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FORWARD, OPERA: Omega-3 fatty acids do not reduce AF occurrence
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LOS ANGELES — Omega-3 fatty acid supplementation before and after cardiac surgery did not decrease risk for postoperative atrial fibrillation, nor did it reduce recurrent atrial fibrillation, according to data from two late-breaking clinical trials presented here.
In the FORWARD trial, supplementation with 1 g of n-3 polyunsaturated fatty acids (PUFA) for 1 year had no effect on the reduction of recurrent AF, Alejandro Macchia, MD, of GESICA Foundation Buenos Aires, Argentina, said during a presentation at the American Heart Association Scientific Sessions 2012.
FORWARD was a prospective, randomized, double blind, placebo-controlled, parallel-group, multicenter trial. Researchers included 586 outpatients with confirmed symptomatic paroxysmal AF that required cardioversion (n=428), at least two episodes of AF in the 6 months before randomization (n=55) or both (n=103). Patients were randomly assigned to 1 g of n-3 PUFA or placebo daily for 1 year for the maintenance of normal sinus rhythm.
At 1 year, 24% of patients assigned n-3 PUFA and 18.9% assigned placebo experience symptomatic recurrence of AF (HR=1.28; 95% CI, 0.9-1.83), documented by a 12-lead ECG.
The composite outcome of all-cause mortality, nonfatal stroke, nonfatal acute MI, systemic embolism, HF or severe bleeding occurred in more patients assigned placebo than n-3 PUFA (6.7% vs. 5.5%; HR=0.86; 95% CI, 0.44-1.66). Macchia said there was no difference between n-3 PUFA and placebo for all-cause mortality alone (1.4% vs. 1.7%; HR=0.8; 95% CI, 0.21-3) or all-cause hospitalization (16.6% vs. 14.1%; HR=1.22; 95% CI, 0.81-1.85).
About 3% of the placebo group and 2% of the n-3 PUFA group discontinued treatment due to intolerance.
Results from OPERA
Supplementation with n-3 PUFA in the short term also appears to have no effect on the reduction of postoperative AF.
Roberto Marchioli, MD, PhD, MPH, from Consorzio Mario Negri Sud Italy, presented data on 1,516 patients (mean age, 64 years, 72% men) assigned to placebo or supplements containing 8 to 10 g of n-3 PUFAs during the 2 to 5 days before cardiac surgery and 2 g daily for 10 days after surgery. At the time of enrollment (August 2010 to June 2010), 41% of patients underwent coronary bypass alone, 52% valve surgery with or without coronary bypass, and 7% other cardiac surgery.
Roberto Marchioli
During the study period, researchers documented 661 postoperative AF episodes in 460 patients — in 30% of the n-3 PUFA group and 30.7% of the placebo group (OR=0.96; 95% CI, 0.77-1.2).
Most cases of AF occurred between 1 and 4 days after surgery, peaking on day 2, according to a press release.
According to Marchioli, there were no significant differences in any secondary postoperative AF endpoints, including sustained, symptomatic or treated postoperative AF (P=.7); postoperative AF excluding atrial flutter (P=.87); total number of days with any postoperative AF (P=.58) or proportion of days free of postoperative AF (P=.88). There were also no between-group differences in MI (P=1), stroke (P=.18), death after 30 days (P=.14) or number of days in the ICU (P=.38). In other secondary analyses, arterial thromboembolism and arterial thromboembolism or death at 30 days were significantly reduced and there was not a significant lower incidence of major CV events observed.
Further, n-3 PUFA was well tolerated, without evidence for significant adverse events or higher bleeding, Marchioli said at a press conference.
“In this large, multinational, placebo-controlled trial, perioperative n-3 PUFA did not reduce postoperative AF,” Marchioli said. “Long-term n-3 PUFA may be more promising to prevent the initial onset of AF in higher-risk adults; this needs to be tested in randomized controlled trials. – by Samantha Costa
For more information:
Macchia A. Late breaking clinical trials. Treatments for prevention of cardiovascular events: A population perspective.
Marchioli R. Late breaking clinical trials. Treatments for prevention of cardiovascular events: A population perspective. Both presented at: the American Heart Association Scientific Sessions; Nov. 3-7, 2012; Los Angeles.
Mozaffarian D. JAMA. 2012;doi:10.1001/jama.2012.28733.
Disclosure: Macchia reports no relevant financial disclosures. Marchioli reports receiving research grants from GlaxoSmithKline, Pronova and Sigma Tau, and speakers’ bureau fees/honoraria from Biocare, Ferrer and Pronova.
Perspective
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William A. Zoghbi, MD, FACC
The OPERA trial looked at patients after cardiac surgery to see whether it will have an influence on AF, which is a common event [after surgery]. In about 30% of the cases, you can see that arrhythmia after surgery. Actually, there was no effect — not even a trend for an effect of these supplements [on this outcome]. Data were really not very strong, although in the past there was some indication omega-3s could be beneficial for postoperative AF. Certainly, I think this is a very good trial telling us there is really no effect on AF.
The other trial, FORWARD, also evaluated [the effect of omega-3 on postoperative AF] and maintaining sinus rhythm in patients with paroxysmal AF. Results showed pretty much the same effect — no change in the incidence of paroxysmal AF and maintenance of sinus rhythm.
I think the story is very strong here as to these supplements really not effecting atrial arrhythmia or AF, either be it preventing it or maintaining sinus rhythm.
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