Document Detail


AMS INSIGHT--absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis.
MedLine Citation:
PMID:  19093148     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.
Authors:
Marc Bosiers; Patrick Peeters; Olivier D'Archambeau; Jeroen Hendriks; Ernst Pilger; Christoph Düber; Thomas Zeller; Andreas Gussmann; Paul N M Lohle; Erich Minar; Dierk Scheinert; Klaus Hausegger; Karl-Ludwig Schulte; Jürgen Verbist; Koen Deloose; J Lammer;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2008-12-18
Journal Detail:
Title:  Cardiovascular and interventional radiology     Volume:  32     ISSN:  1432-086X     ISO Abbreviation:  Cardiovasc Intervent Radiol     Publication Date:  2009 May 
Date Detail:
Created Date:  2009-05-15     Completed Date:  2009-08-11     Revised Date:  2013-06-04    
Medline Journal Info:
Nlm Unique ID:  8003538     Medline TA:  Cardiovasc Intervent Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  424-35     Citation Subset:  IM    
Affiliation:
Department of Vascular Surgery, AZ St-Blasius, Kroonveldlaan 50, 9200, Dendermonde, Belgium. marc.bosiers@telenet.be
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MeSH Terms
Descriptor/Qualifier:
Absorbable Implants*
Aged
Aged, 80 and over
Angiography
Cross-Over Studies
Female
Humans
Ischemia / therapy*
Lower Extremity / blood supply*,  radiography
Male
Metals
Middle Aged
Peripheral Vascular Diseases / radiography,  therapy*
Prospective Studies
Salvage Therapy
Statistics, Nonparametric
Stents*
Treatment Outcome
Vascular Patency
Chemical
Reg. No./Substance:
0/Metals
Investigator
Investigator/Affiliation:
M Bosiers / ; P Peeters / ; O D'Archambeau / ; J Hendriks / ; E Pilger / ; Ch Düber / ; Th Zeller / ; A Gussmann / ; P N M Lohle / ; E Minar / ; D Scheinert / ; K Hausegger / ; K L Schulte / ; J Verbist / ; K Deloose / ; J Lammer /
Comments/Corrections
Erratum In:
Cardiovasc Intervent Radiol. 2009 May;32(3):422-3
Note: multiple author names added

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


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