Cardiovascular Research Institute, Department of Cardiology, Shenyang Northern Hospital, Shenyang, Liaoning 110016 China.
Department of Cardiology, Second Affiliated Hospital of Shenyang Medical College, Shenyang, Liaoning 110000 China.
Mil Med Res. 2016 Apr 27;3:13. doi: 10.1186/s40779-016-0081-6. eCollection 2016.
In worldwide, the mortality rate of acute myocardial infarction (AMI) raises year by year. Although the applications of percutaneous coronary intervention (PCI) and anticoagulants effectively reduce the mortality of patients with acute coronary syndrome (ACS), but also increase the incidence of bleeding. Therefore, drugs with stable anticoagulant effects are urgently required.
We enrolled 894 patients with acute coronary syndrome who underwent percutaneous coronary intervention in Shenyang Northern Hospital from February 2010 to May 2012; 430 patients were included in the fondaparinux group (2.5 mg/d), and 464 were included in the enoxaparin group (1 mg/kg twice daily). Fondaparinux and enoxaparin were applied for 3-7 days. All patients were treated with tirofiban (10 μg/kg for 3 min initially and 0.15 μg/(kg · min) for 1 to 3 days thereafter). The primary efficacy endpoint was the incidence of a major adverse cerebrovascular or cardiovascular event. The primary safety endpoint was bleeding within 30 days and 1 year after percutaneous coronary intervention.
One-year data were available for 422 patients in the fondaparinux group and for 453 in the enoxaparin group. The incidence of a major adverse cerebrovascular or cardiovascular event (10.9 % vs 12.6 %, P = 0.433) and cardiac mortality (0.5 % vs 1.5 %, P = 0.116) were generally lower in the fondaparinux group than in the enoxaparin group, although the differences were not significant. Compared with the enoxaparin group, the fondaparinux group had a significantly decreased rate of bleeding at 30 days (0.9 % vs 2.8 %) and 1 year (2.4 % vs 5.4 %). In addition, the rate of major bleeding events was lower in the fondaparinux group, but this difference was not significant (0.2 % vs 0.9 %, 0.2 % vs 1.1 %).
In tirofiban-treated patients with acute coronary syndrome undergoing percutaneous coronary intervention, fondaparinux presented similar efficacy for ischemia events as enoxaparin. However, fondaparinux significantly decreased the incidence of bleeding, thus providing safer anticoagulation therapy.
在全球范围内，急性心肌梗死（AMI）的死亡率逐年上升。虽然经皮冠状动脉介入治疗（PCI）和抗凝剂的应用有效地降低了急性冠状动脉综合征（ACS）患者的死亡率，但也增加了出血的发生率。因此，急需具有稳定抗凝效果的药物。
我们纳入了 2010 年 2 月至 2012 年 5 月在沈阳北部战区总医院接受经皮冠状动脉介入治疗的 894 例急性冠状动脉综合征患者；其中 430 例患者纳入磺达肝癸钠组（2.5mg/d），464 例患者纳入依诺肝素组（1mg/kg，每日 2 次）。磺达肝癸钠和依诺肝素应用 3-7 天。所有患者均给予替罗非班（初始 10μg/kg 静脉推注，之后 0.15μg/（kg·min）静脉滴注 1-3 天）。主要疗效终点为主要不良心脑血管事件的发生率。主要安全性终点为经皮冠状动脉介入治疗后 30 天和 1 年内的出血情况。
磺达肝癸钠组有 422 例患者和依诺肝素组有 453 例患者获得 1 年数据。磺达肝癸钠组主要不良心脑血管事件（10.9% vs 12.6%，P=0.433）和心脏死亡率（0.5% vs 1.5%，P=0.116）的发生率总体低于依诺肝素组，但差异无统计学意义。与依诺肝素组相比，磺达肝癸钠组 30 天（0.9% vs 2.8%）和 1 年（2.4% vs 5.4%）时的出血发生率显著降低。此外，磺达肝癸钠组主要出血事件的发生率较低，但差异无统计学意义（0.2% vs 0.9%，0.2% vs 1.1%）。
在接受替罗非班治疗的行经皮冠状动脉介入治疗的急性冠状动脉综合征患者中，磺达肝癸钠与依诺肝素的缺血事件疗效相当。然而，磺达肝癸钠可显著降低出血发生率，从而提供更安全的抗凝治疗。
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