Document Detail


Late clinical events after drug-eluting stents: the interplay between stent-related and natural history-driven events.
MedLine Citation:
PMID:  19539253     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We evaluated the relative contributions of drug-eluting stent-specific and background natural history-driven causes for adverse clinical events between 1 and 5 years, in the paclitaxel-eluting stent (PES) and bare-metal stent (BMS) cohorts of the TAXUS randomized clinical trial program.
BACKGROUND: Prior studies have demonstrated that clinical events in the first year after BMS are predominantly stent-related but thereafter tend to be driven more by atherosclerotic activity outside the stented segment. It is not known whether the same is true for PES.
METHODS: Annualized hazard rates (HRs) were calculated for major adverse events in 1,400 TAXUS and 1,397 BMS patients from the randomized and blinded TAXUS I, II, IV, and V trials (median 4.8-year follow-up).
RESULTS: Although target vessel revascularization (TVR) during the first year was driven by target lesion revascularization (TLR), TVR after 1 year involved similar numbers of TLR and non-TLR events. Moreover, the annualized HR for non-target lesion TVR and other major adverse events (including death, myocardial infarction, and stent thrombosis) were relatively constant beyond 1 year and not significantly different between PES and BMS.
CONCLUSIONS: The low and similar late HR for many of the observed late events after BMS and PES suggests that many of the late events after PES reflect background disease activity outside the stented segment rather than stent-related events per se. Analyses of long-term drug-eluting stent outcomes should recognize and attempt to correct for this background event rate by using suitable BMS control subjects.
Authors:
Martin B Leon; Dominic J Allocco; Keith D Dawkins; Donald S Baim
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  2     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-22     Completed Date:  2009-08-27     Revised Date:  2012-08-29    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  504-12     Citation Subset:  IM    
Affiliation:
Center for Interventional Vascular Therapy, Columbia University Medical Center, Herbert Irving Pavilion, New York, NY 10032, USA. mleon@crf.org
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MeSH Terms
Descriptor/Qualifier:
Angioplasty, Balloon, Coronary / adverse effects,  instrumentation*,  mortality
Cardiovascular Agents / administration & dosage*
Coronary Artery Disease / mortality,  therapy*
Coronary Restenosis / etiology,  prevention & control
Disease Progression
Double-Blind Method
Drug-Eluting Stents*
Humans
Metals*
Myocardial Infarction / etiology,  prevention & control
Paclitaxel / administration & dosage*
Platelet Aggregation Inhibitors / therapeutic use
Proportional Hazards Models
Prosthesis Design
Risk Assessment
Risk Factors
Stents*
Thrombosis / etiology,  prevention & control
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Cardiovascular Agents; 0/Metals; 0/Platelet Aggregation Inhibitors; 33069-62-4/Paclitaxel
Comments/Corrections
Comment In:
JACC Cardiovasc Interv. 2009 Jun;2(6):513-4   [PMID:  19539254 ]

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


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