Rokos Ivan C
Drugs. 2005;65(10):1313-6. doi: 10.2165/00003495-200565100-00001.
The SYNERGY (Superior Yield of the New strategy of Enoxaparin, Revascularisation, and GlYcoprotein inhibitors) trial, involving almost 10,000 patients, is a landmark cardiology study published in 2004. The study compared two anticoagulants used as part of a modern early invasive strategy involving angiographic triage of high-risk non-ST-elevation acute coronary syndrome patients. The trial as a whole showed similar efficacy between unfractionated heparin and enoxaparin. Regarding safety, two of the three in-hospital bleeding endpoints reported were similar between the two anticoagulants. Importantly, because of the high rate of pre-enrolment anticoagulant administration, many study participants required an anticoagulant change after randomisation. Thus, close attention is warranted to a prespecified subanalysis of >6000 patients who received 'consistent therapy'; that is, the same anticoagulant was administered pre- and post-enrolment based on intention to treat. In this large 'consistent therapy' cohort, the efficacy endpoint favoured enoxaparin and, as in the overall study population, two of the three reported bleeding endpoints were similar between the two anticoagulants. Finally, the rate of peri-procedural thrombotic complications that occurred during percutaneous coronary intervention was equal for both anticoagulants. Thus, since both anticoagulants have a similar efficacy and safety profile, then the simplicity of the enoxaparin regimen (i.e. no monitoring of activated partial thromboplastin time and easy dose calculation of 1 mg/kg subcutaneously) provides an important and desirable feature relevant to a busy emergency medicine practitioner.
协同(依诺肝素、血管重建和糖蛋白抑制剂新策略的卓越疗效)试验纳入了近10000名患者,是2004年发表的一项具有里程碑意义的心脏病学研究。该研究比较了两种抗凝剂,它们是现代早期侵入性策略的一部分,该策略涉及对高危非ST段抬高急性冠状动脉综合征患者进行血管造影分诊。整个试验显示普通肝素和依诺肝素之间疗效相似。在安全性方面,报告的三个院内出血终点中的两个在两种抗凝剂之间相似。重要的是,由于入组前抗凝剂使用率高,许多研究参与者在随机分组后需要更换抗凝剂。因此,对于>6000名接受“持续治疗”患者的预先指定亚组分析值得密切关注;也就是说,根据意向性治疗,入组前后使用相同的抗凝剂。在这个大型“持续治疗”队列中,疗效终点有利于依诺肝素,并且与整个研究人群一样,报告的三个出血终点中的两个在两种抗凝剂之间相似。最后,两种抗凝剂在经皮冠状动脉介入治疗期间发生的围手术期血栓并发症发生率相等。因此,由于两种抗凝剂具有相似的疗效和安全性,那么依诺肝素方案的简单性(即无需监测活化部分凝血活酶时间,皮下注射1mg/kg剂量计算简便)为忙碌的急诊医学从业者提供了一个重要且理想的特征。