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ESC 2013：CHAMPION研究分析显示坎格雷洛可降低PCI术时的血栓事件

2013-10-14 MedSci MedSci原创

PCI术时的血栓坎格雷洛
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研究要点：1.CHAMPION汇集分析共包括三个关键的试验：CHAMPION-PCI、CHAMPION-PLATFORM和CHAMPION-PHOENIX试验。2.坎格雷洛与氯吡格雷或安慰剂相比可降低PCI术围手术期血栓并发症风险。但轻微出血事件发生增加。3.FDA在2013年7月接受坎格雷洛的新药申请。ESC2013会议上展示了CHAMPION试验的汇集分析结果，研究结果已发表在2013年9月3

 
研究要点：

1.CHAMPION汇集分析共包括三个关键的试验：CHAMPION-PCI、CHAMPION-PLATFORM和CHAMPION-PHOENIX试验。

2.坎格雷洛与氯吡格雷或安慰剂相比可降低PCI术围手术期血栓并发症风险。但轻微出血事件发生增加。

3.FDA在2013年7月接受坎格雷洛的新药申请。

ESC2013会议上展示了CHAMPION试验的汇集分析结果，研究结果已发表在2013年9月3日的Lancet杂志上。以Gabriel Steg博士（法国巴黎Bichat医院）为首的研究团队称，这项研究的数据来自CHAMPION-PCI， CHAMPION-PLATFORM和CHAMPION-PHOENIX试验，因此代表“PCI术时坎格雷洛治疗临床结局的总体证据”。值得一提的是，FDA于2013年7月接受了制造商对坎格雷洛的新药申请。

三项试验的研究对象包括STEMI、non-STEMI以及稳定型冠心病的患者随机分至坎格雷洛组或者对照组（氯吡格雷或安慰剂）治疗。坎格雷洛治疗组的主要结局指标包括48小时内各种原因死亡、再梗、紧急血运重建或支架血栓形成的发生明显低于氯吡格雷或安慰剂组--绝对差值为1.9%及相对风险降低19%。坎格雷洛治疗组支架内血栓发生率减少--绝对差值0.3%及相对风险降低41%。主要的安全结局——非CABG相关的（GUSTO标准）中度出血或输血并发症在各种间无差异，但坎格雷洛组轻微出血发生率较高。

研究人员发现采用TIMI出血分级标准可得出相似的结果，但使用 ACUITY出血标准，坎格雷洛组的大出血和轻微出血发生率均明显升高。不同亚组间治疗的受益和风险结果一致。但对于治疗成本的比较仍需进一步分析。

编者评论：

在编者评论中， Shamir Mehta博士（加拿大麦克马斯特大学）指出，坎格雷洛在市场导向上采用了“迂回路线”。因为此前作为新药申请文件关键数据的前两项试验结果显示，坎格雷洛并没有显著的降低围手术期缺血事件。然而综合试验分析结果“显示出坎格雷洛确是一种有效的抗血小板药物，可减少围手术期的缺血性事件（包括支架血栓和心肌梗死）。

与氯吡格雷不同，坎格雷洛可产生“几乎即刻”的血小板抑制作用。与其他新的抗血小板药物如替卡格雷（阿斯利康的 Brilinta）和普拉格雷（ 礼来/第一-三洋的Effient）以及氯吡格雷不同，坎格雷洛是静脉内给药且生物半衰期较短约3-6分钟，血小板功能会在一小时内正常。

坎格雷洛阳性结果能否说服医生和监管人员，使其相信坎格雷洛优于现已批准的PCI术治疗药物，仍将是个问题。目前尚无比较坎格雷洛与其他抗血小板新药替卡格雷、普拉格雷以及氯吡格雷负荷600mg（CHAMPION试验中仅有一少部分患者使用）效果的试验。

这意味着并不除外“坎格雷洛在某些临床情况下有重要作用”的可能性，这包括：高危STEMI，恶心/呕吐的患者，气管插管的患者，心源性休克的患者。以及其他潜在的临床需要：需早期干预的高危非STEMI，不进行氯吡格雷预处理的治疗中心，具有高危解剖或者临床特征的“接受同时手术或者择期造影后立即行PCI”的稳定型冠心病患者。遗憾的是，替卡格雷和普拉格雷均未这些人群中进行过大规模正式研究。

原文检索：

Steg PG, Bhatt DL, Hamm CW, Stone GW, Gibson CM, Mahaffey KW, Leonardi S, Liu T, Skerjanec S, Day JR, Iwaoka RS, Stuckey TD, Gogia HS, Gruberg L, French WJ, White HD, Harrington RA; for the CHAMPION Investigators.Effect of cangrelor on periprocedural outcomes in percutaneous coronary interventions: a pooled analysis of patient-level data.The Lancet  3 September 2013. 

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    2014-06-24 xiaoyang_ambs

    #血栓事件#

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    2014-07-02 zxl736

    #PCI术#

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    2014-06-03 ms8543593053280928

    #坎格雷洛#

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    2014-01-20 liye789132251

    #CHAMPION#

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