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Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial.
J Am Heart Assoc. 2017 Dec 15; 6(12)JA

Abstract

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.

Authors+Show Affiliations

Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA fwelty@bidmc.harvard.edu.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29246960

Citation

Alfaddagh, Abdulhamied, et al. "Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy On Coronary Artery Plaque in Patients With Coronary Artery Disease: a Randomized Clinical Trial." Journal of the American Heart Association, vol. 6, no. 12, 2017.
Alfaddagh A, Elajami TK, Ashfaque H, et al. Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial. J Am Heart Assoc. 2017;6(12).
Alfaddagh, A., Elajami, T. K., Ashfaque, H., Saleh, M., Bistrian, B. R., & Welty, F. K. (2017). Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial. Journal of the American Heart Association, 6(12). https://doi.org/10.1161/JAHA.117.006981
Alfaddagh A, et al. Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy On Coronary Artery Plaque in Patients With Coronary Artery Disease: a Randomized Clinical Trial. J Am Heart Assoc. 2017 Dec 15;6(12) PubMed PMID: 29246960.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Eicosapentaenoic and Docosahexaenoic Acids Added to Statin Therapy on Coronary Artery Plaque in Patients With Coronary Artery Disease: A Randomized Clinical Trial. AU - Alfaddagh,Abdulhamied, AU - Elajami,Tarec K, AU - Ashfaque,Hasan, AU - Saleh,Mohamad, AU - Bistrian,Bruce R, AU - Welty,Francine K, Y1 - 2017/12/15/ PY - 2017/12/17/entrez PY - 2017/12/17/pubmed PY - 2018/7/22/medline KW - coronary computed tomography angiography KW - coronary plaque subtype KW - eicosapentaenoic acid KW - omega‐3 fatty acids KW - plaque progression JF - Journal of the American Heart Association JO - J Am Heart Assoc VL - 6 IS - 12 N2 - 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. SN - 2047-9980 UR - https://www.unboundmedicine.com/medline/citation/29246960/Effect_of_Eicosapentaenoic_and_Docosahexaenoic_Acids_Added_to_Statin_Therapy_on_Coronary_Artery_Plaque_in_Patients_With_Coronary_Artery_Disease:_A_Randomized_Clinical_Trial_ L2 - https://www.ahajournals.org/doi/10.1161/JAHA.117.006981?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -