OperaV1, PascalFrancis, Curation, bibRecord, 000391

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

Identifieur interne : 000391 ( PascalFrancis/Curation ); précédent : 000390; suivant : 000392

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.

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A08	`01`	`1`	`ENG`	`@1 The ω-3 fatty acids for Prevention of Post-Operative Atrial Fibrillation trial-rationale and design`
A11	`01`	`1`		`@1 MOZAFFARIAN (Dariush)`
A11	`02`	`1`		`@1 MARCHIOLI (Roberto)`
A11	`03`	`1`		`@1 GARDNER (Tim)`
A11	`04`	`1`		`@1 FERRAZZI (Paolo)`
A11	`05`	`1`		`@1 O'GARA (Patrick)`
A11	`06`	`1`		`@1 LATINI (Roberto)`
A11	`07`	`1`		`@1 LIBBY (Peter)`
A11	`08`	`1`		`@1 LOMBARDI (Federico)`
A11	`09`	`1`		`@1 MACCHIA (Alejandro)`
A11	`10`	`1`		`@1 PAGE (Richard)`
A11	`11`	`1`		`@1 SANTINI (Massimo)`
A11	`12`	`1`		`@1 TAVAZZI (Luigi)`
A11	`13`	`1`		`@1 TOGNONI (Gianni)`
A14	`01`			`@1 Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Departments of Epidemiology and Nutrition, Harvard School of Public Health @2 Boston, MA @3 USA @Z 1 aut.`
A14	`02`			`@1 Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro @3 ITA @Z 2 aut.`
A14	`03`			`@1 Christiana Care Health System @2 Newark, DE @3 USA @Z 3 aut.`
A14	`04`			`@1 Cardiovascular Department, Cardiac Surgery, Ospedali Riuniti di Bergamo @2 Bergamo @3 ITA @Z 4 aut.`
A14	`05`			`@1 Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School @2 Boston, MA @3 USA @Z 5 aut. @Z 7 aut.`
A14	`06`			`@1 Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche Mario Negri @2 Milano @3 ITA @Z 6 aut.`
A14	`07`			`@1 University of Milan, Cardiology Division, San Paolo Hospital @2 Milan @3 ITA @Z 8 aut.`
A14	`08`			`@1 GESICA Foundation @2 Buenos Aires @3 ARG @Z 9 aut.`
A14	`09`			`@1 Department of Medicine, University of Wisconsin School of Medicine and Public Health @2 Madison, WI @3 USA @Z 10 aut.`
A14	`10`			`@1 Department of Cardiovascular Diseases, Ospedale San Filippo Neri @2 Rome @3 ITA @Z 11 aut.`
A14	`11`			`@1 GVM Hospitals of Care and Research, Villa Maria Cecilia Hospital @2 Cotignola @3 ITA @Z 12 aut.`
A14	`12`			`@1 Consorzio Mario Negri Sud, Santa Maria Imbaro @3 ITA @Z 13 aut.`
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C01	`01`		`ENG`	@0 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.
C02	`01`	`X`		`@0 002B12A02`
C03	`01`	`X`	`FRE`	`@0 Fibrillation auriculaire @5 01`
C03	`01`	`X`	`ENG`	`@0 Atrial fibrillation @5 01`
C03	`01`	`X`	`SPA`	`@0 Fibrilación auricular @5 01`
C03	`02`	`X`	`FRE`	`@0 Pathologie de l'appareil circulatoire @5 02`
C03	`02`	`X`	`ENG`	`@0 Cardiovascular disease @5 02`
C03	`02`	`X`	`SPA`	`@0 Aparato circulatorio patología @5 02`
C03	`03`	`X`	`FRE`	`@0 Acide gras n-3 @5 09`
C03	`03`	`X`	`ENG`	`@0 n-3 fatty acid @5 09`
C03	`03`	`X`	`SPA`	`@0 Acido graso n-3 @5 09`
C03	`04`	`X`	`FRE`	`@0 Prévention @5 10`
C03	`04`	`X`	`ENG`	`@0 Prevention @5 10`
C03	`04`	`X`	`SPA`	`@0 Prevención @5 10`
C03	`05`	`X`	`FRE`	`@0 Postopératoire @5 11`
C03	`05`	`X`	`ENG`	`@0 Postoperative @5 11`
C03	`05`	`X`	`SPA`	`@0 Postoperatorio @5 11`
C03	`06`	`X`	`FRE`	`@0 Conception @5 12`
C03	`06`	`X`	`ENG`	`@0 Design @5 12`
C03	`06`	`X`	`SPA`	`@0 Diseño @5 12`
C03	`07`	`X`	`FRE`	`@0 Appareil circulatoire @5 13`
C03	`07`	`X`	`ENG`	`@0 Circulatory system @5 13`
C03	`07`	`X`	`SPA`	`@0 Aparato circulatorio @5 13`
C03	`08`	`X`	`FRE`	`@0 Cardiologie @5 14`
C03	`08`	`X`	`ENG`	`@0 Cardiology @5 14`
C03	`08`	`X`	`SPA`	`@0 Cardiología @5 14`
C07	`01`	`X`	`FRE`	`@0 Cardiopathie @5 37`
C07	`01`	`X`	`ENG`	`@0 Heart disease @5 37`
C07	`01`	`X`	`SPA`	`@0 Cardiopatía @5 37`
C07	`02`	`X`	`FRE`	`@0 Trouble de l'excitabilité @5 38`
C07	`02`	`X`	`ENG`	`@0 Excitability disorder @5 38`
C07	`02`	`X`	`SPA`	`@0 Trastorno excitabilidad @5 38`
C07	`03`	`X`	`FRE`	`@0 Trouble du rythme cardiaque @5 39`
C07	`03`	`X`	`ENG`	`@0 Arrhythmia @5 39`
C07	`03`	`X`	`SPA`	`@0 Arritmia @5 39`
N21				`@1 234`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

