First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: A Multi-Imaging Modality Study
Identifieur interne : 005C48 ( Main/Exploration ); précédent : 005C47; suivant : 005C49First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: A Multi-Imaging Modality Study
Auteurs : John A. Ormiston [Nouvelle-Zélande] ; Patrick W. Serruys [Pays-Bas] ; Yoshinobu Onuma [Pays-Bas] ; Robert-Jan Van Geuns [Pays-Bas] ; Bernard De Bruyne [Belgique] ; Dariusz Dudek [Pologne] ; Leif Thuesen [Danemark] ; Pieter C. Smits [Pays-Bas] ; Bernard Chevalier [France] ; Dougal Mcclean [Nouvelle-Zélande] ; Jacques Koolen [Pays-Bas] ; Stephan Windecker [Suisse] ; Robert Whitbourn [Australie] ; Ian Meredith [Australie] ; Cecile Dorange [Belgique] ; Susan Veldhof [Belgique] ; Karine Miquel Hebert [Belgique] ; Richard Rapoza [États-Unis] ; Hector M. Garcia-Garcia [Pays-Bas]Source :
- Circulation. Cardiovascular interventions [ 1941-7640 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Thrombose, Cardiopathie coronaire, Resténose, Pronostic, Etude multicentrique, Homme, Coronarographie, Ultrason, Tomographie en cohérence optique, Complication, Représentation tridimensionnelle, Préopératoire, Suture chirurgicale, Hémodialyse, Imagerie RMN, Long terme, Fixation agrafe, Objet test, Artère, Compliance(volume pression).
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Artery, Complication, Coronary arteriography, Coronary heart disease, Hemodialysis, Human, Long term, Multicenter study, Nuclear magnetic resonance imaging, Optical coherence tomography, Preoperative, Prognosis, Restenosis, Stapling, Suturation, Test object, Three dimensional representation, Thrombosis, Ultrasound.
Abstract
Background-Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes. Methods and Results-The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm2 on optical coherence tomography and 0.17±0.26 mm2 on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm2 on intravascular ultrasound, P=0.003 and 0.77±1.33 m2 on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. Conclusions-This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.
Affiliations:
- Australie, Belgique, Danemark, France, Nouvelle-Zélande, Pays-Bas, Pologne, Suisse, États-Unis
- Canton de Berne, Hollande-Méridionale, Victoria (État)
- Berne, Melbourne, Rotterdam
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: 000F09
- to stream PascalFrancis, to step Curation: 005012
- to stream PascalFrancis, to step Checkpoint: 001119
- to stream Main, to step Merge: 005F54
- to stream Main, to step Curation: 005C48
Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: A Multi-Imaging Modality Study</title>
<author><name sortKey="Ormiston, John A" sort="Ormiston, John A" uniqKey="Ormiston J" first="John A." last="Ormiston">John A. Ormiston</name>
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<s2>Auckland</s2>
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<country>Nouvelle-Zélande</country>
<wicri:noRegion>Auckland City Hospital</wicri:noRegion>
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<author><name sortKey="Serruys, Patrick W" sort="Serruys, Patrick W" uniqKey="Serruys P" first="Patrick W." last="Serruys">Patrick W. Serruys</name>
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<author><name sortKey="Onuma, Yoshinobu" sort="Onuma, Yoshinobu" uniqKey="Onuma Y" first="Yoshinobu" last="Onuma">Yoshinobu Onuma</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>ThoraxCenter, Erasmus Medical Center</s1>
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<author><name sortKey="Geuns, Robert Jan Van" sort="Geuns, Robert Jan Van" uniqKey="Geuns R" first="Robert-Jan Van" last="Geuns">Robert-Jan Van Geuns</name>
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<author><name sortKey="De Bruyne, Bernard" sort="De Bruyne, Bernard" uniqKey="De Bruyne B" first="Bernard" last="De Bruyne">Bernard De Bruyne</name>
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<author><name sortKey="Dudek, Dariusz" sort="Dudek, Dariusz" uniqKey="Dudek D" first="Dariusz" last="Dudek">Dariusz Dudek</name>
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<author><name sortKey="Smits, Pieter C" sort="Smits, Pieter C" uniqKey="Smits P" first="Pieter C." last="Smits">Pieter C. Smits</name>
