Rationale and design of AVERROES: Apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment
Background Many patients with atrial fibrillation (AF) at moderate or high risk for stroke are not treated with a vitamin K antagonist (VKA). Presently, the only alternative to a VKA with a labeled indication for AF is antiplatelet therapy with acetylsalicylic acid (ASA), which is much less effectiv...
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| Veröffentlicht in: | The American heart journal 2010-03, Vol.159 (3), p.348-353.e1 |
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| creator | Eikelboom, John W O'Donnell, Martin Yusuf, Salim Diaz, Rafael Flaker, Greg Hart, Robert Hohnloser, Stefan Joyner, Campbell Lawrence, Jack Pais, Prem Pogue, Janice Synhorst, David Connolly, Stuart J |
| description | Background Many patients with atrial fibrillation (AF) at moderate or high risk for stroke are not treated with a vitamin K antagonist (VKA). Presently, the only alternative to a VKA with a labeled indication for AF is antiplatelet therapy with acetylsalicylic acid (ASA), which is much less effective than a VKA for prevention of stroke. The novel oral factor Xa inhibitor, apixaban, is being developed for prevention of stroke in AF. A noninferiority trial of apixaban versus a VKA (warfarin) is being conducted but does not address the large unmet need of AF patients at risk of stroke who are unsuitable for or unwilling to take a VKA. Apixaban may be an attractive alternative to ASA for prevention of stroke in patients with AF who cannot or will not take a VKA. Design AVERROES is a double-blind, double-dummy superiority trial of apixaban 5 mg twice daily (2.5 mg twice daily in selected patients) compared with ASA 81 to 324 mg once daily in patients with AF and at least 1 risk factor for stroke who have failed or are unsuitable for VKA therapy. The primary outcome is stroke or systemic embolism, and the primary safety outcome is major bleeding. The trial is event driven and is expected to enroll at least 5,600 patients. Conclusions By evaluating the use of apixaban as a replacement for ASA in AF patients who are not treated with a VKA, the AVERROES study is addressing an important unmet clinical need. The results of AVERROES will be complementary to those of a parallel noninferiority trial comparing apixaban with VKA therapy in patients with AF who are able to receive a VKA. |
| doi_str_mv | 10.1016/j.ahj.2009.08.026 |
| format | Article |
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Presently, the only alternative to a VKA with a labeled indication for AF is antiplatelet therapy with acetylsalicylic acid (ASA), which is much less effective than a VKA for prevention of stroke. The novel oral factor Xa inhibitor, apixaban, is being developed for prevention of stroke in AF. A noninferiority trial of apixaban versus a VKA (warfarin) is being conducted but does not address the large unmet need of AF patients at risk of stroke who are unsuitable for or unwilling to take a VKA. Apixaban may be an attractive alternative to ASA for prevention of stroke in patients with AF who cannot or will not take a VKA. Design AVERROES is a double-blind, double-dummy superiority trial of apixaban 5 mg twice daily (2.5 mg twice daily in selected patients) compared with ASA 81 to 324 mg once daily in patients with AF and at least 1 risk factor for stroke who have failed or are unsuitable for VKA therapy. The primary outcome is stroke or systemic embolism, and the primary safety outcome is major bleeding. The trial is event driven and is expected to enroll at least 5,600 patients. Conclusions By evaluating the use of apixaban as a replacement for ASA in AF patients who are not treated with a VKA, the AVERROES study is addressing an important unmet clinical need. The results of AVERROES will be complementary to those of a parallel noninferiority trial comparing apixaban with VKA therapy in patients with AF who are able to receive a VKA.