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Fish Oil and Postoperative Atrial Fibrillation: The Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) Randomized Trial

Identifieur interne : 000466 ( PascalFrancis/Curation ); précédent : 000465; suivant : 000467

Fish Oil and Postoperative Atrial Fibrillation: The Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) Randomized Trial

Auteurs : Dariush Mozaffarian [États-Unis] ; Roberto Marchioli [Italie] ; Alejandro Macchia [Argentine] ; Maria G. Silletta [Italie] ; Paolo Ferrazzi [Italie] ; Timothy J. Gardner [États-Unis] ; Roberto Latini [Italie] ; Peter Libby [États-Unis] ; Federico Lombardi [Italie] ; Patrick T. O'Gara [États-Unis] ; Richard L. Page [États-Unis] ; Luigi Tavazzi [Italie] ; Gianni Tognoni [Italie]

Source :

RBID : Pascal:12-0456324

Descripteurs français

English descriptors

Abstract

Context Postoperative atrial fibrillation or flutter (AF) is one of the most common complications of cardiac surgery and significantly increases morbidity and health care utilization. A few small trials have evaluated whether long-chain n-3-polyunsaturated fatty acids (PUFAs) reduce postoperative AF, with mixed results. Objective To determine whether perioperative n-3-PUFA supplementation reduces postoperative AF. Design, Setting, and Patients The Omega-3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) double-blind, placebo-controlled, randomized clinical trial. A total of 1516 patients scheduled for cardiac surgery in 28 centers in the United States, Italy, and Argentina were enrolled between August 2010 and June 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. Intervention Patients were randomized to receive fish oil (1-g capsules containing ≥840 mg n-3-PUFAs as ethyl esters) or placebo, with preoperative loading of 10 g over 3 to 5 days (or 8 g over 2 days) followed postoperatively by 2 g/d until hospital discharge or postoperative day 10, whichever came first. Main Outcome Measure Occurrence of postoperative AF lasting longer than 30 seconds. Secondary end points were postoperative AF lasting longer than 1 hour, resulting in symptoms, or treated with cardioversion; postoperative AF excluding atrial flutter; time to first postoperative AF; number of AF episodes per patient; hospital utilization ; and major adverse cardiovascular events, 30-day mortality, bleeding, and other adverse events. Results At enrollment, mean age was 64 (SD, 13) years; 72.2% of patients were men, and 51.8% had planned valvular surgery. The primary end point occurred in 233 (30.7%) patients assigned to placebo and 227 (30.0%) assigned to n-3-PUFAs (odds ratio, 0.96 [95% CI, 0.77-1.20]; P=.74). None of the secondary end points were significantly different between the placebo and fish oil groups, including postoperative AF that was sustained, symptomatic, or treated (231 [30.5%] vs 224 [29.6%], P=.70) or number of postoperative AF episodes per patient (1 episode: 156 [20.6%] vs 157 [20.7%]; 2 episodes: 59 [7.8%] vs 49 [6.5%]; ≥3 episodes: 18 [2.4%] vs 21 [2.8%]) (P=.73). Supplementation with n-3-PUFAs was generally well tolerated, with no evidence for increased risk of bleeding or serious adverse events. Conclusion In this large multinational trial among patients undergoing cardiac surgery, perioperative supplementation with n-3-PUFAs, compared with placebo, did not reduce the risk of postoperative AF.
pA  
