title: Safety of Routine Invasive Versus Selective Invasive Therapy in Women with Non-ST-Elevation Acute Coronary Syndrome.
abstract: BACKGROUND
  Prior studies suggested that a routine invasive approach in the management of non-ST-elevation acute coronary syndrome (NSTE-ACS) is beneficial in men, but the data are less conclusive in women. One study conducted exclusively in women found that routine invasive therapy was associated with a markedly increased risk of major bleeding. This pilot randomized controlled trial compared the safety of a routine invasive versus a selective invasive strategy among women.
  
  
  METHODS
  Women with NSTE-ACS and an additional high-risk characteristic were randomized to a routine invasive versus a selective invasive strategy. The primary outcome was the risk of major bleeding. The secondary outcome was the first occurrence of all-cause death, myocardial infarction, stroke, re-hospitalization for ACS, or major bleeding within 6 months.
  
  
  RESULTS
  Twenty-three women were assigned to routine invasive therapy and 17 to selective invasive therapy. Twenty-seven women (68%) had elevated troponin T (mean 0.33 ng/mL) and/or creatinine kinase-MB (mean 23 ng/mL). The risk of major bleeding was similar with both approaches (P = 0.99). At 6 months, the secondary outcome occurred in 9% of the routine invasive group versus 18% of the selective invasive group (risk ratio = 0.49, 95% confidence interval 0.09-2.63, P = 0.63).
  
  
  CONCLUSIONS
  This pilot study demonstrated that a routine invasive approach is safe in women. There was suggestion of benefit from routine invasive therapy compared with selective invasive therapy. These data could be used to design an appropriately powered trial to determine the optimal management strategy among women with NSTE-ACS.
authors.affiliation: North Florida/South Georgia Veterans Affairs Health System, Gainesville, FL, USA. bavryaa@medicine.ufl.edu.|Department of Medicine, University of Florida, Gainesville, FL, USA. bavryaa@medicine.ufl.edu.
authors.forename: Anthony A
authors.initials: AA
authors.lastname: Bavry
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Islam Y
authors.initials: IY
authors.lastname: Elgendy
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Mahmoud
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Manoj P
authors.initials: MP
authors.lastname: Jadhav
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Tianyao
authors.initials: T
authors.lastname: Huo
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Marian C
authors.initials: MC
authors.lastname: Limacher
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Pepine
keywords: Major bleeding; Myocardial infarction; Non-ST-elevation acute coronary syndrome; Sex differences; Women