title: Efficacy and Safety of Cangrelor in Women Versus Men During Percutaneous Coronary Intervention: Insights From the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) Trial.
abstract: BACKGROUND
  Cangrelor is an intravenous ADP receptor antagonist that leads to potent and reversible inhibition of platelet aggregation. The relative safety and efficacy of some antiplatelet drugs in women has been disputed.
  
  
  RESULTS
  The Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial randomized 11,145 patients undergoing elective or urgent percutaneous coronary intervention to cangrelor or clopidogrel. The primary efficacy end point was the composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours; the key secondary end point was stent thrombosis at 48 hours. The primary safety end point was GUSTO severe bleeding at 48 hours. Of subjects analyzed, 3051 (28%) were female. Cangrelor reduced the odds of the primary end point by 35% in women (adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.48-0.89) and by 14% in men (OR, 0.86; 95% CI, 0.70-1.05; P interaction=0.23) compared with clopidogrel. Cangrelor reduced the odds of stent thrombosis by 61% in women (OR, 0.39; 95% CI, 0.20-0.77) and 16% in men (OR, 0.84; 95% CI, 0.53-1.33; P interaction=0.11). The odds of severe bleeding were similar in both women and men treated with cangrelor (0.3% versus 0.2%, P=0.30 [women]; 0.1% versus 0.1%, P=0.41 [men]; P interaction=0.88) versus clopidogrel. Cangrelor increased the odds of moderate bleeding in women (0.9% versus 0.3%, P=0.02), but not in men (0.2% versus 0.2%, P=0.68; P interaction=0.040). The net clinical benefit (primary efficacy and safety end point) favored cangrelor in both women (OR, 0.68; 95% CI, 0.50-0.92) and men (OR, 0.87; 95% CI, 0.71-1.06; P interaction=0.26).
  
  
  CONCLUSIONS
  In CHAMPION PHOENIX, cangrelor reduced the odds of major adverse cardiovascular events and stent thrombosis in women and men and appeared to offer greater net clinical benefit than clopidogrel.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01156571.
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.). modonoghue@partners.org.
authors.forename: Michelle L
authors.initials: ML
authors.lastname: O'Donoghue
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Ph Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Price
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Jayne
authors.initials: J
authors.lastname: Prats
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Tiepu
authors.initials: T
authors.lastname: Liu
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.affiliation: From Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.L.O., D.L.B.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.); FACT, DHU FIRE, Université Paris-Diderot, Sorbonne Paris-Cité, France (G.S.); LVTS INSERM U-1148, Hôpital Bichat, HUPNVS, AP-HP, Paris, France (G.S.); NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (G.S.); Beth Israel Deaconess Medical Center, Division of Cardiology, 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., T.L., E.N.D.); Stanford University Medical School, Stanford, CA (K.W.M., R.A.H.); and Green Lane Cardiovascular Service, Auckland, New Zealand (H.D.W.).
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
mesh_terms: D000249:Adenosine Monophosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D019468:Disease Management; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control; D062645:Percutaneous Coronary Intervention / Q000379:methods* / Q000639:trends; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012727:Sex Characteristics; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000249:Adenosine Monophosphate; C117446:cangrelor
keywords: ADP receptor antagonist; cangrelor; clopidogrel; percutaneous coronary intervention