| Clinical outcomes after unrestricted implantation of everolimus-eluting stents. | |
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MedLine Citation:
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PMID: 20129548 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article |
Journal Detail:
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Title: JACC. Cardiovascular interventions Volume: 2 ISSN: 1876-7605 ISO Abbreviation: JACC Cardiovasc Interv Publication Date: 2009 Dec |
Date Detail:
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Created Date: 2010-02-04 Completed Date: 2010-04-22 Revised Date: 2012-08-29 |
Medline Journal Info:
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Nlm Unique ID: 101467004 Medline TA: JACC Cardiovasc Interv Country: United States |
Other Details:
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Languages: eng Pagination: 1219-26 Citation Subset: IM |
Affiliation:
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Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angioplasty, Balloon, Coronary / adverse effects, instrumentation*, mortality Cardiovascular Agents / administration & dosage* Chi-Square Distribution Coronary Artery Disease / mortality, therapy* Drug-Eluting Stents* Female Humans Kaplan-Meier Estimate Logistic Models Male Middle Aged Myocardial Infarction / etiology Practice Guidelines as Topic Registries Retrospective Studies Risk Assessment Risk Factors Sirolimus / administration & dosage, analogs & derivatives* Thrombosis / etiology Time Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Cardiovascular Agents; 159351-69-6/everolimus; 53123-88-9/Sirolimus |
| Comments/Corrections | |
Comment In:
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JACC Cardiovasc Interv. 2009 Dec;2(12):1236-9
[PMID:
20129550
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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