Document Detail


Two-year follow-up of the Genous™ endothelial progenitor cell capturing stent versus the Taxus Liberté stent in patients with de novo coronary artery lesions with a high-risk of restenosis: A randomized, single-center, pilot study.
MedLine Citation:
PMID:  21542109     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: In the prospective randomized TRIAS pilot study, the bio-engineered Genous™ endothelial progenitor cell capturing stent was compared with the Taxus Liberté(TM) -SR paclitaxel-eluting stent. At 1 year, a statistically non-significant difference in the rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) was observed. We have evaluated the safety and efficacy up to 2 years. METHODS: A total of 193 patients with de novo coronary artery lesions carrying a high risk of restenosis were randomized to a Genous stent versus a Taxus stent. Dual antiplatelet therapy was prescribed for ≥ 1 month after Genous stent implantation and for ≥ 6 months after a Taxus stent. RESULTS: Between 1 and 2 years, patients treated with the Genous stent tended to have fewer episodes of target lesion revascularization (2.0% versus 5.3%), but nearly similar rates of cardiac death (1.0% versus 0%), myocardial infarction (0% versus 1.1%) and stent thrombosis (0% versus 1.1%) when compared with the Taxus stent. As a result, at 2-year follow-up treatment with the Genous stent compared with the Taxus stent resulted in a non-significant difference in target vessel failure (TVR) (20.4% versus 15.8%; risk difference 4.6%, 95%CI -6.2% - 15.5%). No stent thrombosis was observed in the Genous group compared to 5 cases (in 4 patients) in the Taxus group, resulting in a difference as compared with the Taxus stent (risk difference -4.2%; 95%CI -8.2% - -0.2%). CONCLUSIONS: In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a non-significant difference of TVR at 2-year follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 years. Stent thrombosis was only observed after Taxus stent implantation © 2011 Wiley-Liss, Inc.
Authors:
Marcel Am Beijk; Margo Klomp; Nan van Geloven; Karel T Koch; José Ps Henriques; Jan Baan; Marije M Vis; Jan Gp Tijssen; Jan J Piekmd; Robbert J de Winter
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-5-3
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  -     ISSN:  1522-726X     ISO Abbreviation:  -     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-5-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 Wiley-Liss, Inc.
Affiliation:
Department of Cardiology, Academic Medical Center - University of Amsterdam, the Netherlands. m.a.beijk@amc.uva.nl.
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