Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial
Alfaddagh A, Elajami TK, Ashfaque H, Saleh M, Bistrian BR, Welty FK
Journal of the American Heart Association · 70 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Posiblemente financiado por la industria
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2017-12-02 · J Am Heart Assoc · vol. 6 · número 12
- Editorial
- Wiley
- Citado
- 94 citas · más que el 95% de estudios similares · 4.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 54 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC
- Áreas de investigación
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Antioxidant Activity and Oxidative Stress
- Palabras clave
- Medicine, Coronary artery disease, Internal medicine, Docosahexaenoic acid, Cardiology, Randomized controlled trial, Eicosapentaenoic acid, Statin, Clinical trial, Artery, Polyunsaturated fatty acid, Fatty acid
- MeSH
- coronary vessels, humans, disease progression, docosahexaenoic acids, eicosapentaenoic acid, lipoproteins, ldl, hydroxymethylglutaryl-coa reductase inhibitors, coronary angiography, treatment outcome, drug therapy, combination, administration, oral, risk factors, follow-up studies, dose-response relationship, drug, adult, aged, aged, 80 and over, middle aged, female, male, coronary artery disease, young adult, plaque, atherosclerotic, biomarkers, computed tomography angiography
6 autores
- Abdulhamied Alfaddagh🇺🇸Beth Israel Deaconess Medical Center; Harvard University
- Tarec K. Elajami🇺🇸Beth Israel Deaconess Medical Center; Harvard University
- Hasan Ashfaque🇺🇸Beth Israel Deaconess Medical Center; Harvard University
- Mohamad Ali Saleh🇺🇸Beth Israel Deaconess Medical Center; Harvard University
- Bruce Ryan Bistrian🇺🇸Beth Israel Deaconess Medical Center; Harvard University
- Francine K. Welty🇺🇸 · autor de correspondenciaBeth Israel Deaconess Medical Center; Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Although statins reduce cardiovascular events, residual risk remains. Therefore, additional modalities are needed to reduce risk. We evaluated the effect of eicosapentaenoic acid and docosahexaenoic acid in pharmacologic doses added to statin treatment on coronary artery plaque volume.
Methods and results
A total of 285 subjects with stable coronary artery disease on statins were randomized to omega-3 ethyl-ester (1.86 g of eicosapentaenoic acid and 1.5 g of docosahexaenoic acid daily) or no omega-3 (control) for 30 months. Coronary plaque volume was assessed by coronary computed tomographic angiography. Mean (SD) age was 63.0 (7.7) years; mean low-density lipoprotein cholesterol ≤80 mg/dL. In the intention-to-treat analysis, our primary endpoint, noncalcified plaque volume, was not different between groups (P=0.14) but approached significance in the per protocol analysis (P=0.07). When stratified by age in the intention-to-treat analysis, younger omega-3 subjects had significantly less progression of the primary endpoint, noncalcified plaque (P=0.013), and fibrous, calcified and total plaque. In plaque subtype analysis, controls had significant progression of fibrous plaque compared to no change in the omega-3 ethyl-ester group (median % change [interquartile range], 5.0% [-5.7, 20.0] versus -0.1% [-12.3, 14.5], respectively; P=0.018). Among those on low-intensity statins, omega-3 ethyl-ester subjects had attenuation of fibrous plaque progression compared to controls (median % change [interquartile range], 0.3% [-12.8, 9.0] versus 4.8% [-5.1, 19.0], respectively; P=0.032). In contrast, those on high-intensity statins had no difference in plaque change in either treatment arm.
Conclusions
High-dose eicosapentaenoic acid and docosahexaenoic acid provided additional benefit to statins in preventing progression of fibrous coronary plaque in subjects adherent to therapy with well-controlled low-density lipoprotein cholesterol levels. The benefit on low-intensity statin, but not high-intensity statin, suggests that statin intensity affects plaque volume.
Clinical trial registration
URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01624727.
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