Hermanides Renicus S, Ottervanger Jan Paul, ten Berg Jurrien M, Gosselink A T Marcel, van Houwelingen Gert, Dambrink Jan-Henk E, Stella Pieter R, Hamm Christian, van 't Hof Arnoud W J
Isala klinieken, Department of Cardiology, Zwolle, The Netherlands.
J Invasive Cardiol. 2012 Mar;24(3):84-9.
The aim of this subanalysis was to assess the net clinical effect of prehospital administration of tirofiban in ST-elevation myocardial infarction (STEMI) patients with high risk of bleeding.
This is a retrospective subanalysis of the On- TIME 2 trial, a multicenter, controlled randomized trial of the effects of high bolus-dose tirofiban given in the ambulance in STEMI patients. Tirofiban was given on top of aspirin, heparin, and clopidogrel. According to CRUSADE, patients with a moderate to very high baseline risk of bleeding were defined as high risk and patients with a very low or low baseline bleeding risk were defined as low risk. Primary endpoint was net adverse clinical events (NACE) at 30 days (defined as the combined incidence of death, recurrent myocardial infarction, urgent target vessel revascularization, stroke, or non-coronary artery bypass graft [CABG]-related major bleeding).
Of 1309 patients, a high bleeding risk was present in 291 patients (22.2%). In these high-risk bleeding patients, tirofiban significantly improved after percutaneous coronary intervention (PCI) ST-segment resolution. Administration of tirofiban in high-risk bleeding patients showed no difference in 30-day major adverse cardiac events (MACE) (9.4% vs 13.0%; P=.330; relative risk [RR], 0.72; 95% confidence interval [CI], 0.37-1.39). However, pretreatment with tirofiban was associated with a nonsignificant increase in non-CABG related bleeding (8.6% vs 3.6%; P=.082; RR, 2.38; 95% CI, 0.90-6.39). The net clinical effect (30-day NACE) of tirofiban in this group was balanced (11.5% vs 15.2%; P=.365; RR, 0.76; 95% CI, 0.41-1.38).
Prehospital use of tirofiban in STEMI patients with high risk of bleeding improves post-PCI ST-segment resolution, but increases nonsignificantly the risk of non-CABG related bleeding. The net result is a balanced effect on 30-day NACE. Additional studies should clarify how use of bleeding risk scores should modify medical (antiplatelet) therapy.
本亚组分析旨在评估在有高出血风险的ST段抬高型心肌梗死（STEMI）患者中，院前应用替罗非班的净临床效果。
这是对On-TIME 2试验的一项回顾性亚组分析，On-TIME 2试验是一项多中心、对照随机试验，研究在STEMI患者的救护车上给予高负荷剂量替罗非班的效果。替罗非班在阿司匹林、肝素和氯吡格雷的基础上使用。根据CRUSADE标准，基线出血风险为中度至非常高的患者被定义为高风险，基线出血风险非常低或低的患者被定义为低风险。主要终点是30天时的净不良临床事件（NACE）（定义为死亡、再发心肌梗死、紧急靶血管血运重建、中风或非冠状动脉旁路移植术（CABG）相关大出血的合并发生率）。
在1309例患者中，291例（22.2%）存在高出血风险。在这些高风险出血患者中，替罗非班显著改善了经皮冠状动脉介入治疗（PCI）后的ST段回落。在高风险出血患者中应用替罗非班，30天主要不良心脏事件（MACE）无差异（9.4%对13.0%；P=0.330；相对风险[RR]，0.72；95%置信区间[CI]，0.37-1.39）。然而，替罗非班预处理与非CABG相关出血的非显著性增加相关（8.6%对3.6%；P=0.082；RR，2.38；95%CI，0.90-6.39）。替罗非班在该组的净临床效果（30天NACE）是平衡的（11.5%对15.2%；P=0.365；RR，0.76；95%CI，0.41-1.38）。
在有高出血风险的STEMI患者中，院前使用替罗非班可改善PCI后的ST段回落，但非显著性增加非CABG相关出血风险。净结果是对30天NACE有平衡的影响。更多研究应阐明出血风险评分的应用应如何调整药物（抗血小板）治疗。
