Financiado en parte por GlaxoSmithKline
Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial
Mozaffarian D, Marchioli R, Macchia A, Silletta MG, Ferrazzi P, Gardner TJ, Latini R, Libby P, Lombardi F, O'Gara PT, Page RL, Tavazzi L, Tognoni G, OPERA Investigators
JAMA · 164 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- GlaxoSmithKline
- Gobierno
- National Institutes of Health
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- NHLBI NIH HHS
- Subvenciones
- National Heart, Lung, and Blood Institute (R01HL096844); National Heart, Lung, and Blood Institute (RC2-HL101816)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2012-11-05 · JAMA · vol. 308 · número 19 · pág. 2001
- Editorial
- American Medical Association
- Citado
- 231 citas · más que el 100% de estudios similares · 20.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 53 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Atrial Fibrillation Management and Outcomes · Fatty Acid Research and Health · Cardiac, Anesthesia and Surgical Outcomes
- Palabras clave
- fish oil, omega-3 fatty acids, postoperative atrial fibrillation, cardiac surgery, perioperative supplementation, atrial flutter, cardioversion, major adverse cardiovascular events, hemorrhage, 30-day mortality, hospital utilization, heart valve surgery, coronary artery bypass grafting, arrhythmia prevention, ethyl esters
- MeSH
- humans, atrial fibrillation, fatty acids, omega-3, fish oils, treatment outcome, cardiovascular surgical procedures, odds ratio, risk, double-blind method, dietary supplements, aged, middle aged, female, male
14 autores
- Dariush Mozaffarian🇺🇸🇮🇹 · autor de correspondenciaBrigham and Women's Hospital; Harvard University; Mario Negri Sud Foundation
- Roberto Marchioli🇺🇸🇮🇹 · autor de correspondenciaHarvard University; Mario Negri Sud Foundation
- Alejandro Macchia🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Maria Giuseppina Silletta🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Paolo Ferrazzi🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Timothy J. Gardner🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Roberto Latini🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Peter Libby🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Federico Lombardi🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Patrick T. O’Gara🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Richard L. Page🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Luigi Tavazzi🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- Gianni Tognoni🇺🇸🇮🇹Harvard University; Mario Negri Sud Foundation
- for the RED-CABG Steering Committee and Investigators
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 reduces postoperative AF.
Design, setting, and patients
The Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) double-blind, placebo-controlled, randomized clinical trial. A total of 1516 patients scheduled for cardiac surgery in 28 centers in the United States, Italy, and Argentina were enrolled between August 2010 and June 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment.
Intervention
Patients were randomized to receive fish oil (1-g capsules containing ≥840 mg n-3-PUFAs as ethyl esters) or placebo, with preoperative loading of 10 g over 3 to 5 days (or 8 g over 2 days) followed postoperatively by 2 g/d until hospital discharge or postoperative day 10, whichever came first.
Main outcome measure
Occurrence of postoperative AF lasting longer than 30 seconds. Secondary end points were postoperative AF lasting longer than 1 hour, resulting in symptoms, or treated with cardioversion; postoperative AF excluding atrial flutter; time to first postoperative AF; number of AF episodes per patient; hospital utilization; and major adverse cardiovascular events, 30-day mortality, bleeding, and other adverse events.
Results
At enrollment, mean age was 64 (SD, 13) years; 72.2% of patients were men, and 51.8% had planned valvular surgery. The primary end point occurred in 233 (30.7%) patients assigned to placebo and 227 (30.0%) assigned to n-3-PUFAs (odds ratio, 0.96 [95% CI, 0.77-1.20]; P = .74). None of the secondary end points were significantly different between the placebo and fish oil groups, including postoperative AF that was sustained, symptomatic, or treated (231 [30.5%] vs 224 [29.6%], P = .70) or number of postoperative AF episodes per patient (1 episode: 156 [20.6%] vs 157 [20.7%]; 2 episodes: 59 [7.8%] vs 49 [6.5%]; ≥3 episodes: 18 [2.4%] vs 21 [2.8%]) (P = .73). Supplementation with n-3-PUFAs was generally well tolerated, with no evidence for increased risk of bleeding or serious adverse events.
Conclusion
In this large multinational trial among patients undergoing cardiac surgery, perioperative supplementation with n-3-PUFAs, compared with placebo, did not reduce the risk of postoperative AF. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00970489.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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