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 : 005012 ( PascalFrancis/Curation ); précédent : 005011; suivant : 005013First 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.
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<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>
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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>
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<author><name sortKey="Thuesen, Leif" sort="Thuesen, Leif" uniqKey="Thuesen L" first="Leif" last="Thuesen">Leif Thuesen</name>
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<author><name sortKey="Mcclean, Dougal" sort="Mcclean, Dougal" uniqKey="Mcclean D" first="Dougal" last="Mcclean">Dougal Mcclean</name>
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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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<author><name sortKey="Dorange, Cecile" sort="Dorange, Cecile" uniqKey="Dorange C" first="Cecile" last="Dorange">Cecile Dorange</name>
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<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Cardialysis</s1>
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<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>
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<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>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>1941-7640</s0>
</fA01>
<fA03 i2="1"><s0>Circ. Cardiovasc. interv.</s0>
</fA03>
<fA05><s2>5</s2>
</fA05>
<fA06><s2>5</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>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</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>ORMISTON (John A.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>SERRUYS (Patrick W.)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>ONUMA (Yoshinobu)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>GEUNS (Robert-Jan Van)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>DE BRUYNE (Bernard)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>DUDEK (Dariusz)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>THUESEN (Leif)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>SMITS (Pieter C.)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>CHEVALIER (Bernard)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>MCCLEAN (Dougal)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>KOOLEN (Jacques)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>WINDECKER (Stephan)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>WHITBOURN (Robert)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>MEREDITH (Ian)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>DORANGE (Cecile)</s1>
</fA11>
<fA11 i1="16" i2="1"><s1>VELDHOF (Susan)</s1>
</fA11>
<fA11 i1="17" i2="1"><s1>MIQUEL HEBERT (Karine)</s1>
</fA11>
<fA11 i1="18" i2="1"><s1>RAPOZA (Richard)</s1>
</fA11>
<fA11 i1="19" i2="1"><s1>GARCIA-GARCIA (Hector M.)</s1>
</fA11>
<fA14 i1="01"><s1>Auckland City Hospital</s1>
<s2>Auckland</s2>
<s3>NZL</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>ThoraxCenter, Erasmus Medical Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Cardiovascular Center</s1>
<s2>Aalst</s2>
<s3>BEL</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Jagiellonian University</s1>
<s2>Krakow</s2>
<s3>POL</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Skejby Sygehus University Hospital</s1>
<s2>Aarhus</s2>
<s3>DNK</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Maasstad Hospital</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Institut Jacques Cartier</s1>
<s2>Massy</s2>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Christchurch Hospital</s1>
<s2>Christchurch</s2>
<s3>NZL</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Catharina Hospital</s1>
<s2>Eindhoven</s2>
<s3>NLD</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Bern University Hospital</s1>
<s2>Bern</s2>
<s3>CHE</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>St Vincent's Hospital</s1>
<s2>Fitzroy</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Monash Cardiovascular Research Centre</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>14 aut.</sZ>
</fA14>
<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>
</fA14>
<fA14 i1="14"><s1>Abbott Vascular</s1>
<s2>Santa Clara, CA</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Cardialysis</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>19 aut.</sZ>
</fA14>
<fA20><s1>620-632</s1>
</fA20>
<fA21><s1>2012</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>28045</s2>
<s5>354000502078030020</s5>
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<fA44><s0>0000</s0>
<s1>© 2012 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>45 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>12-0423421</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Circulation. Cardiovascular interventions</s0>
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<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B25F</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B27B03</s0>
</fC02>
<fC02 i1="03" i2="X"><s0>002B25G03</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Thrombose</s0>
<s5>01</s5>
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<fC03 i1="01" i2="X" l="ENG"><s0>Thrombosis</s0>
<s5>01</s5>
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<s5>01</s5>
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<fC03 i1="02" i2="X" l="FRE"><s0>Cardiopathie coronaire</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Coronary heart disease</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Cardiopatía coronaria</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Resténose</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Restenosis</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Reestenosis</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Pronostic</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Prognosis</s0>
<s5>10</s5>
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<fC03 i1="04" i2="X" l="SPA"><s0>Pronóstico</s0>
<s5>10</s5>
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<s5>11</s5>
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<fC03 i1="05" i2="X" l="ENG"><s0>Multicenter study</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Estudio multicéntrico</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Homme</s0>
<s5>12</s5>
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<fC03 i1="06" i2="X" l="ENG"><s0>Human</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Hombre</s0>
<s5>12</s5>
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<fC03 i1="07" i2="X" l="FRE"><s0>Coronarographie</s0>
<s5>13</s5>
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<fC03 i1="07" i2="X" l="ENG"><s0>Coronary arteriography</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Coronarografía</s0>
<s5>13</s5>
</fC03>
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<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Ultrasound</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Ultrasonido</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Tomographie en cohérence optique</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Optical coherence tomography</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Tomógrafo óptico de coherencia</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Complication</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Complication</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Complicación</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Représentation tridimensionnelle</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Three dimensional representation</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Representación tridimensional</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Préopératoire</s0>
<s5>18</s5>
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<fC03 i1="12" i2="X" l="ENG"><s0>Preoperative</s0>
<s5>18</s5>
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<s5>18</s5>
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<fC03 i1="13" i2="X" l="FRE"><s0>Suture chirurgicale</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Suturation</s0>
<s5>19</s5>
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<fC03 i1="13" i2="X" l="SPA"><s0>Sutura quirúrgica</s0>
<s5>19</s5>
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<fC03 i1="14" i2="X" l="FRE"><s0>Hémodialyse</s0>
<s5>20</s5>
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<fC03 i1="14" i2="X" l="ENG"><s0>Hemodialysis</s0>
<s5>20</s5>
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<fC03 i1="14" i2="X" l="SPA"><s0>Hemodiálisis</s0>
<s5>20</s5>
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<fC03 i1="15" i2="X" l="FRE"><s0>Imagerie RMN</s0>
<s5>21</s5>
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<fC03 i1="15" i2="X" l="ENG"><s0>Nuclear magnetic resonance imaging</s0>
<s5>21</s5>
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<fC03 i1="15" i2="X" l="SPA"><s0>Imaginería RMN</s0>
<s5>21</s5>
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<fC03 i1="16" i2="X" l="FRE"><s0>Long terme</s0>
<s5>22</s5>
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<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="SPA"><s0>Largo plazo</s0>
<s5>22</s5>
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<fC03 i1="17" i2="X" l="FRE"><s0>Fixation agrafe</s0>
<s5>23</s5>
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<s5>23</s5>
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<s5>23</s5>
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<fC03 i1="18" i2="X" l="FRE"><s0>Objet test</s0>
<s5>24</s5>
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<s5>24</s5>
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<s5>25</s5>
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<s5>25</s5>
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<s5>25</s5>
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<s4>INC</s4>
<s5>86</s5>
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<s5>37</s5>
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<s5>37</s5>
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<s5>37</s5>
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<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Vascular disease</s0>
<s5>38</s5>
</fC07>
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<s5>38</s5>
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<fN21><s1>331</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
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<fN82><s1>OTO</s1>
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