Document Detail


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.
MedLine Citation:
PMID:  21062998     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-11-09
Journal Detail:
Title:  Circulation. Cardiovascular interventions     Volume:  3     ISSN:  1941-7632     ISO Abbreviation:  Circ Cardiovasc Interv     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-12-15     Completed Date:  2011-03-31     Revised Date:  2011-04-29    
Medline Journal Info:
Nlm Unique ID:  101499602     Medline TA:  Circ Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  556-64     Citation Subset:  IM    
Affiliation:
North Shore Hospital, Auckland, New Zealand. johno@mercyangiography.co.nz
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00606333
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MeSH Terms
Descriptor/Qualifier:
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:
33069-62-4/Paclitaxel; 53123-88-9/Sirolimus
Comments/Corrections
Erratum In:
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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