Document Detail

Long-term effects of novel biolimus eluting DEVAX AXXESS plus nitinol self-expanding stent in a porcine coronary model.
MedLine Citation:
PMID:  16810698     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: The purpose of this study was to evaluate the long-term effects of the DEVAX AXXESS biolimus eluting stent (BES) in a porcine coronary model, compared with those of bare metal stent (BMS) and polymer only stent (POS) controls. BACKGROUND: Excessive neointimal growth has been identified as a major cause of late failure of percutaneous coronary interventions. The effect of drug eluting from self-expanding stents for prevention of neointimal hyperplasia has not been studied before. The DEVAX AXXESS is a self-expanding nickel titanium stent, coated with antiproliferative compound-biolimus. METHODS: Twenty juvenile farm swine, 25-35 kg in weight, 3-6 months in age were used. Each animal received a stent to the left anterior descending artery, left circumflex or right coronary arteries as permitted per anatomy. The chronic vascular response after BES implantation was compared with that after BMS and POS implantation at 28, 90, and 180 days follow-up. RESULTS: The 28-day outcome by quantitative coronary angiography (QCA) showed significant increase in minimal luminal diameter (MLD) in the BES (MLD: 2.90 +/- 0.97, 2.39 +/- 0.90, 1.59 +/- 0.91; P = 0.009) compared with BMS and POS, respectively. By histomorphometric analysis, there was also a corresponding significant reduction in neointimal tissue proliferation in the BES (average neointimal area: 2.78 +/- 0.07, 5.46 +/- 0.66, 8.42 +/- 0.85; P = 0.002) compared with that in BMS and POS controls, respectively at 28-days follow-up. At 90 and 180 days, the mean neointimal area was not significantly different between the BES and the controls. CONCLUSIONS: BES favorably modulates the neointimal tissue formation for 28 days, in the porcine coronary model. Long-term inhibition of neointimal hyperplasia is not sustained most likely because of the delayed cellular proliferation and inflammation in the vessel wall.
Mehmet Cilingiroglu; Jim Elliott; Devang Patel; Furman Tio; Holly Matthews; Melissa McCasland; Brett Trauthen; John Elicker; Steven R Bailey
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  68     ISSN:  1522-1946     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2006 Aug 
Date Detail:
Created Date:  2006-08-28     Completed Date:  2007-01-19     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  271-9     Citation Subset:  IM    
Division of Cardiology, Department of Medicine, University of Texas Health Science Center in San Antonio, Texas 78229-3900, USA.
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MeSH Terms
Coated Materials, Biocompatible / administration & dosage*
Coronary Angiography
Immunosuppressive Agents / administration & dosage
Models, Animal
Prosthesis Design
Sirolimus / administration & dosage
Time Factors
Tunica Intima / pathology
Reg. No./Substance:
0/Alloys; 0/Coated Materials, Biocompatible; 0/Immunosuppressive Agents; 0/Polyesters; 0/poly(epsilon-caprolactone-co-lactide); 52013-44-2/nitinol; 53123-88-9/Sirolimus

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

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