在美国和非美国亚组中比较坎格雷洛与标准疗法以实现血小板抑制最佳管理（CHAMPION）PHOENIX试验的患者概况和结局差异
Variation in Patient Profiles and Outcomes in US and Non-US Subgroups of the Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX Trial.
作者信息
Vaduganathan Muthiah, Harrington Robert A, Stone Gregg W, Steg Ph Gabriel, Gibson C Michael, Hamm Christian W, Price Matthew J, Prats Jayne, Deliargyris Efthymios N, Mahaffey Kenneth W, White Harvey D, Bhatt Deepak L
机构信息
From the Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (M.V., D.L.B); Stanford University Medical School, CA (R.A.H., K.W.M.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York City, NY (G.W.S.); FACT (French Alliance for Cardiovascular clinical Trials), DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance-Publique-Hôpitaux de Paris, France, and NHLI, Imperial College, Royal Brompton Hospital, London, UK (P.G.S.); Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.M.G.); Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany (C.W.H.); Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA (M.J.P.); The Medicines Company, Parsippany, NJ (J.P., E.N.D.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W).
出版信息
Circ Cardiovasc Interv. 2016 Jun;9(6):e003612. doi: 10.1161/CIRCINTERVENTIONS.116.003612.
BACKGROUND
The Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX trial demonstrated superiority of cangrelor in reducing ischemic events at 48 hours in patients undergoing percutaneous coronary intervention compared with clopidogrel.
METHODS AND RESULTS
We analyzed all patients included in the modified intention-to-treat analysis in US (n=4097; 37.4%) and non-US subgroups (n=6845; 62.6%). The US cohort was older, had a higher burden of cardiovascular risk factors, and had more frequently undergone prior cardiovascular procedures. US patients more frequently underwent percutaneous coronary intervention for stable angina (77.9% versus 46.2%). Almost all US patients (99.1%) received clopidogrel loading doses of 600 mg, whereas 40.5% of non-US patients received 300 mg. Bivalirudin was more frequently used in US patients (56.7% versus 2.9%). At 48 hours, rates of the primary composite end point were comparable in the US and non-US cohorts (5.5% versus 5.2%; P=0.53). Cangrelor reduced rates of the primary composite end point compared with clopidogrel in US (4.5% versus 6.4%; odds ratio 0.70 [95% confidence interval 0.53-0.92]) and in non-US patients (4.8% versus 5.6%; odds ratio 0.85 [95% confidence interval 0.69-1.05]; interaction P=0.26). Similarly, rates of the key secondary end point, stent thrombosis, were reduced by cangrelor in both regions. Rates of Global Use of Strategies to Open Occluded Arteries (GUSTO)-defined severe bleeding were low and not significantly increased by cangrelor in either region.
CONCLUSIONS
Despite broad differences in clinical profiles and indications for percutaneous coronary intervention by region in a large global cardiovascular clinical trial, cangrelor consistently reduced rates of ischemic end points compared with clopidogrel without an excess in severe bleeding in both the US and non-US subgroups.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01156571.
背景
坎格雷洛对比标准疗法以实现血小板抑制的最佳管理（CHAMPION）PHOENIX试验表明，与氯吡格雷相比，坎格雷洛在接受经皮冠状动脉介入治疗的患者中，48小时时可降低缺血事件发生率。
方法与结果
我们分析了美国（n = 4097；37.4%）和非美国亚组（n = 6845；62.6%）中纳入改良意向性分析的所有患者。美国队列患者年龄更大，心血管危险因素负担更高，且更频繁地接受过先前的心血管手术。美国患者因稳定型心绞痛接受经皮冠状动脉介入治疗的频率更高（77.9%对46.2%）。几乎所有美国患者（99.1%）接受600毫克氯吡格雷负荷剂量，而非美国患者中有40.5%接受300毫克。比伐卢定在美国患者中使用更频繁（56.7%对2.9%）。48小时时，美国和非美国队列的主要复合终点发生率相当（5.5%对5.2%；P = 0.53）。在美国患者中，坎格雷洛与氯吡格雷相比降低了主要复合终点发生率（4.5%对6.4%；优势比0.70 [95%置信区间0.53 - 0.92]），在非美国患者中也是如此（4.8%对5.6%；优势比0.85 [95%置信区间0.69 - 1.05]；交互作用P = 0.26）。同样，关键次要终点支架血栓形成的发生率在两个地区均被坎格雷洛降低。全球急性冠状动脉综合征注册研究（GUSTO）定义的严重出血发生率较低，且在任一地区坎格雷洛均未使其显著增加。
结论
在一项大型全球心血管临床试验中，尽管不同地区经皮冠状动脉介入治疗的临床特征和适应证存在广泛差异，但与氯吡格雷相比，坎格雷洛在美国和非美国亚组中均持续降低缺血终点发生率，且未增加严重出血风险。
临床试验注册
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