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Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus®, paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries : the Nobori 1 trial

Identifieur interne : 009386 ( Main/Exploration ); précédent : 009385; suivant : 009387

Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus®, paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries : the Nobori 1 trial

Auteurs : Bernard Chevalier [France] ; Patrick W. Serruys [Pays-Bas] ; Sigmund Silber [Allemagne] ; Eulogio Garcia [Espagne] ; Harry Suryapranata [Pays-Bas] ; Karl Hauptmann [Allemagne] ; William Wijns [Belgique] ; Gerhard Schuler [Allemagne] ; Farzin Fath-Ordoubadi [Royaume-Uni] ; Stephen Worthley [Australie] ; Leif Thuesen [Danemark] ; Ian Meredith [Australie] ; Marco Bressers [Pays-Bas] ; Hirofumi Nagai [Japon] ; Dragica Paunovic [Belgique]

Source :

RBID : Pascal:07-0102184

Descripteurs français

English descriptors

Abstract

Background: We studied the Nobori<TM> coronary stent coated with a bioabsorbable polymer and the antiproliferative agent Biolimus A9 which may reduce neointimal formation. Methods and results: Patients undergoing percutaneous coronary intervention for de novo lesions in up to two native coronary arteries, in 29 centres across Europe, Asia and Australia were randomly (2:1) assigned to receive the Biolimus A9 eluting stent Nobori<TM> (85 patients) or paclitaxel eluting stent Taxus® (35 patients). The two groups were well matched in baseline characteristics. The primary end point of non-inferiority for in-stent late loss of Nobori<TM> stent versus Taxus® stent, at 9 months, was reached with the values of 0.15±0.27 mm with Nobori<TM> stent and 0.32±0.33 mm with Taxus® stent (p=0.006). Neointimal volume obstruction was 2.2±6.0% and 8.9±9.2% for Nobori<TM> and Taxus® stent respectively (p=0.017). The rates of death, myocardial infarction and any target vessel revascularisation at 9 months were 0%, 4.7%, and 7.1% respectively for Nobori<TM> stent, and 0%, 8.6% and 14.3% respectively for Taxus® stent. Clinically-driven target lesion revascularisation rate was 0% for Nobori<TM> stent and 2.9% for Taxus® stent. Stent thrombosis rates at 9 months were 0% in both groups. Conclusions: In this trial the Nobori<TM> Biolimus A9 eluting stent proved to be safe and effective in reducing neointimal proliferation. The long term safety remains to be confirmed during the extended follow-up period of 5 years.


Affiliations:


