The ω-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design.
Identifieur interne : 000293 ( PubMed/Checkpoint ); précédent : 000292; suivant : 000294The ω-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design.
Auteurs : Dariush Mozaffarian [États-Unis] ; Roberto Marchioli ; Tim Gardner ; Paolo Ferrazzi ; Patrick O'Gara ; Roberto Latini ; Peter Libby ; Federico Lombardi ; Alejandro Macchia ; Richard Page ; Massimo Santini ; Luigi Tavazzi ; Gianni TognoniSource :
- American heart journal ; 2011.
English descriptors
- KwdEn :
- Administration, Oral, Adolescent, Atrial Fibrillation (etiology), Atrial Fibrillation (physiopathology), Atrial Fibrillation (prevention & control), Cardiac Surgical Procedures (adverse effects), Dose-Response Relationship, Drug, Double-Blind Method, Fatty Acids, Omega-3 (administration & dosage), Follow-Up Studies, Heart Diseases (surgery), Humans, Postoperative Complications, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Fatty Acids, Omega-3.
- adverse effects : Cardiac Surgical Procedures.
- etiology : Atrial Fibrillation.
- physiopathology : Atrial Fibrillation.
- prevention & control : Atrial Fibrillation.
- surgery : Heart Diseases.
- Administration, Oral, Adolescent, Dose-Response Relationship, Drug, Double-Blind Method, Follow-Up Studies, Humans, Postoperative Complications, Treatment Outcome.
Abstract
Postoperative atrial fibrillation/flutter (PoAF) commonly complicates cardiac surgery, occurring in 25% to 60% of patients. Postoperative atrial fibrillation/flutter is associated with significant morbidity, higher long-term mortality, and increased health care costs. Novel preventive therapies are clearly needed. In experiments and short-term trials, seafood-derived long-chain ω-3 polyunsaturated fatty acids (PUFAs) influence several risk factors that might reduce risk of PoAF. A few small and generally underpowered trials have evaluated effects of ω-3-PUFAs supplementation on PoAF with mixed results. The OPERA trial is an appropriately powered, investigator-initiated, randomized, double-blind, placebo-controlled, multinational trial to determine whether perioperative oral ω-3-PUFAs reduces occurrence of PoAF in patients undergoing cardiac surgery. Additional aims include evaluation of resource use, biologic pathways and mechanisms, postoperative cognitive decline, and safety. Broad inclusion criteria encompass a "real-world" population of outpatients and inpatients scheduled for cardiac surgery. Treatment comprises a total preoperative loading dose of 8 to 10 g of ω-3-PUFAs or placebo divided over 2 to 5 days, followed by 2 g/d until hospital discharge or postoperative day 10, whichever comes first. Based on anticipated 30% event rate in controls, total enrollment of 1,516 patients (758 per treatment arm) will provide 90% power to detect 25% reduction in PoAF. The OPERA trial will provide invaluable evidence to inform biologic pathways; proof of concept that ω-3-PUFAs influence cardiac arrhythmias; and potential regulatory standards and clinical use of this simple, inexpensive, and low-risk intervention to prevent PoAF.
DOI: 10.1016/j.ahj.2011.03.035
PubMed: 21742090
Affiliations:
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Prevention of Post-Operative Atrial Fibrillation trial--rationale and design.</title><author><name sortKey="Mozaffarian, Dariush" sort="Mozaffarian, Dariush" uniqKey="Mozaffarian D" first="Dariush" last="Mozaffarian">Dariush Mozaffarian</name><affiliation wicri:level="2"><nlm:affiliation>Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. dmozaffa@hsph.harvard.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Marchioli, Roberto" sort="Marchioli, Roberto" uniqKey="Marchioli R" first="Roberto" last="Marchioli">Roberto Marchioli</name></author><author><name sortKey="Gardner, Tim" sort="Gardner, Tim" uniqKey="Gardner T" first="Tim" last="Gardner">Tim Gardner</name></author><author><name sortKey="Ferrazzi, Paolo" sort="Ferrazzi, Paolo" uniqKey="Ferrazzi P" first="Paolo" last="Ferrazzi">Paolo Ferrazzi</name></author><author><name sortKey="O Gara, Patrick" sort="O Gara, Patrick" uniqKey="O Gara P" first="Patrick" last="O'Gara">Patrick O'Gara</name></author><author><name sortKey="Latini, Roberto" sort="Latini, Roberto" uniqKey="Latini R" first="Roberto" last="Latini">Roberto Latini</name></author><author><name sortKey="Libby, Peter" sort="Libby, Peter" uniqKey="Libby P" first="Peter" last="Libby">Peter Libby</name></author><author><name sortKey="Lombardi, Federico" sort="Lombardi, Federico" uniqKey="Lombardi F" first="Federico" last="Lombardi">Federico Lombardi</name></author><author><name sortKey="Macchia, Alejandro" sort="Macchia, Alejandro" uniqKey="Macchia A" first="Alejandro" last="Macchia">Alejandro Macchia</name></author><author><name sortKey="Page, Richard" sort="Page, Richard" uniqKey="Page R" first="Richard" last="Page">Richard Page</name></author><author><name sortKey="Santini, Massimo" sort="Santini, Massimo" uniqKey="Santini M" first="Massimo" last="Santini">Massimo Santini</name></author><author><name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name></author><author><name