Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial.
Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial.
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脱糖苷升高患者对他汀类药物疗法的患者冠状动脉粥样硬化进展的影响：蒸发试验的最终结果。
DOI：
10.1093/eurheartj/ehaa652
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发表时间：
2020-10-21
影响因子：
39.3
通讯作者：
Nelson JR
中科院分区：
文献类型：
--
作者：
Budoff MJ;Bhatt DL;Kinninger A;Lakshmanan S;Muhlestein JB;Le VT;May HT;Shaikh K;Shekar C;Roy SK;Tayek J;Nelson JR
尽管他汀类药物在减少心血管事件和减缓冠状动脉粥样硬化进展方面具有作用，但仍存在显著的心血管（CV）风险。在REDUCE-IT试验中，将高度纯化的二十碳五烯酸乙酯（IPE）添加到他汀类药物中，可使初始CV事件减少25%，总CV事件减少32%，但获益机制尚未完全解释。EVAPORATE试验旨在确定IPE 4 g/天作为饮食和他汀类药物治疗的辅助治疗，是否会导致他汀类药物治疗患者的斑块体积（通过连续多探测器计算机断层扫描（MDCT）测量）较基线的变化大于安慰剂。共有80例患者入组本随机、双盲、安慰剂对照试验。患者必须患有MDCT记录的冠状动脉粥样硬化（一处或多处血管造影狭窄，狭窄≥20%），接受他汀类药物治疗，甘油三酯（TG）水平持续升高。患者在9个月时进行了中期扫描，并在18个月时进行了冠状动脉计算机断层扫描血管造影术的最终扫描。预先规定的主要终点是IPE组和安慰剂组之间18个月时低衰减斑块（VEP）体积的变化。IPE组和安慰剂组之间的基线人口统计学、生命体征和实验室检查结果无显著差异;中位TG水平为259.1 ± 78.1 mg/dL。IPE组的主要终点显著降低，IPE组的斑块体积减少了17%，而安慰剂组的斑块体积增加了一倍多（+109%）（P = 0.0061）。在研究结束时，IPE和安慰剂之间的进展率存在显著差异，涉及其他斑块体积，包括纤维和纤维脂肪（FF）斑块体积，IPE组消退，安慰剂组进展（均P < 0.01）。当进一步校正年龄、性别、糖尿病状态、高血压和基线TG时，组间斑块体积变化仍有显著差异，P < 0.01。在多变量建模中，仅致密钙未显示出组间显著差异（P = 0.053）。在18个月内，与安慰剂相比，在MDCT上显示出伊克沙喷乙酯的血容量显著消退。EVAPORATE提供了关于斑块特征的重要机制数据，这些数据可能与REDUCE-IT结果和IPE的临床使用相关。
Despite the effects of statins in reducing cardiovascular events and slowing progression of coronary atherosclerosis, significant cardiovascular (CV) risk remains. Icosapent ethyl (IPE), a highly purified eicosapentaenoic acid ethyl ester, added to a statin was shown to reduce initial CV events by 25% and total CV events by 32% in the REDUCE-IT trial, with the mechanisms of benefit not yet fully explained. The EVAPORATE trial sought to determine whether IPE 4 g/day, as an adjunct to diet and statin therapy, would result in a greater change from baseline in plaque volume, measured by serial multidetector computed tomography (MDCT), than placebo in statin-treated patients. A total of 80 patients were enrolled in this randomized, double-blind, placebo-controlled trial. Patients had to have coronary atherosclerosis as documented by MDCT (one or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels. Patients underwent an interim scan at 9 months and a final scan at 18 months with coronary computed tomographic angiography. The pre-specified primary endpoint was change in low-attenuation plaque (LAP) volume at 18 months between IPE and placebo groups. Baseline demographics, vitals, and laboratory results were not significantly different between the IPE and placebo groups; the median TG level was 259.1 ± 78.1 mg/dL. There was a significant reduction in the primary endpoint as IPE reduced LAP plaque volume by 17%, while in the placebo group LAP plaque volume more than doubled (+109%) (P = 0.0061). There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group (P < 0.01 for all). When further adjusted for age, sex, diabetes status, hypertension, and baseline TG, plaque volume changes between groups remained significantly different, P < 0.01. Only dense calcium did not show a significant difference between groups in multivariable modelling (P = 0.053). Icosapent ethyl demonstrated significant regression of LAP volume on MDCT compared with placebo over 18 months. EVAPORATE provides important mechanistic data on plaque characteristics that may have relevance to the REDUCE-IT results and clinical use of IPE.
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DOI：
10.1001/jama.2016.21043
发表时间：
2017-02-21
期刊：
JAMA
影响因子：
--
作者：
Budoff MJ;Ellenberg SS;Lewis CE;Mohler ER 3rd;Wenger NK;Bhasin S;Barrett-Connor E;Swerdloff RS;Stephens-Shields A;Cauley JA;Crandall JP;Cunningham GR;Ensrud KE;Gill TM;Matsumoto AM;Molitch ME;Nakanishi R;Nezarat N;Matsumoto S;Hou X;Basaria S;Diem SJ;Wang C;Cifelli D;Snyder PJ
通讯作者：
Snyder PJ
影响因子：
24
作者：
Bhatt, Deepak L.;Steg, Ph Gabriel;Ballantyne, Christie M.
通讯作者：
Ballantyne, Christie M.
影响因子：
39.3
作者：
Boden, William E.;Bhatt, Deepak L.;Luescher, Thomas F.
通讯作者：
Luescher, Thomas F.
影响因子：
3.3
作者：
Miyoshi, Toru;Kohno, Kunihisa;Ito, Hiroshi
通讯作者：
Ito, Hiroshi
影响因子：
5.3
作者：
Nakanishi, Rine;Ceponiene, Indre;Budoff, Matthew J.
通讯作者：
Budoff, Matthew J.