OpenAccessBelV2, France, Analysis, bibRecord, 000129

First-in-man (FIM) study of the Stentys bifurcation stent -30 days results

Identifieur interne : 000129 ( France/Analysis ); précédent : 000128; suivant : 000130

First-in-man (FIM) study of the Stentys bifurcation stent -30 days results

Auteurs : Stefan Verheye [Belgique] ; Eberhard Grube [Allemagne] ; Steve Ramcharitar [Royaume-Uni] ; Joachim J. Schofer [Allemagne] ; Bernhard Witzenbichler [Allemagne] ; Jan Kovac [Royaume-Uni] ; Karl E. Hauptmann [Allemagne] ; Pierfrancesco Agostoni [Belgique] ; Marcus Wiemer [Allemagne] ; Thierry Lefevre [France] ; Patrick W. Serruys [Pays-Bas] ; Robert J. Van Geuns [Pays-Bas]

Source :

EuroIntervention [ 1774-024X ] ; 2009.

RBID : Pascal:09-0126059

Descripteurs français

Pascal (Inist)
- Cardiopathie coronaire, Homme, Mâle, Bifurcation, Stent à élution médicamenteuse, Endoprothèse, Jour, Résultat, Artère coronaire, Métal, Conception.
Wicri :
- topic : Homme, Métal.

English descriptors

KwdEn :
- Bifurcation, Coronary artery, Coronary heart disease, Day, Design, Drug eluting stent, Endoprosthesis, Human, Male, Metal, Result.

Abstract

Aims: We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys<^TM> bifurcation stent. Methods and results: The Stentys<^TM> stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side-branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years. In addition to angiographic QCA evaluation, documentary IVUS and/or OCT were used in all cases to assess the stent's deployment. The patient population consisted of 85% males with an average age of 62 years. Almost half had previous PCI, 31% previous Ml and 5% previous CABG. The majority of lesions (80%) involved the LAD-D, 42% of the patients had disease affecting the side-branch, with all three arms diseased in 24% of the cases. The average lesion length in the main branch was 12.95±3.63 mm with a bifurcation angle of 55° (range 30°-80°). Procedural success was achieved in 39/40 cases (95.5%) due to inability to track the stent in one patient with an extremely tortuous vessel. In total 6 (15%) paclitaxel eluting and 33 (85%) BMS Stentys<^TM> stents were successfully implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved in 37/39 cases (94.9%); in two cases, disconnection was not attempted. The MACE at 30 days was 5.1% as a result of one non Q-wave Ml following the procedure and one ischemia-driven revascularisation six days after the procedure. Conclusions: This first-in-man (FIM) study demonstrates that the Stentys<^TM> stent is safe and feasible resulting in an excellent procedural success rate and a low MACE rate. The struts can be easily and safely disconnected to perform provisional stenting.

Affiliations:

Allemagne, Belgique, France, Pays-Bas, Royaume-Uni
Berlin, Hambourg, Hollande-Méridionale
Berlin, Hambourg, Rotterdam

Links toward previous steps (curation, corpus...)

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to stream PascalFrancis, to step Curation: 000081
to stream PascalFrancis, to step Checkpoint: 000052
to stream Main, to step Merge: 001266
to stream Main, to step Curation: 001264
to stream Main, to step Exploration: 001264
to stream France, to step Extraction: 000129