sortKey="Tognoni, Gianni" sort="Tognoni, Gianni" uniqKey="Tognoni G" first="Gianni" last="Tognoni">Gianni Tognoni</name></author></analytic><series><title level="j">American heart journal</title><idno type="e-ISSN">1097-6744</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Adolescent</term><term>Atrial Fibrillation (etiology)</term><term>Atrial Fibrillation (physiopathology)</term><term>Atrial Fibrillation (prevention & control)</term><term>Cardiac Surgical Procedures (adverse effects)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Fatty Acids, Omega-3 (administration & dosage)</term><term>Follow-Up Studies</term><term>Heart Diseases (surgery)</term><term>Humans</term><term>Postoperative Complications</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Fatty Acids, Omega-3</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Cardiac Surgical Procedures</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Atrial Fibrillation</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Atrial Fibrillation</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Atrial Fibrillation</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Heart Diseases</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Adolescent</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Follow-Up Studies</term><term>Humans</term><term>Postoperative Complications</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Postoperative atrial fibrillation/flutter (PoAF) commonly complicates cardiac surgery, occurring in 25% to 60% of patients. Postoperative atrial fibrillation/flutter is associated with significant morbidity, higher long-term mortality, and increased health care costs. Novel preventive therapies are clearly needed. In experiments and short-term trials, seafood-derived long-chain ω-3 polyunsaturated fatty acids (PUFAs) influence several risk factors that might reduce risk of PoAF. A few small and generally underpowered trials have evaluated effects of ω-3-PUFAs supplementation on PoAF with mixed results. The OPERA trial is an appropriately powered, investigator-initiated, randomized, double-blind, placebo-controlled, multinational trial to determine whether perioperative oral ω-3-PUFAs reduces occurrence of PoAF in patients undergoing cardiac surgery. Additional aims include evaluation of resource use, biologic pathways and mechanisms, postoperative cognitive decline, and safety. Broad inclusion criteria encompass a "real-world" population of outpatients and inpatients scheduled for cardiac surgery. Treatment comprises a total preoperative loading dose of 8 to 10 g of ω-3-PUFAs or placebo divided over 2 to 5 days, followed by 2 g/d until hospital discharge or postoperative day 10, whichever comes first. Based on anticipated 30% event rate in controls, total enrollment of 1,516 patients (758 per treatment arm) will provide 90% power to detect 25% reduction in PoAF. The OPERA trial will provide invaluable evidence to inform biologic pathways; proof of concept that ω-3-PUFAs influence cardiac arrhythmias; and potential regulatory standards and clinical use of this simple, inexpensive, and low-risk intervention to prevent PoAF.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">21742090</PMID><DateCreated><Year>2011</Year><Month>07</Month><Day>11</Day></DateCreated><DateCompleted><Year>2011</Year><Month>09</Month><Day>13</Day></DateCompleted><DateRevised><Year>2015</Year><Month>02</Month><Day>04</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1097-6744</ISSN><JournalIssue CitedMedium="Internet"><Volume>162</Volume><Issue>1</Issue><PubDate><Year>2011</Year><Month>Jul</Month></PubDate></JournalIssue><Title>American heart journal</Title><ISOAbbreviation>Am. Heart J.</ISOAbbreviation></Journal><ArticleTitle>The ω-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design.</ArticleTitle><Pagination><MedlinePgn>56-63.e3</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ahj.2011.03.035</ELocationID><Abstract><AbstractText>Postoperative atrial fibrillation/flutter (PoAF) commonly complicates cardiac surgery, occurring in 25% to 60% of patients. Postoperative atrial fibrillation/flutter is associated with significant morbidity, higher long-term mortality, and increased health care costs. Novel preventive therapies are clearly needed. In experiments and short-term trials, seafood-derived long-chain ω-3 polyunsaturated fatty acids (PUFAs) influence several risk factors that might reduce risk of PoAF. A few small and generally underpowered trials have evaluated effects of ω-3-PUFAs supplementation on PoAF with mixed results. The OPERA trial is an appropriately powered, investigator-initiated, randomized, double-blind, placebo-controlled, multinational trial to determine whether perioperative oral ω-3-PUFAs reduces occurrence of PoAF in patients undergoing cardiac surgery. Additional aims include evaluation of resource use, biologic pathways and mechanisms, postoperative cognitive decline, and safety. Broad inclusion criteria encompass a "real-world" population of outpatients and inpatients scheduled for cardiac surgery. Treatment comprises a total preoperative loading dose of 8 to 10 g of ω-3-PUFAs or placebo divided over 2 to 5 days, followed by 2 g/d until hospital discharge or postoperative day 10, whichever comes first. Based on anticipated 30% event rate in controls, total enrollment of 1,516 patients (758 per treatment arm) will provide 90% power to detect 25% reduction in PoAF. The OPERA trial will provide invaluable evidence to inform biologic pathways; proof of concept that ω-3-PUFAs influence cardiac arrhythmias; and potential regulatory standards and clinical use of this simple, inexpensive, and low-risk intervention to prevent PoAF.