| Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study. | |
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MedLine Citation:
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PMID: 23339805 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Aims: To report the four-month and nine-month angiographic results as well as one-year clinical follow-up from the first-in-man study with the silicon carbide and sirolimus-eluting bioabsorbable polymer (poly-L-lactic acid (PLLA) polymer) -coated cobalt-chromium Orsiro stent. Methods and results: A group of 30 patients with documented myocardial ischaemia related to a single de novo coronary stenosis up to 22 mm in length, in vessels with a 2.5 to 3.5 mm reference diameter, and between >50% and <90% diameter stenosis were enrolled at two sites. The primary endpoint of the study was in-stent late lumen loss at nine months. The secondary endpoints included major adverse cardiac events (MACE) at one year defined as the composite of cardiac death, ischaemia-driven target lesion revascularisation (TLR) and target vessel myocardial infarction (MI). Procedural success was 100%. Angiographic late lumen loss was 0.12±0.19 mm and 0.05±0.22 mm at four and nine months respectively. At one-year clinical follow-up, the composite MACE was 10% with one patient who died from cardiac death and two patients who had ischaemia-driven target lesion revascularisation. There was no report of MI or stent thrombosis. Conclusions: The Orsiro drug-eluting stent demonstrated potency with low rates of in-stent neointimal hyperplasia and cardiovascular events but warrants further evaluation in a larger population cohort with longer follow-up time points. |
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Authors:
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Martial Hamon; Rodica Niculescu; Dan Deleanu; Maria Dorobantu; Neil J Weissman; Ron Waksman |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology Volume: 8 ISSN: 1969-6213 ISO Abbreviation: EuroIntervention Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-01-23 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101251040 Medline TA: EuroIntervention Country: France |
Other Details:
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Languages: eng Pagination: 1006-11 Citation Subset: IM |
Affiliation:
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Centre Hospitalier Universitaire de Caen, Caen, France. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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