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Le document en format XML

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<name sortKey="Garcia, Eulogio" sort="Garcia, Eulogio" uniqKey="Garcia E" first="Eulogio" last="Garcia">Eulogio Garcia</name>
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<name sortKey="Suryapranata, Harry" sort="Suryapranata, Harry" uniqKey="Suryapranata H" first="Harry" last="Suryapranata">Harry Suryapranata</name>
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<name sortKey="Hauptmann, Karl" sort="Hauptmann, Karl" uniqKey="Hauptmann K" first="Karl" last="Hauptmann">Karl Hauptmann</name>
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<name sortKey="Wijns, William" sort="Wijns, William" uniqKey="Wijns W" first="William" last="Wijns">William Wijns</name>
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<country>Belgique</country>
<wicri:noRegion>Onze-Lieve-Vrouw Hospital</wicri:noRegion>
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<name sortKey="Schuler, Gerhard" sort="Schuler, Gerhard" uniqKey="Schuler G" first="Gerhard" last="Schuler">Gerhard Schuler</name>
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<name sortKey="Fath Ordoubadi, Farzin" sort="Fath Ordoubadi, Farzin" uniqKey="Fath Ordoubadi F" first="Farzin" last="Fath-Ordoubadi">Farzin Fath-Ordoubadi</name>
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<s1>Royal Infirmary</s1>
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<country>Royaume-Uni</country>
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<settlement type="city">Manchester</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Manchester</region>
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<name sortKey="Worthley, Stephen" sort="Worthley, Stephen" uniqKey="Worthley S" first="Stephen" last="Worthley">Stephen Worthley</name>
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<s1>Royal Adelaide Hospital</s1>
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<country>Australie</country>
<wicri:noRegion>Royal Adelaide Hospital</wicri:noRegion>
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<name sortKey="Thuesen, Leif" sort="Thuesen, Leif" uniqKey="Thuesen L" first="Leif" last="Thuesen">Leif Thuesen</name>
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<s2>Aarhus</s2>
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<country>Danemark</country>
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<name sortKey="Meredith, Ian" sort="Meredith, Ian" uniqKey="Meredith I" first="Ian" last="Meredith">Ian Meredith</name>
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<s1>Monash Medical Centre</s1>
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<wicri:noRegion>Monash Medical Centre</wicri:noRegion>
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<name sortKey="Bressers, Marco" sort="Bressers, Marco" uniqKey="Bressers M" first="Marco" last="Bressers">Marco Bressers</name>
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<name sortKey="Nagai, Hirofumi" sort="Nagai, Hirofumi" uniqKey="Nagai H" first="Hirofumi" last="Nagai">Hirofumi Nagai</name>
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<s1>Terumo Corporation</s1>
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<country>Japon</country>
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<settlement type="city">Tokyo</settlement>
<region type="région">Région de Kantō</region>
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<name sortKey="Paunovic, Dragica" sort="Paunovic, Dragica" uniqKey="Paunovic D" first="Dragica" last="Paunovic">Dragica Paunovic</name>
<affiliation wicri:level="1">
<inist:fA14 i1="15">
<s1>Terumo Europe</s1>
<s2>Leuven</s2>
<s3>BEL</s3>
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</inist:fA14>
<country>Belgique</country>
<wicri:noRegion>Terumo Europe</wicri:noRegion>
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<title xml:lang="en" level="a">Randomised comparison of Nobori<
<sup>TM</sup>
>, biolimus A9-eluting coronary stent with a Taxus®, paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries : the Nobori 1 trial</title>
<author>
<name sortKey="Chevalier, Bernard" sort="Chevalier, Bernard" uniqKey="Chevalier B" first="Bernard" last="Chevalier">Bernard Chevalier</name>
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<s1>Centre Cardiologique du Nord</s1>
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<country>France</country>
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<region type="region">Île-de-France</region>
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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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<s1>Erasmus MC</s1>
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</inist:fA14>
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<name sortKey="Silber, Sigmund" sort="Silber, Sigmund" uniqKey="Silber S" first="Sigmund" last="Silber">Sigmund Silber</name>
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<inist:fA14 i1="03">
<s1>Kardiologische Gemeinschaftspraxis und HKL</s1>
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<s3>DEU</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName>
<region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
