Optimal duration of dual antiplatelet therapy following treatment with the endeavor zotarolimus-eluting stent in real-world Japanese patients with coronary artery disease (OPERA): study design and rationale.
Identifieur interne : 000151 ( PubMed/Checkpoint ); précédent : 000150; suivant : 000152Optimal duration of dual antiplatelet therapy following treatment with the endeavor zotarolimus-eluting stent in real-world Japanese patients with coronary artery disease (OPERA): study design and rationale.
Auteurs : Masato Nakamura [Japon] ; Shinsuke Nanto ; Atsushi Hirayama ; Tadateru Takayama ; Masakatsu Nishikawa ; Kazuo Kimura ; Satoshi Morita ; Tadanori Aizawa ; Ryuta Asano ; Yuji Matsumaru ; Chikuma Hamada ; Takaaki IsshikiSource :
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions ; 2014.
Descripteurs français
- Wicri :
- geographic : Japon.
English descriptors
- KwdEn :
- Aged, Coronary Artery Disease (epidemiology), Coronary Artery Disease (therapy), Drug Therapy, Combination, Drug-Eluting Stents, Follow-Up Studies, Humans, Incidence, Japan (epidemiology), Male, Platelet Aggregation Inhibitors (therapeutic use), Practice Guidelines as Topic, Prospective Studies, Prosthesis Design, Sirolimus (analogs & derivatives), Sirolimus (pharmacology), Treatment Outcome.
- MESH :
- chemical , analogs & derivatives : Sirolimus.
- chemical , pharmacology : Sirolimus.
- chemical , therapeutic use : Platelet Aggregation Inhibitors.
- geographic , epidemiology : Japan.
- epidemiology : Coronary Artery Disease.
- therapy : Coronary Artery Disease.
- Aged, Drug Therapy, Combination, Drug-Eluting Stents, Follow-Up Studies, Humans, Incidence, Male, Practice Guidelines as Topic, Prospective Studies, Prosthesis Design, Treatment Outcome.
Abstract
In patients with coronary artery disease (CAD), there is an increasing therapeutic need among interventional cardiologists to conduct dual antiplatelet therapy (DAPT) whose duration is shorter than current guideline-recommended 6-12 months after the implantation of drug-eluting stents. However, no clinical grounds sufficient to rationalize the need are available.
DOI: 10.1002/ccd.25282
PubMed: 24382824
Affiliations:
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pubmed:24382824Le document en format XML
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sort="Hirayama, Atsushi" uniqKey="Hirayama A" first="Atsushi" last="Hirayama">Atsushi Hirayama</name></author><author><name sortKey="Takayama, Tadateru" sort="Takayama, Tadateru" uniqKey="Takayama T" first="Tadateru" last="Takayama">Tadateru Takayama</name></author><author><name sortKey="Nishikawa, Masakatsu" sort="Nishikawa, Masakatsu" uniqKey="Nishikawa M" first="Masakatsu" last="Nishikawa">Masakatsu Nishikawa</name></author><author><name sortKey="Kimura, Kazuo" sort="Kimura, Kazuo" uniqKey="Kimura K" first="Kazuo" last="Kimura">Kazuo Kimura</name></author><author><name sortKey="Morita, Satoshi" sort="Morita, Satoshi" uniqKey="Morita S" first="Satoshi" last="Morita">Satoshi Morita</name></author><author><name sortKey="Aizawa, Tadanori" sort="Aizawa, Tadanori" uniqKey="Aizawa T" first="Tadanori" last="Aizawa">Tadanori Aizawa</name></author><author><name sortKey="Asano, Ryuta" sort="Asano, Ryuta" uniqKey="Asano R" first="Ryuta" last="Asano">Ryuta Asano</name></author><author><name 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patients with coronary artery disease (OPERA): study design and rationale.</title><author><name sortKey="Nakamura, Masato" sort="Nakamura, Masato" uniqKey="Nakamura M" first="Masato" last="Nakamura">Masato Nakamura</name><affiliation wicri:level="3"><nlm:affiliation>Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo</wicri:regionArea><placeName><settlement type="city">Tokyo</settlement></placeName></affiliation></author><author><name sortKey="Nanto, Shinsuke" sort="Nanto, Shinsuke" uniqKey="Nanto S" first="Shinsuke" last="Nanto">Shinsuke Nanto</name></author><author><name sortKey="Hirayama, Atsushi" sort="Hirayama, Atsushi" uniqKey="Hirayama A" first="Atsushi" last="Hirayama">Atsushi Hirayama</name></author><author><name sortKey="Takayama, Tadateru" sort="Takayama, Tadateru" uniqKey="Takayama T" first="Tadateru" last="Takayama">Tadateru Takayama</name></author><author><name sortKey="Nishikawa, Masakatsu" sort="Nishikawa, Masakatsu" uniqKey="Nishikawa M" first="Masakatsu" last="Nishikawa">Masakatsu Nishikawa</name></author><author><name sortKey="Kimura, Kazuo" sort="Kimura, Kazuo" uniqKey="Kimura K" first="Kazuo" last="Kimura">Kazuo Kimura</name></author><author><name sortKey="Morita, Satoshi" sort="Morita, Satoshi" uniqKey="Morita S" first="Satoshi" last="Morita">Satoshi Morita</name></author><author><name sortKey="Aizawa, Tadanori" sort="Aizawa, Tadanori" uniqKey="Aizawa T" first="Tadanori" last="Aizawa">Tadanori Aizawa</name></author><author><name sortKey="Asano, Ryuta" sort="Asano, Ryuta" uniqKey="Asano R" first="Ryuta" last="Asano">Ryuta Asano</name></author><author><name sortKey="Matsumaru, Yuji" sort="Matsumaru, Yuji" uniqKey="Matsumaru Y" first="Yuji" last="Matsumaru">Yuji Matsumaru</name></author><author><name