title: The effect of cangrelor and access site on ischaemic and bleeding events: insights from CHAMPION PHOENIX.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov identifier: NCT01156571.
authors.affiliation: Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.
authors.forename: J Antonio
authors.initials: JA
authors.lastname: Gutierrez
authors.affiliation: Stanford University Medical School, Stanford, CA, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.affiliation: Geisinger Medical Center, Danville, PA, USA.
authors.forename: James C
authors.initials: JC
authors.lastname: Blankenship
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY, USA.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance-Publique-Hôpitaux de Paris, Paris, France NHLI, Imperial College, Royal Brompton Hospital, London, UK.
authors.forename: Ph Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Beth Israel Deaconess Medical Center, Division of Cardiology, Boston, MA, USA.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany.
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.affiliation: Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Price
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY, USA.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.affiliation: The Medicines Company, Parsippany, NJ, USA.
authors.forename: Jayne
authors.initials: J
authors.lastname: Prats
authors.affiliation: The Medicines Company, Parsippany, NJ, USA.
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.affiliation: Stanford University Medical School, Stanford, CA, USA.
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.affiliation: Green Lane Cardiovascular Service, Auckland, New Zealand.
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.affiliation: Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA dlbhattmd@post.harvard.edu.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
mesh_terms: D000249:Adenosine Monophosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000368:Aged; D000077144:Clopidogrel; D003328:Coronary Thrombosis / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005263:Femoral Artery; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017202:Myocardial Ischemia / Q000628:therapy*; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D058921:Purinergic P2Y Receptor Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D017534:Radial Artery; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D000249:Adenosine Monophosphate; C117446:cangrelor; D000077144:Clopidogrel; D013988:Ticlopidine
keywords: Percutaneous coronary intervention; Platelet inhibition; Radial artery