Document Detail

Relationship of late loss in lumen diameter to coronary restenosis in sirolimus-eluting stents.
MedLine Citation:
PMID:  15655127     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Observed rates of restenosis after drug-eluting stenting are low (<10%). Identification of a reliable and powerful angiographic end point will be useful in future trials. METHODS AND RESULTS: Late loss (postprocedural minimum lumen diameter minus 8-month minimum lumen diameter) was measured in the angiographic cohorts of the SIRIUS (n=703) and E-SIRIUS (n=308) trials. Two techniques, the standard normal approximation and an optimized power transformation, were used to predict binary angiographic restenosis rates and compare them with observed restenosis rates. The mean in-stent late loss observed in the SIRIUS trial was 0.17+/-0.45 mm (sirolimus) versus 1.00+/-0.70 mm (control). If a normal distribution was assumed, late loss accurately estimated in-stent binary angiographic restenosis for the control arm (predicted 35.4% versus observed 35.4%) but underestimated it in the sirolimus arm (predicted 0.6% versus observed 3.2%). Power transformation improved the reliability of the estimate in the sirolimus arm (predicted 3.2% [CI 1.0% to 6.7%]) with similar improvements in the E-SIRIUS trial (predicted 4.0% [CI 1.2% to 7.0%] versus observed 3.9%). In the sirolimus-eluting stent arm, in-stent late loss correlated better with target-lesion revascularization than in-segment late loss (c-statistic=0.915 versus 0.665). CONCLUSIONS: Because distributions of late loss with a low mean are right-skewed, the use of a transformation improves the accuracy of predicting low binary restenosis rates. Late loss is monotonically correlated with the probability of restenosis and yields a more efficient estimate of the restenosis process in the era of lower binary restenosis rates.
Laura Mauri; E John Orav; A James O'Malley; Jeffrey W Moses; Martin B Leon; David R Holmes; Paul S Teirstein; Joachim Schofer; Günter Breithardt; Donald E Cutlip; Dean J Kereiakes; Chunxue Shi; Brian G Firth; Dennis J Donohoe; Richard E Kuntz
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Publication Detail:
Type:  Comparative Study; Journal Article     Date:  2005-01-17
Journal Detail:
Title:  Circulation     Volume:  111     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2005 Jan 
Date Detail:
Created Date:  2005-01-25     Completed Date:  2005-06-22     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  321-7     Citation Subset:  AIM; IM    
Brigham and Women's Hospital, Boston, Mass 02116, USA.
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MeSH Terms
Coronary Restenosis / diagnosis*,  pathology,  prevention & control
Follow-Up Studies
Randomized Controlled Trials as Topic
Regression Analysis
Sirolimus / therapeutic use*
Reg. No./Substance:

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