| Six-month results of the NEVO Res-Elution I (NEVO RES-I) trial: a randomized, multicenter comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberté paclitaxel-eluting stent in de novo native coronary artery lesions. | |
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MedLine Citation:
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PMID: 21062998 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Drug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis, which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. METHODS AND RESULTS: NEVO ResElution-I was a prospective randomized study in 394 patients with coronary artery disease comparing the NEVO SES with the TAXUS Liberté paclitaxel-eluting coronary stent (TAXUS Liberté PES) stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronary intervention (PCI), the primary end point favored NEVO SES (0.13±0.31 mm versus 0.36±0.48 mm, P<0.001 for noninferiority and superiority). The study was not powered for clinical end points and showed no significant difference for NEVO SES versus TAXUS Liberté PES: death: 0.5 versus 1.6%, P=0.36; myocardial infarction: 2.0 versus 2.6%, P=0.75; target lesion revascularization: 1.5 versus 3.2%, P=0.33; major adverse cardiac events: 4.0 versus 7.4%, P=0.19. No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberté PES. Intravascular ultrasound showed lower percent volume obstruction for NEVO SES (5.5±11% versus 11.5±9.7%, P=0.016). CONCLUSIONS: This trial proved the superiority of NEVO SES over TAXUS Liberté PES for the primary angiographic end point of in-stent late loss. No stent thrombosis occurred in the NEVO SES group. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00606333. |
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Authors:
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John A Ormiston; Alexandre Abizaid; John Spertus; Jean Fajadet; Laura Mauri; Joachim Schofer; Stefan Verheye; Joseph Dens; Leif Thuesen; Christophe Dubois; Rainer Hoffmann; William Wijns; Peter J Fitzgerald; Jeffrey J Popma; Nathalie Macours; Ana Cebrian; Hans-Peter Stoll; Campbell Rogers; Christian Spaulding; |
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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 Date: 2010-11-09 |
Journal Detail:
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Title: Circulation. Cardiovascular interventions Volume: 3 ISSN: 1941-7632 ISO Abbreviation: Circ Cardiovasc Interv Publication Date: 2010 Dec |
Date Detail:
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Created Date: 2010-12-15 Completed Date: 2011-03-31 Revised Date: 2011-04-29 |
Medline Journal Info:
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Nlm Unique ID: 101499602 Medline TA: Circ Cardiovasc Interv Country: United States |
Other Details:
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Languages: eng Pagination: 556-64 Citation Subset: IM |
Affiliation:
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North Shore Hospital, Auckland, New Zealand. johno@mercyangiography.co.nz |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00606333 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angioplasty, Balloon, Coronary* Coronary Angiography Coronary Artery Disease / therapy* Drug-Eluting Stents* Female Humans Male Middle Aged Paclitaxel / administration & dosage* Prospective Studies Single-Blind Method Sirolimus / administration & dosage* Ultrasonography, Interventional |
| Chemical | |
Reg. No./Substance:
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33069-62-4/Paclitaxel; 53123-88-9/Sirolimus |
| Comments/Corrections | |
Erratum In:
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Circ Cardiovasc Interv. 2011 Feb 1;4(1):e4 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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