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2009.08.026</identifier><identifier>PMID: 20211294</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject><![CDATA[Aged ; Aged, 80 and over ; Anticoagulants ; Aspirin - administration & dosage ; Aspirin - adverse effects ; Atrial Fibrillation - drug therapy ; Biological and medical sciences ; Cardiac arrhythmia ; Cardiac dysrhythmias ; Cardiology. Vascular system ; Cardiovascular ; Double-Blind Method ; Drug Administration Schedule ; Drug therapy ; Fibrinolytic Agents - administration & dosage ; Fibrinolytic Agents - adverse effects ; Heart ; Hemorrhage - chemically induced ; Humans ; Industrialized nations ; Medical sciences ; Metabolites ; Middle Aged ; Neurology ; Older people ; Patients ; Platelet Aggregation Inhibitors - administration & dosage ; Platelet Aggregation Inhibitors - adverse effects ; Pyrazoles - administration & dosage ; Pyrazoles - adverse effects ; Pyridones - administration & dosage ; Pyridones - adverse effects ; Research Design ; Retreatment ; Risk factors ; Stroke ; Stroke - prevention & control ; Treatment Failure ; Vascular diseases and vascular malformations of the nervous system ; Vitamin K - antagonists & inhibitors ; Warfarin - therapeutic use]]></subject><ispartof>The American heart journal, 2010-03, Vol.159 (3), p.348-353.e1</ispartof><rights>Mosby, Inc.</rights><rights>2010 Mosby, Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Elsevier Limited Mar 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c531t-b4ab4361b71fc2dbc8050fbb1ccb43a20022d9476b35107e66ead33c06ea2c893</citedby><cites>FETCH-LOGICAL-c531t-b4ab4361b71fc2dbc8050fbb1ccb43a20022d9476b35107e66ead33c06ea2c893</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1504597844?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>315,782,786,3552,27931,27932,46002,64392,64394,64396,72476</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22571306$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20211294$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Eikelboom, John W</creatorcontrib><creatorcontrib>O'Donnell, Martin</creatorcontrib><creatorcontrib>Yusuf, Salim</creatorcontrib><creatorcontrib>Diaz, Rafael</creatorcontrib><creatorcontrib>Flaker, Greg</creatorcontrib><creatorcontrib>Hart, Robert</creatorcontrib><creatorcontrib>Hohnloser, Stefan</creatorcontrib><creatorcontrib>Joyner, Campbell</creatorcontrib><creatorcontrib>Lawrence, Jack</creatorcontrib><creatorcontrib>Pais, Prem</creatorcontrib><creatorcontrib>Pogue, Janice</creatorcontrib><creatorcontrib>Synhorst, David</creatorcontrib><creatorcontrib>Connolly, Stuart J</creatorcontrib><title>Rationale and design of AVERROES: Apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background Many patients with atrial fibrillation (AF) at moderate or high risk for stroke are not treated with a vitamin K antagonist (VKA). Presently, the only alternative to a VKA with a labeled indication for AF is antiplatelet therapy with acetylsalicylic acid (ASA), which is much less effective than a VKA for prevention of stroke. The novel oral factor Xa inhibitor, apixaban, is being developed for prevention of stroke in AF. A noninferiority trial of apixaban versus a VKA (warfarin) is being conducted but does not address the large unmet need of AF patients at risk of stroke who are unsuitable for or unwilling to take a VKA. Apixaban may be an attractive alternative to ASA for prevention of stroke in patients with AF who cannot or will not take a VKA. Design AVERROES is a double-blind, double-dummy superiority trial of apixaban 5 mg twice daily (2.5 mg twice daily in selected patients) compared with ASA 81 to 324 mg once daily in patients with AF and at least 1 risk factor for stroke who have failed or are unsuitable for VKA therapy. The primary outcome is stroke or systemic embolism, and the primary safety outcome is major bleeding. The trial is event driven and is expected to enroll at least 5,600 patients. Conclusions By evaluating the use of apixaban as a replacement for ASA in AF patients who are not treated with a VKA, the AVERROES study is addressing an important unmet clinical need. The results of AVERROES will be complementary to those of a parallel noninferiority trial comparing apixaban with VKA therapy in patients with AF who are able to receive a VKA.