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Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.

Identifieur interne : 000037 ( PubMed/Corpus ); précédent : 000036; suivant : 000038

Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.

Auteurs : Gérard Helft ; Philippe Gabriel Steg ; Claude Le Feuvre ; Jean-Louis Georges ; Didier Carrie ; Xavier Dreyfus ; Alain Furber ; Florence Leclercq ; Hélène Eltchaninoff ; Jean-François Falquier ; Patrick Henry ; Simon Cattan ; Laurent Sebagh ; Pierre-Louis Michel ; Albert Tuambilangana ; Nadjib Hammoudi ; Franck Boccara ; Guillaume Cayla ; Hervé Douard ; Abdourahmane Diallo ; Emmanuel Berman ; Michel Komajda ; Jean-Philippe Metzger ; Eric Vicaut

Source :

RBID : pubmed:26364288

Abstract

This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation.

DOI: 10.1093/eurheartj/ehv481
PubMed: 26364288

Links to Exploration step

pubmed:26364288

Le document en format XML

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<name sortKey="Georges, Jean Louis" sort="Georges, Jean Louis" uniqKey="Georges J" first="Jean-Louis" last="Georges">Jean-Louis Georges</name>
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<name sortKey="Falquier, Jean Francois" sort="Falquier, Jean Francois" uniqKey="Falquier J" first="Jean-François" last="Falquier">Jean-François Falquier</name>
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<name sortKey="Henry, Patrick" sort="Henry, Patrick" uniqKey="Henry P" first="Patrick" last="Henry">Patrick Henry</name>
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<name sortKey="Cattan, Simon" sort="Cattan, Simon" uniqKey="Cattan S" first="Simon" last="Cattan">Simon Cattan</name>
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<nlm:affiliation>Centre Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France.</nlm:affiliation>
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<name sortKey="Sebagh, Laurent" sort="Sebagh, Laurent" uniqKey="Sebagh L" first="Laurent" last="Sebagh">Laurent Sebagh</name>
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<name sortKey="Michel, Pierre Louis" sort="Michel, Pierre Louis" uniqKey="Michel P" first="Pierre-Louis" last="Michel">Pierre-Louis Michel</name>
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<name sortKey="Tuambilangana, Albert" sort="Tuambilangana, Albert" uniqKey="Tuambilangana A" first="Albert" last="Tuambilangana">Albert Tuambilangana</name>
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<name sortKey="Hammoudi, Nadjib" sort="Hammoudi, Nadjib" uniqKey="Hammoudi N" first="Nadjib" last="Hammoudi">Nadjib Hammoudi</name>
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<name sortKey="Cayla, Guillaume" sort="Cayla, Guillaume" uniqKey="Cayla G" first="Guillaume" last="Cayla">Guillaume Cayla</name>
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<name sortKey="Douard, Herve" sort="Douard, Herve" uniqKey="Douard H" first="Hervé" last="Douard">Hervé Douard</name>
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<name sortKey="Vicaut, Eric" sort="Vicaut, Eric" uniqKey="Vicaut E" first="Eric" last="Vicaut">Eric Vicaut</name>
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<name sortKey="Steg, Philippe Gabriel" sort="Steg, Philippe Gabriel" uniqKey="Steg P" first="Philippe Gabriel" last="Steg">Philippe Gabriel Steg</name>
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<nlm:affiliation>DHU FIRE, Université Paris-Diderot, Sorbonne-Paris-Cité, Paris, France Hôpital Bichat, Assistance Publique Hôpitaux de Paris, INSERM-U1148, Paris, France NHLI, Royal Brompton Hospital, Imperial College, London, UK.</nlm:affiliation>
</affiliation>
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<name sortKey="Le Feuvre, Claude" sort="Le Feuvre, Claude" uniqKey="Le Feuvre C" first="Claude" last="Le Feuvre">Claude Le Feuvre</name>
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<nlm:affiliation>Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France.</nlm:affiliation>
</affiliation>
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<name sortKey="Georges, Jean Louis" sort="Georges, Jean Louis" uniqKey="Georges J" first="Jean-Louis" last="Georges">Jean-Louis Georges</name>
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<nlm:affiliation>Centre Hospitalier Versailles, Le Chesnay, France.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Carrie, Didier" sort="Carrie, Didier" uniqKey="Carrie D" first="Didier" last="Carrie">Didier Carrie</name>
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<nlm:affiliation>Centre Hospitalier Universitaire Rangueil, Toulouse, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Dreyfus, Xavier" sort="Dreyfus, Xavier" uniqKey="Dreyfus X" first="Xavier" last="Dreyfus">Xavier Dreyfus</name>
<affiliation>
<nlm:affiliation>Espace Médical Mounier, Grenoble, France.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Furber, Alain" sort="Furber, Alain" uniqKey="Furber A" first="Alain" last="Furber">Alain Furber</name>
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<name sortKey="Leclercq, Florence" sort="Leclercq, Florence" uniqKey="Leclercq F" first="Florence" last="Leclercq">Florence Leclercq</name>
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<name sortKey="Eltchaninoff, Helene" sort="Eltchaninoff, Helene" uniqKey="Eltchaninoff H" first="Hélène" last="Eltchaninoff">Hélène Eltchaninoff</name>
<affiliation>
<nlm:affiliation>Centre Hospitalier Universitaire, Rouen, France INSERM U 1096, Rouen, France.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Falquier, Jean Francois" sort="Falquier, Jean Francois" uniqKey="Falquier J" first="Jean-François" last="Falquier">Jean-François Falquier</name>
<affiliation>
<nlm:affiliation>Polyclinique de Bergerac, Bergerac, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Henry, Patrick" sort="Henry, Patrick" uniqKey="Henry P" first="Patrick" last="Henry">Patrick Henry</name>
<affiliation>
<nlm:affiliation>Hôpital Lariboisière, Assistance Publique Hôpitaux de Paris, Paris 7, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Cattan, Simon" sort="Cattan, Simon" uniqKey="Cattan S" first="Simon" last="Cattan">Simon Cattan</name>
<affiliation>
<nlm:affiliation>Centre Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Sebagh, Laurent" sort="Sebagh, Laurent" uniqKey="Sebagh L" first="Laurent" last="Sebagh">Laurent Sebagh</name>
<affiliation>
<nlm:affiliation>Hôpital Privé de l'Ouest Parisien, Trappes, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Michel, Pierre Louis" sort="Michel, Pierre Louis" uniqKey="Michel P" first="Pierre-Louis" last="Michel">Pierre-Louis Michel</name>
<affiliation>
<nlm:affiliation>Hôpital Tenon, Assistance Publique Hôpitaux de Paris, Paris 6, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Tuambilangana, Albert" sort="Tuambilangana, Albert" uniqKey="Tuambilangana A" first="Albert" last="Tuambilangana">Albert Tuambilangana</name>
<affiliation>
<nlm:affiliation>Hôpital Cherbourg, Cherbourg, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Hammoudi, Nadjib" sort="Hammoudi, Nadjib" uniqKey="Hammoudi N" first="Nadjib" last="Hammoudi">Nadjib Hammoudi</name>
<affiliation>
<nlm:affiliation>Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France IHU, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Boccara, Franck" sort="Boccara, Franck" uniqKey="Boccara F" first="Franck" last="Boccara">Franck Boccara</name>
<affiliation>
<nlm:affiliation>Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Paris Pierre et Marie Curie, Paris, France INSERM UMR_S 938, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Cayla, Guillaume" sort="Cayla, Guillaume" uniqKey="Cayla G" first="Guillaume" last="Cayla">Guillaume Cayla</name>
<affiliation>
<nlm:affiliation>Centre Hospitalier Universitaire Nîmes, Université de Montpellier, Nîmes, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Douard, Herve" sort="Douard, Herve" uniqKey="Douard H" first="Hervé" last="Douard">Hervé Douard</name>
<affiliation>
<nlm:affiliation>Centre Hospitalier Universitaire, Bordeaux, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Diallo, Abdourahmane" sort="Diallo, Abdourahmane" uniqKey="Diallo A" first="Abdourahmane" last="Diallo">Abdourahmane Diallo</name>
<affiliation>
