Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Duke Clinical Research Institute, Durham, NC.
Am Heart J. 2014 Sep;168(3):354-362.e2. doi: 10.1016/j.ahj.2014.04.020. Epub 2014 Jun 9.
Erythropoiesis-stimulating agents (ESAs) have been investigated in small studies in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Erythropoiesis-stimulating agents did not show a clear effect on left ventricular function or clinical outcome, but some studies suggested an increased risk of thromboembolic events.
A systematic literature search in MEDLINE was performed, until December 2012. We included randomized clinical trials investigating the effect of ESAs in STEMI patients undergoing primary PCI, with ≥30 days of follow-up. The primary end point was a composite of all-cause mortality, myocardial infarction, and stent thrombosis after PCI. Secondary end point was all-cause mortality.
Individual patient data were obtained from 10 of 11 trials, including 97.3% (1,242/1,277) of all patients randomized to control (n = 600) or to ESAs (n = 642). Baseline characteristics were well balanced between the treatment allocations. Mean follow-up time was 248 (±131) days. The primary end point occurred in 3.5% (20/577) in the control group and in 2.1% (13/610) in the ESA group (hazard ratio for ESAs, 0.63; 95% CI [0.31-1.27]; P = .20). Mortality occurred in 13 (2.3%) in the control group and 5 (0.8%) in the ESA group (hazard ratio for ESAs, 0.38; 95% CI [0.13-1.06]; P = .06).
Erythropoiesis-stimulating agent administration does not result in an increased risk of adverse cardiac events in STEMI patients undergoing primary PCI. Results of ongoing studies may provide further insight to the potential beneficial clinical effects of ESAs in STEMI patients.
促红细胞生成素刺激剂(ESAs)已在接受直接经皮冠状动脉介入治疗(PCI)的 ST 段抬高型心肌梗死(STEMI)患者的小型研究中进行了研究。ESA 对左心室功能或临床结局没有明显影响,但一些研究表明血栓栓塞事件的风险增加。
对 MEDLINE 进行了系统的文献检索,截至 2012 年 12 月。我们纳入了评估接受直接 PCI 的 STEMI 患者使用 ESA 的效果的随机临床试验,随访时间至少为 30 天。主要终点是 PCI 后全因死亡率、心肌梗死和支架血栓形成的复合终点。次要终点是全因死亡率。
从 11 项试验中的 10 项获得了个体患者数据,包括随机分配至对照组(n = 600)或 ESA 组(n = 642)的所有患者的 97.3%(1242/1277)。治疗分配之间的基线特征平衡良好。平均随访时间为 248(±131)天。对照组的主要终点发生率为 3.5%(20/577),ESA 组为 2.1%(13/610)(ESA 的风险比为 0.63;95%CI[0.31-1.27];P = 0.20)。对照组的死亡率为 13(2.3%),ESA 组为 5(0.8%)(ESA 的风险比为 0.38;95%CI[0.13-1.06];P = 0.06)。
在接受直接 PCI 的 STEMI 患者中,ESA 给药不会增加不良心脏事件的风险。正在进行的研究的结果可能会进一步深入了解 ESA 在 STEMI 患者中的潜在有益的临床效果。