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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial</title><author><name sortKey="Jolly, Sanjit S" sort="Jolly, Sanjit S" uniqKey="Jolly S" first="Sanjit S" last="Jolly">Sanjit S. Jolly</name></author><author><name sortKey="Cairns, John A" sort="Cairns, John A" uniqKey="Cairns J" first="John A" last="Cairns">John A. Cairns</name></author><author><name sortKey="Yusuf, Salim" sort="Yusuf, Salim" uniqKey="Yusuf S" first="Salim" last="Yusuf">Salim Yusuf</name></author><author><name sortKey="Rokoss, Michael J" sort="Rokoss, Michael J" uniqKey="Rokoss M" first="Michael J" last="Rokoss">Michael J. Rokoss</name></author><author><name sortKey="Gao, Peggy" sort="Gao, Peggy" uniqKey="Gao P" first="Peggy" last="Gao">Peggy Gao</name></author><author><name sortKey="Meeks, Brandi" sort="Meeks, Brandi" uniqKey="Meeks B" first="Brandi" last="Meeks">Brandi Meeks</name></author><author><name sortKey="Kedev, Sasko" sort="Kedev, Sasko" uniqKey="Kedev S" first="Sasko" last="Kedev">Sasko Kedev</name></author><author><name sortKey="Stankovic, Goran" sort="Stankovic, Goran" uniqKey="Stankovic G" first="Goran" last="Stankovic">Goran Stankovic</name></author><author><name sortKey="Moreno, Raul" sort="Moreno, Raul" uniqKey="Moreno R" first="Raul" last="Moreno">Raul Moreno</name></author><author><name sortKey="Gershlick, Anthony" sort="Gershlick, Anthony" uniqKey="Gershlick A" first="Anthony" last="Gershlick">Anthony Gershlick</name></author><author><name sortKey="Chowdhary, Saqib" sort="Chowdhary, Saqib" uniqKey="Chowdhary S" first="Saqib" last="Chowdhary">Saqib Chowdhary</name></author><author><name sortKey="Lavi, Shahar" sort="Lavi, Shahar" uniqKey="Lavi S" first="Shahar" last="Lavi">Shahar Lavi</name></author><author><name sortKey="Niemela, Kari" sort="Niemela, Kari" uniqKey="Niemela K" first="Kari" last="Niemela">Kari Niemela</name></author><author><name sortKey="Bernat, Ivo" sort="Bernat, Ivo" uniqKey="Bernat I" first="Ivo" last="Bernat">Ivo Bernat</name></author><author><name sortKey="Cantor, Warren J" sort="Cantor, Warren J" uniqKey="Cantor W" first="Warren J" last="Cantor">Warren J. Cantor</name></author><author><name sortKey="Cheema, Asim N" sort="Cheema, Asim N" uniqKey="Cheema A" first="Asim N" last="Cheema">Asim N. Cheema</name></author><author><name sortKey="Steg, Philippe Gabriel" sort="Steg, Philippe Gabriel" uniqKey="Steg P" first="Philippe Gabriel" last="Steg">Philippe Gabriel Steg</name></author><author><name sortKey="Welsh, Robert C" sort="Welsh, Robert C" uniqKey="Welsh R" first="Robert C" last="Welsh">Robert C. Welsh</name></author><author><name sortKey="Sheth, Tej" sort="Sheth, Tej" uniqKey="Sheth T" first="Tej" last="Sheth">Tej Sheth</name></author><author><name sortKey="Bertrand, Olivier F" sort="Bertrand, Olivier F" uniqKey="Bertrand O" first="Olivier F" last="Bertrand">Olivier F. Bertrand</name></author><author><name sortKey="Avezum, Alvaro" sort="Avezum, Alvaro" uniqKey="Avezum A" first="Alvaro" last="Avezum">Alvaro Avezum</name></author><author><name sortKey="Bhindi, Ravinay" sort="Bhindi, Ravinay" uniqKey="Bhindi R" first="Ravinay" last="Bhindi">Ravinay Bhindi</name></author><author><name sortKey="Natarajan, Madhu K" sort="Natarajan, Madhu K" uniqKey="Natarajan M" first="Madhu K" last="Natarajan">Madhu K. Natarajan</name></author><author><name sortKey="Horak, David" sort="Horak, David" uniqKey="Horak D" first="David" last="Horak">David Horak</name></author><author><name sortKey="Leung, Raymond C M" sort="Leung, Raymond C M" uniqKey="Leung R" first="Raymond C M" last="Leung">Raymond C M. Leung</name></author><author><name sortKey="Kassam, Saleem" sort="Kassam, Saleem" uniqKey="Kassam S" first="Saleem" last="Kassam">Saleem Kassam</name></author><author><name sortKey="Rao, Sunil V" sort="Rao, Sunil V" uniqKey="Rao S" first="Sunil V" last="Rao">Sunil V. Rao</name></author><author><name