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Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI.

Identifieur interne : 003911 ( PubMed/Corpus ); précédent : 003910; suivant : 003912

Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI.

Auteurs : Sanjit S. Jolly ; John Cairns ; Salim Yusuf ; Brandi Meeks ; Olga Shestakovska ; Lehana Thabane ; Kari Niemel ; Philippe Gabriel Steg ; Olivier F. Bertrand ; Sunil V. Rao ; Alvaro Avezum ; Warren J. Cantor ; Samir B. Pancholy ; Raul Moreno ; Anthony Gershlick ; Ravinay Bhindi ; Robert C. Welsh ; Asim N. Cheema ; Shahar Lavi ; Michael Rokoss ; Vladimír Džavík

Source :

RBID : pubmed:24576514

English descriptors

Abstract

A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy.

DOI: 10.1016/j.ahj.2013.12.002
PubMed: 24576514

Links to Exploration step

pubmed:24576514

Le document en format XML

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<name sortKey="Niemel, Kari" sort="Niemel, Kari" uniqKey="Niemel K" first="Kari" last="Niemel">Kari Niemel</name>
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<nlm:affiliation>Tampere Heart Center and University Hospital, Tampere, Finland.</nlm:affiliation>
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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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<name sortKey="Rao, Sunil V" sort="Rao, Sunil V" uniqKey="Rao S" first="Sunil V" last="Rao">Sunil V. Rao</name>
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<name sortKey="Avezum, Alvaro" sort="Avezum, Alvaro" uniqKey="Avezum A" first="Alvaro" last="Avezum">Alvaro Avezum</name>
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<nlm:affiliation>Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.</nlm:affiliation>
</affiliation>
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<name sortKey="Cantor, Warren J" sort="Cantor, Warren J" uniqKey="Cantor W" first="Warren J" last="Cantor">Warren J. Cantor</name>
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<nlm:affiliation>Southlake Regional Health Centre, University of Toronto, Newmarket, Canada.</nlm:affiliation>
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<name sortKey="Pancholy, Samir B" sort="Pancholy, Samir B" uniqKey="Pancholy S" first="Samir B" last="Pancholy">Samir B. Pancholy</name>
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<nlm:affiliation>The Commonwealth Medical College, Scranton, PA.</nlm:affiliation>
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<name sortKey="Moreno, Raul" sort="Moreno, Raul" uniqKey="Moreno R" first="Raul" last="Moreno">Raul Moreno</name>
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<nlm:affiliation>Hospital La Paz, Madrid, Spain.</nlm:affiliation>
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<name sortKey="Gershlick, Anthony" sort="Gershlick, Anthony" uniqKey="Gershlick A" first="Anthony" last="Gershlick">Anthony Gershlick</name>
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<nlm:affiliation>National Institute for Health Research, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, University Hospitals of Leicester, Glenfield Hospital, Leicester, United Kingdom.</nlm:affiliation>
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<name sortKey="Bhindi, Ravinay" sort="Bhindi, Ravinay" uniqKey="Bhindi R" first="Ravinay" last="Bhindi">Ravinay Bhindi</name>
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<name sortKey="Welsh, Robert C" sort="Welsh, Robert C" uniqKey="Welsh R" first="Robert C" last="Welsh">Robert C. Welsh</name>
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<nlm:affiliation>University of Alberta, Edmonton, Canada.</nlm:affiliation>
</affiliation>
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<name sortKey="Cheema, Asim N" sort="Cheema, Asim N" uniqKey="Cheema A" first="Asim N" last="Cheema">Asim N. Cheema</name>
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<nlm:affiliation>St Michael's Hospital, University of Toronto, Toronto, Canada.</nlm:affiliation>
</affiliation>
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<name sortKey="Lavi, Shahar" sort="Lavi, Shahar" uniqKey="Lavi S" first="Shahar" last="Lavi">Shahar Lavi</name>
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<nlm:affiliation>London Health Sciences Centre, Western University, London, Canada.</nlm:affiliation>
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<name sortKey="Rokoss, Michael" sort="Rokoss, Michael" uniqKey="Rokoss M" first="Michael" last="Rokoss">Michael Rokoss</name>
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<nlm:affiliation>McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Dzavik, Vladimir" sort="Dzavik, Vladimir" uniqKey="Dzavik V" first="Vladimír" last="Džavík">Vladimír Džavík</name>
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<nlm:affiliation>Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Canada.</nlm:affiliation>
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<term>Microcirculation</term>
<term>Myocardial Infarction (therapy)</term>
<term>Percutaneous Coronary Intervention (methods)</term>
<term>Prospective Studies</term>
<term>Suction (methods)</term>
<term>Thrombectomy (methods)</term>
<term>Treatment Outcome</term>
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<term>Percutaneous Coronary Intervention</term>
<term>Suction</term>
<term>Thrombectomy</term>
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<term>Myocardial Infarction</term>
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<div type="abstract" xml:lang="en">A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy.</div>
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<Title>American heart journal</Title>
<ISOAbbreviation>Am. Heart J.</ISOAbbreviation>
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<ArticleTitle>Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI.</ArticleTitle>
<Pagination>
<MedlinePgn>315-321.e1</MedlinePgn>
</Pagination>
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<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI.</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="METHODS">This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients.</AbstractText>
<AbstractText Label="SUMMARY" NlmCategory="CONCLUSIONS">The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.</AbstractText>
<CopyrightInformation>Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.</CopyrightInformation>
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<Affiliation>Duke Clinical Research Institute, Duke University, Durham, NC.</Affiliation>
</AffiliationInfo>
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<LastName>Avezum</LastName>
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<Affiliation>Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.</Affiliation>
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</AffiliationInfo>
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</AffiliationInfo>
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<Affiliation>National Institute for Health Research, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, University Hospitals of Leicester, Glenfield Hospital, Leicester, United Kingdom.</Affiliation>
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