The ω-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design.
Identifieur interne : 000886 ( Ncbi/Merge ); précédent : 000885; suivant : 000887The 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
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 000311
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pubmed:21742090Le document en format XML
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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 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>
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<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>
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<QualifierName MajorTopicYN="N" UI="Q000601">surgery</QualifierName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName>
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<Day>10</Day>
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<ArticleId IdType="doi">10.1016/j.ahj.2011.03.035</ArticleId>
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<affiliations><list><country><li>États-Unis</li>
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<region><li>Massachusetts</li>
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<tree><noCountry><name sortKey="Ferrazzi, Paolo" sort="Ferrazzi, Paolo" uniqKey="Ferrazzi P" first="Paolo" last="Ferrazzi">Paolo Ferrazzi</name>
<name sortKey="Gardner, Tim" sort="Gardner, Tim" uniqKey="Gardner T" first="Tim" last="Gardner">Tim Gardner</name>
<name sortKey="Latini, Roberto" sort="Latini, Roberto" uniqKey="Latini R" first="Roberto" last="Latini">Roberto Latini</name>
<name sortKey="Libby, Peter" sort="Libby, Peter" uniqKey="Libby P" first="Peter" last="Libby">Peter Libby</name>
<name sortKey="Lombardi, Federico" sort="Lombardi, Federico" uniqKey="Lombardi F" first="Federico" last="Lombardi">Federico Lombardi</name>
<name sortKey="Macchia, Alejandro" sort="Macchia, Alejandro" uniqKey="Macchia A" first="Alejandro" last="Macchia">Alejandro Macchia</name>
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<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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<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>
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<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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