A novel approach to systematically implement the universal definition of myocardial infarction: insights from the CHAMPION PLATFORM trial
Objective To reassess the efficacy of cangrelor efficacy using the universal definition of myocardial infarction (MI). Design We adopted a novel approach to systematically implement the universal definition of MI. Two physicians blinded to treatment allocation reviewed plots of CK-MB and troponin va...
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Veröffentlicht in: | Heart (British Cardiac Society) 2013-09, Vol.99 (17), p.1282-1287 |
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creator | Leonardi, Sergio Truffa, Adriano A M Neely, Megan L Tricoci, Pierluigi White, Harvey D Gibson, C Michael Wilson, Matthew Stone, Gregg W Harrington, Robert A Bhatt, Deepak L Mahaffey, Kenneth W |
description | Objective To reassess the efficacy of cangrelor efficacy using the universal definition of myocardial infarction (MI). Design We adopted a novel approach to systematically implement the universal definition of MI. Two physicians blinded to treatment allocation reviewed plots of CK-MB and troponin values in relation to time of randomisation and percutaneous coronary intervention (PCI) to identify patients with stable or falling biomarkers pre-PCI (ie, primary cohort), and those with post-PCI CK-MB elevations. Setting The CHAMPION PLATFORM trial. Patients Non-ST-elevation acute coronary syndromes (95%) and stable angina patients (5%). Interventions Cangrelor versus placebo. Main outcome measures The efficacy of cangrelor compared with placebo using the reclassified events (type 4a MI) and the original clinical events committee-adjudicated (CEC PCI-MI) results was investigated. Results Of 5295 patients, 3406 (64.4%) were in the primary cohort. Type 4a MI occurred in 4.3% (226 events/5295 patients) while original CEC PCI-MI occurred in 6.5% (344 events/5295 patients), a significant difference (p |
doi_str_mv | 10.1136/heartjnl-2012-303103 |
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Design We adopted a novel approach to systematically implement the universal definition of MI. Two physicians blinded to treatment allocation reviewed plots of CK-MB and troponin values in relation to time of randomisation and percutaneous coronary intervention (PCI) to identify patients with stable or falling biomarkers pre-PCI (ie, primary cohort), and those with post-PCI CK-MB elevations. Setting The CHAMPION PLATFORM trial. Patients Non-ST-elevation acute coronary syndromes (95%) and stable angina patients (5%). Interventions Cangrelor versus placebo. Main outcome measures The efficacy of cangrelor compared with placebo using the reclassified events (type 4a MI) and the original clinical events committee-adjudicated (CEC PCI-MI) results was investigated. Results Of 5295 patients, 3406 (64.4%) were in the primary cohort. Type 4a MI occurred in 4.3% (226 events/5295 patients) while original CEC PCI-MI occurred in 6.5% (344 events/5295 patients), a significant difference (p<0.0001). Using the reclassified MI events, the primary composite endpoint of death, MI, or ischaemia-driven revascularisation through 48 h occurred in 5.4% of patients (4.9% cangrelor, 6.0% placebo; OR 0.80; 95% CI 0.63 to 1.02) as opposed to 7.5% of the primary analyses (7.0% cangrelor, 8.0% placebo; OR 0.87; 95% CI 0.71 to 1.07). Conclusions Systematic, strict implementation of the universal MI definition with emphasis on baseline assessment may enhance discrimination in detecting PCI-MI and may allow for more rigorous assessment of interventions in patients undergoing early PCI.