通过多种定义评估，坎格雷洛可使围手术期心肌梗死持续减少：CHAMPION PHOENIX研究（坎格雷洛与标准治疗以实现血小板抑制的最佳管理）的结果
Consistent Reduction in Periprocedural Myocardial Infarction With Cangrelor as Assessed by Multiple Definitions: Findings From CHAMPION PHOENIX (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition).
作者信息
Cavender Matthew A, Bhatt Deepak L, Stone Gregg W, White Harvey D, Steg Ph Gabriel, Gibson C Michael, Hamm Christian W, Price Matthew J, Leonardi Sergio, Prats Jayne, Deliargyris Efthymios N, Mahaffey Kenneth W, Harrington Robert A
机构信息
From University of North Carolina, Chapel Hill (M.A.C.); Brigham and Women's Hospital, Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.); Columbia University, New York, NY (G.W.S.); University of Auckland, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Université Paris-Diderot, Sorbonne Paris Cité, INSERM U-1148, DHU FIRE, Hópital Bichat, Assistance Publique-Hópitaux de Paris, Paris, France (P.G.S.); Institute of Cardiovascular Medicine and Science, National Lung and Heart Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.); Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (C.M.G.); Kerckhoff Clinic and Thoraxcenter, Bad Nauheim, Germany (C.W.H.); Scripps Clinic, La Jolla, CA (M.J.P.); UOC Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (S.L.); The Medicines Company, Parsippany, NJ (J.P., E.N.D.); and Stanford University, Palo Alto, CA (K.W.M., R.A.H.).
出版信息
Circulation. 2016 Sep 6;134(10):723-33. doi: 10.1161/CIRCULATIONAHA.115.020829. Epub 2016 Aug 1.
BACKGROUND
Cangrelor is an intravenous P2Y12 inhibitor approved to reduce periprocedural ischemic events in patients undergoing percutaneous coronary intervention not pretreated with a P2Y12 inhibitor.
METHODS
A total of 11 145 patients were randomized to cangrelor or clopidogrel in the CHAMPION PHOENIX trial (Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). We explored the effects of cangrelor on myocardial infarction (MI) using different definitions and performed sensitivity analyses on the primary end point of the trial.
RESULTS
A total of 462 patients (4.2%) undergoing percutaneous coronary intervention had an MI as defined by the second universal definition. The majority of these MIs (n=433, 93.7%) were type 4a. Treatment with cangrelor reduced the incidence of MI at 48 hours (3.8% versus 4.7%; odds ratio [OR], 0.80; 95% confidence interval [CI], 0.67-0.97; P=0.02). When the Society of Coronary Angiography and Intervention definition of periprocedural MI was applied to potential ischemic events, there were fewer total MIs (n=134); however, the effects of cangrelor on MI remained significant (OR, 0.65; 95% CI, 0.46-0.92; P=0.01). Similar effects were seen in the evaluation of the effects of cangrelor on MIs with peak creatinine kinase-MB ≥10 times the upper limit of normal (OR, 0.64; 95% CI, 0.45-0.91) and those with peak creatinine kinase-MB ≥10 times the upper limit of normal, ischemic symptoms, or ECG changes (OR, 0.63; 95% CI, 0.48-0.84). MIs defined by any of these definitions were associated with increased risk of death at 30 days. Treatment with cangrelor reduced the composite end point of death, MI (Society of Coronary Angiography and Intervention definition), ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis (1.4% versus 2.1%; OR, 0.69; 95% CI, 0.51-0.92).
CONCLUSIONS
MI in patients undergoing percutaneous coronary intervention, regardless of definition, remains associated with increased risk of death in the current era. Cangrelor compared with clopidogrel significantly reduces MI regardless of the definition.
CLINICAL TRIAL REGISTRATION
URL: http://clinicaltrials.gov. Unique identifier: NCT01156571.
背景
坎格雷洛是一种静脉注射用P2Y12抑制剂，被批准用于降低未接受P2Y12抑制剂预处理的经皮冠状动脉介入治疗患者的围手术期缺血事件。
方法
在CHAMPION PHOENIX试验（坎格雷洛与标准治疗以实现血小板抑制的最佳管理）中，共有11145例患者被随机分为接受坎格雷洛或氯吡格雷治疗。我们使用不同定义探讨了坎格雷洛对心肌梗死（MI）的影响，并对试验的主要终点进行了敏感性分析。
结果
共有462例（4.2%）接受经皮冠状动脉介入治疗的患者发生了第二次通用定义所定义的MI。这些MI中的大多数（n = 433，93.7%）为4a型。坎格雷洛治疗降低了48小时时MI的发生率（3.8%对4.7%；优势比[OR]，0.80；95%置信区间[CI]，0.67 - 0.97；P = 0.02）。当将冠状动脉造影和介入学会围手术期MI的定义应用于潜在缺血事件时，总的MI病例数较少（n = 134）；然而，坎格雷洛对MI的影响仍然显著（OR，0.65；95% CI，0.46 - 0.92；P = 0.01）。在评估坎格雷洛对肌酸激酶同工酶MB峰值≥正常上限10倍的MI（OR，0.64；95% CI，0.45 - 0.91）以及肌酸激酶同工酶MB峰值≥正常上限10倍、有缺血症状或心电图改变的MI（OR，0.63；95% CI，0.48 - 0.84）的影响时，也观察到了类似的效果。由这些定义中的任何一种所定义的MI均与30天死亡风险增加相关。坎格雷洛治疗降低了死亡、MI（冠状动脉造影和介入学会定义）、缺血驱动的血运重建或学术研究联盟明确支架血栓形成的复合终点（1.4%对2.1%；OR，0.69；95% CI，0.51 - 0.92）。
结论
在当前时代，经皮冠状动脉介入治疗患者中的MI，无论定义如何，仍然与死亡风险增加相关。与氯吡格雷相比，坎格雷洛无论定义如何均能显著降低MI。
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