Department of Cardiology, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands.
Cardiovasc Drugs Ther. 2013 Oct;27(5):433-9. doi: 10.1007/s10557-013-6470-0.
The HEBE III trial showed that epoetin alfa administration in patients with a first ST-elevation myocardial infarction (STEMI) did not improve left ventricular function at 6 weeks after primary percutaneous coronary intervention (PCI). The long term effects of erythropoiesis- stimulating agents on cardiovascular morbidity and mortality are unknown, therefore we evaluated clinical events at 1 year after PCI.
A total of 529 patients with a first STEMI and successful primary PCI were randomized to standard optimal medical treatment (N = 266) or an additional bolus of 60,000 IU epoetin alfa administered intravenously (N = 263) within 3 h after PCI. Analyses were performed by intention to treat.
At 1 year after STEMI, 485 patients had complete follow-up. The rate of the composite end point of all-cause mortality, re-infarction, target vessel revascularization, stroke and/or heart failure was 6.4 % (N = 15) in the epoetin alfa group and 9.6 % (N = 24) in the control group (p = 0.18). Thromboembolic events were present in 1.3 % (N = 3) of patients in the epoetin alfa group and 2.4 % (N = 6) in the control group. There was no evidence of benefit from epoetin alfa administration in subgroups of patients.
Administration of a single bolus of epoetin alfa in patients with STEMI does not result in a reduction of cardiovascular events at 1 year after primary PCI. There was a comparable incidence of thromboembolic complications in both treatment groups, suggesting that epoetin alfa administration is safe at long term.
HEBE III 试验表明,促红细胞生成素α治疗首次 ST 段抬高型心肌梗死(STEMI)患者,在经皮冠状动脉介入治疗(PCI)后 6 周时,并未改善左心室功能。然而,红细胞生成刺激剂对心血管发病率和死亡率的长期影响尚不清楚,因此我们评估了 PCI 后 1 年的临床事件。
共 529 例首次发生 STEMI 且成功接受 PCI 的患者,随机分为标准最佳药物治疗组(N=266)或在 PCI 后 3 小时内额外静脉注射 60000IU 促红细胞生成素α(N=263)。采用意向治疗进行分析。
在 STEMI 后 1 年,485 例患者有完整的随访。在促红细胞生成素α组中,全因死亡率、再梗死、靶血管血运重建、卒中和/或心力衰竭的复合终点发生率为 6.4%(N=15),在对照组中为 9.6%(N=24)(p=0.18)。促红细胞生成素α组中有 1.3%(N=3)的患者发生血栓栓塞事件,对照组中有 2.4%(N=6)。在患者亚组中,没有证据表明促红细胞生成素α治疗有获益。
在 STEMI 患者中单次给予促红细胞生成素α,并不会降低 PCI 后 1 年的心血管事件发生率。两组治疗的血栓栓塞并发症发生率相当,表明长期应用促红细胞生成素α是安全的。