Department of Cardiology, Isala Hospital, Zwolle, the Netherlands.
Department of Cardiology, Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain; Department of Cardiology, IIS-Fundacion Jimenez Díaz Hospital, Madrid, Spain.
J Am Coll Cardiol. 2016 Jun 14;67(23):2705-2715. doi: 10.1016/j.jacc.2016.03.522. Epub 2016 Apr 3.
The impact of intravenous (IV) beta-blockers before primary percutaneous coronary intervention (PPCI) on infarct size and clinical outcomes is not well established.
This study sought to conduct the first double-blind, placebo-controlled international multicenter study testing the effect of early IV beta-blockers before PPCI in a general ST-segment elevation myocardial infarction (STEMI) population.
STEMI patients presenting <12 h from symptom onset in Killip class I to II without atrioventricular block were randomized 1:1 to IV metoprolol (2 × 5-mg bolus) or matched placebo before PPCI. Primary endpoint was myocardial infarct size as assessed by cardiac magnetic resonance imaging (CMR) at 30 days. Secondary endpoints were enzymatic infarct size and incidence of ventricular arrhythmias. Safety endpoints included symptomatic bradycardia, symptomatic hypotension, and cardiogenic shock.
A total of 683 patients (mean age 62 ± 12 years; 75% male) were randomized to metoprolol (n = 336) or placebo (n = 346). CMR was performed in 342 patients (54.8%). Infarct size (percent of left ventricle [LV]) by CMR did not differ between the metoprolol (15.3 ± 11.0%) and placebo groups (14.9 ± 11.5%; p = 0.616). Peak and area under the creatine kinase curve did not differ between both groups. LV ejection fraction by CMR was 51.0 ± 10.9% in the metoprolol group and 51.6 ± 10.8% in the placebo group (p = 0.68). The incidence of malignant arrhythmias was 3.6% in the metoprolol group versus 6.9% in placebo (p = 0.050). The incidence of adverse events was not different between groups.
In a nonrestricted STEMI population, early intravenous metoprolol before PPCI was not associated with a reduction in infarct size. Metoprolol reduced the incidence of malignant arrhythmias in the acute phase and was not associated with an increase in adverse events. (Early-Beta blocker Administration before reperfusion primary PCI in patients with ST-elevation Myocardial Infarction [EARLY-BAMI]; EudraCT no: 2010-023394-19).
静脉内（IV）β受体阻滞剂在直接经皮冠状动脉介入治疗（PPCI）前对梗死面积和临床结局的影响尚未得到充分证实。
本研究旨在进行首例双盲、安慰剂对照的国际多中心研究，以测试一般 ST 段抬高型心肌梗死（STEMI）患者在 PPCI 前早期静脉内使用β受体阻滞剂的效果。
在 Killip 分级 I 至 II 级且无房室传导阻滞的 STEMI 患者中，从症状发作起<12 小时内，将患者以 1:1 的比例随机分配至静脉内给予美托洛尔（2×5mg 推注）或匹配的安慰剂，然后再进行 PPCI。主要终点是通过 30 天心脏磁共振成像（CMR）评估的心肌梗死面积。次要终点是酶学的梗死面积和室性心律失常的发生率。安全性终点包括有症状的心动过缓、有症状的低血压和心源性休克。
共纳入 683 例患者（平均年龄 62±12 岁；75%为男性），随机分为美托洛尔组（n=336）或安慰剂组（n=346）。对 342 例患者（54.8%）进行了 CMR 检查。CMR 测量的梗死面积（左心室[LV]的百分比）在美托洛尔组（15.3±11.0%）和安慰剂组（14.9±11.5%；p=0.616）之间无差异。两组间肌酸激酶曲线的峰值和面积也无差异。CMR 测量的 LV 射血分数在美托洛尔组为 51.0±10.9%，在安慰剂组为 51.6±10.8%（p=0.68）。美托洛尔组恶性心律失常的发生率为 3.6%，安慰剂组为 6.9%（p=0.050）。两组间不良事件的发生率无差异。
在非受限的 STEMI 人群中，在 PPCI 前早期静脉内给予美托洛尔与梗死面积的减少无关。美托洛尔降低了急性期恶性心律失常的发生率，且与不良事件的增加无关。（直接再灌注治疗前 ST 段抬高型心肌梗死患者的早期β受体阻滞剂给药[EARLY-BAMI]；EudraCT 编号：2010-023394-19）。
