Document Detail


Early- and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries.
MedLine Citation:
PMID:  19463443     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: This study aimed to evaluate the degradation rate and long-term vascular responses to the absorbable metal stent (AMS).
BACKGROUND: The AMS demonstrated feasibility and safety at 4 months in human coronary arteries.
METHODS: The PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting) was a prospective, multicenter clinical trial of 63 patients with coronary artery disease who underwent AMS implantation. Angiography and intravascular ultrasound (IVUS) were conducted immediately after AMS deployment and at 4 months. Eight patients who did not require repeat revascularization at 4 months underwent late angiographic and IVUS follow-up from 12 to 28 months.
RESULTS: The AMS was well-expanded upon deployment without immediate recoil. The major contributors for restenosis as detected by IVUS at 4 months were: decrease of external elastic membrane volume (42%), extra-stent neointima (13%), and intra-stent neointima (45%). From 4 months to late follow-up, paired IVUS analysis demonstrated complete stent degradation with durability of the 4-month IVUS indexes. The neointima was reduced by 3.6 +/- 5.2 mm(3), with an increase in the stent cross sectional area of 0.5 +/- 1.0 mm(2) (p = NS). The median in-stent minimal lumen diameter was increased from 1.87 to 2.17 mm at long-term follow-up. The median angiographic late loss was reduced from 0.62 to 0.40 mm by quantitative coronary angiography from 4 months to late follow-up.
CONCLUSIONS: Intravascular ultrasound imaging supports the safety profile of AMS with degradation at 4 months and maintains durability of the results without any early or late adverse findings. Slower degradation is warranted to provide sufficient radial force to improve long-term patency rates of the AMS.
Authors:
Ron Waksman; Raimund Erbel; Carlo Di Mario; Jozef Bartunek; Bernard de Bruyne; Franz R Eberli; Paul Erne; Michael Haude; Mark Horrigan; Charles Ilsley; Dirk Böse; Hans Bonnier; Jacques Koolen; Thomas F Lüscher; Neil J Weissman;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  2     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-05-25     Completed Date:  2009-08-03     Revised Date:  2014-09-05    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  312-20     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Absorbable Implants*
Aged
Alloys*
Angioplasty, Balloon, Coronary / adverse effects,  instrumentation*
Coronary Angiography*
Coronary Artery Disease / radiography,  therapy*,  ultrasonography
Coronary Restenosis / etiology,  prevention & control*,  radiography,  ultrasonography
District of Columbia
Feasibility Studies
Female
Humans
Magnesium*
Male
Middle Aged
Prospective Studies
Prosthesis Design
Stents*
Time Factors
Treatment Outcome
Tunica Intima / radiography,  ultrasonography
Ultrasonography, Interventional*
United States
Victoria
Chemical
Reg. No./Substance:
0/Alloys; I38ZP9992A/Magnesium

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


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