| A randomised comparison of novolimus-eluting and zotarolimus-eluting coronary stents: 9-month follow-up results of the EXCELLA II study. | |
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MedLine Citation:
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PMID: 20562069 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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AIMS: Novolimus, a macrocyclic lactone with anti-proliferative properties, has a similar efficacy to currently available agents; however it requires a lower dose, and less polymer, and is therefore conceivably safer. METHODS AND RESULTS: The EXCELLA II study was a prospective, multicentre, single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardial vessels in a ratio of 2:1 to treatment with either the Elixir DESyne Novolimus Eluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA) or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA, USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-months follow-up. In-stent percent volume obstruction (%VO) was measured in a?sub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up. Clinical secondary endpoints included a device orientated composite of cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, the in-stent LLL was 0.11+/-0.32 mm in the NES arm, as compared to 0.63+/-0.42 mm in the ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was 4.5+/-5.1% and 20.9+/-11.3% for NES and ZES, respectively (p<0.001). There was no significant difference between stent groups in the device orientated composite endpoint (NES 2.9% vs. ZES 5.6%, -2.8% [-8.8%, 3.3%], p=0.45) or its individual components of cardiac death, target vessel MI and CI-TLR. CONCLUSIONS: This non-inferiority randomised study not only met its primary endpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL. |
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Authors:
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Patrick W Serruys; Scot Garg; Alexandre Abizaid; John Ormiston; Stephan Windecker; Stefan Verheye; Christophe Dubois; Jim Stewart; Karl E Hauptmann; Joachim Schofer; Karl Stangl; Bernhard Witzenbichler; Marcus Wiemer; Emanuele Barbato; Ton de Vries; Anne-Marie den Drijver; Hiromasa Otake; Lynn Meredith; Sara Toyloy; Peter Fitzgerald |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
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: 6 ISSN: 1969-6213 ISO Abbreviation: EuroIntervention Publication Date: 2010 Jun |
Date Detail:
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Created Date: 2010-06-21 Completed Date: 2010-12-02 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: 195-205 Citation Subset: IM |
Affiliation:
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Erasmus Medisch Centrum, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Coronary Artery Disease
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therapy* Drug-Eluting Stents* Female Follow-Up Studies Humans Macrolides / administration & dosage* Male Middle Aged Prospective Studies Single-Blind Method Sirolimus / administration & dosage, analogs & derivatives* Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Macrolides; 0/novolimus; 0/zotarolimus; 53123-88-9/Sirolimus |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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