Document Detail

Long-term impact of routinely detected early and late incomplete stent apposition: an integrated intravascular ultrasound analysis of the TAXUS IV, V, and VI and TAXUS ATLAS workhorse, long lesion, and direct stent studies.
MedLine Citation:
PMID:  20488404     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events.
BACKGROUND: The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable.
METHODS: We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials.
RESULTS: There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis.
CONCLUSIONS: Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up.
Daniel H Steinberg; Gary S Mintz; Lazar Mandinov; Alan Yu; Steven G Ellis; Eberhard Grube; Keith D Dawkins; John Ormiston; Mark A Turco; Gregg W Stone; Neil J Weissman
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  3     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-05-21     Completed Date:  2010-08-30     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:  486-94     Citation Subset:  IM    
Copyright Information:
Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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MeSH Terms
Angioplasty, Balloon, Coronary / adverse effects,  instrumentation*
Cardiovascular Agents / administration & dosage*
Cardiovascular Diseases / etiology,  radiography,  ultrasonography*
Coronary Angiography
Coronary Restenosis / etiology,  ultrasonography
Double-Blind Method
Drug-Eluting Stents*
Kaplan-Meier Estimate
Middle Aged
Paclitaxel / administration & dosage*
Prospective Studies
Prosthesis Design
Thrombosis / etiology,  ultrasonography
Time Factors
Treatment Outcome
Ultrasonography, Interventional*
Reg. No./Substance:
0/Cardiovascular Agents; 0/Metals; 33069-62-4/Paclitaxel
Comment In:
JACC Cardiovasc Interv. 2010 May;3(5):495-7   [PMID:  20488405 ]

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