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

Identifieur interne : 000C15 ( Main/Exploration ); précédent : 000C14; suivant : 000C16

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 :

RBID : Pascal:11-0345371

Descripteurs français

English descriptors

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.


Affiliations:


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Le document en format XML

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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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<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>
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<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>
</front>
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