PCI 中用坎格瑞洛进行血小板抑制对缺血事件的影响。

Effect of platelet inhibition with cangrelor during PCI on ischemic events.

机构信息

VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA 02132, USA.

出版信息

N Engl J Med. 2013 Apr 4;368(14):1303-13. doi: 10.1056/NEJMoa1300815. Epub 2013 Mar 10.

DOI:10.1056/NEJMoa1300815

PMID:23473369

Abstract

BACKGROUND

The 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.

METHODS

In 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.

RESULTS

The 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.

CONCLUSIONS

Cangrelor 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.).

摘要

背景

经皮冠状动脉介入治疗（PCI）过程中抗血小板治疗的强度是 PCI 相关缺血性并发症的重要决定因素。坎格雷洛是一种强效的静脉内二磷酸腺苷（ADP）受体拮抗剂，起效迅速，作用可迅速逆转。

方法

在一项双盲、安慰剂对照试验中，我们将 11145 名正在接受紧急或择期 PCI 且接受指南推荐治疗的患者随机分组，分别接受坎格雷洛推注和输注，或接受 600 mg 或 300 mg 负荷剂量氯吡格雷。主要疗效终点为随机分组后 48 小时内死亡、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；主要次要终点为 48 小时内的支架血栓形成。主要安全性终点为 48 小时内严重出血。

结果

坎格雷洛组的主要疗效终点发生率为 4.7%，氯吡格雷组为 5.9%（坎格雷洛组校正优势比，0.78；95%置信区间[CI]，0.66 至 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 至 4.22；P=0.44）。坎格雷洛组有 0.8%的患者发生支架血栓形成，氯吡格雷组有 1.4%的患者发生支架血栓形成（比值比，0.62；95%CI，0.43 至 0.90；P=0.01）。两组与研究治疗相关的不良事件发生率均较低，但坎格雷洛组比氯吡格雷组更常发生短暂性呼吸困难（1.2%比 0.3%）。坎格雷洛对主要终点的益处在多个预先指定的亚组中是一致的。