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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 : 005C49

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

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 :

RBID : Pascal:12-0423421

Descripteurs français

English descriptors

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.


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Le document en format XML

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<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>
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<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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<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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<name sortKey="Chevalier, Bernard" sort="Chevalier, Bernard" uniqKey="Chevalier B" first="Bernard" last="Chevalier">Bernard Chevalier</name>
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<name sortKey="Mcclean, Dougal" sort="Mcclean, Dougal" uniqKey="Mcclean D" first="Dougal" last="Mcclean">Dougal Mcclean</name>
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<name sortKey="Koolen, Jacques" sort="Koolen, Jacques" uniqKey="Koolen J" first="Jacques" last="Koolen">Jacques Koolen</name>
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<name sortKey="Windecker, Stephan" sort="Windecker, Stephan" uniqKey="Windecker S" first="Stephan" last="Windecker">Stephan Windecker</name>
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<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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