坎格雷洛及穿刺部位对缺血和出血事件的影响：来自CHAMPION PHOENIX试验的见解
The effect of cangrelor and access site on ischaemic and bleeding events: insights from CHAMPION PHOENIX.
作者信息
Gutierrez J Antonio, Harrington Robert A, Blankenship James C, Stone Gregg W, Steg Ph Gabriel, Gibson C Michael, Hamm Christian W, Price Matthew J, Généreux Philippe, Prats Jayne, Deliargyris Efthymios N, Mahaffey Kenneth W, White Harvey D, Bhatt Deepak L
机构信息
Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.
Stanford University Medical School, Stanford, CA, USA.
出版信息
Eur Heart J. 2016 Apr 7;37(14):1122-30. doi: 10.1093/eurheartj/ehv498. Epub 2015 Sep 23.
AIMS
To assess whether the use of the femoral or radial approach for percutaneous coronary intervention (PCI) interacted with the efficacy and safety of cangrelor, an intravenous P2Y12 inhibitor, in CHAMPION PHOENIX.
METHODS AND RESULTS
A total of 11 145 patients were randomly assigned in a double-dummy, double-blind manner either to a cangrelor bolus and 2-h infusion or to clopidogrel at the time of PCI. The primary endpoint, a composite of death, myocardial infarction, ischaemia-driven revascularization, or stent thrombosis, and the primary safety endpoint, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) defined severe bleeding, were evaluated at 48 h. Of the patients undergoing PCI and receiving study drug treatment, a total of 8064 (74%) and 2855 (26%) patients underwent femoral or radial PCI, respectively. Among the femoral cohort, the primary endpoint rate was 4.8% with cangrelor vs. 6.0% with clopidogrel (odds ratio, OR [95% confidence interval, CI] = 0.79 [0.65-0.96]); among the radial cohort, the primary endpoint was 4.4% with cangrelor vs. 5.7% with clopidogrel (OR [95% CI] = 0.76 [0.54-1.06]), P-interaction 0.83. The rate of GUSTO severe bleeding in the femoral cohort was 0.2% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.73 [0.51-5.93]). Among the radial cohort, the rate of GUSTO severe bleeding was 0.1% with cangrelor vs. 0.1% with clopidogrel (OR [95% CI] = 1.02 [0.14-7.28]), P-interaction 0.65. The evaluation of safety endpoints with the more sensitive ACUITY-defined bleeding found major bleeding in the femoral cohort to be 5.2% with cangrelor vs. 3.1% with clopidogrel (OR [95% CI] = 1.69 [1.35-2.12]); among the radial cohort the rate of ACUITY major bleeding was 1.5% with cangrelor vs. 0.7% with clopidogrel (OR [95% CI] = 2.17 [1.02-4.62], P-interaction 0.54).
CONCLUSION
In CHAMPION PHOENIX, cangrelor reduced ischaemic events with no significant increase in GUSTO-defined severe bleeding. The absolute rates of bleeding, regardless of the definition, tended to be lower when PCI was performed via the radial artery.
CLINICAL TRIAL REGISTRATION
http://www.clinicaltrials.gov identifier: NCT01156571.
目的
在CHAMPION PHOENIX研究中，评估经皮冠状动脉介入治疗（PCI）时采用股动脉或桡动脉途径是否会影响静脉P2Y12抑制剂坎格雷洛的疗效和安全性。
方法与结果
总共11145例患者以双模拟、双盲方式随机分配，在PCI时接受坎格雷洛推注及2小时输注或氯吡格雷治疗。在48小时时评估主要终点，即死亡、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，以及主要安全性终点，即全球冠状动脉闭塞开通策略（GUSTO）定义的严重出血。在接受PCI并接受研究药物治疗的患者中，分别有8064例（74%）和2855例（26%）患者接受了股动脉或桡动脉PCI。在股动脉组中，坎格雷洛治疗组的主要终点发生率为4.8%，氯吡格雷治疗组为6.0%（优势比，OR[95%置信区间，CI]=0.79[0.65-0.96]）；在桡动脉组中，坎格雷洛治疗组的主要终点发生率为4.4%，氯吡格雷治疗组为5.7%（OR[95%CI]=0.76[0.54-1.06]），交互作用P值为0.83。股动脉组中，坎格雷洛治疗组的GUSTO严重出血发生率为0.2%，氯吡格雷治疗组为0.1%（OR[95%CI]=1.73[0.51-5.93]）。在桡动脉组中，坎格雷洛治疗组的GUSTO严重出血发生率为0.1%，氯吡格雷治疗组为0.1%（OR[95%CI]=1.02[0.14-7.28]），交互作用P值为0.65。采用更敏感的急性冠状动脉综合征全球登记处（ACUITY）定义的出血对安全性终点进行评估，发现股动脉组中坎格雷洛治疗组的大出血发生率为5.2%，氯吡格雷治疗组为3.1%（OR[95%CI]=1.69[1.35-2.12]）；在桡动脉组中，ACUITY大出血发生率坎格雷洛治疗组为1.5%，氯吡格雷治疗组为0.7%（OR[95%CI]=2.17[1.02-4.62]），交互作用P值为0.54。
结论
在CHAMPION PHOENIX研究中，坎格雷洛减少了缺血事件，且GUSTO定义的严重出血无显著增加。无论采用何种定义，经桡动脉进行PCI时出血的绝对发生率往往较低。
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