</description><identifier>ISSN: 1355-6037</identifier><identifier>EISSN: 1468-201X</identifier><identifier>DOI: 10.1136/heartjnl-2012-303103</identifier><identifier>PMID: 23434768</identifier><language>eng</language><publisher>England: BMJ Publishing Group Ltd and British Cardiovascular Society</publisher><subject>Acute Coronary Syndrome - therapy ; Acute coronary syndromes ; Adenosine Monophosphate - analogs & derivatives ; Adenosine Monophosphate - therapeutic use ; Aged ; Biomarkers ; Biomarkers - blood ; Clinical trials ; Creatine Kinase, MB Form - analysis ; Female ; Heart attacks ; Humans ; Logistic Models ; Male ; Middle Aged ; Myocardial Infarction - blood ; Myocardial Infarction - diagnosis ; Myocardial Infarction - therapy ; Percutaneous Coronary Intervention - adverse effects ; Purinergic P2Y Receptor Antagonists - therapeutic use ; Randomized Controlled Trials as Topic ; Risk Assessment ; Sensitivity and Specificity ; Studies ; Troponin - blood</subject><ispartof>Heart (British Cardiac Society), 2013-09, Vol.99 (17), p.1282-1287</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Copyright: 2013 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b413t-55b9cc3b4a9761c2568cfac9993b14e0dbc26a32a152040bba8d0235b9f3176a3</citedby><cites>FETCH-LOGICAL-b413t-55b9cc3b4a9761c2568cfac9993b14e0dbc26a32a152040bba8d0235b9f3176a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://heart.bmj.com/content/99/17/1282.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://heart.bmj.com/content/99/17/1282.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,314,780,784,3194,23569,27922,27923,77370,77401</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23434768$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Leonardi, Sergio</creatorcontrib><creatorcontrib>Truffa, Adriano A M</creatorcontrib><creatorcontrib>Neely, Megan L</creatorcontrib><creatorcontrib>Tricoci, Pierluigi</creatorcontrib><creatorcontrib>White, Harvey D</creatorcontrib><creatorcontrib>Gibson, C Michael</creatorcontrib><creatorcontrib>Wilson, Matthew</creatorcontrib><creatorcontrib>Stone, Gregg W</creatorcontrib><creatorcontrib>Harrington, Robert A</creatorcontrib><creatorcontrib>Bhatt, Deepak L</creatorcontrib><creatorcontrib>Mahaffey, Kenneth W</creatorcontrib><title>A novel approach to systematically implement the universal definition of myocardial infarction: insights from the CHAMPION PLATFORM trial</title><title>Heart (British Cardiac Society)</title><addtitle>Heart</addtitle><description>Objective To reassess the efficacy of cangrelor efficacy using the universal definition of myocardial infarction (MI). Design We adopted a novel approach to systematically implement the universal definition of MI. Two physicians blinded to treatment allocation reviewed plots of CK-MB and troponin values in relation to time of randomisation and percutaneous coronary intervention (PCI) to identify patients with stable or falling biomarkers pre-PCI (ie, primary cohort), and those with post-PCI CK-MB elevations. Setting The CHAMPION PLATFORM trial. Patients Non-ST-elevation acute coronary syndromes (95%) and stable angina patients (5%). Interventions Cangrelor versus placebo. Main outcome measures The efficacy of cangrelor compared with placebo using the reclassified events (type 4a MI) and the original clinical events committee-adjudicated (CEC PCI-MI) results was investigated. Results Of 5295 patients, 3406 (64.4%) were in the primary cohort. Type 4a MI occurred in 4.3% (226 events/5295 patients) while original CEC PCI-MI occurred in 6.5% (344 events/5295 patients), a significant difference (p<0.0001). Using the reclassified MI events, the primary composite endpoint of death, MI, or ischaemia-driven revascularisation through 48 h occurred in 5.4% of patients (4.9% cangrelor, 6.0% placebo; OR 0.80; 95% CI 0.63 to 1.02) as opposed to 7.5% of the primary analyses (7.0% cangrelor, 8.0% placebo; OR 0.87; 95% CI 0.71 to 1.07). Conclusions Systematic, strict implementation of the universal MI definition with emphasis on baseline assessment may enhance discrimination in detecting PCI-MI and may allow for more rigorous assessment of interventions in patients undergoing early PCI.