Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.
Eur Heart J. 2010 Nov;31(21):2593-600. doi: 10.1093/eurheartj/ehq304. Epub 2010 Aug 29.
Cardioprotective effects of erythropoietin (EPO) have been shown in experimental and smaller clinical studies. We performed a prospective, multicentre, randomized trial to assess the effects of a single high dose of EPO after primary coronary intervention (PCI) for an ST-elevation myocardial infarction (STEMI). Methods and results Patients with a successful PCI for a first STEMI were randomized to receive either standard medical care alone, or in combination with a single bolus with 60,000 IU i.v. of epoetin alfa within 3 h after PCI. Primary endpoint was left ventricular ejection fraction (LVEF) after 6 weeks, assessed by planar radionuclide ventriculography. Pre-specified secondary endpoints included enzymatic infarct size and major adverse cardiovascular events. A total of 529 patients were enrolled (EPO n = 263, control n = 266). At baseline (before EPO administration), groups were well-matched for all relevant characteristics. After a mean of 6.5 (± 2.0) weeks, LVEF was 0.53 (± 0.10) in the EPO group and 0.52 (± 0.11) in the control group (P = 0.41). Median area under the curve (inter-quartile range) after 72 h for creatinine kinase was 50 136 (28 212-76 664)U/L per 72 h in the EPO group and 53 510 (33 973-90 486)U/L per 72 h in the control group (P = 0.058). More major adverse cardiac events occurred in the control than in the EPO group (19 vs. 8; P = 0.032). Conclusion A single high dose of EPO after a successful PCI for a STEMI did not improve LVEF after 6 weeks. However, the use of EPO was related to less major adverse cardiovascular events and a favourable clinical safety profile.
NCT00449488; http://www.clinicaltrials.gov/ct2/show/NCT00449488?term=voors&rank=2.
促红细胞生成素（EPO）已在实验和较小的临床研究中显示出心脏保护作用。我们进行了一项前瞻性、多中心、随机试验，以评估在 ST 段抬高型心肌梗死（STEMI）患者行经皮冠状动脉介入治疗（PCI）后单次给予高剂量 EPO 的效果。
成功行 PCI 治疗的首次 STEMI 患者被随机分为仅接受标准药物治疗组，或在 PCI 后 3 小时内接受单次静脉注射 60000IU 促红素阿尔法治疗组。主要终点为 6 周时的左心室射血分数（LVEF），通过平面放射性核素心室造影评估。预先指定的次要终点包括酶性梗死面积和主要不良心血管事件。共纳入 529 例患者（EPO 组 263 例，对照组 266 例）。在基线（EPO 给药前），两组在所有相关特征方面均匹配良好。平均 6.5（±2.0）周后，EPO 组的 LVEF 为 0.53（±0.10），对照组为 0.52（±0.11）（P=0.41）。EPO 组 72 小时内肌酸激酶的曲线下面积中位数（四分位距）为 50136（28212-76664）U/L/72h，对照组为 53510（33973-90486）U/L/72h（P=0.058）。对照组发生的主要不良心脏事件多于 EPO 组（19 例 vs. 8 例；P=0.032）。
在 STEMI 患者成功行 PCI 后单次给予高剂量 EPO 不会改善 6 周后的 LVEF。然而，EPO 的使用与较少的主要不良心血管事件和有利的临床安全性相关。
NCT00449488；http://www.clinicaltrials.gov/ct2/show/NCT00449488?term=voors&rank=2。
