Dumaine Raphaelle, Borentain Maria, Bertel Osmund, Bode Christoph, Gallo Richard, White Harvey D, Collet Jean-Philippe, Steinhubl Steven R, Montalescot Gilles
Centre Hospitalier Universitaire Pitié-Salpêtrière, Institute of Cardiology, Bureau 2-236, 47 Blvd de l'Hôpital, 75013, Paris, France.
Arch Intern Med. 2007 Dec 10;167(22):2423-30. doi: 10.1001/archinte.167.22.2423.
Despite its limitations, unfractionated heparin (UFH) is the recommended anticoagulant during percutaneous coronary intervention (PCI). Few randomized trials have compared low-molecular-weight heparin (LMWH) and UFH, and most lacked the power to detect a difference between the 2 anticoagulants in terms of safety or efficacy. Our objective was to perform a meta-analysis of randomized trials comparing the efficacy and safety of LMWH vs UFH as anticoagulants in the setting of PCI.
We used MEDLINE, randomized trials presented at major cardiology conferences, and journal article bibliographies from January 1998 and September 2006. Two reviewers independently identified randomized studies comparing the intravenous administration of LMWH vs UFH among patients undergoing PCI. Data on sample size, baseline characteristics, and outcomes of interest were independently extracted and analyzed.
Thirteen trials including 7318 patients met the inclusion criteria. A total of 4201 patients (57.4%) received LMWH, and 3117 patients (42.6%) received UFH. Intravenous LMWH use was associated with a significant reduction in the risk of major bleeding compared with UFH (odds ratio [OR], 0.57; 95% confidence interval [CI], 0.40-0.82; P = .002). A trend toward a reduction in minor bleeding was also observed among LMWH-treated patients (OR, 0.75; 95% CI, 0.47-1.20; P = .24). Similar efficacy was observed between LMWH and UFH regarding the double end point of death or myocardial infarction (OR, 0.99; 95% CI, 0.79-1.24; P = .93). There were no significant differences in death, myocardial infarction, and urgent revascularization between patients receiving LMWH and those receiving UFH.
The use of intravenous LMWH during PCI is associated with a significant reduction in major bleeding events compared with UFH, without compromising outcomes on hard ischemic end points.
尽管普通肝素（UFH）存在局限性，但它仍是经皮冠状动脉介入治疗（PCI）期间推荐使用的抗凝剂。很少有随机试验比较低分子量肝素（LMWH）和UFH，而且大多数试验没有足够的能力检测这两种抗凝剂在安全性或有效性方面的差异。我们的目的是对比较LMWH与UFH作为PCI抗凝剂的疗效和安全性的随机试验进行荟萃分析。
我们使用了MEDLINE、在主要心脏病学会议上发表的随机试验以及1998年1月至2006年9月的期刊文章参考文献。两名审阅者独立识别比较接受PCI患者中静脉注射LMWH与UFH的随机研究。独立提取并分析样本量、基线特征和感兴趣的结局数据。
13项试验共纳入7318例患者，符合纳入标准。共有4201例患者（57.4%）接受LMWH，3117例患者（42.6%）接受UFH。与UFH相比，静脉使用LMWH与大出血风险显著降低相关（优势比[OR]，0.57；95%置信区间[CI]，0.40 - 0.82；P = 0.002）。在接受LMWH治疗的患者中也观察到轻微出血有减少趋势（OR，0.75；95% CI，0.47 - 1.20；P = 0.24）。在死亡或心肌梗死的双重终点方面，LMWH和UFH的疗效相似（OR，0.99；95% CI，0.79 - 1.24；P = 0.93）。接受LMWH和UFH的患者在死亡、心肌梗死和紧急血运重建方面无显著差异。
与UFH相比，PCI期间静脉使用LMWH与大出血事件显著减少相关，且不影响严重缺血终点的结局。
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