Document Detail

Real world safety and efficacy of the Janus Tacrolimus-Eluting stent: long-term clinical outcome and angiographic findings from the Tacrolimus-Eluting STent (TEST) registry.
MedLine Citation:
PMID:  19156896     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: We sought to evaluate the safety and performance of the Janus Tacrolimus-Eluting stent (TES) in an unselected population of patients, without application of restrictive clinical or angiographic criteria. BACKGROUND: Continued attention to the safety, efficacy, and deliverability of first-generation drug eluting stents has led to the development of new antiproliferative agents with alternative stent platforms and different drug carrier vehicles. METHODS: The TEST (Tacrolimus Eluting STent) registry is a prospective, nonrandomized single-center registry in which 140 consecutive patients who underwent single- or multi-vessel percutaneous coronary intervention between February 2005 and August 2005 were enrolled. RESULTS: The composite rate of major adverse cardiac events (MACE) at 22 months clinical follow-up was 40.9%. The rate of mortality, myocardial infarction, and target lesion revascularization (TLR) were 5.5%, 11%, and 31.5%, respectively. Angiographic follow-up at 8 months was achieved in 74% of patients; binary restenosis occurred in 39.4% of lesions. Most restenosis lesions (94.6%) had a diffuse pattern, while focal restenosis was observed in 5.4% of cases. Definite or probable stent thrombosis was observed in 2.4% of patients. CONCLUSIONS: The present prospective, nonrandomized, TEST registry indicated high MACE and restenosis rates, and thereby rather discouraging long-term outcomes with use of the Janus TES in an unselected "real world" population of patients who underwent single- or multi-vessel percutaneous coronary intervention.
Corrado Tamburino; Maria Elena Di Salvo; Davide Capodanno; Piera Capranzano; Rosario Parisi; Francesca Mirabella; Francesco Scardaci; Gianpaolo Ussia; Alfredo Ruggero Galassi; Damiana Fiscella; Roxana Mehran; George Dangas
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  73     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-01-28     Completed Date:  2009-03-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  243-8     Citation Subset:  IM    
Copyright Information:
(c) 2009 Wiley-Liss, Inc.
Division of Cardiology, Department of Cardiovascular Diseases, Ferrarotto Hospital, University of Catania, Italy.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary / adverse effects,  instrumentation*,  mortality
Cardiovascular Agents / administration & dosage*
Coronary Angiography*
Coronary Restenosis / etiology,  mortality,  prevention & control*,  radiography
Coronary Stenosis / mortality,  radiography,  therapy*
Drug-Eluting Stents*
Kaplan-Meiers Estimate
Middle Aged
Myocardial Infarction / etiology,  mortality,  prevention & control*,  radiography
Prospective Studies
Prosthesis Design
Risk Assessment
Tacrolimus / administration & dosage*
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Cardiovascular Agents; 109581-93-3/Tacrolimus
Comment In:
Catheter Cardiovasc Interv. 2009 Feb 1;73(2):249-50   [PMID:  19156897 ]

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