sortKey="El Omar, Magdi" sort="El Omar, Magdi" uniqKey="El Omar M" first="Magdi" last="El-Omar">Magdi El-Omar</name></author><author><name sortKey="Mehta, Shamir R" sort="Mehta, Shamir R" uniqKey="Mehta S" first="Shamir R" last="Mehta">Shamir R. Mehta</name></author><author><name sortKey="Velianou, James L" sort="Velianou, James L" uniqKey="Velianou J" first="James L" last="Velianou">James L. Velianou</name></author><author><name sortKey="Pancholy, Samir" sort="Pancholy, Samir" uniqKey="Pancholy S" first="Samir" last="Pancholy">Samir Pancholy</name></author><author><name sortKey="Dzavik, Vladimir" sort="Dzavik, Vladimir" uniqKey="Dzavik V" first="Vladimír" last="Džavík">Vladimír Džavík</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26474811</idno><idno type="pmc">5007127</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5007127</idno><idno type="RBID">PMC:5007127</idno><idno type="doi">10.1016/S0140-6736(15)00448-1</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">001F29</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001F29</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial</title><author><name sortKey="Jolly, Sanjit S" sort="Jolly, Sanjit S" uniqKey="Jolly S" first="Sanjit S" last="Jolly">Sanjit S. Jolly</name></author><author><name sortKey="Cairns, John A" sort="Cairns, John A" uniqKey="Cairns J" first="John A" last="Cairns">John A. Cairns</name></author><author><name sortKey="Yusuf, Salim" sort="Yusuf, Salim" uniqKey="Yusuf S" first="Salim" last="Yusuf">Salim Yusuf</name></author><author><name sortKey="Rokoss, Michael J" sort="Rokoss, Michael J" uniqKey="Rokoss M" first="Michael J" last="Rokoss">Michael J. Rokoss</name></author><author><name sortKey="Gao, Peggy" sort="Gao, Peggy" uniqKey="Gao P" first="Peggy" last="Gao">Peggy Gao</name></author><author><name sortKey="Meeks, Brandi" sort="Meeks, Brandi" uniqKey="Meeks B" first="Brandi" last="Meeks">Brandi Meeks</name></author><author><name sortKey="Kedev, Sasko" sort="Kedev, Sasko" uniqKey="Kedev S" first="Sasko" last="Kedev">Sasko Kedev</name></author><author><name sortKey="Stankovic, Goran" sort="Stankovic, Goran" uniqKey="Stankovic G" first="Goran" last="Stankovic">Goran Stankovic</name></author><author><name sortKey="Moreno, Raul" sort="Moreno, Raul" uniqKey="Moreno R" first="Raul" last="Moreno">Raul Moreno</name></author><author><name sortKey="Gershlick, Anthony" sort="Gershlick, Anthony" uniqKey="Gershlick A" first="Anthony" last="Gershlick">Anthony Gershlick</name></author><author><name sortKey="Chowdhary, Saqib" sort="Chowdhary, Saqib" uniqKey="Chowdhary S" first="Saqib" last="Chowdhary">Saqib Chowdhary</name></author><author><name sortKey="Lavi, Shahar" sort="Lavi, Shahar" uniqKey="Lavi S" first="Shahar" last="Lavi">Shahar Lavi</name></author><author><name sortKey="Niemela, Kari" sort="Niemela, Kari" uniqKey="Niemela K" first="Kari" last="Niemela">Kari Niemela</name></author><author><name sortKey="Bernat, Ivo" sort="Bernat, Ivo" uniqKey="Bernat I" first="Ivo" last="Bernat">Ivo Bernat</name></author><author><name sortKey="Cantor, Warren J" sort="Cantor, Warren J" uniqKey="Cantor W" first="Warren J" last="Cantor">Warren J. Cantor</name></author><author><name sortKey="Cheema, Asim N" sort="Cheema, Asim N" uniqKey="Cheema A" first="Asim N" last="Cheema">Asim N. Cheema</name></author><author><name sortKey="Steg, Philippe Gabriel" sort="Steg, Philippe Gabriel" uniqKey="Steg P" first="Philippe Gabriel" last="Steg">Philippe Gabriel Steg</name></author><author><name sortKey="Welsh, Robert C" sort="Welsh, Robert C" uniqKey="Welsh R" first="Robert C" last="Welsh">Robert C. Welsh</name></author><author><name sortKey="Sheth, Tej" sort="Sheth, Tej" uniqKey="Sheth T" first="Tej" last="Sheth">Tej Sheth</name></author><author><name sortKey="Bertrand, Olivier F" sort="Bertrand, Olivier F" uniqKey="Bertrand O" first="Olivier F" last="Bertrand">Olivier