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<author><name sortKey="Chevalier, Bernard" sort="Chevalier, Bernard" uniqKey="Chevalier B" first="Bernard" last="Chevalier">Bernard Chevalier</name>
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<author><name sortKey="Koolen, Jacques" sort="Koolen, Jacques" uniqKey="Koolen J" first="Jacques" last="Koolen">Jacques Koolen</name>
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<s2>Eindhoven</s2>
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<author><name sortKey="Windecker, Stephan" sort="Windecker, Stephan" uniqKey="Windecker S" first="Stephan" last="Windecker">Stephan Windecker</name>
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<s2>Bern</s2>
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<author><name sortKey="Whitbourn, Robert" sort="Whitbourn, Robert" uniqKey="Whitbourn R" first="Robert" last="Whitbourn">Robert Whitbourn</name>
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<s2>Fitzroy</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
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</affiliation>
</author>
<author><name sortKey="Meredith, Ian" sort="Meredith, Ian" uniqKey="Meredith I" first="Ian" last="Meredith">Ian Meredith</name>
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<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dorange, Cecile" sort="Dorange, Cecile" uniqKey="Dorange C" first="Cecile" last="Dorange">Cecile Dorange</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Abbott Vascular</s1>
<s2>Diegem</s2>
<s3>BEL</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
<wicri:noRegion>Abbott Vascular</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Veldhof, Susan" sort="Veldhof, Susan" uniqKey="Veldhof S" first="Susan" last="Veldhof">Susan Veldhof</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Abbott Vascular</s1>
<s2>Diegem</s2>
<s3>BEL</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
<wicri:noRegion>Abbott Vascular</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Miquel Hebert, Karine" sort="Miquel Hebert, Karine" uniqKey="Miquel Hebert K" first="Karine" last="Miquel Hebert">Karine Miquel Hebert</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Abbott Vascular</s1>
<s2>Diegem</s2>
<s3>BEL</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
<wicri:noRegion>Abbott Vascular</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rapoza, Richard" sort="Rapoza, Richard" uniqKey="Rapoza R" first="Richard" last="Rapoza">Richard Rapoza</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Abbott Vascular</s1>
<s2>Santa Clara, CA</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Abbott Vascular</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Garcia Garcia, Hector M" sort="Garcia Garcia, Hector M" uniqKey="Garcia Garcia H" first="Hector M." last="Garcia-Garcia">Hector M. Garcia-Garcia</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Cardialysis</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName><settlement type="city">Rotterdam</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Circulation. Cardiovascular interventions</title>
<title level="j" type="abbreviated">Circ. Cardiovasc. interv.</title>
<idno type="ISSN">1941-7640</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Circulation. Cardiovascular interventions</title>
<title level="j" type="abbreviated">Circ. Cardiovasc. interv.</title>
<idno type="ISSN">1941-7640</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Artery</term>
<term>Complication</term>
<term>Coronary arteriography</term>
<term>Coronary heart disease</term>
<term>Hemodialysis</term>
<term>Human</term>
<term>Long term</term>
<term>Multicenter study</term>
<term>Nuclear magnetic resonance imaging</term>
<term>Optical coherence tomography</term>
<term>Preoperative</term>
<term>Prognosis</term>
<term>Restenosis</term>
<term>Stapling</term>
<term>Suturation</term>
<term>Test object</term>
<term>Three dimensional representation</term>
<term>Thrombosis</term>
<term>Ultrasound</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Thrombose</term>
<term>Cardiopathie coronaire</term>
<term>Resténose</term>
<term>Pronostic</term>
<term>Etude multicentrique</term>
<term>Homme</term>
<term>Coronarographie</term>
<term>Ultrason</term>
