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Circ Cardiovasc Interv · Jun 2016
Randomized Controlled Trial Multicenter Study Comparative StudyVariation 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.
- Muthiah Vaduganathan, Robert A Harrington, Gregg W Stone, Ph Gabriel Steg, C Michael Gibson, Christian W Hamm, Matthew J Price, Jayne Prats, Efthymios N Deliargyris, Kenneth W Mahaffey, Harvey D White, and Deepak L Bhatt.
- 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).
- Circ Cardiovasc Interv. 2016 Jun 1; 9 (6).
BackgroundThe 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 ResultsWe 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.ConclusionsDespite 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 RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01156571.© 2016 The Authors.
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