Bergmeijer Thomas O, van Oevelen Mathijs, Janssen Paul W A, Godschalk Thea C, Lichtveld Robert A, Kelder Johannes C, Voskuil Michiel, Mosterd Arend, Montalescot Gilles, Ten Berg Jurriën M
Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
Regional Ambulance Service Utrecht (RAVU), Bilthoven, The Netherlands.
TH Open. 2018 Oct 11;2(4):e357-e368. doi: 10.1055/s-0038-1673389. eCollection 2018 Oct.
The objective of this registry was to study the safety of prehospital initiation of ticagrelor compared with clopidogrel. Ticagrelor has replaced clopidogrel in many hospitals as the routinely used antiplatelet drug in patients with ST-segment elevation myocardial infarction (STEMI). Nevertheless, in the PLATelet inhibition and patient Outcomes (PLATO) trial, ticagrelor was associated with an increase in non-CABG (non-coronary artery bypass grafting)-related major bleeding. Data comparing the safety of ticagrelor and clopidogrel after prehospital initiation of treatment are not available. A retrospective, multicenter registry was performed. Selection criteria were the administration of a prehospital loading dose of ticagrelor or clopidogrel according to the ambulance STEMI treatment protocol and the presentation to a percutaneous coronary intervention-capable hospital in our region between January 2011 and December 2012. Follow-up was performed using the electronic patient files for the time period between the antiplatelet loading dose and hospital discharge. The data were analyzed using a primary bleeding end point (any bleeding) and a secondary thrombotic end point (all-cause mortality, spontaneous myocardial infarction, definite stent thrombosis, stroke, or transient ischemic attack). Data of 304 clopidogrel-treated and 309 ticagrelor-treated patients were available for analysis. No significant difference in bleeding rate was observed between both groups, using univariate (17.8 vs. 20.1%; = 0.47; odds ratio, 1.16 [95% confidence interval, 0.78-1.74]) and multivariate ( = 0.42) analysis. Also for the secondary thrombotic end point (6.3 vs. 4.9%, = 0.45), no significant differences were observed. In this real-world registry, no significant differences in bleeding or thrombotic event rate were found between ticagrelor and clopidogrel after prehospital initiation of treatment.
本注册研究的目的是比较替格瑞洛与氯吡格雷在院前启动用药时的安全性。在许多医院，替格瑞洛已取代氯吡格雷，成为ST段抬高型心肌梗死（STEMI）患者常规使用的抗血小板药物。然而，在血小板抑制和患者预后（PLATO）试验中，替格瑞洛与非冠状动脉旁路移植术（非CABG）相关的大出血增加有关。目前尚无比较院前启动治疗后替格瑞洛和氯吡格雷安全性的数据。
进行了一项回顾性多中心注册研究。选择标准为根据救护车STEMI治疗方案给予替格瑞洛或氯吡格雷的院前负荷剂量，且于2011年1月至2012年12月期间在本地区能进行经皮冠状动脉介入治疗的医院就诊。使用电子患者档案对从抗血小板负荷剂量至出院期间进行随访。采用主要出血终点（任何出血）和次要血栓形成终点（全因死亡率、自发性心肌梗死、明确的支架血栓形成、中风或短暂性脑缺血发作）对数据进行分析。
共有304例接受氯吡格雷治疗的患者和309例接受替格瑞洛治疗的患者的数据可供分析。单因素分析（17.8%对20.1%；P = 0.47；优势比，1.16[95%置信区间，0.78 - 1.74]）和多因素分析（P = 0.42）显示，两组间出血率无显著差异。次要血栓形成终点（6.3%对4.9%，P = 0.45）也未观察到显著差异。
在这项真实世界注册研究中，院前启动治疗后，替格瑞洛和氯吡格雷在出血或血栓形成事件发生率方面无显著差异。