<term>Tomographie en cohérence optique</term>
<term>Complication</term>
<term>Représentation tridimensionnelle</term>
<term>Préopératoire</term>
<term>Suture chirurgicale</term>
<term>Hémodialyse</term>
<term>Imagerie RMN</term>
<term>Long terme</term>
<term>Fixation agrafe</term>
<term>Objet test</term>
<term>Artère</term>
<term>Compliance(volume pression)</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background-Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes. Methods and Results-The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm<sup>2</sup>
on optical coherence tomography and 0.17±0.26 mm<sup>2</sup>
on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm<sup>2</sup>
on intravascular ultrasound, P=0.003 and 0.77±1.33 m<sup>2</sup>
on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. Conclusions-This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>Danemark</li>
<li>France</li>
<li>Nouvelle-Zélande</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Canton de Berne</li>
<li>Hollande-Méridionale</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Berne</li>
<li>Melbourne</li>
<li>Rotterdam</li>
</settlement>
</list>
<tree><country name="Nouvelle-Zélande"><noRegion><name sortKey="Ormiston, John A" sort="Ormiston, John A" uniqKey="Ormiston J" first="John A." last="Ormiston">John A. Ormiston</name>
</noRegion>
<name sortKey="Mcclean, Dougal" sort="Mcclean, Dougal" uniqKey="Mcclean D" first="Dougal" last="Mcclean">Dougal Mcclean</name>
</country>
<country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Serruys, Patrick W" sort="Serruys, Patrick W" uniqKey="Serruys P" first="Patrick W." last="Serruys">Patrick W. Serruys</name>
</region>
<name sortKey="Garcia Garcia, Hector M" sort="Garcia Garcia, Hector M" uniqKey="Garcia Garcia H" first="Hector M." last="Garcia-Garcia">Hector M. Garcia-Garcia</name>
<name sortKey="Geuns, Robert Jan Van" sort="Geuns, Robert Jan Van" uniqKey="Geuns R" first="Robert-Jan Van" last="Geuns">Robert-Jan Van Geuns</name>
<name sortKey="Koolen, Jacques" sort="Koolen, Jacques" uniqKey="Koolen J" first="Jacques" last="Koolen">Jacques Koolen</name>
<name sortKey="Onuma, Yoshinobu" sort="Onuma, Yoshinobu" uniqKey="Onuma Y" first="Yoshinobu" last="Onuma">Yoshinobu Onuma</name>
<name sortKey="Smits, Pieter C" sort="Smits, Pieter C" uniqKey="Smits P" first="Pieter C." last="Smits">Pieter C. Smits</name>
</country>
<country name="Belgique"><noRegion><name sortKey="De Bruyne, Bernard" sort="De Bruyne, Bernard" uniqKey="De Bruyne B" first="Bernard" last="De Bruyne">Bernard De Bruyne</name>
</noRegion>
<name sortKey="Dorange, Cecile" sort="Dorange, Cecile" uniqKey="Dorange C" first="Cecile" last="Dorange">Cecile Dorange</name>
<name sortKey="Miquel Hebert, Karine" sort="Miquel Hebert, Karine" uniqKey="Miquel Hebert K" first="Karine" last="Miquel Hebert">Karine Miquel Hebert</name>
<name sortKey="Veldhof, Susan" sort="Veldhof, Susan" uniqKey="Veldhof S" first="Susan" last="Veldhof">Susan Veldhof</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Dudek, Dariusz" sort="Dudek, Dariusz" uniqKey="Dudek D" first="Dariusz" last="Dudek">Dariusz Dudek</name>
</noRegion>
</country>
<country name="Danemark"><noRegion><name sortKey="Thuesen, Leif" sort="Thuesen, Leif" uniqKey="Thuesen L" first="Leif" last="Thuesen">Leif Thuesen</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Chevalier, Bernard" sort="Chevalier, Bernard" uniqKey="Chevalier B" first="Bernard" last="Chevalier">Bernard Chevalier</name>
</noRegion>
</country>
<country name="Suisse"><region name="Canton de Berne"><name sortKey="Windecker, Stephan" sort="Windecker, Stephan" uniqKey="Windecker S" first="Stephan" last="Windecker">Stephan Windecker</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="Whitbourn, Robert" sort="Whitbourn, Robert" uniqKey="Whitbourn R" first="Robert" last="Whitbourn">Robert Whitbourn</name>
</noRegion>
<name sortKey="Meredith, Ian" sort="Meredith, Ian" uniqKey="Meredith I" first="Ian" last="Meredith">Ian Meredith</name>
</country>
<country name="États-Unis"><noRegion><name sortKey="Rapoza, Richard" sort="Rapoza, Richard" uniqKey="Rapoza R" first="Richard" last="Rapoza">Richard Rapoza</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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