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比较伊伐布雷定和美托洛尔在伴有左心室功能障碍的再灌注前壁心肌梗死早期的疗效:初步发现。

Comparison of ivabradine versus metoprolol in early phases of reperfused anterior myocardial infarction with impaired left ventricular function: preliminary findings.

机构信息

Division of Cardiology, Paolo Borsellino, G.F. Ingrassia Hospital, Palermo, Italy.

出版信息

J Card Fail. 2009 Dec;15(10):856-63. doi: 10.1016/j.cardfail.2009.05.013. Epub 2009 Jul 3.

Abstract

BACKGROUND

beta-blockers in ST-segment elevation myocardial infarction (STEMI) are indicated for patients without a contraindication, particularly in patients with high heart rates (HR) or blood pressures. Epidemiological studies have shown that elevated HR represents a risk factor for cardiovascular morbidity. The study investigates the feasibility, tolerability, and the effects after 30 days of follow-up of ivabradine (IVA) versus metoprolol (METO) in early phases of anterior STEMI reperfused by percutaneous coronary intervention (PCI).

METHODS AND RESULTS

Patients with a first anterior STEMI, Killip class I-II, an acceptable echocardiographic window, and admitted within 4hours of the onset of symptoms, with an ejection fraction <50%. METO or IVA, 12hours after PCI (double blind), were administered twice per day. Blood pressure (BP), heart rate (HR), electrocardiogram (ECG), and laboratory parameters were monitored during the study. At entry, day 10, day 30, and day 60, by echocardiography, the ESV, EDV, E/A ratio, E wave deceleration time, isovolumetric relaxation time were measured. A total of 155 (50 females, 105 males) patients were randomized in 2 groups: a group received METO (76 patients) 12hours after PCI and a group received IVA (79 patients) 12hours after PCI. The 2 groups were similar for clinical characteristics. No difference was evidenced in HR, systolic blood pressure, diastolic blood pressure, age (range, 39-73 years), sex, ejection fraction (EF), creatine kinase peak, between the 2 groups at entry. Both groups were similar for time to angiography and interventional procedures and number of vessels diseased. IVA group: the 79 patients showed 2 side effects and 5 readmissions: 4 for ischemic events and 1 for heart failure, and 1 sudden death; METO group: the 76 patients had 4 ischemic events, 2 side effects, and 1 patient died during re-acute MI (intrastent thrombosis) and 8 readmissions for heart failure signs. The systolic blood pressure and diastolic blood pressure showed a significant reduction in both groups, P < .0001, respectively), and significant lower values were observed in METO group, P=.0001). The HR was significantly reduced in both groups, P < .0001). IVA group showed a significant increase in EF, P=.0001, with concomitant reduction in ESV and EDV (P=.0001, and .048, respectively). The diastolic parameters were similar in both groups during study period.

CONCLUSIONS

Our results suggest that ivabradine may be administered early (12hours after PCI) to patients with successful PCI for anterior STEMI with an impaired left ventricular function and high HR and sinus rhythm. A larger sample of patients and further studies are required to evaluate the effects of ivabradine on clinical end points.

摘要

背景

β受体阻滞剂适用于无禁忌证的 ST 段抬高型心肌梗死(STEMI)患者,特别是心率(HR)或血压高的患者。流行病学研究表明,HR 升高是心血管发病率的危险因素。本研究旨在探讨伊伐布雷定(IVA)与美托洛尔(METO)在经皮冠状动脉介入治疗(PCI)早期治疗前壁 STEMI 患者中的可行性、耐受性和 30 天随访后的效果。

方法和结果

入选首次前壁 STEMI、心功能 Killip Ⅰ-Ⅱ级、可接受的超声心动图窗和症状发作后 4 小时内、射血分数(EF)<50%的患者。在 PCI 后 12 小时(双盲),给予 METO 或 IVA,每日 2 次。在研究期间监测血压(BP)、心率(HR)、心电图(ECG)和实验室参数。在入组时、第 10 天、第 30 天和第 60 天,通过超声心动图测量 ESV、EDV、E/A 比值、E 波减速时间、等容舒张时间。共随机分为 2 组:155 例(女性 50 例,男性 105 例)患者接受 METO(76 例)或 IVA(79 例)治疗,分别在 PCI 后 12 小时。2 组患者临床特征相似。2 组在 HR、收缩压、舒张压、年龄(范围 39-73 岁)、性别、EF、肌酸激酶峰值、入组时无差异。2 组间血管造影和介入治疗时间及病变血管数均无差异。IVA 组:79 例患者出现 2 种副作用和 5 例再入院:4 例为缺血事件,1 例为心力衰竭,1 例为猝死;METO 组:76 例患者出现 4 例缺血事件、2 种副作用和 1 例因急性再梗死(支架内血栓形成)和 8 例心力衰竭征象而再次入院。2 组收缩压和舒张压均明显下降,P<.0001),METO 组下降更明显,P=.0001)。2 组 HR 均明显下降,P<.0001)。IVA 组 EF 显著升高,P=.0001,同时 ESV 和 EDV 降低(P=.0001 和 P=.048)。研究期间,2 组舒张参数相似。

结论

我们的结果表明,对于成功接受 PCI 治疗的前壁 STEMI 患者,伴有左心室功能障碍、HR 高和窦性心律,可早期(PCI 后 12 小时)给予伊伐布雷定。需要更大的患者样本和进一步的研究来评估伊伐布雷定对临床终点的影响。

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