1.5% vs. 7.7%, noninferiority p < 0.001), noninferiority was not established for the difference in target vessel revascularization (6.2% vs. 0%, noninferiority p = 0.21). Clinical symptoms improved significantly in both treatment groups in comparison with baseline, and the percentage of patients free from angina after 12 months was 81% versus 74% (p = 0.49). CONCLUSIONS: In isolated proximal LAD disease, SES is noninferior to MIDCAB surgery at 12-month follow-up with respect to MACE at a similar relief in clinical symptoms.
Authors:
Holger Thiele; Patrick Neumann-Schniedewind; Stephan Jacobs; Enno Boudriot; Thomas Walther; Friedrich-Wilhelm Mohr; Gerhard Schuler; Volkmar Falk
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  53     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-22     Completed Date:  2009-07-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2324-31     Citation Subset:  AIM; IM    
Affiliation:
Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany. thielh@medizin.uni-leipzig.de
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00299429
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MeSH Terms
Descriptor/Qualifier:
Aged
Coronary Angiography
Coronary Artery Bypass*
Coronary Stenosis / surgery*
Drug-Eluting Stents*
Exercise Tolerance
Female
Humans
Male
Middle Aged
Prosthesis Implantation*
Quality of Life
Sirolimus / administration & dosage
Surgical Procedures, Minimally Invasive
Treatment Outcome
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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