Positive Health Online

Abstract

MOZAFFARIAN and COLLEAGUES, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. dmozaffa@hsph.harvard.edu  described the OPERA trial to study the effects of omega-3-PUFAS upon cardiac events and postoperative atrial fibrillation/flutter (PoAF).

Background

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 omega-3 polyunsaturated fatty acids (PUFAs) influence several risk factors that might reduce risk of PoAF.

Methodology

A few small and generally underpowered trials have evaluated effects of omega-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 omega-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.

Results

Treatment comprises a total preoperative loading dose of 8 to 10 g of omega-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 enrolment of 1,516 patients (758 per treatment arm) will provide 90% power to detect 25% reduction in PoAF.

Conclusion

The OPERA trial will provide invaluable evidence to inform biologic pathways; proof of concept that omega-3-PUFAs influence cardiac arrhythmias; and potential regulatory standards and clinical use of this simple, inexpensive, and low-risk intervention to prevent PoAF.

References

Mozaffarian D, Marchioli R, Gardner T, Ferrazzi P, O'Gara P, Latini R, Libby P, Lombardi F, Macchia A, Page R, Santini M, Tavazzi L and Tognoni G. The omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design. American Heart Journal. 162(1):56-63.e3. Jul 2011. Other ID Source: NLM. NIHMS304087 [Available on 07/01/12] Source: NLM. PMC3134828 [Available on 07/01/12]