OperaV1, Main, Exploration, bibRecord, 000C15

The ω-3 fatty acids for Prevention of Post-Operative Atrial Fibrillation trial-rationale and design

Identifieur interne : 000C15 ( Main/Exploration ); précédent : 000C14; suivant : 000C16

The ω-3 fatty acids for Prevention of Post-Operative Atrial Fibrillation trial-rationale and design

Auteurs : Dariush Mozaffarian [États-Unis] ; Roberto Marchioli [Italie] ; Tim Gardner [États-Unis] ; Paolo Ferrazzi [Italie] ; Patrick O'Gara [États-Unis] ; Roberto Latini [Italie] ; Peter Libby [États-Unis] ; Federico Lombardi [Italie] ; Alejandro Macchia [Argentine] ; Richard Page [États-Unis] ; Massimo Santini [Italie] ; Luigi Tavazzi [Italie] ; Gianni Tognoni [Italie]

Source :

The American heart journal [ 0002-8703 ] ; 2011.

RBID : Pascal:11-0345371

Descripteurs français

Pascal (Inist)
- Fibrillation auriculaire, Pathologie de l'appareil circulatoire, Acide gras n-3, Prévention, Postopératoire, Conception, Appareil circulatoire, Cardiologie.

English descriptors

KwdEn :
- Atrial fibrillation, Cardiology, Cardiovascular disease, Circulatory system, Design, Postoperative, Prevention, n-3 fatty acid.

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 longchain w-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, placebocontrolled, 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.

Affiliations:

Argentine, Italie, États-Unis
Delaware, Latium, Massachusetts, Wisconsin
Rome

Links toward previous steps (curation, corpus...)

to stream PascalFrancis, to step Corpus: 000149
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Le document en format XML

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<wicri:noRegion>Cotignola</wicri:noRegion>
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<author><name sortKey="Marchioli, Roberto" sort="Marchioli, Roberto" uniqKey="Marchioli R" first="Roberto" last="Marchioli">Roberto Marchioli</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro</s1>
<s3>ITA</s3>
<sZ>2 aut.</sZ>
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<author><name sortKey="Lombardi, Federico" sort="Lombardi, Federico" uniqKey="Lombardi F" first="Federico" last="Lombardi">Federico Lombardi</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>University of Milan, Cardiology Division, San Paolo Hospital</s1>
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<author><name sortKey="Macchia, Alejandro" sort="Macchia, Alejandro" uniqKey="Macchia A" first="Alejandro" last="Macchia">Alejandro Macchia</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>GESICA Foundation</s1>
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<wicri:noRegion>GESICA Foundation</wicri:noRegion>
</affiliation>
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<author><name sortKey="Page, Richard" sort="Page, Richard" uniqKey="Page R" first="Richard" last="Page">Richard Page</name>
<affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Department of Medicine, University of Wisconsin School of Medicine and Public Health</s1>
<s2>Madison, WI</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
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<country>États-Unis</country>
<placeName><region type="state">Wisconsin</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Santini, Massimo" sort="Santini, Massimo" uniqKey="Santini M" first="Massimo" last="Santini">Massimo Santini</name>
<affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Cardiovascular Diseases, Ospedale San Filippo Neri</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName><settlement type="city">Rome</settlement>
<region nuts="2">Latium</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>GVM Hospitals of Care and Research, Villa Maria Cecilia Hospital</s1>
<s2>Cotignola</s2>
<s3>ITA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Cotignola</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tognoni, Gianni" sort="Tognoni, Gianni" uniqKey="Tognoni G" first="Gianni" last="Tognoni">Gianni Tognoni</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Consorzio Mario Negri Sud, Santa Maria Imbaro</s1>
<s3>ITA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Consorzio Mario Negri Sud, Santa Maria Imbaro</wicri:noRegion>
</affiliation>
</author>
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<series><title level="j" type="main">The American heart journal</title>
<title level="j" type="abbreviated">Am. heart j.</title>
<idno type="ISSN">0002-8703</idno>
<imprint><date when="2011">2011</date>
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<seriesStmt><title level="j" type="main">The American heart journal</title>
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</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Atrial fibrillation</term>
<term>Cardiology</term>
<term>Cardiovascular disease</term>
<term>Circulatory system</term>
<term>Design</term>
<term>Postoperative</term>
<term>Prevention</term>
<term>n-3 fatty acid</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Fibrillation auriculaire</term>
<term>Pathologie de l'appareil circulatoire</term>
<term>Acide gras n-3</term>
<term>Prévention</term>
<term>Postopératoire</term>
<term>Conception</term>
<term>Appareil circulatoire</term>
<term>Cardiologie</term>
</keywords>
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<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 longchain w-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, placebocontrolled, 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>
<affiliations><list><country><li>Argentine</li>
<li>Italie</li>
<li>États-Unis</li>
</country>
<region><li>Delaware</li>
<li>Latium</li>
<li>Massachusetts</li>
<li>Wisconsin</li>
</region>
<settlement><li>Rome</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Mozaffarian, Dariush" sort="Mozaffarian, Dariush" uniqKey="Mozaffarian D" first="Dariush" last="Mozaffarian">Dariush Mozaffarian</name>
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<name sortKey="Gardner, Tim" sort="Gardner, Tim" uniqKey="Gardner T" first="Tim" last="Gardner">Tim Gardner</name>
<name sortKey="Libby, Peter" sort="Libby, Peter" uniqKey="Libby P" first="Peter" last="Libby">Peter Libby</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>
</country>
<country name="Italie"><noRegion><name sortKey="Marchioli, Roberto" sort="Marchioli, Roberto" uniqKey="Marchioli R" first="Roberto" last="Marchioli">Roberto Marchioli</name>
</noRegion>
<name sortKey="Ferrazzi, Paolo" sort="Ferrazzi, Paolo" uniqKey="Ferrazzi P" first="Paolo" last="Ferrazzi">Paolo Ferrazzi</name>
<name sortKey="Latini, Roberto" sort="Latini, Roberto" uniqKey="Latini R" first="Roberto" last="Latini">Roberto Latini</name>
<name sortKey="Lombardi, Federico" sort="Lombardi, Federico" uniqKey="Lombardi F" first="Federico" last="Lombardi">Federico Lombardi</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>
</country>
<country name="Argentine"><noRegion><name sortKey="Macchia, Alejandro" sort="Macchia, Alejandro" uniqKey="Macchia A" first="Alejandro" last="Macchia">Alejandro Macchia</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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   |texte=   The ω-3 fatty acids for Prevention of Post-Operative Atrial Fibrillation trial-rationale and design
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The ω-3 fatty acids for Prevention of Post-Operative Atrial Fibrillation trial-rationale and design

The ω-3 fatty acids for Prevention of Post-Operative Atrial Fibrillation trial-rationale and design

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