Document Detail


The ω-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial--rationale and design.
MedLine Citation:
PMID:  21742090     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Dariush Mozaffarian; Roberto Marchioli; Tim Gardner; Paolo Ferrazzi; Patrick O'Gara; Roberto Latini; Peter Libby; Federico Lombardi; Alejandro Macchia; Richard Page; Massimo Santini; Luigi Tavazzi; Gianni Tognoni
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, American Recovery and Reinvestment Act; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2011-06-12
Journal Detail:
Title:  American heart journal     Volume:  162     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-07-11     Completed Date:  2011-09-13     Revised Date:  2013-06-28    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  56-63.e3     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2011 Mosby, Inc. All rights reserved.
Affiliation:
Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. dmozaffa@hsph.harvard.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00970489
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Atrial Fibrillation / etiology,  physiopathology,  prevention & control*
Cardiac Surgical Procedures / adverse effects*
Dose-Response Relationship, Drug
Double-Blind Method
Fatty Acids, Omega-3 / administration & dosage*
Follow-Up Studies
Heart Diseases / surgery
Humans
Postoperative Complications
Treatment Outcome
Grant Support
ID/Acronym/Agency:
RC2 HL101816-01/HL/NHLBI NIH HHS; RC2-HL101816/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Fatty Acids, Omega-3
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  A multicenter, randomized, controlled study of mechanical left ventricular unloading with counterpul...
Next Document:  Troponin measurements during drug development-considerations for monitoring and management of potent...