Serveur d'exploration sur les relations entre la France et l'Australie

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Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II).

Identifieur interne : 002637 ( PubMed/Curation ); précédent : 002636; suivant : 002638

Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II).

Auteurs : Yuki Ishibashi [Pays-Bas] ; Shimpei Nakatani [Pays-Bas] ; Yohei Sotomi [Pays-Bas] ; Pannipa Suwannasom [Thaïlande] ; Maik J. Grundeken [Pays-Bas] ; Hector M. Garcia-Garcia [Pays-Bas] ; Antonio L. Bartorelli [Italie] ; Robert Whitbourn [Australie] ; Bernard Chevalier [France] ; Alexandre Abizaid [Brésil] ; John A. Ormiston [Nouvelle-Zélande] ; Richard J. Rapoza [États-Unis] ; Susan Veldhof [Belgique] ; Yoshinobu Onuma [Pays-Bas] ; Patrick W. Serruys [Royaume-Uni]

Source :

RBID : pubmed:26585622

Descripteurs français

English descriptors

Abstract

This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax).

DOI: 10.1016/j.jcin.2015.07.026
PubMed: 26585622

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pubmed:26585622

Le document en format XML

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<front>
<div type="abstract" xml:lang="en">This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax).</div>
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<Year>2015</Year>
<Month>11</Month>
<Day>20</Day>
</DateCreated>
<DateCompleted>
<Year>2016</Year>
<Month>09</Month>
<Day>13</Day>
</DateCompleted>
<DateRevised>
<Year>2016</Year>
<Month>11</Month>
<Day>26</Day>
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<Volume>8</Volume>
<Issue>13</Issue>
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<Year>2015</Year>
<Month>Nov</Month>
</PubDate>
</JournalIssue>
<Title>JACC. Cardiovascular interventions</Title>
<ISOAbbreviation>JACC Cardiovasc Interv</ISOAbbreviation>
</Journal>
<ArticleTitle>Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II).</ArticleTitle>
<Pagination>
<MedlinePgn>1715-26</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jcin.2015.07.026</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S1936-8798(15)01294-7</ELocationID>
<Abstract>
<AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax).</AbstractText>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">A total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Of 1,248 patients, pre-procedural Dmax was assessed in 1,232 patients (98.7%). In 649 (52.7%) patients, both proximal and distal Dmax values were smaller than the nominal size of the implanted scaffold (scaffold oversize group), whereas in 583 (47.3%) of patients, the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold nonoversize group (MACE 6.6% vs. 3.3%; log-rank p < 0.01, all MI: 4.6% vs. 2.4%; log-rank p = 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% vs. 1.9%; p = 0.08). The independent MACE determinants were both Dmax smaller than the scaffold nominal size (odds ratio [OR]: 2.13, 95% confidence interval [CI]: 1.22 to 3.70; p < 0.01) and the implantation of overlapping scaffolds (OR: 2.10, 95% CI: 1.17 to 3.80; p = 0.01).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Implantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI. (ABSORB Clinical Investigation, Cohort B [ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND], NCT01023789; ABSORB II Randomized Controlled Trial [ABSORB II], NCT01425281).</AbstractText>
<CopyrightInformation>Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Ishibashi</LastName>
<ForeName>Yuki</ForeName>
<Initials>Y</Initials>
<AffiliationInfo>
<Affiliation>Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Nakatani</LastName>
<ForeName>Shimpei</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sotomi</LastName>
<ForeName>Yohei</ForeName>
<Initials>Y</Initials>
<AffiliationInfo>
<Affiliation>Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Suwannasom</LastName>
<ForeName>Pannipa</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Northern Region Heart Center, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Grundeken</LastName>
<ForeName>Maik J</ForeName>
<Initials>MJ</Initials>
<AffiliationInfo>
<Affiliation>Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Garcia-Garcia</LastName>
<ForeName>Hector M</ForeName>
<Initials>HM</Initials>
<AffiliationInfo>
<Affiliation>Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bartorelli</LastName>
<ForeName>Antonio L</ForeName>
<Initials>AL</Initials>
<AffiliationInfo>
<Affiliation>Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Whitbourn</LastName>
