Szük Tibor, Gyöngyösi Mariann, Homorodi Nóra, Kristóf Eva, Király Csaba, Edes István F, Facskó Andrea, Pavo Noemi, Sodeck Gottfried, Strehblow Christoph, Farhan Serdar, Maurer Gerald, Glogar Dietmar, Domanovits Hans, Huber Kurt, Edes István
Department of Cardiology, Medical University of Vienna, Vienna, Austria.
Am Heart J. 2007 Feb;153(2):289-95. doi: 10.1016/j.ahj.2006.10.030.
The aim of our prospective multicenter Clopidogrel Registry was to evaluate the efficacy and safety of a 300-mg loading dose of clopidogrel at the time of ad hoc stenting in patients with suspected coronary artery disease who were not pretreated with clopidogrel for any reason, and to compare the 30-day clinical event rates with the outcome of patients pretreated with a loading dose of clopidogrel 6 to 24 hours before stenting.
Between March 2002 and February 2004, 4160 consecutively included patients received a 300-mg loading dose of clopidogrel immediately after (group 1, n = 2679) or 6 to 24 hours before stenting (group 2, n = 1481).
The primary end point (triple composite end point of acute myocardial infarction, all-cause death, and urgent repeat target vessel revascularization) at 30 days occurred in 4.74% versus 2.77% in groups 1 and 2, respectively (P = .002). The secondary end point events, the stent thrombosis, occurred significantly more frequently in group 1, with a trend toward increase in incidence of death, target vessel revascularization, or need for glycoprotein IIb/IIIa antagonists during percutaneous coronary intervention. Pretreatment with clopidogrel was associated with more major bleeding (secondary safety end point) (0.41% vs 1.35% in groups 1 and 2, respectively; P = .001).
The results of our multicenter prospective Clopidogrel Registry demonstrate lower efficacy of a 300-mg loading dose of clopidogrel at the time of stenting compared with pretreatment 6 to 24 hours before percutaneous coronary intervention on the 30-day composite clinical end point in the large unselected patient cohort, which suggests the benefit of clopidogrel pretreatment in all incoming patients with suspected significant coronary artery disease scheduled for coronary angiography.
我们的前瞻性多中心氯吡格雷注册研究旨在评估在因任何原因未预先接受氯吡格雷治疗的疑似冠状动脉疾病患者进行临时支架置入时，300毫克负荷剂量氯吡格雷的疗效和安全性，并将30天临床事件发生率与在支架置入前6至24小时接受氯吡格雷负荷剂量预处理的患者的结果进行比较。
在2002年3月至2004年2月期间，4160例连续纳入的患者在支架置入后立即（第1组，n = 2679）或在支架置入前6至24小时（第2组，n = 1481）接受300毫克氯吡格雷负荷剂量。
30天时的主要终点（急性心肌梗死、全因死亡和紧急再次靶血管血运重建的三联复合终点）在第1组和第2组中的发生率分别为4.74%和2.77%（P = .002）。次要终点事件，即支架血栓形成，在第1组中明显更频繁发生，在经皮冠状动脉介入治疗期间死亡、靶血管血运重建或需要糖蛋白IIb/IIIa拮抗剂的发生率有增加趋势。氯吡格雷预处理与更多的大出血（次要安全终点）相关（第1组和第2组分别为0.41%和1.35%；P = .001）。
我们多中心前瞻性氯吡格雷注册研究的结果表明，在大型未选择的患者队列中，与经皮冠状动脉介入治疗前6至24小时进行预处理相比，在支架置入时给予300毫克氯吡格雷负荷剂量的疗效较低，这表明对所有计划进行冠状动脉造影的疑似严重冠状动脉疾病患者进行氯吡格雷预处理有益。
