The ω-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design.
Identifieur interne : 000A47 ( Main/Exploration ); précédent : 000A46; suivant : 000A48The 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
Affiliations:
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Le document en format XML
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sort="Gardner, Tim" uniqKey="Gardner T" first="Tim" last="Gardner">Tim Gardner</name></author><author><name sortKey="Ferrazzi, Paolo" sort="Ferrazzi, Paolo" uniqKey="Ferrazzi P" first="Paolo" last="Ferrazzi">Paolo Ferrazzi</name></author><author><name sortKey="O Gara, Patrick" sort="O Gara, Patrick" uniqKey="O Gara P" first="Patrick" last="O'Gara">Patrick O'Gara</name></author><author><name sortKey="Latini, Roberto" sort="Latini, Roberto" uniqKey="Latini R" first="Roberto" last="Latini">Roberto Latini</name></author><author><name sortKey="Libby, Peter" sort="Libby, Peter" uniqKey="Libby P" first="Peter" last="Libby">Peter Libby</name></author><author><name sortKey="Lombardi, Federico" sort="Lombardi, Federico" uniqKey="Lombardi F" first="Federico" last="Lombardi">Federico Lombardi</name></author><author><name sortKey="Macchia, Alejandro" sort="Macchia, Alejandro" uniqKey="Macchia A" first="Alejandro" last="Macchia">Alejandro Macchia</name></author><author><name sortKey="Page, Richard" 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type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Marchioli, Roberto" sort="Marchioli, Roberto" uniqKey="Marchioli R" first="Roberto" last="Marchioli">Roberto Marchioli</name></author><author><name sortKey="Gardner, Tim" sort="Gardner, Tim" uniqKey="Gardner T" first="Tim" last="Gardner">Tim Gardner</name></author><author><name sortKey="Ferrazzi, Paolo" sort="Ferrazzi, Paolo" uniqKey="Ferrazzi P" first="Paolo" last="Ferrazzi">Paolo Ferrazzi</name></author><author><name sortKey="O Gara, Patrick" sort="O Gara, Patrick" uniqKey="O Gara P" first="Patrick" last="O'Gara">Patrick O'Gara</name></author><author><name sortKey="Latini, Roberto" sort="Latini, Roberto" uniqKey="Latini R" first="Roberto" last="Latini">Roberto Latini</name></author><author><name sortKey="Libby, Peter" sort="Libby, Peter" uniqKey="Libby P" first="Peter" last="Libby">Peter Libby</name></author><author><name sortKey="Lombardi, Federico" sort="Lombardi, Federico" uniqKey="Lombardi F" first="Federico" last="Lombardi">Federico Lombardi</name></author><author><name sortKey="Macchia, Alejandro" sort="Macchia, Alejandro" uniqKey="Macchia A" first="Alejandro" last="Macchia">Alejandro Macchia</name></author><author><name sortKey="Page, Richard" sort="Page, Richard" uniqKey="Page R" first="Richard" last="Page">Richard Page</name></author><author><name sortKey="Santini, Massimo" sort="Santini, Massimo" uniqKey="Santini M" first="Massimo" last="Santini">Massimo Santini</name></author><author><name sortKey="Tavazzi, Luigi" sort="Tavazzi, Luigi" uniqKey="Tavazzi L" first="Luigi" last="Tavazzi">Luigi Tavazzi</name></author><author><name sortKey="Tognoni, Gianni" sort="Tognoni, Gianni" uniqKey="Tognoni G" first="Gianni" last="Tognoni">Gianni Tognoni</name></author></analytic><series><title level="j">American heart journal</title><idno type="e-ISSN">1097-6744</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Adolescent</term><term>Atrial Fibrillation (etiology)</term><term>Atrial Fibrillation (physiopathology)</term><term>Atrial Fibrillation (prevention & control)</term><term>Cardiac Surgical Procedures (adverse effects)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Fatty Acids, Omega-3 (administration & dosage)</term><term>Follow-Up Studies</term><term>Heart Diseases (surgery)</term><term>Humans</term><term>Postoperative Complications</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Fatty Acids, Omega-3</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Cardiac Surgical Procedures</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Atrial Fibrillation</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Atrial Fibrillation</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Atrial Fibrillation</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Heart Diseases</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Adolescent</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Follow-Up Studies</term><term>Humans</term><term>Postoperative Complications</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><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></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Massachusetts</li></region></list><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><name sortKey="Marchioli, Roberto" sort="Marchioli, Roberto" uniqKey="Marchioli R" first="Roberto" last="Marchioli">Roberto Marchioli</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><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></noCountry><country name="États-Unis"><region name="Massachusetts"><name sortKey="Mozaffarian, Dariush" sort="Mozaffarian, Dariush" uniqKey="Mozaffarian D" first="Dariush" last="Mozaffarian">Dariush Mozaffarian</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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