Document Detail


A randomised comparison of novolimus-eluting and zotarolimus-eluting coronary stents: 9-month follow-up results of the EXCELLA II study.
MedLine Citation:
PMID:  20562069     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
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:
Created Date:  2010-06-21     Completed Date:  2010-12-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  195-205     Citation Subset:  IM    
Affiliation:
Erasmus Medisch Centrum, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
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MeSH Terms
Descriptor/Qualifier:
Coronary Artery Disease / 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:
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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