Document Detail

Late loss in lumen diameter and binary restenosis for drug-eluting stent comparison.
MedLine Citation:
PMID:  15967844     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Published rates of coronary restenosis have fallen below 10% in drug-eluting stent trials. Early evaluations of new stents have used continuous end points that are presumed surrogates for restenosis, but the generalizability and power of such end points have not been examined systematically. METHODS AND RESULTS: We examined the relationship between incremental changes in observed late loss in lumen diameter and the probability of restenosis using reported late loss from 22 published trials of various types of stents (bare-metal, drug-eluting, and small-vessel stents). Next, the power of late loss differences was compared with that of corresponding binary restenosis rates. The relationship between mean late loss and its SD was linear and did not vary with stent type (drug-eluting or bare-metal) or vessel diameter. At all levels of late loss examined (0 to 1 mm), incremental changes were associated with increasing restenosis risk (with an increasing magnitude of effect at higher levels of late loss). The power to detect a treatment effect was greater for late loss than for binary angiographic restenosis (> or =32% relative increase in power, > or =24% absolute increase for late loss between 0.2 and 0.6 mm). CONCLUSIONS: Late loss is monotonically related to restenosis risk in published stent trials. It is a generalizable and powerful angiographic end point in early or small trials of new drug-eluting stents.
Laura Mauri; E John Orav; Richard E Kuntz
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Publication Detail:
Type:  Comparative Study; Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't     Date:  2005-06-20
Journal Detail:
Title:  Circulation     Volume:  111     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2005 Jun 
Date Detail:
Created Date:  2005-06-28     Completed Date:  2006-02-03     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3435-42     Citation Subset:  AIM; IM    
Brigham and Women's Hospital and Harvard Medical School, Boston, Mass 02116, USA.
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MeSH Terms
Clinical Trials as Topic / statistics & numerical data
Coronary Angiography
Coronary Restenosis / diagnosis*,  pathology
Coronary Vessels / pathology*
Pharmaceutical Preparations / administration & dosage
Predictive Value of Tests
Risk Factors
Stents / adverse effects*
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Pharmaceutical Preparations
Comment In:
Circulation. 2005 Dec 13;112(24):e358; author reply e358   [PMID:  16344394 ]

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