| MAHOROBA, first-in-man study: 6-month results of a biodegradable polymer sustained release tacrolimus-eluting stent in de novo coronary stenoses. | |
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MedLine Citation:
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PMID: 19406868 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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AIMS: To report the 4-month angiographic and 6-month clinical follow-up in first-in-man study using the tacrolimus-eluting bioabsorbable polymer-coated cobalt-chromium MAHOROBA stent. METHODS AND RESULTS: A total of 47 patients with either stable angina or unstable angina, or silent myocardial ischaemia, based on a de novo coronary stenosis that could be covered by a single 18 mm stent in a native coronary artery with a diameter between 3.0 and 3.5 mm were enrolled at three sites. The primary endpoint was in-stent late loss at 4 months. The secondary endpoints include %volume obstruction of the stents assessed by intravascular ultrasound (IVUS) at 4 months and major adverse cardiac events (MACE) at 6 months. Forty-seven patients were enrolled. Procedural success was achieved in 97.9%. At 4-month follow-up, in-stent late loss was 0.99 +/- 0.46 mm, whereas in-stent %volume obstruction in IVUS was 34.8 +/- 15.8%. At 6 months, there were no deaths, but 2 patients suffered from a myocardial infarction and 11 patients required ischaemia-driven repeat revascularization. The composite MACE rate was 23.4%. CONCLUSION: This tacrolimus-eluting stent failed to prevent neointimal hyperplasia, despite the theoretical advantages of the tacrolimus, which has less inhibitory effects on endothelial cells than smooth muscle cells. |
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Authors:
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Yoshinobu Onuma; Patrick Serruys; Peter den Heijer; Kaiyum Sheik Joesoef; Henricus Duckers; Evelyn Regar; Neville Kukreja; Shuzou Tanimoto; Hector M Garcia-Garcia; Heleen van Beusekom; Willem van der Giessen; Takuji Nishide |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't Date: 2009-04-30 |
Journal Detail:
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Title: European heart journal Volume: 30 ISSN: 1522-9645 ISO Abbreviation: Eur. Heart J. Publication Date: 2009 Jun |
Date Detail:
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Created Date: 2009-06-15 Completed Date: 2009-07-28 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8006263 Medline TA: Eur Heart J Country: England |
Other Details:
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Languages: eng Pagination: 1477-85 Citation Subset: IM |
Affiliation:
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Thoraxcenter, Erasmus Medical Center, Ba-583, s-Gravendijkwal 230, Rotterdam, The Netherlands. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Absorbable Implants* Aged Angioplasty, Transluminal, Percutaneous Coronary / methods Coronary Angiography Coronary Stenosis / mortality, therapy* Drug-Eluting Stents / adverse effects* Feasibility Studies Female Humans Hyperplasia / prevention & control Immunosuppressive Agents / therapeutic use* Male Middle Aged Prospective Studies Tacrolimus / therapeutic use* Thrombosis / mortality, prevention & control* Time Factors Treatment Outcome Tunica Intima / pathology Ultrasonography, Interventional |
| Chemical | |
Reg. No./Substance:
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0/Immunosuppressive Agents; 109581-93-3/Tacrolimus |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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