F. Bertrand</name></author><author><name sortKey="Avezum, Alvaro" sort="Avezum, Alvaro" uniqKey="Avezum A" first="Alvaro" last="Avezum">Alvaro Avezum</name></author><author><name sortKey="Bhindi, Ravinay" sort="Bhindi, Ravinay" uniqKey="Bhindi R" first="Ravinay" last="Bhindi">Ravinay Bhindi</name></author><author><name sortKey="Natarajan, Madhu K" sort="Natarajan, Madhu K" uniqKey="Natarajan M" first="Madhu K" last="Natarajan">Madhu K. Natarajan</name></author><author><name sortKey="Horak, David" sort="Horak, David" uniqKey="Horak D" first="David" last="Horak">David Horak</name></author><author><name sortKey="Leung, Raymond C M" sort="Leung, Raymond C M" uniqKey="Leung R" first="Raymond C M" last="Leung">Raymond C M. Leung</name></author><author><name sortKey="Kassam, Saleem" sort="Kassam, Saleem" uniqKey="Kassam S" first="Saleem" last="Kassam">Saleem Kassam</name></author><author><name sortKey="Rao, Sunil V" sort="Rao, Sunil V" uniqKey="Rao S" first="Sunil V" last="Rao">Sunil V. Rao</name></author><author><name sortKey="El Omar, Magdi" sort="El Omar, Magdi" uniqKey="El Omar M" first="Magdi" last="El-Omar">Magdi El-Omar</name></author><author><name sortKey="Mehta, Shamir R" sort="Mehta, Shamir R" uniqKey="Mehta S" first="Shamir R" last="Mehta">Shamir R. Mehta</name></author><author><name sortKey="Velianou, James L" sort="Velianou, James L" uniqKey="Velianou J" first="James L" last="Velianou">James L. Velianou</name></author><author><name sortKey="Pancholy, Samir" sort="Pancholy, Samir" uniqKey="Pancholy S" first="Samir" last="Pancholy">Samir Pancholy</name></author><author><name sortKey="Dzavik, Vladimir" sort="Dzavik, Vladimir" uniqKey="Dzavik V" first="Vladimír" last="Džavík">Vladimír Džavík</name></author></analytic><series><title level="j">Lancet (London, England)</title><idno type="ISSN">0140-6736</idno><idno type="eISSN">1474-547X</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><sec id="S1"><title>Background</title><p id="P2">Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice.</p></sec><sec id="S2"><title>Methods</title><p id="P3">The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044.</p></sec><sec id="S3"><title>Findings</title><p id="P4">Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10 064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1·00 [95% CI 0·87–1·15], p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 [95% CI 0·76–1·14], p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 [95% CI 1·10–2·51], p=0·015).</p></sec><sec id="S4"><title>Interpretation</title><p id="P5">Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">2985213R</journal-id><journal-id journal-id-type="pubmed-jr-id">5470</journal-id><journal-id journal-id-type="nlm-ta">Lancet</journal-id><journal-id journal-id-type="iso-abbrev">Lancet</journal-id><journal-title-group><journal-title>Lancet (London, England)</journal-title></journal-title-group><issn pub-type="ppub">0140-6736</issn><issn pub-type="epub">1474-547X</issn></journal-meta><article-meta><article-id pub-id-type="pmid">26474811</article-id><article-id pub-id-type="pmc">5007127</article-id><article-id pub-id-type="doi">10.1016/S0140-6736(15)00448-1</article-id><article-id pub-id-type="manuscript">CAMS5775</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Jolly</surname><given-names>Sanjit S</given-names></name><degrees>MD</degrees><aff id="A1">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Cairns</surname><given-names>John A</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><aff id="A2">University of British Columbia, Vancouver, BC, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Yusuf</surname><given-names>Salim</given-names><prefix>Prof.