Effect of Platelet Inhibition with Cangrelor during PCI on Ischemic Events
Effect of Platelet Inhibition with Cangrelor during PCI on Ischemic Events
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DOI：
10.1056/nejmoa1300815
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发表时间：
2013-04-04
影响因子：
158.5
通讯作者：
Harrington, Robert A.
中科院分区：
文献类型：
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作者：
Bhatt, Deepak L.;Stone, Gregg W.;Harrington, Robert A.
经皮冠状动脉介入治疗（PCI）期间抗血小板治疗的强度是PCI相关缺血并发症的重要决定因素。坎格雷洛是一种有效的静脉注射二磷酸腺苷（ADP）受体拮抗剂，作用迅速，具有迅速可逆的作用。方法在一项双盲，安慰剂对照试验中，我们随机分配11，145例接受紧急或择期PCI并接受指南-推荐的治疗是接受大剂量和输注坎格雷洛或接受600 mg或300 mg负荷剂量的氯吡格雷。主要疗效终点是随机化后48小时的死亡、心肌梗死、缺血驱动的血运重建或支架血栓形成的复合终点;关键次要终点是48小时的支架血栓形成。坎格雷洛组和氯吡格雷组的主要疗效终点发生率分别为4.7%和5.9%（坎格雷洛的校正比值比为0.78; 95%可信区间[CI]为0.66 ~ 0.93; P = 0.005）。坎格雷洛组的主要安全性终点发生率为0.16%，氯吡格雷组为0.11%（比值比，1.50; 95%CI，0.53 - 4.22; P = 0.44）。坎格雷洛组和氯吡格雷组分别有0.8%和1.4%的患者发生支架内血栓形成（比值比，0.62; 95%CI，0.43 - 0.90; P = 0.01）。两组中与研究治疗相关的不良事件发生率均较低，尽管坎格雷洛组的一过性呼吸困难发生率明显高于氯吡格雷组（1.2% vs. 0.3%）。从坎格雷洛的好处相对于主要终点是一致的，在多个预先指定的subgroup.CONCLUSIONSCangrelor显着降低缺血性事件，包括支架血栓形成，在PCI期间，没有显着增加严重出血。（由药品公司资助; CHAMPION PHOENIX ClinicalTrials.gov编号，NCT 01156571。
BACKGROUNDThe intensity of antiplatelet therapy during percutaneous coronary intervention (PCI) is an important determinant of PCI-related ischemic complications. Cangrelor is a potent intravenous adenosine diphosphate (ADP)-receptor antagonist that acts rapidly and has quickly reversible effects.METHODSIn a double-blind, placebo-controlled trial, we randomly assigned 11,145 patients who were undergoing either urgent or elective PCI and were receiving guideline-recommended therapy to receive a bolus and infusion of cangrelor or to receive a loading dose of 600 mg or 300 mg of clopidogrel. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours after randomization; the key secondary end point was stent thrombosis at 48 hours. The primary safety end point was severe bleeding at 48 hours.RESULTSThe rate of the primary efficacy end point was 4.7% in the cangrelor group and 5.9% in the clopidogrel group (adjusted odds ratio with cangrelor, 0.78; 95% confidence interval [CI], 0.66 to 0.93; P = 0.005). The rate of the primary safety end point was 0.16% in the cangrelor group and 0.11% in the clopidogrel group (odds ratio, 1.50; 95% CI, 0.53 to 4.22; P = 0.44). Stent thrombosis developed in 0.8% of the patients in the cangrelor group and in 1.4% in the clopidogrel group (odds ratio, 0.62; 95% CI, 0.43 to 0.90; P = 0.01). The rates of adverse events related to the study treatment were low in both groups, though transient dyspnea occurred significantly more frequently with cangrelor than with clopidogrel (1.2% vs. 0.3%). The benefit from cangrelor with respect to the primary end point was consistent across multiple prespecified subgroups.CONCLUSIONSCangrelor significantly reduced the rate of ischemic events, including stent thrombosis, during PCI, with no significant increase in severe bleeding. (Funded by the Medicines Company; CHAMPION PHOENIX ClinicalTrials.gov number, NCT01156571.)