Pitiè-Salpêtrière University Hospital, Paris, France.
JACC Cardiovasc Interv. 2010 Feb;3(2):203-12. doi: 10.1016/j.jcin.2009.11.012.
The aim of this study was to assess the risk-benefit of enoxaparin (Sanofi-Aventis, Paris, France) in primary percutaneous coronary intervention (PCI).
Randomized studies have demonstrated the superiority of enoxaparin over unfractionated heparin (UFH) in acute ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytics.
In the FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) trial--a double-blind, placebo-controlled study-2,452 patients with STEMI were randomized to primary PCI or facilitated PCI with abciximab alone or with half-dose reteplase. In this prospective FINESSE substudy, centers pre-specified use of either enoxaparin (0.5 mg/kg intravenous [IV], 0.3 mg/kg subcutaneous [SC]) or UFH (40 U/kg IV, 3,000 U maximum) with PCI. A logistic-regression model and a propensity multivariate model, both adjusted for baseline variables, were used to evaluate primary safety and secondary efficacy end points for enoxaparin versus UFH.
Enoxaparin was administered to 759 patients and UFH to 1,693 patients. Nonintracranial Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding was not significantly different, but lower nonintracranial TIMI major bleeding was found with enoxaparin (2.6% vs. UFH 4.4%, logistic-regression adjusted odds ratio [OR]: 0.55; 95% confidence interval [CI]: 0.31 to 0.99, p = 0.045), whereas intracranial hemorrhage was similar (0.27% vs. 0.24%, adjusted OR: 1.03; 95% CI: 0.11 to 9.68, p = 0.980). Lower death, myocardial infarction, urgent revascularization, or refractory ischemia through 30 days was also associated with enoxaparin (5.3%) versus UFH (8.0%, adjusted OR: 0.47, 95% CI: 0.31 to 0.72, p = 0.0005) as was all-cause mortality through 90 days (3.8% vs. 5.6%, respectively, adjusted OR: 0.59, 95% CI: 0.35 to 0.99, p = 0.046). End points evaluating the net clinical benefit also significantly favored enoxaparin over UFH.
Enoxaparin seems to be associated with a lower risk of cardiovascular outcomes compared with UFH in patients with STEMI undergoing primary PCI. Confirmation of these findings in a randomized study is warranted. (A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction [Finesse]; NCT00046228).
本研究旨在评估依诺肝素（赛诺菲-安万特，巴黎，法国）在直接经皮冠状动脉介入治疗（PCI）中的风险效益。
随机研究表明，在接受溶栓治疗的急性 ST 段抬高型心肌梗死（STEMI）患者中，依诺肝素优于未分级肝素（UFH）。
在 FINESSE（促进介入治疗以加快事件恢复速度）试验中——一项双盲、安慰剂对照研究——2452 名 STEMI 患者被随机分配至直接 PCI 或联合阿昔单抗的直接 PCI 或联合半剂量瑞替普酶的直接 PCI。在这项前瞻性 FINESSE 子研究中，中心预先指定使用依诺肝素（0.5mg/kg 静脉[IV]，0.3mg/kg 皮下[SC]）或 UFH（40U/kg IV，最大 3000U）进行 PCI。使用逻辑回归模型和倾向多元模型，均根据基线变量进行调整，以评估依诺肝素与 UFH 的主要安全性和次要疗效终点。
依诺肝素组 759 例，UFH 组 1693 例。非颅内血栓溶解心肌梗死（TIMI）主要/次要出血无显著差异，但依诺肝素组非颅内 TIMI 主要出血较低（2.6%对 UFH 4.4%，调整后的优势比[OR]：0.55；95%置信区间[CI]：0.31 至 0.99，p=0.045），而颅内出血相似（0.27%对 UFH 0.24%，调整后的 OR：1.03；95%CI：0.11 至 9.68，p=0.980）。30 天内死亡、心肌梗死、紧急血运重建或难治性缺血也与依诺肝素相关（5.3%对 UFH 8.0%，调整后的 OR：0.47，95%CI：0.31 至 0.72，p=0.0005），90 天内全因死亡率也如此（分别为 3.8%和 5.6%，调整后的 OR：0.59，95%CI：0.35 至 0.99，p=0.046）。评估净临床获益的终点也明显有利于依诺肝素优于 UFH。
与 UFH 相比，依诺肝素似乎与 STEMI 患者直接 PCI 后心血管结局风险降低相关。需要在随机研究中证实这些发现。（阿昔单抗和瑞替普酶在心肌梗死后导管插入术前应用的研究[Finesse]；NCT00046228）。
