Document Detail

Clinical outcomes after unrestricted implantation of everolimus-eluting stents.
MedLine Citation:
PMID:  20129548     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of unrestricted everolimus-eluting stent (EES) implantation in a contemporary cohort of real-world patients.
BACKGROUND: The randomized SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials have evaluated the performance of EES, resulting in their approval by the Food and Drug Administration, but data regarding unselected usage, including off-label indications are lacking.
METHODS: Consecutive patients treated with EES (either PROMUS, Boston Scientific Corp., Natick, Massachusetts, or XIENCE-V, Abbott Vascular Devices, Santa Clara, California) between October 2006 and February 2008 were analyzed. End points were cardiac death, myocardial infarction (MI), ischemic-driven target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE) (a composite of cardiac death, MI, TLR) during follow-up.
RESULTS: We identified 345 patients (573 lesions) treated with EES. The majority of patients (71.9%) were treated for > or =1 off-label or untested indication. Clinical follow-up was completed in 99%. At a median follow-up of 378 days (interquartile range 334 to 473), MACE occurred in 36 (10.6%) patients, TLR in 27 (7.9%), MI in 7 (2.1%), and cardiac death in 7 (2.1%). Definite and probable ST was observed in 3 (0.9%) cases. Off-label EES implantation was not associated with a statistically significant increased risk of MACE (12.2% vs. 6.3%, p = 0.17), TLR (9.3% vs. 4.2%, p = 0.18), or ST (0.8% vs. 1.1%, p = 1.0). On multivariable analysis, previous bypass surgery (p = 0.002) and diabetes (p = 0.03) were associated with MACE.
CONCLUSIONS: In unrestricted daily practice, EES were implanted predominantly for off-label indications and associated with a relative low rate of MACE and TLR.
Azeem Latib; Luca Ferri; Alfonso Ielasi; Cosmo Godino; Alaide Chieffo; Valeria Magni; Giorgio Bassanelli; Andrew S P Sharp; Robert Gerber; Iassen Michev; Mauro Carlino; Flavio Airoldi; Giuseppe M Sangiorgi; Matteo Montorfano; Antonio Colombo
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  2     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2010-02-04     Completed Date:  2010-04-22     Revised Date:  2014-09-05    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1219-26     Citation Subset:  IM    
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MeSH Terms
Angioplasty, Balloon, Coronary / adverse effects,  instrumentation*,  mortality
Cardiovascular Agents / administration & dosage*
Chi-Square Distribution
Coronary Artery Disease / mortality,  therapy*
Drug-Eluting Stents*
Kaplan-Meier Estimate
Logistic Models
Middle Aged
Myocardial Infarction / etiology
Practice Guidelines as Topic
Retrospective Studies
Risk Assessment
Risk Factors
Sirolimus / administration & dosage,  analogs & derivatives*
Thrombosis / etiology
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Cardiovascular Agents; 159351-69-6/everolimus; W36ZG6FT64/Sirolimus
Comment In:
JACC Cardiovasc Interv. 2009 Dec;2(12):1236-9   [PMID:  20129550 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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