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Le document en format XML

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<author><name sortKey="Mozaffarian, Dariush" sort="Mozaffarian, Dariush" uniqKey="Mozaffarian D" first="Dariush" last="Mozaffarian">Dariush Mozaffarian</name>
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<author><name sortKey="Ferrazzi, Paolo" sort="Ferrazzi, Paolo" uniqKey="Ferrazzi P" first="Paolo" last="Ferrazzi">Paolo Ferrazzi</name>
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<author><name sortKey="O Gara, Patrick" sort="O Gara, Patrick" uniqKey="O Gara P" first="Patrick" last="O'Gara">Patrick O'Gara</name>
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<author><name sortKey="Latini, Roberto" sort="Latini, Roberto" uniqKey="Latini R" first="Roberto" last="Latini">Roberto Latini</name>
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<author><name sortKey="Libby, Peter" sort="Libby, Peter" uniqKey="Libby P" first="Peter" last="Libby">Peter Libby</name>
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<author><name sortKey="Lombardi, Federico" sort="Lombardi, Federico" uniqKey="Lombardi F" first="Federico" last="Lombardi">Federico Lombardi</name>
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<author><name sortKey="Macchia, Alejandro" sort="Macchia, Alejandro" uniqKey="Macchia A" first="Alejandro" last="Macchia">Alejandro Macchia</name>
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<author><name sortKey="Page, Richard" sort="Page, Richard" uniqKey="Page R" first="Richard" last="Page">Richard Page</name>
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<author><name sortKey="Santini, Massimo" sort="Santini, Massimo" uniqKey="Santini M" first="Massimo" last="Santini">Massimo Santini</name>
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<author><name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name>
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<author><name sortKey="Tognoni, Gianni" sort="Tognoni, Gianni" uniqKey="Tognoni G" first="Gianni" last="Tognoni">Gianni Tognoni</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">The ω-3 fatty acids for Prevention of Post-Operative Atrial Fibrillation trial-rationale and design</title>
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<author><name sortKey="Marchioli, Roberto" sort="Marchioli, Roberto" uniqKey="Marchioli R" first="Roberto" last="Marchioli">Roberto Marchioli</name>
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<s3>ITA</s3>
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<author><name sortKey="Gardner, Tim" sort="Gardner, Tim" uniqKey="Gardner T" first="Tim" last="Gardner">Tim Gardner</name>
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</author>
<author><name sortKey="Ferrazzi, Paolo" sort="Ferrazzi, Paolo" uniqKey="Ferrazzi P" first="Paolo" last="Ferrazzi">Paolo Ferrazzi</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Cardiovascular Department, Cardiac Surgery, Ospedali Riuniti di Bergamo</s1>
<s2>Bergamo</s2>
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<country>Italie</country>
</affiliation>
</author>
<author><name sortKey="O Gara, Patrick" sort="O Gara, Patrick" uniqKey="O Gara P" first="Patrick" last="O'Gara">Patrick O'Gara</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
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</author>
<author><name sortKey="Latini, Roberto" sort="Latini, Roberto" uniqKey="Latini R" first="Roberto" last="Latini">Roberto Latini</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche Mario Negri</s1>
<s2>Milano</s2>
<s3>ITA</s3>
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</inist:fA14>
<country>Italie</country>
</affiliation>
</author>
<author><name sortKey="Libby, Peter" sort="Libby, Peter" uniqKey="Libby P" first="Peter" last="Libby">Peter Libby</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>7 aut.</sZ>
</inist:fA14>
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</affiliation>
</author>
<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>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Italie</country>
</affiliation>
</author>
<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>
<s2>Buenos Aires</s2>
<s3>ARG</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Argentine</country>
</affiliation>
</author>
<author><name sortKey="Page, Richard" sort="Page, Richard" uniqKey="Page R" first="Richard" last="Page">Richard Page</name>
<affiliation wicri:level="1"><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>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author><name sortKey="Santini, Massimo" sort="Santini, Massimo" uniqKey="Santini M" first="Massimo" last="Santini">Massimo Santini</name>
<affiliation wicri:level="1"><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>
</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>
</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>
</affiliation>
</author>
</analytic>
<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>
<title level="j" type="abbreviated">Am. heart j.</title>
<idno type="ISSN">0002-8703</idno>
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<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>
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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>
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<fA08 i1="01" i2="1" l="ENG"><s1>The ω-3 fatty acids for Prevention of Post-Operative Atrial Fibrillation trial-rationale and design</s1>
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<fA14 i1="01"><s1>Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Departments of Epidemiology and Nutrition, Harvard School of Public Health</s1>
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<fC01 i1="01" l="ENG"><s0>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.</s0>
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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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