<ForeName>Robert</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>St. Vincent's Hospital, Fitzroy, Victoria, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Chevalier</LastName>
<ForeName>Bernard</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>Institut Cardiovasculaire Paris Sud, Massy, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Abizaid</LastName>
<ForeName>Alexandre</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Instituto de Cardiologia Dante Pazzanese, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ormiston</LastName>
<ForeName>John A</ForeName>
<Initials>JA</Initials>
<AffiliationInfo>
<Affiliation>Auckland City Hospital, Auckland, New Zealand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Rapoza</LastName>
<ForeName>Richard J</ForeName>
<Initials>RJ</Initials>
<AffiliationInfo>
<Affiliation>Abbott Vascular, Santa Clara, California.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Veldhof</LastName>
<ForeName>Susan</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Abbott Vascular, Diegem, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Onuma</LastName>
<ForeName>Yoshinobu</ForeName>
<Initials>Y</Initials>
<AffiliationInfo>
<Affiliation>Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: yoshinobuonuma@gmail.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Serruys</LastName>
<ForeName>Patrick W</ForeName>
<Initials>PW</Initials>
<AffiliationInfo>
<Affiliation>International Centre for Cardiovascular Health, Imperial College, London, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y">
<DataBank>
<DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList>
<AccessionNumber>NCT00856856</AccessionNumber>
<AccessionNumber>NCT01023789</AccessionNumber>
<AccessionNumber>NCT01425281</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList>
<PublicationType UI="D003160">Comparative Study</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
</Article>
<MedlineJournalInfo>
<Country>United States</Country>
<MedlineTA>JACC Cardiovasc Interv</MedlineTA>
<NlmUniqueID>101467004</NlmUniqueID>
<ISSNLinking>1936-8798</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D020341" MajorTopicYN="Y">Absorbable Implants</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D017023" MajorTopicYN="Y">Coronary Angiography</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D003324" MajorTopicYN="N">Coronary Artery Disease</DescriptorName>
<QualifierName UI="Q000000981" MajorTopicYN="N">diagnostic imaging</QualifierName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D003331" MajorTopicYN="N">Coronary Vessels</DescriptorName>
<QualifierName UI="Q000000981" MajorTopicYN="Y">diagnostic imaging</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016015" MajorTopicYN="N">Logistic Models</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015999" MajorTopicYN="N">Multivariate Analysis</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009203" MajorTopicYN="N">Myocardial Infarction</DescriptorName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016017" MajorTopicYN="N">Odds Ratio</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D062645" MajorTopicYN="N">Percutaneous Coronary Intervention</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000295" MajorTopicYN="Y">instrumentation</QualifierName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011237" MajorTopicYN="N">Predictive Value of Tests</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011474" MajorTopicYN="N">Prosthesis Design</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">bioresorbable scaffold</Keyword>
<Keyword MajorTopicYN="N">major adverse cardiac event(s)</Keyword>
<Keyword MajorTopicYN="N">maximal lumen diameter</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData>
<History>
<PubMedPubDate PubStatus="received">
<Year>2015</Year>
<Month>06</Month>
<Day>01</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2015</Year>
<Month>07</Month>
<Day>21</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2015</Year>
<Month>07</Month>
<Day>30</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2015</Year>
<Month>11</Month>
<Day>21</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed">
<Year>2015</Year>
<Month>11</Month>
<Day>21</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline">
<Year>2016</Year>
<Month>9</Month>
<Day>14</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">26585622</ArticleId>
<ArticleId IdType="pii">S1936-8798(15)01294-7</ArticleId>
<ArticleId IdType="doi">10.1016/j.jcin.2015.07.026</ArticleId>
</ArticleIdList>
</PubmedData>
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