<settlement type="city">Munich</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Garcia, Eulogio" sort="Garcia, Eulogio" uniqKey="Garcia E" first="Eulogio" last="Garcia">Eulogio Garcia</name>
<affiliation wicri:level="3">
<inist:fA14 i1="04">
<s1>Gregorio Marañón</s1>
<s2>Madrid</s2>
<s3>ESP</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
<placeName>
<settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Suryapranata, Harry" sort="Suryapranata, Harry" uniqKey="Suryapranata H" first="Harry" last="Suryapranata">Harry Suryapranata</name>
<affiliation wicri:level="1">
<inist:fA14 i1="05">
<s1>Isala Clinic</s1>
<s2>Zwolle</s2>
<s3>NLD</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<wicri:noRegion>Isala Clinic</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Hauptmann, Karl" sort="Hauptmann, Karl" uniqKey="Hauptmann K" first="Karl" last="Hauptmann">Karl Hauptmann</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>Krankenhaus der Barmherzigen Brüder</s1>
<s2>Trier</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Trier</wicri:noRegion>
<wicri:noRegion>Krankenhaus der Barmherzigen Brüder</wicri:noRegion>
<wicri:noRegion>Krankenhaus der Barmherzigen Brüder</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Wijns, William" sort="Wijns, William" uniqKey="Wijns W" first="William" last="Wijns">William Wijns</name>
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<inist:fA14 i1="07">
<s1>Onze-Lieve-Vrouw Hospital</s1>
<s2>Aalst</s2>
<s3>BEL</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
<wicri:noRegion>Onze-Lieve-Vrouw Hospital</wicri:noRegion>
</affiliation>
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<name sortKey="Schuler, Gerhard" sort="Schuler, Gerhard" uniqKey="Schuler G" first="Gerhard" last="Schuler">Gerhard Schuler</name>
<affiliation wicri:level="3">
<inist:fA14 i1="08">
<s1>Universitätsklinikum</s1>
<s2>Leipzig</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName>
<region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Leipzig</region>
<settlement type="city">Leipzig</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Fath Ordoubadi, Farzin" sort="Fath Ordoubadi, Farzin" uniqKey="Fath Ordoubadi F" first="Farzin" last="Fath-Ordoubadi">Farzin Fath-Ordoubadi</name>
<affiliation wicri:level="3">
<inist:fA14 i1="09">
<s1>Royal Infirmary</s1>
<s2>Manchester</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<placeName>
<settlement type="city">Manchester</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Manchester</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Worthley, Stephen" sort="Worthley, Stephen" uniqKey="Worthley S" first="Stephen" last="Worthley">Stephen Worthley</name>
<affiliation wicri:level="1">
<inist:fA14 i1="10">
<s1>Royal Adelaide Hospital</s1>
<s2>Adelaide</s2>
<s3>AUS</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Royal Adelaide Hospital</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Thuesen, Leif" sort="Thuesen, Leif" uniqKey="Thuesen L" first="Leif" last="Thuesen">Leif Thuesen</name>
<affiliation wicri:level="1">
<inist:fA14 i1="11">
<s1>Skejby Sygehus, Aarhus University Hospital</s1>
<s2>Aarhus</s2>
<s3>DNK</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Danemark</country>
<wicri:noRegion>Aarhus</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Meredith, Ian" sort="Meredith, Ian" uniqKey="Meredith I" first="Ian" last="Meredith">Ian Meredith</name>
<affiliation wicri:level="1">
<inist:fA14 i1="12">
<s1>Monash Medical Centre</s1>
<s2>Clayton, Victoria</s2>
<s3>AUS</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Monash Medical Centre</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Bressers, Marco" sort="Bressers, Marco" uniqKey="Bressers M" first="Marco" last="Bressers">Marco Bressers</name>
<affiliation wicri:level="3">
<inist:fA14 i1="13">
<s1>Cardialysis BV</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>13 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>
<author>
<name sortKey="Nagai, Hirofumi" sort="Nagai, Hirofumi" uniqKey="Nagai H" first="Hirofumi" last="Nagai">Hirofumi Nagai</name>
<affiliation wicri:level="3">
<inist:fA14 i1="14">
<s1>Terumo Corporation</s1>
<s2>Tokyo</s2>
<s3>JPN</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Japon</country>
<placeName>
<settlement type="city">Tokyo</settlement>
<region type="région">Région de Kantō</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Paunovic, Dragica" sort="Paunovic, Dragica" uniqKey="Paunovic D" first="Dragica" last="Paunovic">Dragica Paunovic</name>
<affiliation wicri:level="1">
<inist:fA14 i1="15">
<s1>Terumo Europe</s1>
<s2>Leuven</s2>
<s3>BEL</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
<wicri:noRegion>Terumo Europe</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">EuroIntervention</title>
<title level="j" type="abbreviated">EuroIntervention</title>
<idno type="ISSN">1774-024X</idno>
<imprint>
<date when="2007">2007</date>
</imprint>
</series>
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<title level="j" type="main">EuroIntervention</title>
<title level="j" type="abbreviated">EuroIntervention</title>
<idno type="ISSN">1774-024X</idno>
</seriesStmt>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Antineoplastic agent</term>
