Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.
Atherosclerosis. 2013 Aug;229(2):482-8. doi: 10.1016/j.atherosclerosis.2013.04.022. Epub 2013 Apr 24.
Recently, randomized controlled trials (RCTs) have shown that therapy with new oral activated factor X (Xa) inhibitors in acute coronary syndrome (ACS) yielded a reduction of ischemic events. However, this therapy was associated with a dose-related increase in major bleeding complications. We aimed to perform a systematic review and meta-analysis to appraise the clinical efficacy and safety of the lowest doses of oral factor Xa inhibitors compared with placebo in patients after a recent ACS.
The primary endpoint was cardiovascular mortality. The rate of new myocardial infarction (MI) was the secondary efficacy endpoint, whereas major bleeding complications were recorded as a safety endpoint. Five RCTs were included in the meta-analysis enrolling a total of 25,643 patients.
There was no significant difference in mortality between patients treated with new antithrombotics compared with those receiving the standard therapy: odds ratio (OR), [95% confidence interval (CI)] = 0.97 [0.72-1.31], p = 0.86. Recurrent MI rates were decreased in the anti-Xa group: OR [95%CI] = 0.86 [0.76-0.98], p = 0.02, number needed to treat (NNT) = 189. The administration of new oral anticoagulants was associated with a strongly increased risk of major bleedings compared with the standard treatment: OR [95%CI] = 3.24 [2.29-4.59], p < 0.001, number needed to harm (NNH) = 104; similarly, intracranial bleeding rates were significantly higher in the anti-Xa arm.
The addition of the new oral anticoagulants on top of standard therapy in the setting of ACS results in an excessive risk of major bleedings without any clear evidence of outweighing clinical benefits.
最近，随机对照试验（RCT）表明，新型口服激活因子 X（Xa）抑制剂治疗急性冠状动脉综合征（ACS）可降低缺血事件的发生。然而，这种治疗与剂量相关的大出血并发症增加有关。我们旨在进行系统评价和荟萃分析，评估最近 ACS 后使用最低剂量口服 Xa 抑制剂与安慰剂相比的临床疗效和安全性。
主要终点是心血管死亡率。新发心肌梗死（MI）发生率为次要疗效终点，而大出血并发症则作为安全性终点记录。荟萃分析纳入了 5 项 RCT，共纳入 25643 名患者。
与接受标准治疗的患者相比，使用新型抗血栓药物治疗的患者死亡率无显著差异：比值比（OR）[95%置信区间（CI）] = 0.97 [0.72-1.31]，p = 0.86。抗 Xa 组的复发性 MI 发生率降低：OR [95%CI] = 0.86 [0.76-0.98]，p = 0.02，需要治疗的人数（NNT）= 189。与标准治疗相比，新型口服抗凝剂的应用与大出血风险显著增加相关：OR [95%CI] = 3.24 [2.29-4.59]，p < 0.001，需要伤害的人数（NNH）= 104；同样，抗 Xa 组颅内出血发生率也显著升高。
在 ACS 患者中，在标准治疗的基础上加用新型口服抗凝剂会导致大出血的风险过高，而没有明显证据表明临床获益超过风险。
