| Early- and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries. | |
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MedLine Citation:
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PMID: 19463443 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Clinical Trial; Journal Article; Multicenter Study |
Journal Detail:
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Title: JACC. Cardiovascular interventions Volume: 2 ISSN: 1876-7605 ISO Abbreviation: JACC Cardiovasc Interv Publication Date: 2009 Apr |
Date Detail:
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Created Date: 2009-05-25 Completed Date: 2009-08-03 Revised Date: 2012-08-29 |
Medline Journal Info:
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Nlm Unique ID: 101467004 Medline TA: JACC Cardiovasc Interv Country: United States |
Other Details:
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Languages: eng Pagination: 312-20 Citation Subset: IM |
Affiliation:
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Division of Cardiology, Washington Hospital Center, Washington, DC 20010, USA. ron.waksman@medstar.net |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Alloys; 7439-95-4/Magnesium |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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