ω-3 酸乙酯对急性心肌梗死后左心室重构的影响：OMEGA-REMODEL 随机临床试验
Effect of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction: The OMEGA-REMODEL Randomized Clinical Trial.
作者信息
Heydari Bobak, Abdullah Shuaib, Pottala James V, Shah Ravi, Abbasi Siddique, Mandry Damien, Francis Sanjeev A, Lumish Heidi, Ghoshhajra Brian B, Hoffmann Udo, Appelbaum Evan, Feng Jiazhuo H, Blankstein Ron, Steigner Michael, McConnell Joseph P, Harris William, Antman Elliott M, Jerosch-Herold Michael, Kwong Raymond Y
机构信息
From Noninvasive Cardiovascular Imaging Section, Cardiovascular Division, Department of Medicine and Department of Radiology, Brigham and Women's Hospital, Boston, MA (B.H., S.A., R.S., S.A., D.M., J.H.F., R.B., M.S., M.J.-H., R.Y.K.); Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA (B.H., S.A., R.S., S.A., D.M., J.H.F., E.M.A., R.Y.K.); Department of Internal Medicine, Sanford School of Medicine, University of South Dakota, Sioux Fall (J.V.P., W.H.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (R.S., S.A.F.); Department of Radiology, Massachusetts General Hospital, Boston (H.L., B.B.G., U.F.); Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (E.A.); Health Diagnostic Laboratory, Inc., Richmond, VA (J.P.M.); and OmegaQuant Analytics, LLC, Sioux Falls, SD (W.H.).
出版信息
Circulation. 2016 Aug 2;134(5):378-91. doi: 10.1161/CIRCULATIONAHA.115.019949.
BACKGROUND
Omega-3 fatty acids from fish oil have been associated with beneficial cardiovascular effects, but their role in modifying cardiac structures and tissue characteristics in patients who have had an acute myocardial infarction while receiving current guideline-based therapy remains unknown.
METHODS
In a multicenter, double-blind, placebo-controlled trial, participants presenting with an acute myocardial infarction were randomly assigned 1:1 to 6 months of high-dose omega-3 fatty acids (n=180) or placebo (n=178). Cardiac magnetic resonance imaging was used to assess cardiac structure and tissue characteristics at baseline and after study therapy. The primary study endpoint was change in left ventricular systolic volume index. Secondary endpoints included change in noninfarct myocardial fibrosis, left ventricular ejection fraction, and infarct size.
RESULTS
By intention-to-treat analysis, patients randomly assigned to omega-3 fatty acids experienced a significant reduction of left ventricular systolic volume index (-5.8%, P=0.017), and noninfarct myocardial fibrosis (-5.6%, P=0.026) in comparison with placebo. Per-protocol analysis revealed that those patients who achieved the highest quartile increase in red blood cell omega-3 index experienced a 13% reduction in left ventricular systolic volume index in comparison with the lowest quartile. In addition, patients in the omega-3 fatty acid arm underwent significant reductions in serum biomarkers of systemic and vascular inflammation and myocardial fibrosis. There were no adverse events associated with high-dose omega-3 fatty acid therapy.
CONCLUSIONS
Treatment of patients with acute myocardial infarction with high-dose omega-3 fatty acids was associated with reduction of adverse left ventricular remodeling, noninfarct myocardial fibrosis, and serum biomarkers of systemic inflammation beyond current guideline-based standard of care.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00729430.
背景
鱼油中的ω-3脂肪酸已被证实具有有益的心血管效应，但其在接受当前基于指南治疗的急性心肌梗死患者中对心脏结构和组织特征的改善作用仍不明确。
方法
在一项多中心、双盲、安慰剂对照试验中，急性心肌梗死患者被随机1:1分配接受6个月的高剂量ω-3脂肪酸治疗（n = 180）或安慰剂治疗（n = 178）。采用心脏磁共振成像在基线和研究治疗后评估心脏结构和组织特征。主要研究终点为左心室收缩容积指数的变化。次要终点包括非梗死心肌纤维化的变化、左心室射血分数和梗死面积。
结果
在意向性分析中，随机分配接受ω-3脂肪酸治疗的患者与安慰剂组相比，左心室收缩容积指数显著降低（-5.8%，P = 0.017），非梗死心肌纤维化显著降低（-5.6%，P = 0.026）。符合方案分析显示，红细胞ω-3指数增加至最高四分位数的患者与最低四分位数的患者相比，左心室收缩容积指数降低了13%。此外，ω-3脂肪酸治疗组患者的全身和血管炎症以及心肌纤维化的血清生物标志物显著降低。高剂量ω-3脂肪酸治疗未出现不良事件。
结论
高剂量ω-3脂肪酸治疗急性心肌梗死患者与不良左心室重构、非梗死心肌纤维化的减轻以及全身炎症血清生物标志物的降低相关，超出了当前基于指南的标准治疗。
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