sortKey="Hamada, Chikuma" sort="Hamada, Chikuma" uniqKey="Hamada C" first="Chikuma" last="Hamada">Chikuma Hamada</name></author><author><name sortKey="Isshiki, Takaaki" sort="Isshiki, Takaaki" uniqKey="Isshiki T" first="Takaaki" last="Isshiki">Takaaki Isshiki</name></author></analytic><series><title level="j">Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions</title><idno type="e-ISSN">1522-726X</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Coronary Artery Disease (epidemiology)</term><term>Coronary Artery Disease (therapy)</term><term>Drug Therapy, Combination</term><term>Drug-Eluting Stents</term><term>Follow-Up Studies</term><term>Humans</term><term>Incidence</term><term>Japan (epidemiology)</term><term>Male</term><term>Platelet Aggregation Inhibitors (therapeutic use)</term><term>Practice Guidelines as Topic</term><term>Prospective Studies</term><term>Prosthesis Design</term><term>Sirolimus (analogs & derivatives)</term><term>Sirolimus (pharmacology)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Sirolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Sirolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Platelet Aggregation Inhibitors</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Japan</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Coronary Artery Disease</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Coronary Artery Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Drug Therapy, Combination</term><term>Drug-Eluting Stents</term><term>Follow-Up Studies</term><term>Humans</term><term>Incidence</term><term>Male</term><term>Practice Guidelines as Topic</term><term>Prospective Studies</term><term>Prosthesis Design</term><term>Treatment Outcome</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Japon</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In patients with coronary artery disease (CAD), there is an increasing therapeutic need among interventional cardiologists to conduct dual antiplatelet therapy (DAPT) whose duration is shorter than current guideline-recommended 6-12 months after the implantation of drug-eluting stents. However, no clinical grounds sufficient to rationalize the need are available.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">24382824</PMID><DateCreated><Year>2014</Year><Month>08</Month><Day>21</Day></DateCreated><DateCompleted><Year>2015</Year><Month>05</Month><Day>12</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1522-726X</ISSN><JournalIssue CitedMedium="Internet"><Volume>84</Volume><Issue>3</Issue><PubDate><Year>2014</Year><Month>Sep</Month><Day>1</Day></PubDate></JournalIssue><Title>Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions</Title><ISOAbbreviation>Catheter Cardiovasc Interv</ISOAbbreviation></Journal><ArticleTitle>Optimal duration of dual antiplatelet therapy following treatment with the endeavor zotarolimus-eluting stent in real-world Japanese patients with coronary artery disease (OPERA): study design and rationale.</ArticleTitle><Pagination><MedlinePgn>368-74</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/ccd.25282</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In patients with coronary artery disease (CAD), there is an increasing therapeutic need among interventional cardiologists to conduct dual antiplatelet therapy (DAPT) whose duration is shorter than current guideline-recommended 6-12 months after the implantation of drug-eluting stents. However, no clinical grounds sufficient to rationalize the need are available.</AbstractText><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">To define the optimal duration of DAPT and to examine the safety and efficacy of the Endeavor zotarolimus-eluting stent (E-ZES) in real-world Japanese patients with CAD.</AbstractText><AbstractText Label="STUDY DESIGN" NlmCategory="METHODS">The present prospective, nonrandomized, multicenter, controlled study is uniquely designed to examine the analysis set to be formulated after integrating two different databases consisting of the following two study arms: the 3-month DAPT arm, in which 1,210 patients were consecutively enrolled at 106 medical institutions; and the 12-month DAPT arm, in which 1,210 patients will be consecutively extracted from the Endeavor Japan post-marketing surveillance at 60 medical institutions. The primary endpoint is "net adverse cardiac and cerebrovascular events-death, myocardial infarction, cerebrovascular accident, and major bleeding)" at 12 months after implantation. The secondary endpoints are as follows: major adverse cardiac events at 1, 3, 6, 9, and 12 months after implantation; target vessel revascularization and target lesion revascularization at 9 and 12 months after implantation; and stent thrombosis, DAPT compliance, and bleeding events at 12 months after implantation. Noninferiority in the E-ZES's profiles between the study arms will be investigated.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The present study will provide insight into the optimal duration of DAPT after the E-ZES implantation in individual, real-world patients with CAD.</AbstractText><CopyrightInformation>© 2013 Wiley Periodicals, Inc.