A01 01  1    @0 0098-7484
A03   1    @0 JAMA j. Am. Med. Assoc.
A05       @2 308
A06       @2 19
A08 01  1  ENG  @1 Fish Oil and Postoperative Atrial Fibrillation: The Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) Randomized Trial
A11 01  1    @1 MOZAFFARIAN (Dariush)
A11 02  1    @1 MARCHIOLI (Roberto)
A11 03  1    @1 MACCHIA (Alejandro)
A11 04  1    @1 SILLETTA (Maria G.)
A11 05  1    @1 FERRAZZI (Paolo)
A11 06  1    @1 GARDNER (Timothy J.)
A11 07  1    @1 LATINI (Roberto)
A11 08  1    @1 LIBBY (Peter)
A11 09  1    @1 LOMBARDI (Federico)
A11 10  1    @1 O'GARA (Patrick T.)
A11 11  1    @1 PAGE (Richard L.)
A11 12  1    @1 TAVAZZI (Luigi)
A11 13  1    @1 TOGNONI (Gianni)
A14 01      @1 Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School @3 USA @Z 1 aut. @Z 8 aut. @Z 10 aut.
A14 02      @1 Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School @3 USA @Z 1 aut.
A14 03      @1 Departments of Epidemiology and Nutrition, Harvard School of Public Health @2 Boston, Massachusetts @3 USA @Z 1 aut.
A14 04      @1 Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud @2 Santa Maria Imbaro @3 ITA @Z 2 aut. @Z 4 aut. @Z 13 aut.
A14 05      @1 GESICA Foundation @2 Buenos Aires @3 ARG @Z 3 aut.
A14 06      @1 Ospedali Riuniti di Bergamo @2 Bergamo @3 ITA @Z 5 aut.
A14 07      @1 The Center for Heart and Vascular Health, Christiana Care Health System @2 Newark Delware @3 USA @Z 6 aut.
A14 08      @1 Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche Mario Negri @2 Milan @3 ITA @Z 7 aut.
A14 09      @1 Department of Health Sciences, University of Milan @2 Milan @3 ITA @Z 9 aut.
A14 10      @1 Department of Medicine, University of Wisconsin School of Medicine & Public Health @2 Madison @3 USA @Z 11 aut.
A14 11      @1 GVM Hospitals of Care and Research, Villa Maria Cecilia Hospital @2 Cotignola @3 ITA @Z 12 aut.
A17 01  1    @1 OPERA Investigators @3 INC
A20       @1 2001-2011
A21       @1 2012
A23 01      @0 ENG
A43 01      @1 INIST @2 5051 @5 354000506875740100
A44       @0 0000 @1 © 2012 INIST-CNRS. All rights reserved.
A45       @0 44 ref.
A47 01  1    @0 12-0456324
A60       @1 P
A61       @0 A
A64 01  1    @0 JAMA, the journal of the American Medical Association
A66 01      @0 USA
C01 01    ENG  @0 Context Postoperative atrial fibrillation or flutter (AF) is one of the most common complications of cardiac surgery and significantly increases morbidity and health care utilization. A few small trials have evaluated whether long-chain n-3-polyunsaturated fatty acids (PUFAs) reduce postoperative AF, with mixed results. Objective To determine whether perioperative n-3-PUFA supplementation reduces postoperative AF. Design, Setting, and Patients The Omega-3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) double-blind, placebo-controlled, randomized clinical trial. A total of 1516 patients scheduled for cardiac surgery in 28 centers in the United States, Italy, and Argentina were enrolled between August 2010 and June 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. Intervention Patients were randomized to receive fish oil (1-g capsules containing ≥840 mg n-3-PUFAs as ethyl esters) or placebo, with preoperative loading of 10 g over 3 to 5 days (or 8 g over 2 days) followed postoperatively by 2 g/d until hospital discharge or postoperative day 10, whichever came first. Main Outcome Measure Occurrence of postoperative AF lasting longer than 30 seconds. Secondary