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 : 000467Fish 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 :
- JAMA, the journal of the American Medical Association [ 0098-7484 ] ; 2012.
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English descriptors
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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.
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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="O Gara, Patrick T" sort="O Gara, Patrick T" uniqKey="O Gara P" first="Patrick T." last="O'Gara">Patrick T. O'Gara</name>
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<author><name sortKey="Page, Richard L" sort="Page, Richard L" uniqKey="Page R" first="Richard L." last="Page">Richard L. Page</name>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><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>
<term>Prévention</term>
<term>Essai clinique</term>
<term>Randomisation</term>
<term>Médecine</term>
<term>Traitement</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Chirurgie</term>
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<front><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>
</front>
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<fA11 i1="12" i2="1"><s1>TAVAZZI (Luigi)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>TOGNONI (Gianni)</s1>
</fA11>
<fA14 i1="01"><s1>Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School</s1>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School</s1>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Departments of Epidemiology and Nutrition, Harvard School of Public Health</s1>
<s2>Boston, Massachusetts</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud</s1>
<s2>Santa Maria Imbaro</s2>
<s3>ITA</s3>
<sZ>2 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>GESICA Foundation</s1>
<s2>Buenos Aires</s2>
<s3>ARG</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Ospedali Riuniti di Bergamo</s1>
<s2>Bergamo</s2>
<s3>ITA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>The Center for Heart and Vascular Health, Christiana Care Health System</s1>
<s2>Newark Delware</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche Mario Negri</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Department of Health Sciences, University of Milan</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Department of Medicine, University of Wisconsin School of Medicine & Public Health</s1>
<s2>Madison</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</fA14>
<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>
</fA14>
<fA17 i1="01" i2="1"><s1>OPERA Investigators</s1>
<s3>INC</s3>
</fA17>
<fA20><s1>2001-2011</s1>
</fA20>
<fA21><s1>2012</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>5051</s2>
<s5>354000506875740100</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2012 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>44 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>12-0456324</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>JAMA, the journal of the American Medical Association</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><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>
</fC01>
<fC02 i1="01" i2="X"><s0>002B01</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B12A02</s0>
</fC02>
<fC02 i1="03" i2="X"><s0>002B30A03</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Chirurgie</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Surgery</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Cirugía</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Huile poisson</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Fish oil</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Aceite pescado</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Postopératoire</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Postoperative</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Postoperatorio</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Fibrillation auriculaire</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Atrial fibrillation</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Fibrilación auricular</s0>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Acide gras n-3</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>n-3 fatty acid</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Acido graso n-3</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Prévention</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Prevention</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Prevención</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Essai clinique</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Clinical trial</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Ensayo clínico</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Randomisation</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Randomization</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Aleatorización</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Médecine</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Medicine</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Medicina</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Traitement</s0>
<s5>25</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Treatment</s0>
<s5>25</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>25</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'appareil circulatoire</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Cardiovascular disease</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Aparato circulatorio patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Cardiopathie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Heart disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Cardiopatía</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Trouble de l'excitabilité</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Excitability disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Trastorno excitabilidad</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Trouble du rythme cardiaque</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Arrhythmia</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Arritmia</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Acide gras insaturé</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Unsaturated fatty acid</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Acido graso no saturado</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Lipide</s0>
<s5>42</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Lipids</s0>
<s5>42</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Lípido</s0>
<s5>42</s5>
</fC07>
<fN21><s1>353</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>
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