title: The efficacy of ticagrelor is maintained in women with acute coronary syndromes participating in the prospective, randomized, PLATelet inhibition and patient Outcomes (PLATO) trial.
abstract: OBJECTIVE
  The aim of this study was to assess the relationship between sex and clinical outcomes and treatment-related complications in patients with ST-elevation or non-ST-elevation acute coronary syndromes (ACS) randomized to treatment with ticagrelor or clopidogrel in the PLATelet inhibition and patient Outcomes (PLATO) trial.
  
  
  METHODS
  The associations between sex subgroup and the primary composite outcomes, secondary outcomes, and major bleeding endpoints as well as interaction of sex subgroup with treatment effects were analysed using Cox proportional-hazards models.
  
  
  RESULTS
  Sex was not significantly associated with the probability of the primary composite endpoint [adjusted hazard ratio (HR): 1.02 (0.91-1.16)], or other adverse cardiovascular endpoints. Ticagrelor was similarly more effective than clopidogrel in reducing rates of the primary endpoint in women 11.2 vs. 13.2% [adjusted HR: 0.88 (0.74-1.06)] and men 9.4 vs. 11.1% [adjusted HR: 0.86 (0.76-0.97)] (interaction P-value 0.78), all-cause death in women 5.8 vs. 6.8% [adjusted HR: 0.90 (0.69-1.16)] and men 4.0 vs. 5.7% [adjusted HR: 0.80 (0.67-0.96)] (interaction P-value 0.49), and definite stent thrombosis in women 1.2 vs. 1.4% [adjusted HR: 0.71 (0.36-1.38)] and men 1.4 vs. 2.1% [adjusted HR: 0.63 (0.45-0.89)] (interaction P-value 0.78). The treatments did not differ for PLATO-defined overall major bleeding complications in women [adjusted HR: 1.01 (0.83-1.23)] or men [adjusted HR: 1.10 (0.98-1.24)]. Sex had no significant association with these outcomes (interactions P = 0.43-0.88).
  
  
  CONCLUSIONS
  Female sex is not an independent risk factor for adverse clinical outcomes in moderate-to-high risk ACS patients. Ticagrelor has a similar efficacy and safety profile in men and women.
authors.affiliation: Medical Department, Hospital Unit West, GI, Landevej 61, Herning 7400, Denmark steehust@rm.dk.
authors.forename: Steen
authors.initials: S
authors.lastname: Husted
authors.affiliation: Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Stefan K
authors.initials: SK
authors.lastname: James
authors.affiliation: Cardiovascular Division, Washington University School of Medicine, St Louis, MO, USA.
authors.forename: Richard G
authors.initials: RG
authors.lastname: Bach
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Richard C
authors.initials: RC
authors.lastname: Becker
authors.affiliation: Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Budaj
authors.affiliation: Cardiology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Magda
authors.initials: M
authors.lastname: Heras
authors.affiliation: AstraZeneca Research and Development, Mölndal, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Himmelmann
authors.affiliation: AstraZeneca Research and Development, Wilmington, DE, USA.
authors.forename: Jay
authors.initials: J
authors.lastname: Horrow
authors.affiliation: Medizinishe Klinik, Universitätsklinikum Heidelberg, Heidelberg, Germany.
authors.forename: Hugo A
authors.initials: HA
authors.lastname: Katus
authors.affiliation: Division of Hematology and Laboratory Services Coagulation Disorders, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Riita
authors.initials: R
authors.lastname: Lassila
authors.affiliation: Santo Andre Hospital, Leiria, Portugal.
authors.forename: Joao
authors.initials: J
authors.lastname: Morais
authors.affiliation: Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: José C
authors.initials: JC
authors.lastname: Nicolau
authors.affiliation: INSERM-Unité 698, Paris, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, France Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France.
authors.forename: Ph Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Department of Cardiovascular Science, University of Sheffield, Sheffield, UK.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Storey
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Wojdyla
authors.affiliation: Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Wallentin
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000241:Adenosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000368:Aged; D000077144:Clopidogrel; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006083:Graft Occlusion, Vascular / Q000517:prevention & control; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D058921:Purinergic P2Y Receptor Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D012737:Sex Factors; D015607:Stents; D020521:Stroke / Q000209:etiology; D000077486:Ticagrelor; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D000077144:Clopidogrel; D000077486:Ticagrelor; D000241:Adenosine; D013988:Ticlopidine
keywords: Acute coronary syndromes; P2Y12 receptor; Platelets; Sex; Thrombosis; Ticagrelor