Bedside Monitoring to Adjust Antiplatelet Therapy for Coronary Stenting
Bedside Monitoring to Adjust Antiplatelet Therapy for Coronary Stenting
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DOI：
10.1056/nejmoa1209979
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发表时间：
2012-11-29
影响因子：
158.5
通讯作者：
Montalescot, Gilles
中科院分区：
文献类型：
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作者：
Collet, Jean-Philippe;Cuisset, Thomas;Montalescot, Gilles
背景：患者对口服抗血小板治疗的反应是多种多样的。床边监测提供了通过个体化治疗改善冠状动脉支架置入术后预后的机会。方法我们在38个中心随机将2440名接受冠状动脉支架置入术的患者分配到血小板功能监测策略中，对抗血小板治疗反应较差的患者进行药物调整，或在没有监测和药物调整的情况下对传统策略进行调整。主要终点包括死亡、心肌梗死、支架血栓形成、中风或支架植入后1年的紧急血运重建。对于监测组患者，在支架植入前在导尿室和2-4周后在门诊使用VerifyNow P2Y12和阿司匹林护理点检测。结果在监测组中，服用氯吡格雷(34.5%)或阿司匹林(7.6%)的患者血小板反应性高，导致在手术过程中额外给予氯吡格雷、普拉格雷或阿司匹林以及糖蛋白IIb/IIIa抑制剂。监测组主终点发生率为34.6%，高于常规治疗组的31.1%(危险比1.13；95%可信区间0.98~1.29；P=0.10)。主要继发终点支架血栓形成或急诊血管重建率分别为4.9%和4.6%(风险比，1.06；95%CI，0.74~1.52；P=0.77)。主要出血事件的发生率在两组之间没有显著差异。结论本研究显示，与没有监测的标准抗血小板治疗相比，应用血小板功能监测和冠状动脉支架置入术治疗调整的临床结果没有显著改善。(由心血管试验倡议和组织的网络等盟友资助；北极诊所试验.gov编号，NCT00827411。)
BACKGROUNDPatients' responses to oral antiplatelet therapy are subject to variation. Bedside monitoring offers the opportunity to improve outcomes after coronary stenting by individualizing therapy.METHODSWe randomly assigned 2440 patients scheduled for coronary stenting at 38 centers to a strategy of platelet-function monitoring, with drug adjustment in patients who had a poor response to antiplatelet therapy, or to a conventional strategy without monitoring and drug adjustment. The primary end point was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization 1 year after stent implantation. For patients in the monitoring group, the VerifyNow P2Y12 and aspirin point-of-care assays were used in the catheterization laboratory before stent implantation and in the outpatient clinic 2 to 4 weeks later.RESULTSIn the monitoring group, high platelet reactivity in patients taking clopidogrel (34.5% of patients) or aspirin (7.6%) led to the administration of an additional bolus of clopidogrel, prasugrel, or aspirin along with glycoprotein IIb/IIIa inhibitors during the procedure. The primary end point occurred in 34.6% of the patients in the monitoring group, as compared with 31.1% of those in the conventional-treatment group (hazard ratio, 1.13; 95% confidence interval [CI], 0.98 to 1.29; P=0.10). The main secondary end point, stent thrombosis or any urgent revascularization, occurred in 4.9% of the patients in the monitoring group and 4.6% of those in the conventional-treatment group (hazard ratio, 1.06; 95% CI, 0.74 to 1.52; P=0.77). The rate of major bleeding events did not differ significantly between groups.CONCLUSIONSThis study showed no significant improvements in clinical outcomes with platelet-function monitoring and treatment adjustment for coronary stenting, as compared with standard antiplatelet therapy without monitoring. (Funded by Allies in Cardiovascular Trials Initiatives and Organized Networks and others; ARCTIC ClinicalTrials.gov number, NCT00827411.)