<nlm:affiliation>Unité de Recherche Clinique Lariboisière St Louis Hôpital Fernand Widal, Assistance Publique Hôpitaux de Paris, Université Paris-Diderot, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Berman, Emmanuel" sort="Berman, Emmanuel" uniqKey="Berman E" first="Emmanuel" last="Berman">Emmanuel Berman</name>
<affiliation>
<nlm:affiliation>Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Komajda, Michel" sort="Komajda, Michel" uniqKey="Komajda M" first="Michel" last="Komajda">Michel Komajda</name>
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<nlm:affiliation>Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France IHU, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Metzger, Jean Philippe" sort="Metzger, Jean Philippe" uniqKey="Metzger J" first="Jean-Philippe" last="Metzger">Jean-Philippe Metzger</name>
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</affiliation>
</author>
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<name sortKey="Vicaut, Eric" sort="Vicaut, Eric" uniqKey="Vicaut E" first="Eric" last="Vicaut">Eric Vicaut</name>
<affiliation>
<nlm:affiliation>Unité de Recherche Clinique Lariboisière St Louis Hôpital Fernand Widal, Assistance Publique Hôpitaux de Paris, Université Paris-Diderot, Paris, France PARTNERS/F-CRIN, Paris, France.</nlm:affiliation>
</affiliation>
</author>
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<title level="j">European heart journal</title>
<idno type="eISSN">1522-9645</idno>
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<date when="2016" type="published">2016</date>
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<div type="abstract" xml:lang="en">This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation.</div>
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<DateCreated>
<Year>2016</Year>
<Month>01</Month>
<Day>22</Day>
</DateCreated>
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<Journal>
<ISSN IssnType="Electronic">1522-9645</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>37</Volume>
<Issue>4</Issue>
<PubDate>
<Year>2016</Year>
<Month>Jan</Month>
<Day>21</Day>
</PubDate>
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<Title>European heart journal</Title>
<ISOAbbreviation>Eur. Heart J.</ISOAbbreviation>
</Journal>
<ArticleTitle>Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.</ArticleTitle>
<Pagination>
<MedlinePgn>365-74</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1093/eurheartj/ehv481</ELocationID>
<Abstract>
<AbstractText Label="AIM" NlmCategory="OBJECTIVE">This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation.</AbstractText>
<AbstractText Label="METHODS AND RESULTS" NlmCategory="RESULTS">Patients (N = 1799) who had undergone placement of ≥1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009-January 2013). Patients (N = 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1:1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50-1.28; P = 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34-1.22; P = 0.18). Rates of major bleeding were identical (2.0%, P = 0.95).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment.</AbstractText>
<AbstractText Label="CLINICALTRIALSGOV NUMBER" NlmCategory="UNASSIGNED">NCT00822536.</AbstractText>
<CopyrightInformation>Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Helft</LastName>
<ForeName>Gérard</ForeName>
<Initials>G</Initials>
<AffiliationInfo>
<Affiliation>Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France IHU, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France gerard.helft@aphp.fr.</Affiliation>
</AffiliationInfo>
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<LastName>Steg</LastName>
<ForeName>Philippe Gabriel</ForeName>
<Initials>PG</Initials>
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<Affiliation>DHU FIRE, Université Paris-Diderot, Sorbonne-Paris-Cité, Paris, France Hôpital Bichat, Assistance Publique Hôpitaux de Paris, INSERM-U1148, Paris, France NHLI, Royal Brompton Hospital, Imperial College, London, UK.</Affiliation>
</AffiliationInfo>
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<LastName>Le Feuvre</LastName>
<ForeName>Claude</ForeName>
<Initials>C</Initials>
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