Gibson C Michael, Murphy Sabina A, Montalescot Gilles, Morrow David A, Ardissino Diego, Cohen Marc, Gulba Dietrich C, Kracoff Oscar H, Lewis Basil S, Roguin Nathan, Antman Elliott M, Braunwald Eugene
Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
J Am Coll Cardiol. 2007 Jun 12;49(23):2238-46. doi: 10.1016/j.jacc.2007.01.093. Epub 2007 May 25.
We sought to evaluate whether enoxaparin (ENOX) is superior to unfractionated heparin (UFH) as adjunctive therapy for patients with ST-segment elevation myocardial infarction (STEMI) who receive fibrinolytic therapy and subsequently undergo percutaneous coronary intervention (PCI) by analyzing data from the ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction 25) trial.
Limited data are available on the use of ENOX compared with UFH as adjunctive therapy in STEMI patients treated with fibrinolytic therapy and subsequent PCI.
A total of 20,479 STEMI patients who received fibrinolytic therapy were randomized to a strategy of ENOX throughout index hospitalization or UFH for at least 48 h, with blinded study drug to continue if PCI was performed. The primary end point of death or recurrent MI through 30 days was compared for ENOX versus UFH among the patients who underwent subsequent PCI (n = 4,676).
After initial fibrinolysis, fewer patients underwent PCI through 30 days in the ENOX versus the UFH group (22.8% vs. 24.2%; p = 0.027). Among patients who underwent PCI by 30 days, the primary end point occurred in 10.7% of ENOX and 13.8% of UFH patients (0.77 relative risk; p < 0.001). There were no differences in major bleeding for ENOX versus UFH (1.4% vs. 1.6%; p = NS). Results were similar when PCI was carried out in patients receiving blinded study drug during PCI (n = 2,178).
Among patients treated with fibrinolytic therapy for STEMI who underwent subsequent PCI, ENOX administration was associated with a reduced risk of death or recurrent MI without difference in the risk of major bleeding. The strategy of ENOX support for fibrinolytic therapy followed by PCI is superior to UFH and provides a seamless transition from the medical management to the interventional management phase of STEMI without the need for introducing a second anticoagulant in the cardiac catheterization laboratory.
我们试图通过分析“急性心肌梗死治疗中依诺肝素与溶栓再灌注-心肌梗死溶栓25”（ExTRACT-TIMI 25）试验的数据，评估对于接受纤维蛋白溶解疗法并随后接受经皮冠状动脉介入治疗（PCI）的ST段抬高型心肌梗死（STEMI）患者，依诺肝素（ENOX）作为辅助治疗是否优于普通肝素（UFH）。
与UFH相比，关于ENOX在接受纤维蛋白溶解疗法及后续PCI的STEMI患者中作为辅助治疗的使用数据有限。
总共20479例接受纤维蛋白溶解疗法的STEMI患者被随机分配至在整个住院期间采用ENOX治疗策略或采用UFH治疗至少48小时，若进行PCI则继续使用盲法研究药物。在接受后续PCI的患者（n = 4676）中，比较ENOX与UFH在30天内的死亡或复发性心肌梗死主要终点。
初始纤维蛋白溶解后，30天内接受PCI的患者在ENOX组比UFH组更少（22.8%对24.2%；p = 0.027）。在30天内接受PCI的患者中，主要终点在ENOX组患者中发生率为10.7%，在UFH组患者中为13.8%（相对风险0.77；p < 0.001）。ENOX与UFH在大出血方面无差异（1.4%对1.6%；p = 无显著差异）。当在PCI期间接受盲法研究药物的患者中进行PCI时（n = 2178），结果相似。
在接受纤维蛋白溶解疗法治疗STEMI并随后接受PCI的患者中，使用ENOX与死亡或复发性心肌梗死风险降低相关，且大出血风险无差异。ENOX支持纤维蛋白溶解疗法随后进行PCI的策略优于UFH，并提供了从STEMI的药物治疗阶段到介入治疗阶段的无缝过渡，而无需在心脏导管实验室引入第二种抗凝剂。
