| Relationship of late loss in lumen diameter to coronary restenosis in sirolimus-eluting stents. | |
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MedLine Citation:
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PMID: 15655127 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Comparative Study; Journal Article Date: 2005-01-17 |
Journal Detail:
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Title: Circulation Volume: 111 ISSN: 1524-4539 ISO Abbreviation: Circulation Publication Date: 2005 Jan |
Date Detail:
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Created Date: 2005-01-25 Completed Date: 2005-06-22 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0147763 Medline TA: Circulation Country: United States |
Other Details:
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Languages: eng Pagination: 321-7 Citation Subset: AIM; IM |
Affiliation:
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Brigham and Women's Hospital, Boston, Mass 02116, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Coronary Restenosis
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diagnosis*,
pathology,
prevention & control Follow-Up Studies Humans Probability Prognosis Randomized Controlled Trials as Topic Regression Analysis Sirolimus / therapeutic use* Stents* |
| Chemical | |
Reg. No./Substance:
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53123-88-9/Sirolimus |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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