end points were postoperative AF lasting longer than 1 hour, resulting in symptoms, or treated with cardioversion; postoperative AF excluding atrial flutter; time to first postoperative AF; number of AF episodes per patient; hospital utilization ; and major adverse cardiovascular events, 30-day mortality, bleeding, and other adverse events. Results At enrollment, mean age was 64 (SD, 13) years; 72.2% of patients were men, and 51.8% had planned valvular surgery. The primary end point occurred in 233 (30.7%) patients assigned to placebo and 227 (30.0%) assigned to n-3-PUFAs (odds ratio, 0.96 [95% CI, 0.77-1.20]; P=.74). None of the secondary end points were significantly different between the placebo and fish oil groups, including postoperative AF that was sustained, symptomatic, or treated (231 [30.5%] vs 224 [29.6%], P=.70) or number of postoperative AF episodes per patient (1 episode: 156 [20.6%] vs 157 [20.7%]; 2 episodes: 59 [7.8%] vs 49 [6.5%]; ≥3 episodes: 18 [2.4%] vs 21 [2.8%]) (P=.73). Supplementation with n-3-PUFAs was generally well tolerated, with no evidence for increased risk of bleeding or serious adverse events. Conclusion In this large multinational trial among patients undergoing cardiac surgery, perioperative supplementation with n-3-PUFAs, compared with placebo, did not reduce the risk of postoperative AF.
C02 01  X    @0 002B01
C02 02  X    @0 002B12A02
C02 03  X    @0 002B30A03
C03 01  X  FRE  @0 Chirurgie @5 01
C03 01  X  ENG  @0 Surgery @5 01
C03 01  X  SPA  @0 Cirugía @5 01
C03 02  X  FRE  @0 Huile poisson @5 02
C03 02  X  ENG  @0 Fish oil @5 02
C03 02  X  SPA  @0 Aceite pescado @5 02
C03 03  X  FRE  @0 Postopératoire @5 03
C03 03  X  ENG  @0 Postoperative @5 03
C03 03  X  SPA  @0 Postoperatorio @5 03
C03 04  X  FRE  @0 Fibrillation auriculaire @5 04
C03 04  X  ENG  @0 Atrial fibrillation @5 04
C03 04  X  SPA  @0 Fibrilación auricular @5 04
C03 05  X  FRE  @0 Acide gras n-3 @5 05
C03 05  X  ENG  @0 n-3 fatty acid @5 05
C03 05  X  SPA  @0 Acido graso n-3 @5 05
C03 06  X  FRE  @0 Prévention @5 06
C03 06  X  ENG  @0 Prevention @5 06
C03 06  X  SPA  @0 Prevención @5 06
C03 07  X  FRE  @0 Essai clinique @5 08
C03 07  X  ENG  @0 Clinical trial @5 08
C03 07  X  SPA  @0 Ensayo clínico @5 08
C03 08  X  FRE  @0 Randomisation @5 09
C03 08  X  ENG  @0 Randomization @5 09
C03 08  X  SPA  @0 Aleatorización @5 09
C03 09  X  FRE  @0 Médecine @5 11
C03 09  X  ENG  @0 Medicine @5 11
C03 09  X  SPA  @0 Medicina @5 11
C03 10  X  FRE  @0 Traitement @5 25
C03 10  X  ENG  @0 Treatment @5 25
C03 10  X  SPA  @0 Tratamiento @5 25
C07 01  X  FRE  @0 Pathologie de l'appareil circulatoire @5 37
C07 01  X  ENG  @0 Cardiovascular disease @5 37
C07 01  X  SPA  @0 Aparato circulatorio patología @5 37
C07 02  X  FRE  @0 Cardiopathie @5 38
C07 02  X  ENG  @0 Heart disease @5 38
C07 02  X  SPA  @0 Cardiopatía @5 38
C07 03  X  FRE  @0 Trouble de l'excitabilité @5 39
C07 03  X  ENG  @0 Excitability disorder @5 39
C07 03  X  SPA  @0 Trastorno excitabilidad @5 39
C07 04  X  FRE  @0 Trouble du rythme cardiaque @5 40
C07 04  X  ENG  @0 Arrhythmia @5 40
C07 04  X  SPA  @0 Arritmia @5 40
C07 05  X  FRE  @0 Acide gras insaturé @5 41
C07 05  X  ENG  @0 Unsaturated fatty acid @5 41
C07 05  X  SPA  @0 Acido graso no saturado @5 41
C07 06  X  FRE  @0 Lipide @5 42
C07 06  X  ENG  @0 Lipids @5 42
C07 06  X  SPA  @0 Lípido @5 42
N21       @1 353
N44 01      @1 OTO
N82       @1 OTO