<term>Artery stenosis</term>
<term>Clinical trial</term>
<term>Comparative study</term>
<term>Coronary artery</term>
<term>Coronary heart disease</term>
<term>Drug eluting stent</term>
<term>Human</term>
<term>Paclitaxel</term>
<term>Patient</term>
<term>Randomization</term>
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<term>Cardiopathie coronaire</term>
<term>Sténose artère</term>
<term>Randomisation</term>
<term>Etude comparative</term>
<term>Artère coronaire</term>
<term>Paclitaxel</term>
<term>Homme</term>
<term>Malade</term>
<term>Essai clinique</term>
<term>Anticancéreux</term>
<term>Stent à élution médicamenteuse</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: We studied the Nobori<
<sup>TM</sup>
> coronary stent coated with a bioabsorbable polymer and the antiproliferative agent Biolimus A9 which may reduce neointimal formation. Methods and results: Patients undergoing percutaneous coronary intervention for de novo lesions in up to two native coronary arteries, in 29 centres across Europe, Asia and Australia were randomly (2:1) assigned to receive the Biolimus A9 eluting stent Nobori<
<sup>TM</sup>
> (85 patients) or paclitaxel eluting stent Taxus® (35 patients). The two groups were well matched in baseline characteristics. The primary end point of non-inferiority for in-stent late loss of Nobori<
<sup>TM</sup>
> stent versus Taxus® stent, at 9 months, was reached with the values of 0.15±0.27 mm with Nobori<
<sup>TM</sup>
> stent and 0.32±0.33 mm with Taxus® stent (p=0.006). Neointimal volume obstruction was 2.2±6.0% and 8.9±9.2% for Nobori<
<sup>TM</sup>
> and Taxus® stent respectively (p=0.017). The rates of death, myocardial infarction and any target vessel revascularisation at 9 months were 0%, 4.7%, and 7.1% respectively for Nobori<
<sup>TM</sup>
> stent, and 0%, 8.6% and 14.3% respectively for Taxus® stent. Clinically-driven target lesion revascularisation rate was 0% for Nobori<
<sup>TM</sup>
> stent and 2.9% for Taxus® stent. Stent thrombosis rates at 9 months were 0% in both groups. Conclusions: In this trial the Nobori<
<sup>TM</sup>
> Biolimus A9 eluting stent proved to be safe and effective in reducing neointimal proliferation. The long term safety remains to be confirmed during the extended follow-up period of 5 years.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>Danemark</li>
<li>Espagne</li>
<li>France</li>
<li>Japon</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
</country>
<region>
<li>Angleterre</li>
<li>Bavière</li>
<li>Communauté de Madrid</li>
<li>District de Haute-Bavière</li>
<li>District de Leipzig</li>
<li>Grand Manchester</li>
<li>Hollande-Méridionale</li>
<li>Région de Kantō</li>
<li>Saxe (Land)</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Leipzig</li>
<li>Madrid</li>
<li>Manchester</li>
<li>Munich</li>
<li>Rotterdam</li>
<li>Saint-Denis (Seine-Saint-Denis)</li>
<li>Tokyo</li>
</settlement>
</list>
<tree>
<country name="France">
<region name="Île-de-France">
<name sortKey="Chevalier, Bernard" sort="Chevalier, Bernard" uniqKey="Chevalier B" first="Bernard" last="Chevalier">Bernard Chevalier</name>
</region>
</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="Bressers, Marco" sort="Bressers, Marco" uniqKey="Bressers M" first="Marco" last="Bressers">Marco Bressers</name>
<name sortKey="Suryapranata, Harry" sort="Suryapranata, Harry" uniqKey="Suryapranata H" first="Harry" last="Suryapranata">Harry Suryapranata</name>
</country>
<country name="Allemagne">
<region name="Bavière">
<name sortKey="Silber, Sigmund" sort="Silber, Sigmund" uniqKey="Silber S" first="Sigmund" last="Silber">Sigmund Silber</name>
</region>
<name sortKey="Hauptmann, Karl" sort="Hauptmann, Karl" uniqKey="Hauptmann K" first="Karl" last="Hauptmann">Karl Hauptmann</name>
<name sortKey="Schuler, Gerhard" sort="Schuler, Gerhard" uniqKey="Schuler G" first="Gerhard" last="Schuler">Gerhard Schuler</name>
</country>
<country name="Espagne">
<region name="Communauté de Madrid">
<name sortKey="Garcia, Eulogio" sort="Garcia, Eulogio" uniqKey="Garcia E" first="Eulogio" last="Garcia">Eulogio Garcia</name>
</region>
</country>
<country name="Belgique">
<noRegion>
<name sortKey="Wijns, William" sort="Wijns, William" uniqKey="Wijns W" first="William" last="Wijns">William Wijns</name>
</noRegion>
<name sortKey="Paunovic, Dragica" sort="Paunovic, Dragica" uniqKey="Paunovic D" first="Dragica" last="Paunovic">Dragica Paunovic</name>
</country>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Fath Ordoubadi, Farzin" sort="Fath Ordoubadi, Farzin" uniqKey="Fath Ordoubadi F" first="Farzin" last="Fath-Ordoubadi">Farzin Fath-Ordoubadi</name>
</region>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Worthley, Stephen" sort="Worthley, Stephen" uniqKey="Worthley S" first="Stephen" last="Worthley">Stephen Worthley</name>
</noRegion>
<name sortKey="Meredith, Ian" sort="Meredith, Ian" uniqKey="Meredith I" first="Ian" last="Meredith">Ian Meredith</name>
</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="Japon">
<region name="Région de Kantō">
<name sortKey="Nagai, Hirofumi" sort="Nagai, Hirofumi" uniqKey="Nagai H" first="Hirofumi" last="Nagai">Hirofumi Nagai</name>
</region>
</country>
</tree>
</affiliations>
</record>

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