</description><subject>Acute Coronary Syndrome - therapy</subject><subject>Acute coronary syndromes</subject><subject>Adenosine Monophosphate - analogs & derivatives</subject><subject>Adenosine Monophosphate - therapeutic use</subject><subject>Aged</subject><subject>Biomarkers</subject><subject>Biomarkers - blood</subject><subject>Clinical trials</subject><subject>Creatine Kinase, MB Form - analysis</subject><subject>Female</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - blood</subject><subject>Myocardial Infarction - diagnosis</subject><subject>Myocardial Infarction - therapy</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Purinergic P2Y Receptor Antagonists - therapeutic use</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Risk Assessment</subject><subject>Sensitivity and Specificity</subject><subject>Studies</subject><subject>Troponin - blood</subject><issn>1355-6037</issn><issn>1468-201X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkcFu1DAURS0EoqXwBwhZYtNNWjt2nITdaNTSomlnWgp0ZzmOw3iI7antVJ1P4K9xSNsFK1Z-8j336T5dAN5jdIQxYcdrJXzc2D7LEc4zgghG5AXYx5RV49ftyzSTosgYIuUeeBPCBiFE64q9Bns5oYSWrNoHv2fQunvVQ7HdeifkGkYHwy5EZUTUUvT9Dmqz7ZVRNsK4VnCw-l75IHrYqk5bHbWz0HXQ7JwUvtVJ0LYTXo7CpzQH_XMdA-y8M38XzM9mF6vz5SVcLWY3p8vrCxh9cr0FrzrRB_Xu8T0A305PbuZn2WL5-Xw-W2QNxSRmRdHUUpKGirpkWOYFq2QnZF3XpMFUobaRORMkF7jIEUVNI6oW5SS5OoLLpByAw2lvuvduUCFyo4NUfS-sckPgmOIKU0IYSejHf9CNG7xN6TguK1TmZcXqRNGJkt6F4FXHt14b4XccIz5WxZ-q4mNVfKoq2T48Lh8ao9pn01M3CcgmQKc2Hp514X9xVpKy4Jff55z9YF9WV7df-ZjjeOIbs_m_CH8Ao_2wjg</recordid><startdate>201309</startdate><enddate>201309</enddate><creator>Leonardi, Sergio</creator><creator>Truffa, Adriano A M</creator><creator>Neely, Megan L</creator><creator>Tricoci, Pierluigi</creator><creator>White, Harvey D</creator><creator>Gibson, C Michael</creator><creator>Wilson, Matthew</creator><creator>Stone, Gregg W</creator><creator>Harrington, Robert A</creator><creator>Bhatt, Deepak L</creator><creator>Mahaffey, Kenneth W</creator><general>BMJ Publishing Group Ltd and British Cardiovascular Society</general><general>BMJ Publishing Group LTD</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>201309</creationdate><title>A novel approach to systematically implement the universal definition of myocardial infarction: insights from the CHAMPION PLATFORM trial</title><author>Leonardi, Sergio ; Truffa, Adriano A M ; Neely, Megan L ; Tricoci, Pierluigi ; White, Harvey D ; Gibson, C Michael ; Wilson, Matthew ; Stone, Gregg W ; Harrington, Robert A ; Bhatt, Deepak L ; Mahaffey, Kenneth W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b413t-55b9cc3b4a9761c2568cfac9993b14e0dbc26a32a152040bba8d0235b9f3176a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Acute Coronary Syndrome - therapy</topic><topic>Acute coronary syndromes</topic><topic>Adenosine Monophosphate - analogs & derivatives</topic><topic>Adenosine Monophosphate - therapeutic use</topic><topic>Aged</topic><topic>Biomarkers</topic><topic>Biomarkers - blood</topic><topic>Clinical trials</topic><topic>Creatine Kinase, MB Form - analysis</topic><topic>Female</topic><topic>Heart attacks</topic><topic>Humans</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial Infarction - blood</topic><topic>Myocardial Infarction - diagnosis</topic><topic>Myocardial Infarction - therapy</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Purinergic P2Y Receptor Antagonists - therapeutic use</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Risk Assessment</topic><topic>Sensitivity and Specificity</topic><topic>Studies</topic><topic>Troponin - blood</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Leonardi, Sergio</creatorcontrib><creatorcontrib>Truffa, Adriano A M</creatorcontrib><creatorcontrib>Neely, Megan L</creatorcontrib><creatorcontrib>Tricoci, Pierluigi</creatorcontrib><creatorcontrib>White, Harvey D</creatorcontrib><creatorcontrib>Gibson, C