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

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• 作者：Dariush Mozaffarian MD ; DrPH^a ; ^m ; ^* ; ^{dmozaffa@hsph.harvard.edu"" rel=""nofollow} ; ^{marchioli@negrisud.it"" rel=""nofollow} ; Roberto Marchioli MD^b ; ^m ; ^* ; ^{marchioli@negrisud.it"" rel=""nofollow} ; Tim Gardner MD^c ; ^m ; Paolo Ferrazzi MD^d ; ^m ; Patrick O'Gara MD^e ; ^m ; Roberto Latini MD^f ; ^m ; Peter Libby MD^e ; ^m ; Federico Lombardi MD^g ; ^m ; Alejandro Macchia MD^h ; ^m ; Richard Page MDⁱ ; ^m ; Massimo Santini MD^j ; ^m ; Luigi Tavazzi MD^k ; ^m ; Gianni Tognoni MD^l ; ^m
• 刊名：American Heart Journal
• 出版年：2011
• 出版时间：July 2011
• 年：2011
• 卷：162
• 期：1
• 页码：56-63.e3
• 全文大小：222 K

文摘

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.