| Long-term evaluation of paclitaxel-coated stents for treatment of native coronary lesions. First results of both the clinical and angiographic 18 month follow-up of TAXUS I. | |
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MedLine Citation:
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PMID: 14579046 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The development of restenoses due to tissue proliferation within the stented segment is a major limitation of conventional stent implantations. Recently published studies have shown that drug-eluting stents effectively decrease the incidence of stent restenosis at 6 month follow-up as compared to bare metal stents. However, a persistent efficacy of this stent design beyond the 6 month period still needs to be proven. Therefore, in this study, we are demonstrating the first 18 month follow-up results of a Paclitaxel-coated coronary stent, based on the patient population of the TAXUS I study, a multicenter randomized study to evaluate both safety and efficacy of the Paclitaxel-coated NIRx stent as compared to an uncoated, bare metal stent. In this study we evaluated the long-term outcome of NIRx patients of our center, in which 20 out of 31 patients of the TAXUS I study with NIRx stent implantation have been enrolled. A clinical follow-up was available in 20 out of 20 patients (100%) 535 +/- 82 days post stent implantation (17.8 months). An angiographic follow-up was available in 14 out of 20 patients (70%) 580 +/- 77 days post stent implantation (19.1 months). The MACE rate at 18 month follow-up was 0.0%. There was no stent restenosis in the study group up to 18 month post drug-eluting stent implantation. There was one non-clinically driven target vessel revascularization due to a stent edge lumen renarrowing, which was subsequently calculated as a 43% diameter stenosis. Accordingly, this event was not regarded as MACE. The IVUS analysis of the study population has shown a decrease of the mean minimum lumen area from 8.45 mm(2) postinterventional to 6.87 mm(2) at 6 month follow-up with a relative mean maximum plaque area of 16%. At 18 month follow-up, there were no additional significant changes with a mean minimum lumen area of 7.16 mm(2) and a relative mean maximum plaque area of 13.4%. The reported results of the 18 month follow-up of TAXUS I are the first experiences demonstrating a persistent benefit of the Paclitaxel-coated NIRx stent. Therefore, this stent design seems to be safe and effective, even in long-term follow-up. |
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Authors:
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L Büllesfeld; U Gerckens; R Müller; E Grube |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Zeitschrift für Kardiologie Volume: 92 ISSN: 0300-5860 ISO Abbreviation: Z Kardiol Publication Date: 2003 Oct |
Date Detail:
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Created Date: 2003-10-27 Completed Date: 2004-05-04 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0360430 Medline TA: Z Kardiol Country: Germany |
Other Details:
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Languages: eng Pagination: 825-32 Citation Subset: IM |
Affiliation:
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Abt. für Kardiologie/Angiologie, Krankenhaus and Herzzentrum Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. LBuellesfeld@gmx.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angioplasty, Transluminal, Percutaneous Coronary / instrumentation* Antineoplastic Agents, Phytogenic* Coated Materials, Biocompatible* Coronary Angiography Coronary Restenosis / diagnosis, prevention & control* Coronary Stenosis / diagnosis, therapy* Feasibility Studies Female Follow-Up Studies Germany Humans Male Middle Aged Paclitaxel* Stents* Treatment Outcome Ultrasonography, Interventional |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents, Phytogenic; 0/Coated Materials, Biocompatible; 33069-62-4/Paclitaxel |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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