Michael</creatorcontrib><creatorcontrib>Wilson, Matthew</creatorcontrib><creatorcontrib>Stone, Gregg W</creatorcontrib><creatorcontrib>Harrington, Robert A</creatorcontrib><creatorcontrib>Bhatt, Deepak L</creatorcontrib><creatorcontrib>Mahaffey, Kenneth W</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Heart (British Cardiac Society)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Leonardi, Sergio</au><au>Truffa, Adriano A M</au><au>Neely, Megan L</au><au>Tricoci, Pierluigi</au><au>White, Harvey D</au><au>Gibson, C Michael</au><au>Wilson, Matthew</au><au>Stone, Gregg W</au><au>Harrington, Robert A</au><au>Bhatt, Deepak L</au><au>Mahaffey, Kenneth W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A novel approach to systematically implement the universal definition of myocardial infarction: insights from the CHAMPION PLATFORM trial</atitle><jtitle>Heart (British Cardiac Society)</jtitle><addtitle>Heart</addtitle><date>2013-09</date><risdate>2013</risdate><volume>99</volume><issue>17</issue><spage>1282</spage><epage>1287</epage><pages>1282-1287</pages><issn>1355-6037</issn><eissn>1468-201X</eissn><abstract>Objective To reassess the efficacy of cangrelor efficacy using the universal definition of myocardial infarction (MI). Design We adopted a novel approach to systematically implement the universal definition of MI. Two physicians blinded to treatment allocation reviewed plots of CK-MB and troponin values in relation to time of randomisation and percutaneous coronary intervention (PCI) to identify patients with stable or falling biomarkers pre-PCI (ie, primary cohort), and those with post-PCI CK-MB elevations. Setting The CHAMPION PLATFORM trial. Patients Non-ST-elevation acute coronary syndromes (95%) and stable angina patients (5%). Interventions Cangrelor versus placebo. Main outcome measures The efficacy of cangrelor compared with placebo using the reclassified events (type 4a MI) and the original clinical events committee-adjudicated (CEC PCI-MI) results was investigated. Results Of 5295 patients, 3406 (64.4%) were in the primary cohort. Type 4a MI occurred in 4.3% (226 events/5295 patients) while original CEC PCI-MI occurred in 6.5% (344 events/5295 patients), a significant difference (p<0.0001). Using the reclassified MI events, the primary composite endpoint of death, MI, or ischaemia-driven revascularisation through 48 h occurred in 5.4% of patients (4.9% cangrelor, 6.0% placebo; OR 0.80; 95% CI 0.63 to 1.02) as opposed to 7.5% of the primary analyses (7.0% cangrelor, 8.0% placebo; OR 0.87; 95% CI 0.71 to 1.07). Conclusions Systematic, strict implementation of the universal MI definition with emphasis on baseline assessment may enhance discrimination in detecting PCI-MI and may allow for more rigorous assessment of interventions in patients undergoing early PCI.</abstract><cop>England</cop><pub>BMJ Publishing Group Ltd and British Cardiovascular Society</pub><pmid>23434768</pmid><doi>10.1136/heartjnl-2012-303103</doi><tpages>6</tpages></addata></record> |
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subjects | Acute Coronary Syndrome - therapy Acute coronary syndromes Adenosine Monophosphate - analogs & derivatives Adenosine Monophosphate - therapeutic use Aged Biomarkers Biomarkers - blood Clinical trials Creatine Kinase, MB Form - analysis Female Heart attacks Humans Logistic Models Male Middle Aged Myocardial Infarction - blood Myocardial Infarction - diagnosis Myocardial Infarction - therapy Percutaneous Coronary Intervention - adverse effects Purinergic P2Y Receptor Antagonists - therapeutic use Randomized Controlled Trials as Topic Risk Assessment Sensitivity and Specificity Studies Troponin - blood |
title | A novel approach to systematically implement the universal definition of myocardial infarction: insights from the CHAMPION PLATFORM trial |
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