在急性心肌梗塞后的Apolipoprotein A1输液和心血管结果
C Michael Gibson1, Danielle Duffy1, Serge Korjian1
1From the Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (C.M.G., S.K., G.C.), and the Department of Medicine, Cardiovascular Division (P.L.), and the Center for Cardiovascular Disease Prevention (P.M.R.), Brigham and Women's Hospital (F.M.S.), Harvard Medical School, and the Harvard T.H. Chan School of Public Health (F.M.S.) - all in Boston; CSL Behring, King of Prussia, PA (D.D., M.H., P.T., L.I.D., S.J.M.); INECO Neurociencias, Rosario, Argentina (M.C.B.); Duke Clinical Research Institute, Duke Health, Durham, NC (J.H.A., R.D.L., T.J.P.); the Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland (A.M.L.); Instituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo (J.C.N.), and the Brazilian Clinical Research Institute (R.D.L.) - both in Sao Paulo; the Heart and Vascular Center of Semmelweis University, Budapest, Hungary (B.M.); Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.); Radboud University Medical Center, Nijmegen and Noordwest Ziekenhuisgroep, Alkmaar (J.H.C.), and the University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.) - both in the Netherlands; Krakowski Szpital Specjalistyczny im. Jana Pawła II, Krakow (J.T.), and the Department of Cardiology and Structural Heart Disease, School of Medicine in Katowice, Medical University of Silesia, Katowice (M.T.) - both in Poland; the National Scientific Center, Kyiv, Ukraine (A.P.); the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (M.B.); the Canadian VIGOUR Centre, University of Alberta, Edmonton, and St. Michael's Hospital, Unity Health Toronto, and Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto - all in Canada (S.G.G.); Mount Sinai Fuster Heart Hospital (D.L.B.) and Zena and Michael A. Wiener Cardiovascular Institute (R.M.), Icahn School of Medicine at Mount Sinai, and Weill Cornell Medicine (R.A.H.) - both in New York; Université Paris-Cité, INSERM Unité 1148, FACT and Assistance Publique-Hopitaux de Paris, Hôpital Bichat, Paris (P.G.S.); South Australian Health and Medical Research Institute/SAHMRI, Adelaide, SA (P.A.), and Victorian Heart Institute, Monash University, Melbourne, VIC (S.J.N.) - both in Australia; the Heart Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany (C.B.); Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and London School of Hygiene and Tropical Medicine, London (S.J.P.).
在急性心肌梗塞后,CSL112输液并没有降低复发性心血管事件的风险. 这项研究发现,在CSL112和安慰剂组之间,主要的不良心血管事件没有显著差异.
科学领域:
- 心脏病学 心脏病学
- 生物化学 生物化学
背景情况:
- 在急性心肌梗塞后,经常出现复发性心血管事件.
- 低胆固醇排泄,由阿波利波蛋白A1 (ApoA1) 介导,与心血管风险增加有关.
- CSL112,一个血衍生的人类ApoA1,增强胆固醇排泄能力.
研究的目的:
- 评估CSL112输液在减少急性心肌梗塞后复发性心血管事件的疗效.
- 评估CSL112在这个患者群体中的安全性.
主要方法:
- 进行了一项国际双盲,安慰剂对照试验 (AEGIS-II).
- 18,219名患有急性心肌梗塞,多血管冠状动脉疾病和风险因素的患者每周接受四次CSL112或安慰剂输液.
- 主要终点是90天内心肌梗塞,中风或心血管死亡的复合结果.
主要成果:
- 在90天 (4.8%对5.2%),180天 (6.9%对7.6%) 或365天 (9.8%对10.5%) 的初级终点风险中没有显著差异.
- 主要终点的危险比率在随访期间始终接近1.
- 不良事件发生率相似,在CSL112组中,过敏事件的增加值得注意.
结论:
- 在急性心肌梗塞后的高风险患者中,与安慰剂相比,每周四次注射CSL112并没有显著降低心肌梗塞,中风或心血管死亡的风险.
- 在90天内,CSL112在预防重大心血管不良事件方面没有表现出有效性.
- 这项研究表明,在这种情况下,CSL112对心血管事件的二次预防无效.
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