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticoagulants</subject><subject>Aspirin - administration & dosage</subject><subject>Aspirin - adverse effects</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Cardiac arrhythmia</subject><subject>Cardiac dysrhythmias</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Fibrinolytic Agents - administration & dosage</subject><subject>Fibrinolytic Agents - adverse effects</subject><subject>Heart</subject><subject>Hemorrhage - chemically induced</subject><subject>Humans</subject><subject>Industrialized nations</subject><subject>Medical sciences</subject><subject>Metabolites</subject><subject>Middle Aged</subject><subject>Neurology</subject><subject>Older people</subject><subject>Patients</subject><subject>Platelet Aggregation Inhibitors - administration & dosage</subject><subject>Platelet Aggregation Inhibitors - adverse effects</subject><subject>Pyrazoles - administration & dosage</subject><subject>Pyrazoles - adverse effects</subject><subject>Pyridones - administration & dosage</subject><subject>Pyridones - adverse effects</subject><subject>Research Design</subject><subject>Retreatment</subject><subject>Risk factors</subject><subject>Stroke</subject><subject>Stroke - prevention & control</subject><subject>Treatment Failure</subject><subject>Vascular diseases and vascular malformations of the nervous system</subject><subject>Vitamin K - antagonists & inhibitors</subject><subject>Warfarin - therapeutic use</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kttuEzEQhlcIREvhAbhBlhDiKmHs3eyBSkhRFQ6iUqUUuLVmvbON08062N5AHo53Y5YEKvWCC2ts65t_xvM7SZ5LmEqQ-Zv1FFfrqQKoplBOQeUPklMJVTHJiyx7mJwCgJqUBaQnyZMQ1nzMVZk_Tk4UKClVlZ0mv5YYreuxI4F9IxoK9qYXrhXzb4vl8mpx_VbMt_Yn1tiLHfkwBIGG4r4L2Fmz58Vn24joxNbTjvooQvTuloTtBUZvsROtrb3tuj-FxJYDU0H8WDmxwh2JFm1HjXBeoCcx9GGwEWtuqOWrHe83LPWZ24t443obooieMG5Y5WnyqMUu0LNjPEu-vl98ufg4ubz68Olifjkxs1TGSZ1hnaW5rAvZGtXUpoQZtHUtjeF75AEq1VRZkdfpTEJBeU7YpKkBjsqUVXqWvD7obr37PlCIemODIX5TT24IukjTQioFI_nyHrl2g-f5Bi1nkM2qoswypuSBMt6F4KnVW2836Pdagh6t1WvN1urRWg2lZms558VReag31PzL-OslA6-OAAaDXeuxNzbccWpWyBRGofMDRzyxnSWvg2FLDDXWk4m6cfa_bby7l20621sueEt7Cnev1UFp0NfjHxy_IFQskhVl-huhG9jY</recordid><startdate>20100301</startdate><enddate>20100301</enddate><creator>Eikelboom, John W</creator><creator>O'Donnell, Martin</creator><creator>Yusuf, Salim</creator><creator>Diaz, Rafael</creator><creator>Flaker, Greg</creator><creator>Hart, Robert</creator><creator>Hohnloser, Stefan</creator><creator>Joyner, Campbell</creator><creator>Lawrence, Jack</creator><creator>Pais, Prem</creator><creator>Pogue, Janice</creator><creator>Synhorst, David</creator><creator>Connolly, Stuart J</creator><general>Mosby, Inc</general><general>Mosby</general><general>Elsevier Limited</general><scope>IQODW</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>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20100301</creationdate><title>Rationale and design of AVERROES: Apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment</title><author>Eikelboom, John W ; O'Donnell, Martin ; Yusuf, Salim ; Diaz, Rafael ; Flaker, Greg ; Hart, Robert ; Hohnloser, Stefan ; Joyner, Campbell ; Lawrence, Jack ; Pais, Prem ; Pogue, Janice ; Synhorst, David ; Connolly, Stuart J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c531t-b4ab4361b71fc2dbc8050fbb1ccb43a20022d9476b35107e66ead33c06ea2c893</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticoagulants</topic><topic>Aspirin - administration & dosage</topic><topic>Aspirin - adverse effects</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Biological and medical sciences</topic><topic>Cardiac arrhythmia</topic><topic>Cardiac dysrhythmias</topic><topic>Cardiology. Vascular system</topic><topic>Cardiovascular</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug therapy</topic><topic>Fibrinolytic Agents - administration & dosage</topic><topic>Fibrinolytic Agents - adverse effects</topic><topic>Heart</topic><topic>Hemorrhage - chemically induced</topic><topic>Humans</topic><topic>Industrialized nations</topic><topic>Medical sciences</topic><topic>Metabolites</topic><topic>Middle Aged</topic><topic>Neurology</topic><topic>Older people</topic><topic>Patients</topic><topic>Platelet Aggregation Inhibitors - administration & dosage</topic><topic>Platelet Aggregation Inhibitors - adverse effects</topic><topic>Pyrazoles - administration & dosage</topic><topic>Pyrazoles - adverse effects</topic><topic>Pyridones - administration & dosage</topic><topic>Pyridones - adverse effects</topic><topic>Research Design</topic><topic>Retreatment</topic><topic>Risk factors</topic><topic>Stroke</topic><topic>Stroke - prevention & control</topic><topic>Treatment Failure</topic><topic>Vascular diseases and vascular malformations of the nervous system</topic><topic>Vitamin K - antagonists & inhibitors</topic><topic>Warfarin - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Eikelboom, John