</prefix></name><degrees>MBBS</degrees><aff id="A3">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Rokoss</surname><given-names>Michael J</given-names></name><degrees>MD</degrees><aff id="A4">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Gao</surname><given-names>Peggy</given-names></name><degrees>MSc</degrees><aff id="A5">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Meeks</surname><given-names>Brandi</given-names></name><degrees>MEng</degrees><aff id="A6">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Kedev</surname><given-names>Sasko</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><aff id="A7">University Clinic of Cardiology, Sts. Cyril and Methodius University, Skopje, Macedonia</aff></contrib><contrib contrib-type="author"><name><surname>Stankovic</surname><given-names>Goran</given-names></name><degrees>MD</degrees><aff id="A8">Clinical Center of Serbia and Department of Cardiology, Medical Faculty, University of Belgrade, Belgrade, Serbia</aff></contrib><contrib contrib-type="author"><name><surname>Moreno</surname><given-names>Raul</given-names></name><degrees>MD</degrees><aff id="A9">University Hospital La Paz, Madrid, Spain</aff></contrib><contrib contrib-type="author"><name><surname>Gershlick</surname><given-names>Anthony</given-names><prefix>Prof.</prefix></name><degrees>MB</degrees><aff id="A10">Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK</aff></contrib><contrib contrib-type="author"><name><surname>Chowdhary</surname><given-names>Saqib</given-names></name><degrees>MD</degrees><aff id="A11">University Hospitals South Manchester, Manchester Academic Health Science Centre, Manchester, UK</aff></contrib><contrib contrib-type="author"><name><surname>Lavi</surname><given-names>Shahar</given-names></name><degrees>MD</degrees><aff id="A12">London Health Sciences Centre, Department of Medicine, London, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Niemela</surname><given-names>Kari</given-names></name><degrees>MD</degrees><aff id="A13">Heart Center, Tampere University Hospital, Tampere, Finland</aff></contrib><contrib contrib-type="author"><name><surname>Bernat</surname><given-names>Ivo</given-names></name><degrees>MD</degrees><aff id="A14">University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic</aff></contrib><contrib contrib-type="author"><name><surname>Cantor</surname><given-names>Warren J</given-names></name><degrees>MD</degrees><aff id="A15">Southlake Regional Health Centre, Newmarket, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Cheema</surname><given-names>Asim N</given-names></name><degrees>MD</degrees><aff id="A16">St Michael’s Hospital, Toronto, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Steg</surname><given-names>Philippe Gabriel</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><aff id="A17">Université Paris-Diderot, Sorbonne Paris-Cité, INSERM Unité 1148, Hôpital Bichat, Assistance Publique–Hôpitaux de Paris, Paris, France</aff></contrib><contrib contrib-type="author"><name><surname>Welsh</surname><given-names>Robert C</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><aff id="A18">Mazankowski Alberta Heart Institute, Department of Medicine, Edmonton, AB, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Sheth</surname><given-names>Tej</given-names></name><degrees>MD</degrees><aff id="A19">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Bertrand</surname><given-names>Olivier F</given-names></name><degrees>MD</degrees><aff id="A20">Quebec Heart–Lung Institute, Laval University, Quebec, QC, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Avezum</surname><given-names>Alvaro</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><aff id="A21">Dante Pazzanese Institute of Cardiology, University of Santo Amaro, Sao Paulo, Brazil</aff></contrib><contrib contrib-type="author"><name><surname>Bhindi</surname><given-names>Ravinay</given-names></name><degrees>MBBS</degrees><aff id="A22">Royal North Shore Hospital, Sydney, Australia</aff></contrib><contrib contrib-type="author"><name><surname>Natarajan</surname><given-names>Madhu