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Nakamura</LastName><ForeName>Masato</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nanto</LastName><ForeName>Shinsuke</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Hirayama</LastName><ForeName>Atsushi</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Takayama</LastName><ForeName>Tadateru</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Nishikawa</LastName><ForeName>Masakatsu</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Kimura</LastName><ForeName>Kazuo</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Morita</LastName><ForeName>Satoshi</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Aizawa</LastName><ForeName>Tadanori</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Asano</LastName><ForeName>Ryuta</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Matsumaru</LastName><ForeName>Yuji</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>Hamada</LastName><ForeName>Chikuma</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Isshiki</LastName><ForeName>Takaaki</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><CollectiveName>OPERA Steering Committee and Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D018848">Controlled Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>12</Month><Day>31</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Catheter Cardiovasc Interv</MedlineTA><NlmUniqueID>100884139</NlmUniqueID><ISSNLinking>1522-1946</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010975">Platelet Aggregation Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>H4GXR80IZE</RegistryNumber><NameOfSubstance UI="C489443">zotarolimus</NameOfSubstance></Chemical><Chemical><RegistryNumber>W36ZG6FT64</RegistryNumber><NameOfSubstance UI="D020123">Sirolimus</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Catheter Cardiovasc Interv. 2014 Sep 1;84(3):375-6</RefSource><PMID Version="1">25142422</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D003324">Coronary Artery Disease</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000453">epidemiology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000628">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004359">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D054855">Drug-Eluting Stents</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015994">Incidence</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" Type="Geographic" UI="D007564">Japan</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000453">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010975">Platelet Aggregation Inhibitors</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D017410">Practice Guidelines as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011446">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011474">Prosthesis Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D020123">Sirolimus</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000031">analogs & derivatives</QualifierName><QualifierName MajorTopicYN="N" UI="Q000494">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">coronary artery disease</Keyword><Keyword MajorTopicYN="N">drug-eluting stent</Keyword><Keyword MajorTopicYN="N">dual antipalete therapy</Keyword><Keyword MajorTopicYN="N">major bleeding</Keyword><Keyword MajorTopicYN="N">stent thrombosis</Keyword></KeywordList><InvestigatorList><Investigator ValidYN="Y"><LastName>Suzuki</LastName><ForeName>Takahide</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ako</LastName><ForeName>Junya</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Omura</LastName><ForeName>Nobuhiro</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Yamazaki</LastName><ForeName>Kenji</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ando</LastName><ForeName>Hiroyuki</ForeName><Initials>H</Initials></Investigator><Investigator ValidYN="Y"><LastName>Yajima</LastName><ForeName>Junji</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Nishi</LastName><ForeName>Yutaro</ForeName><Initials>Y</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ohta</LastName><ForeName>Hiroshi</ForeName><Initials>H</Initials></Investigator><Investigator 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uniqKey="Matsumaru Y" first="Yuji" last="Matsumaru">Yuji Matsumaru</name><name sortKey="Morita, Satoshi" sort="Morita, Satoshi" uniqKey="Morita S" first="Satoshi" last="Morita">Satoshi Morita</name><name sortKey="Nanto, Shinsuke" sort="Nanto, Shinsuke" uniqKey="Nanto S" first="Shinsuke" last="Nanto">Shinsuke Nanto</name><name sortKey="Nishikawa, Masakatsu" sort="Nishikawa, Masakatsu" uniqKey="Nishikawa M" first="Masakatsu" last="Nishikawa">Masakatsu Nishikawa</name><name sortKey="Takayama, Tadateru" sort="Takayama, Tadateru" uniqKey="Takayama T" first="Tadateru" last="Takayama">Tadateru Takayama</name></noCountry><country name="Japon"><noRegion><name sortKey="Nakamura, Masato" sort="Nakamura, Masato" uniqKey="Nakamura M" first="Masato" last="Nakamura">Masato Nakamura</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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