Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France.
Am Heart J. 2011 Jan;161(1):5-12.e5. doi: 10.1016/j.ahj.2010.09.029.
individual response to oral antiplatelet therapy is subject to variability, and bedside monitoring offers the opportunity of individualizing therapy for stent implantation. Time and consequence of discontinuation of thienopyridine after stenting is also an unsolved issue after drug eluting stent (DES) implantation.
the ARCTIC trial is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose adjustment in suboptimal responders as compared to a more conventional strategy without monitoring and without dose adjustment to reduce the primary end point evaluated 1 year after DES implantation. At the end of the 1-year follow-up, all patients will be randomized again to test the superiority of a strategy of pursuit of dual antiplatelet therapy beyond 1 year as compared to a strategy of interruption. ARCTIC is a multicenter, prospective, open-label study with parallel arms and a double randomization. Two thousand four hundred sixty-six patients with stable angina/ischemia or non-ST-elevation Acute Coronary Syndrome undergoing percutaneous coronary intervention (PCI) with DES implantation are being enrolled. The primary end point for the 2 tested hypotheses is the time to first occurrence of all-cause mortality, nonfatal myocardial infarction, definite/probable stent thrombosis, urgent revascularization, or nonfatal stroke. Platelet function analyses will be performed at the time of PCI and repeated 2 to 4 weeks after PCI.
ARCTIC tests the hypothesis of personalized oral antiplatelet therapy at the time of and after DES implantation. It also examines the clinical impact of thienopyridine interruption 1 year after DES implantation.
个体对抗血小板治疗的反应存在变异性，床边监测为支架植入提供了个体化治疗的机会。支架置入后噻吩吡啶的停药时间和后果也是药物洗脱支架（DES）植入后的一个未解决的问题。
ARCTIC 试验旨在证明血小板功能监测与剂量调整策略在反应不佳者中的优越性，与不监测和不剂量调整的更传统策略相比，以降低 DES 植入后 1 年评估的主要终点。在 1 年随访结束时，所有患者将再次随机分组，以测试在 1 年以上继续双联抗血小板治疗策略的优越性与中断策略相比。ARCTIC 是一项多中心、前瞻性、开放标签、平行臂和双随机研究。正在招募 2466 例稳定性心绞痛/缺血或非 ST 段抬高急性冠状动脉综合征患者行经皮冠状动脉介入治疗（PCI）和 DES 植入。两个测试假设的主要终点是全因死亡率、非致死性心肌梗死、明确/可能的支架血栓形成、紧急血运重建或非致死性卒中等首次发生的时间。在 PCI 时和 PCI 后 2 至 4 周重复进行血小板功能分析。
ARCTIC 试验在 DES 植入时和之后检验了个体化口服抗血小板治疗的假设。它还检查了 DES 植入 1 年后噻吩吡啶中断的临床影响。
