随机试验评估联合治疗-他汀类药物和二十碳五烯酸（RESPECT-EPA）在二级预防中的疗效。
Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy-Statin and Eicosapentaenoic Acid (RESPECT-EPA).
机构信息
Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan (K.M., H.I., Y.N., H.D.).
Japan Red Cross Society, Nasu Red Cross Hospital, Otawara, Tochigi, Japan (T.I.).
出版信息
Circulation. 2024 Aug 6;150(6):425-434. doi: 10.1161/CIRCULATIONAHA.123.065520. Epub 2024 Jun 14.
BACKGROUND
Low plasma levels of eicosapentaenoic acid (EPA) are associated with cardiovascular events. This trial aimed to assess the clinical benefits of icosapent ethyl in patients with coronary artery disease, a low EPA/arachidonic acid (AA) ratio, and statin treatment.
METHODS
In this prospective, multicenter, randomized, open-label, blinded end-point study, patients with stable coronary artery disease and a low EPA/AA ratio (<0.4) were randomized to EPA (1800 of icosapent ethyl administered daily) or control group. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina pectoris, and coronary revascularization. The secondary composite end points of coronary events included sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina requiring emergency hospitalization and coronary revascularization, or coronary revascularization.
RESULTS
Overall, 3884 patients were enrolled at 95 sites in Japan. Among them, 2506 patients had a low EPA/AA ratio, and 1249 and 1257 patients were randomized to the EPA and control group, respectively. The median EPA/AA ratio was 0.243 (interquartile range, 0.180-0.314) and 0.235 (interquartile range, 0.163-0.310) in the EPA and control group, respectively. Over a median period of 5 years, the primary end point occurred in 112 of 1225 patients (9.1%) and 155 of 1235 patients (12.6%) in the EPA and control group, respectively (hazard ratio, 0.79 [95% CI, 0.62-1.00]; =0.055). Meanwhile, the secondary composite end point of coronary events in the EPA group was significantly lower (81/1225 [6.6%] versus 120/1235 [9.7%] patients; hazard ratio, 0.73 [95% CI, 0.55-0.97]). Adverse events did not differ between the groups, but the rate of new-onset atrial fibrillation was significantly higher in the EPA group (3.1% versus 1.6%; =0.017).
CONCLUSIONS
Icosapent ethyl treatment resulted in a numerically lower risk of cardiovascular events that did not reach statistical significance in patients with chronic coronary artery disease, a low EPA/AA ratio, and statin treatment.
REGISTRATION
URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000012069.
背景
血浆二十碳五烯酸（EPA）水平低与心血管事件有关。本试验旨在评估icosapent ethyl 对冠状动脉疾病、低 EPA/花生四烯酸（AA）比值和他汀类药物治疗患者的临床益处。
方法
在这项前瞻性、多中心、随机、开放标签、盲终点研究中，稳定型冠状动脉疾病且 EPA/AA 比值低（<0.4）的患者被随机分配至 EPA 组（每天给予 1800 icosapent ethyl）或对照组。主要终点是心血管死亡、非致死性心肌梗死、非致死性缺血性卒中等复合终点的组合，不稳定型心绞痛和冠状动脉血运重建。包括心源性猝死、致死性和非致死性心肌梗死、需要紧急住院治疗的不稳定型心绞痛和冠状动脉血运重建或冠状动脉血运重建在内的冠状动脉事件的次要复合终点。
结果
总体而言，日本 95 个地点共纳入 3884 例患者。其中，2506 例患者 EPA/AA 比值低，1249 例和 1257 例患者分别随机分配至 EPA 组和对照组。EPA 组和对照组的 EPA/AA 比值中位数分别为 0.243（四分位间距，0.180-0.314）和 0.235（四分位间距，0.163-0.310）。中位随访 5 年期间，EPA 组和对照组分别有 112 例（9.1%）和 155 例（12.6%）患者发生主要终点事件（风险比，0.79 [95%CI，0.62-1.00]；=0.055）。同时，EPA 组的冠状动脉事件次要复合终点显著降低（81/1225 [6.6%]与 120/1235 [9.7%]患者；风险比，0.73 [95%CI，0.55-0.97]）。两组不良事件无差异，但 EPA 组新发心房颤动发生率明显更高（3.1%比 1.6%；=0.017）。
结论
icosapent ethyl 治疗可使慢性冠状动脉疾病、低 EPA/AA 比值和他汀类药物治疗患者的心血管事件风险降低，但未达到统计学意义。
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