</AbstractText><CopyrightInformation>Copyright © 2011 Mosby, Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mozaffarian</LastName><ForeName>Dariush</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. dmozaffa@hsph.harvard.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marchioli</LastName><ForeName>Roberto</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Gardner</LastName><ForeName>Tim</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Ferrazzi</LastName><ForeName>Paolo</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>O'Gara</LastName><ForeName>Patrick</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Latini</LastName><ForeName>Roberto</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Libby</LastName><ForeName>Peter</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Lombardi</LastName><ForeName>Federico</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Macchia</LastName><ForeName>Alejandro</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Page</LastName><ForeName>Richard</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Santini</LastName><ForeName>Massimo</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Tavazzi</LastName><ForeName>Luigi</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Tognoni</LastName><ForeName>Gianni</ForeName><Initials>G</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00970489</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>RC2 HL101816</GrantID><Acronym>HL</Acronym><Agency>NHLBI NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>RC2 HL101816-01</GrantID><Acronym>HL</Acronym><Agency>NHLBI NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>RC2-HL101816</GrantID><Acronym>HL</Acronym><Agency>NHLBI NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D057666">Research Support, American Recovery and Reinvestment Act</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2011</Year><Month>06</Month><Day>12</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Am Heart J</MedlineTA><NlmUniqueID>0370465</NlmUniqueID><ISSNLinking>0002-8703</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015525">Fatty Acids, Omega-3</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Circulation. 2000 Mar 28;101(12):1403-8</RefSource><PMID Version="1">10736284</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Am Coll Cardiol. 2011 Nov 8;58(20):2047-67</RefSource><PMID Version="1">22051327</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2003 Feb 8;361(9356):477-85</RefSource><PMID 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Version="1">12022486</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000284">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000293">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D001281">Atrial Fibrillation</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000209">etiology</QualifierName><QualifierName MajorTopicYN="N" UI="Q000503">physiopathology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000517">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006348">Cardiac Surgical Procedures</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000009">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015525">Fatty Acids, Omega-3</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006331">Heart Diseases</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000601">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011183">Postoperative Complications</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">NIHMS304087</OtherID><OtherID 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first="Alejandro" last="Macchia">Alejandro Macchia</name><name sortKey="Marchioli, Roberto" sort="Marchioli, Roberto" uniqKey="Marchioli R" first="Roberto" last="Marchioli">Roberto Marchioli</name><name sortKey="O Gara, Patrick" sort="O Gara, Patrick" uniqKey="O Gara P" first="Patrick" last="O'Gara">Patrick O'Gara</name><name sortKey="Page, Richard" sort="Page, Richard" uniqKey="Page R" first="Richard" last="Page">Richard Page</name><name sortKey="Santini, Massimo" sort="Santini, Massimo" uniqKey="Santini M" first="Massimo" last="Santini">Massimo Santini</name><name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name><name sortKey="Tognoni, Gianni" sort="Tognoni, Gianni" uniqKey="Tognoni G" first="Gianni" last="Tognoni">Gianni Tognoni</name></noCountry><country name="États-Unis"><region name="Massachusetts"><name sortKey="Mozaffarian, Dariush" sort="Mozaffarian, Dariush" uniqKey="Mozaffarian D" first="Dariush" last="Mozaffarian">Dariush Mozaffarian</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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