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<name sortKey="Latini, Roberto" sort="Latini, Roberto" uniqKey="Latini R" first="Roberto" last="Latini">Roberto Latini</name>
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<name sortKey="Lombardi, Federico" sort="Lombardi, Federico" uniqKey="Lombardi F" first="Federico" last="Lombardi">Federico Lombardi</name>
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<name sortKey="Marchioli, Roberto" sort="Marchioli, Roberto" uniqKey="Marchioli R" first="Roberto" last="Marchioli">Roberto Marchioli</name>
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<name sortKey="Macchia, Alejandro" sort="Macchia, Alejandro" uniqKey="Macchia A" first="Alejandro" last="Macchia">Alejandro Macchia</name>
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<s1>GESICA Foundation</s1>
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<name sortKey="Silletta, Maria G" sort="Silletta, Maria G" uniqKey="Silletta M" first="Maria G." last="Silletta">Maria G. Silletta</name>
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<name sortKey="Ferrazzi, Paolo" sort="Ferrazzi, Paolo" uniqKey="Ferrazzi P" first="Paolo" last="Ferrazzi">Paolo Ferrazzi</name>
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<s1>Ospedali Riuniti di Bergamo</s1>
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<country>Italie</country>
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<name sortKey="Gardner, Timothy J" sort="Gardner, Timothy J" uniqKey="Gardner T" first="Timothy J." last="Gardner">Timothy J. Gardner</name>
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<s1>The Center for Heart and Vascular Health, Christiana Care Health System</s1>
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<country>États-Unis</country>
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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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<name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name>
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<name sortKey="Tognoni, Gianni" sort="Tognoni, Gianni" uniqKey="Tognoni G" first="Gianni" last="Tognoni">Gianni Tognoni</name>
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<s1>Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud</s1>
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<title level="j" type="main">JAMA, the journal of the American Medical Association</title>
<title level="j" type="abbreviated">JAMA j. Am. Med. Assoc.</title>
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<term>Atrial fibrillation</term>
<term>Clinical trial</term>
<term>Fish oil</term>
<term>Medicine</term>
<term>Postoperative</term>
<term>Prevention</term>
<term>Randomization</term>
<term>Surgery</term>
<term>Treatment</term>
<term>n-3 fatty acid</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Chirurgie</term>
<term>Huile poisson</term>
<term>Postopératoire</term>
<term>Fibrillation auriculaire</term>
<term>Acide gras n-3</term>
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<div type="abstract" xml:lang="en">Context Postoperative atrial fibrillation or flutter (AF) is one of the most common complications of cardiac surgery and significantly increases morbidity and health care utilization. A few small trials have evaluated whether long-chain n-3-polyunsaturated fatty acids (PUFAs) reduce postoperative AF, with mixed results. Objective To determine whether perioperative n-3-PUFA supplementation reduces postoperative AF. Design, Setting, and Patients The Omega-3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) double-blind, placebo-controlled, randomized clinical trial. A total of 1516 patients scheduled for cardiac surgery in 28 centers in the United States, Italy, and Argentina were enrolled between August 2010 and June 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. Intervention Patients were randomized to receive fish oil (1-g capsules containing ≥840 mg n-3-PUFAs as ethyl esters) or placebo, with preoperative loading of 10 g over 3 to 5 days (or 8 g over 2 days) followed postoperatively by 2 g/d until hospital discharge or postoperative day 10, whichever came first. Main Outcome Measure Occurrence of postoperative AF lasting longer than 30 seconds. Secondary end points were postoperative AF lasting longer than 1 hour, resulting in symptoms, or treated with cardioversion; postoperative AF excluding atrial flutter; time to first postoperative AF; number of AF episodes per patient; hospital utilization ; and major adverse cardiovascular events, 30-day mortality, bleeding, and other adverse events. Results At enrollment, mean age was 64 (SD, 13) years; 72.2% of patients were men, and 51.8% had planned valvular surgery. The primary end point occurred in 233 (30.7%) patients assigned to placebo and 227 (30.0%) assigned to n-3-PUFAs (odds ratio, 0.96 [95% CI, 0.77-1.20]; P=.
