Deutsches Herzzentrum München and 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Lazarettstrasse36, Munich, Germany.
J Am Coll Cardiol. 2012 Jul 31;60(5):369-77. doi: 10.1016/j.jacc.2012.02.044. Epub 2012 Jun 6.
The ISAR-REACT 4 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment-4) platelet substudy aimed to determine the relevance of high on-clopidogrel treatment platelet reactivity (HPR) in non-ST-segment elevation myocardial infarction patients that received abciximab with unfractionated heparin (UFH) or bivalirudin during percutaneous coronary intervention (PCI).
In patients undergoing PCI, HPR has been linked to a higher risk for ischemic events. The influence of HPR on clinical outcomes may differ with regard to the adjunctive antithrombotic treatment administered. In ISAR-REACT 4, bivalirudin treatment showed similar efficacy profiles as compared to abciximab with UFH. The impact of HPR on clinical outcomes in abciximab with UFH versus bivalirudin treated non-ST-segment elevation myocardial infarction patients has never been investigated specifically.
A total of 564 patients (274 in abciximab/UFH group vs. 290 in bivalirudin group) were enrolled in this study. Presence or absence of HPR following clopidogrel loading was determined by platelet function testing on a Multiplate analyzer (Verum Diagnostica, Munich, Germany). Per study group and stratified in HPR and no-HPR patients, the 30-day incidence of a combined efficacy endpoint (death, myocardial infarction, urgent target vessel revascularization) was determined.
For abciximab with UFH, the incidence of the efficacy endpoint was similar in HPR versus no-HPR patients (9.4% vs. 6.7%; odds ratio: 1.4; 95% confidence interval: 0.6 to 3.5; p = 0.43). For bivalirudin, the incidence of the efficacy endpoint was significantly higher in HPR versus no-HPR patients (22.0% vs. 5.0%; odds ratio: 5.4; 95% confidence interval: 2.4 to 12.1; p < 0.0001).
For patients with a risk profile similar to the subjects enrolled in this platelet substudy, the impact of HPR on clinical outcomes may depend on the type of adjunctive antithrombotic therapy used during PCI. Further investigations are warranted to clarify whether assessment of platelet function may help tailoring antithrombotic therapy during PCI.
ISAR-REACT 4（冠状动脉内支架置入和抗栓方案：快速早期冠状动脉治疗-4）血小板亚研究旨在确定在接受经皮冠状动脉介入治疗（PCI）时接受阿昔单抗联合普通肝素（UFH）或比伐卢定的非 ST 段抬高型心肌梗死患者中高氯吡格雷治疗血小板反应性（HPR）的相关性。
在接受 PCI 的患者中，HPR 与缺血事件风险增加有关。HPR 对临床结局的影响可能因辅助抗栓治疗的不同而有所不同。在 ISAR-REACT 4 中，与 UFH 联合阿昔单抗相比，比伐卢定治疗显示出相似的疗效。HPR 对接受 UFH 联合阿昔单抗与比伐卢定治疗的非 ST 段抬高型心肌梗死患者的临床结局的影响尚未专门研究。
共有 564 名患者（阿昔单抗/UFH 组 274 名，比伐卢定组 290 名）入组本研究。通过 Verum Diagnostica（慕尼黑，德国）的 Multiplate 分析仪测定氯吡格雷负荷后血小板功能试验确定 HPR 的存在或不存在。根据研究组和 HPR 与非 HPR 患者分层，确定 30 天内联合疗效终点（死亡、心肌梗死、紧急靶血管血运重建）的发生率。
对于 UFH 联合阿昔单抗，HPR 患者的疗效终点发生率与非 HPR 患者相似（9.4% vs. 6.7%；比值比：1.4；95%置信区间：0.6 至 3.5；p = 0.43）。对于比伐卢定，HPR 患者的疗效终点发生率明显高于非 HPR 患者（22.0% vs. 5.0%；比值比：5.4；95%置信区间：2.4 至 12.1；p < 0.0001）。
对于与本血小板亚研究入组患者风险特征相似的患者，HPR 对临床结局的影响可能取决于 PCI 期间使用的辅助抗栓治疗类型。需要进一步研究以阐明评估血小板功能是否有助于调整 PCI 期间的抗栓治疗。
