The ω-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design.
نویسندگان
چکیده
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.
منابع مشابه
A randomized controlled trial to prevent post-operative atrial fibrillation by antioxidant reinforcement.
OBJECTIVES This study was designed to assess whether the reinforcement of the antioxidant system, through n-3 fatty acids plus antioxidant vitamin supplementation, could reduce the incidence of post-operative atrial fibrillation. BACKGROUND Therapy to prevent post-operative atrial fibrillation remains suboptimal. Although oxidative stress plays a key role in the pathogenesis of this arrhythmi...
متن کاملShould Physicians Continue to Recommend Fish Oil for Patients with Atrial Fibrillation?
Many physicians recommend the use of fish oil or omega-3 polyunsaturated fatty acids (n-3 PUFA) in atrial fibrillation (AF) patients. N-3 PUFA have demonstrated anti-fibrillatory properties in several animal studies, however, data regarding their efficacy in preventing AF in humans have been mixed. This article critically reviews studies that have investigated the use of n-3 PUFA for the second...
متن کاملFish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial.
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 red...
متن کاملOxidative stress biomarkers and incidence of postoperative atrial fibrillation in the Omegaâ•’3 Fatty Acids for Prevention of Postoperative Atrial Fibrillation (OPERA) trial
متن کامل
تأثیر ویتامین C در کاهش بروز فیبریلاسیون دهلیزی بعد از عمل جراحی بای‌پس کرونری: کارآزمایی بالینی تصادفی دوسوکور
Background: Atrial fibrillation is the most common arrhythmia after cardiac surgery. Vitamin C as an antioxidant has an important role in reducing the incidence of postop-erative atrial fibrillation. The present study aimed at administrating vitamin C as a way to reduce the incidence of post-CABG atrial fibrillation. Methods: In this double-blind, parallel clinical trial, 170 patients with cor...
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ورودعنوان ژورنال:
- American heart journal
دوره 162 1 شماره
صفحات -
تاریخ انتشار 2011