K</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><aff id="A23">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Horak</surname><given-names>David</given-names></name><degrees>MD</degrees><aff id="A24">Krajská Nemocnice Liberec, Liberec, Czech Republic</aff></contrib><contrib contrib-type="author"><name><surname>Leung</surname><given-names>Raymond C M</given-names></name><degrees>MD</degrees><aff id="A25">CK Hui Heart Centre, Edmonton, AB, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Kassam</surname><given-names>Saleem</given-names></name><degrees>MD</degrees><aff id="A26">Rouge Valley Health System, Toronto, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Rao</surname><given-names>Sunil V</given-names></name><degrees>MD</degrees><aff id="A27">Duke Clinical Research Institute, Durham, NC, USA</aff></contrib><contrib contrib-type="author"><name><surname>El-Omar</surname><given-names>Magdi</given-names></name><degrees>MD</degrees><aff id="A28">Central Manchester Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK</aff></contrib><contrib contrib-type="author"><name><surname>Mehta</surname><given-names>Shamir R</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><aff id="A29">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Velianou</surname><given-names>James L</given-names></name><degrees>MD</degrees><aff id="A30">McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Pancholy</surname><given-names>Samir</given-names></name><degrees>MD</degrees><aff id="A31">Northeast Clinical Trials Group, Scranton, PA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Džavík</surname><given-names>Vladimír</given-names><prefix>Prof.</prefix></name><degrees>MD</degrees><aff id="A32">Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada</aff></contrib><on-behalf-of>for the TOTAL Investigators</on-behalf-of></contrib-group><author-notes><corresp id="FN1">Correspondence to: Dr Sanjit S Jolly, Rm C3 118 CVSRI Building, Hamilton General Hospital, 237 Barton St East, Hamilton, ON L8L 2X2, Canada, <email>sanjit.jolly@phri.ca</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>14</day><month>6</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>22</day><month>10</month><year>2015</year></pub-date><pub-date pub-type="ppub"><day>9</day><month>1</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>31</day><month>8</month><year>2016</year></pub-date><volume>387</volume><issue>10014</issue><fpage>127</fpage><lpage>135</lpage><pmc-comment>elocation-id from pubmed: 10.1016/S0140-6736(15)00448-1</pmc-comment>
<abstract><title>Summary</title><sec id="S1"><title>Background</title><p id="P2">Two large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice.</p></sec><sec id="S2"><title>Methods</title><p id="P3">The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included patients who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044.</p></sec><sec id="S3"><title>Findings</title><p id="P4">Between Aug 5, 2010, and July 25, 2014, 10 732 eligible patients were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population comprised 10 064 patients (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 patients in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1·00 [95% CI 0·87–1·15], p=0·99). Cardiovascular death within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0·93 [95% CI 0·76–1·14], p=0·48). The key safety outcome, stroke within 1 year, occurred in 60 patients (1·2%) in the thrombectomy group compared with 36 (0·7%) in the PCI alone group (HR 1·66 [95% CI 1·10–2·51], p=0·015).</p></sec><sec id="S4"><title>Interpretation</title><p id="P5">Routine thrombus aspiration during PCI for STEMI did not reduce longer-term clinical outcomes and might be associated with an increase in stroke. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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