<sub>74</sub>
). None of the secondary end points were significantly different between the placebo and fish oil groups, including postoperative AF that was sustained, symptomatic, or treated (231 [30.5%] vs 224 [29.6%], P=.70) or number of postoperative AF episodes per patient (1 episode: 156 [20.6%] vs 157 [20.7%]; 2 episodes: 59 [7.8%] vs 49 [6.5%]; ≥3 episodes: 18 [2.4%] vs 21 [2.8%]) (P=.73). Supplementation with n-3-PUFAs was generally well tolerated, with no evidence for increased risk of bleeding or serious adverse events. Conclusion In this large multinational trial among patients undergoing cardiac surgery, perioperative supplementation with n-3-PUFAs, compared with placebo, did not reduce the risk of postoperative AF.</div>
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<s0>Context Postoperative atrial fibrillation or flutter (AF) is one of the most common complications of cardiac surgery and significantly increases morbidity and health care utilization. A few small trials have evaluated whether long-chain n-3-polyunsaturated fatty acids (PUFAs) reduce postoperative AF, with mixed results. Objective To determine whether perioperative n-3-PUFA supplementation reduces postoperative AF. Design, Setting, and Patients The Omega-3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) double-blind, placebo-controlled, randomized clinical trial. A total of 1516 patients scheduled for cardiac surgery in 28 centers in the United States, Italy, and Argentina were enrolled between August 2010 and June 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. Intervention Patients were randomized to receive fish oil (1-g capsules containing ≥840 mg n-3-PUFAs as ethyl esters) or placebo, with preoperative loading of 10 g over 3 to 5 days (or 8 g over 2 days) followed postoperatively by 2 g/d until hospital discharge or postoperative day 10, whichever came first. Main Outcome Measure Occurrence of postoperative AF lasting longer than 30 seconds. Secondary end points were postoperative AF lasting longer than 1 hour, resulting in symptoms, or treated with cardioversion; postoperative AF excluding atrial flutter; time to first postoperative AF; number of AF episodes per patient; hospital utilization ; and major adverse cardiovascular events, 30-day mortality, bleeding, and other adverse events. Results At enrollment, mean age was 64 (SD, 13) years; 72.2% of patients were men, and 51.8% had planned valvular surgery. The primary end point occurred in 233 (30.7%) patients assigned to placebo and 227 (30.0%) assigned to n-3-PUFAs (odds ratio, 0.96 [95% CI, 0.77-1.20]; P=.
<sub>74</sub>
). None of the secondary end points were significantly different between the placebo and fish oil groups, including postoperative AF that was sustained, symptomatic, or treated (231 [30.5%] vs 224 [29.6%], P=.70) or number of postoperative AF episodes per patient (1 episode: 156 [20.6%] vs 157 [20.7%]; 2 episodes: 59 [7.8%] vs 49 [6.5%]; ≥3 episodes: 18 [2.4%] vs 21 [2.8%]) (P=.73). Supplementation with n-3-PUFAs was generally well tolerated, with no evidence for increased risk of bleeding or serious adverse events. Conclusion In this large multinational trial among patients undergoing cardiac surgery, perioperative supplementation with n-3-PUFAs, compared with placebo, did not reduce the risk of postoperative AF.</s0>
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   |type=    RBID
   |clé=     Pascal:12-0456324
   |texte=   Fish Oil and Postoperative Atrial Fibrillation: The Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) Randomized Trial
}}

Wicri

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