W</creatorcontrib><creatorcontrib>O'Donnell, Martin</creatorcontrib><creatorcontrib>Yusuf, Salim</creatorcontrib><creatorcontrib>Diaz, Rafael</creatorcontrib><creatorcontrib>Flaker, Greg</creatorcontrib><creatorcontrib>Hart, Robert</creatorcontrib><creatorcontrib>Hohnloser, Stefan</creatorcontrib><creatorcontrib>Joyner, Campbell</creatorcontrib><creatorcontrib>Lawrence, Jack</creatorcontrib><creatorcontrib>Pais, Prem</creatorcontrib><creatorcontrib>Pogue, Janice</creatorcontrib><creatorcontrib>Synhorst, David</creatorcontrib><creatorcontrib>Connolly, Stuart J</creatorcontrib><collection>Pascal-Francis</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>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</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 Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eikelboom, John W</au><au>O'Donnell, Martin</au><au>Yusuf, Salim</au><au>Diaz, Rafael</au><au>Flaker, Greg</au><au>Hart, Robert</au><au>Hohnloser, Stefan</au><au>Joyner, Campbell</au><au>Lawrence, Jack</au><au>Pais, Prem</au><au>Pogue, Janice</au><au>Synhorst, David</au><au>Connolly, Stuart J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rationale and design of AVERROES: Apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2010-03-01</date><risdate>2010</risdate><volume>159</volume><issue>3</issue><spage>348</spage><epage>353.e1</epage><pages>348-353.e1</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background Many patients with atrial fibrillation (AF) at moderate or high risk for stroke are not treated with a vitamin K antagonist (VKA). Presently, the only alternative to a VKA with a labeled indication for AF is antiplatelet therapy with acetylsalicylic acid (ASA), which is much less effective than a VKA for prevention of stroke. The novel oral factor Xa inhibitor, apixaban, is being developed for prevention of stroke in AF. A noninferiority trial of apixaban versus a VKA (warfarin) is being conducted but does not address the large unmet need of AF patients at risk of stroke who are unsuitable for or unwilling to take a VKA. Apixaban may be an attractive alternative to ASA for prevention of stroke in patients with AF who cannot or will not take a VKA. Design AVERROES is a double-blind, double-dummy superiority trial of apixaban 5 mg twice daily (2.5 mg twice daily in selected patients) compared with ASA 81 to 324 mg once daily in patients with AF and at least 1 risk factor for stroke who have failed or are unsuitable for VKA therapy. The primary outcome is stroke or systemic embolism, and the primary safety outcome is major bleeding. The trial is event driven and is expected to enroll at least 5,600 patients. Conclusions By evaluating the use of apixaban as a replacement for ASA in AF patients who are not treated with a VKA, the AVERROES study is addressing an important unmet clinical need. The results of AVERROES will be complementary to those of a parallel noninferiority trial comparing apixaban with VKA therapy in patients with AF who are able to receive a VKA.</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>20211294</pmid><doi>10.1016/j.ahj.2009.08.026</doi><tpages>6</tpages></addata></record> |
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| subjects | Aged Aged, 80 and over Anticoagulants Aspirin - administration & dosage Aspirin - adverse effects Atrial Fibrillation - drug therapy Biological and medical sciences Cardiac arrhythmia Cardiac dysrhythmias Cardiology. Vascular system Cardiovascular Double-Blind Method Drug Administration Schedule Drug therapy Fibrinolytic Agents - administration & dosage Fibrinolytic Agents - adverse effects Heart Hemorrhage - chemically induced Humans Industrialized nations Medical sciences Metabolites Middle Aged Neurology Older people Patients Platelet Aggregation Inhibitors - administration & dosage Platelet Aggregation Inhibitors - adverse effects Pyrazoles - administration & dosage Pyrazoles - adverse effects Pyridones - administration & dosage Pyridones - adverse effects Research Design Retreatment Risk factors Stroke Stroke - prevention & control Treatment Failure Vascular diseases and vascular malformations of the nervous system Vitamin K - antagonists & inhibitors Warfarin - therapeutic use |
| title | Rationale and design of AVERROES: Apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment |
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