Links to Exploration step

Pascal:09-0126059

Le document en format XML

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<author><name sortKey="Agostoni, Pierfrancesco" sort="Agostoni, Pierfrancesco" uniqKey="Agostoni P" first="Pierfrancesco" last="Agostoni">Pierfrancesco Agostoni</name>
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</affiliation>
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<author><name sortKey="Wiemer, Marcus" sort="Wiemer, Marcus" uniqKey="Wiemer M" first="Marcus" last="Wiemer">Marcus Wiemer</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Herz-and Diabeteszentrum NRW</s1>
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<s3>DEU</s3>
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<s2>Massy</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
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<wicri:noRegion>Massy</wicri:noRegion>
<wicri:noRegion>Institut Hospitalier Jacques Cartier</wicri:noRegion>
<wicri:noRegion>Institut Hospitalier Jacques Cartier</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Serruys, Patrick W" sort="Serruys, Patrick W" uniqKey="Serruys P" first="Patrick W." last="Serruys">Patrick W. Serruys</name>
<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Thoraxcenter, Erasmus MC</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>11 aut.</sZ>
<sZ>12 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="Van Geuns, Robert J" sort="Van Geuns, Robert J" uniqKey="Van Geuns R" first="Robert J." last="Van Geuns">Robert J. Van Geuns</name>
<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Thoraxcenter, Erasmus MC</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName><settlement type="city">Rotterdam</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
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<title level="j" type="abbreviated">EuroIntervention</title>
<idno type="ISSN">1774-024X</idno>
<imprint><date when="2009">2009</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Bifurcation</term>
<term>Coronary artery</term>
<term>Coronary heart disease</term>
<term>Day</term>
<term>Design</term>
<term>Drug eluting stent</term>
<term>Endoprosthesis</term>
<term>Human</term>
<term>Male</term>
<term>Metal</term>
<term>Result</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Cardiopathie coronaire</term>
<term>Homme</term>
<term>Mâle</term>
<term>Bifurcation</term>
<term>Stent à élution médicamenteuse</term>
<term>Endoprothèse</term>
<term>Jour</term>
<term>Résultat</term>
<term>Artère coronaire</term>
<term>Métal</term>
<term>Conception</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
<term>Métal</term>
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<front><div type="abstract" xml:lang="en">Aims: We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys<<sup>TM</sup>
> bifurcation stent. Methods and results: The Stentys<<sup>TM</sup>
> stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side-branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years. In addition to angiographic QCA evaluation, documentary IVUS and/or OCT were used in all cases to assess the stent's deployment. The patient population consisted of 85% males with an average age of 62 years. Almost half had previous PCI, 31% previous Ml and 5% previous CABG. The majority of lesions (80%) involved the LAD-D, 42% of the patients had disease affecting the side-branch, with all three arms diseased in 24% of the cases. The average lesion length in the main branch was 12.95±3.63 mm with a bifurcation angle of 55° (range 30°-80°). Procedural success was achieved in 39/40 cases (95.5%) due to inability to track the stent in one patient with an extremely tortuous vessel. In total 6 (15%) paclitaxel eluting and 33 (85%) BMS Stentys<<sup>TM</sup>
> stents were successfully implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved in 37/39 cases (94.9%); in two cases, disconnection was not attempted. The MACE at 30 days was 5.1% as a result of one non Q-wave Ml following the procedure and one ischemia-driven revascularisation six days after the procedure. Conclusions: This first-in-man (FIM) study demonstrates that the Stentys<<sup>TM</sup>
> stent is safe and feasible resulting in an excellent procedural success rate and a low MACE rate. The struts can be easily and safely disconnected to perform provisional stenting.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Belgique</li>
<li>France</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
</country>
<region><li>Berlin</li>
<li>Hambourg</li>
<li>Hollande-Méridionale</li>
</region>
<settlement><li>Berlin</li>
<li>Hambourg</li>
<li>Rotterdam</li>
</settlement>
</list>
<tree><country name="Belgique"><noRegion><name sortKey="Verheye, Stefan" sort="Verheye, Stefan" uniqKey="Verheye S" first="Stefan" last="Verheye">Stefan Verheye</name>
</noRegion>
<name sortKey="Agostoni, Pierfrancesco" sort="Agostoni, Pierfrancesco" uniqKey="Agostoni P" first="Pierfrancesco" last="Agostoni">Pierfrancesco Agostoni</name>
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<country name="Allemagne"><noRegion><name sortKey="Grube, Eberhard" sort="Grube, Eberhard" uniqKey="Grube E" first="Eberhard" last="Grube">Eberhard Grube</name>
</noRegion>
<name sortKey="Hauptmann, Karl E" sort="Hauptmann, Karl E" uniqKey="Hauptmann K" first="Karl E." last="Hauptmann">Karl E. Hauptmann</name>
<name sortKey="Schofer, Joachim J" sort="Schofer, Joachim J" uniqKey="Schofer J" first="Joachim J." last="Schofer">Joachim J. Schofer</name>
<name sortKey="Wiemer, Marcus" sort="Wiemer, Marcus" uniqKey="Wiemer M" first="Marcus" last="Wiemer">Marcus Wiemer</name>
<name sortKey="Witzenbichler, Bernhard" sort="Witzenbichler, Bernhard" uniqKey="Witzenbichler B" first="Bernhard" last="Witzenbichler">Bernhard Witzenbichler</name>
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<country name="Royaume-Uni"><noRegion><name sortKey="Ramcharitar, Steve" sort="Ramcharitar, Steve" uniqKey="Ramcharitar S" first="Steve" last="Ramcharitar">Steve Ramcharitar</name>
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<name sortKey="Kovac, Jan" sort="Kovac, Jan" uniqKey="Kovac J" first="Jan" last="Kovac">Jan Kovac</name>
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<country name="France"><noRegion><name sortKey="Lefevre, Thierry" sort="Lefevre, Thierry" uniqKey="Lefevre T" first="Thierry" last="Lefevre">Thierry Lefevre</name>
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<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>
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<name sortKey="Van Geuns, Robert J" sort="Van Geuns, Robert J" uniqKey="Van Geuns R" first="Robert J." last="Van Geuns">Robert J. Van Geuns</name>
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   |texte=   First-in-man (FIM) study of the Stentys bifurcation stent -30 days results
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First-in-man (FIM) study of the Stentys bifurcation stent -30 days results

First-in-man (FIM) study of the Stentys bifurcation stent -30 days results

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