title: Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease: A pre-specified subset analysis of the Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation (COURAGE) trial.
abstract: OBJECTIVE
  To determine whether sex-based differences exist in clinical effectiveness of percutaneous coronary intervention (PCI) when added to optimal medical therapy (OMT) in patients with stable coronary artery disease.
  
  
  BACKGROUND
  A prior pre-specified unadjusted analysis from COURAGE showed that women randomized to PCI had a lower rate of death or myocardial infarction during a median 4.6-year follow-up with a trend for interaction with respect to sex.
  
  
  METHODS
  We analyzed outcomes in 338 women (15%) and 1949 men (85%) randomized to PCI plus OMT versus OMT alone after adjustment for relevant baseline characteristics.
  
  
  RESULTS
  There was no difference in treatment effect by sex for the primary end point (death or myocardial infarction; HR, 0.89; 95% CI, 0.77-1.03 for women and HR, 1.02, 95% CI 0.96-1.10 for men; P for interaction = .07). Although the event rate was low, a trend for interaction by sex was nonetheless noted for hospitalization for heart failure, with only women, but not men, assigned to PCI experiencing significantly fewer events as compared to their counterparts receiving OMT alone (HR, 0.59; 95% CI, 0.40-0.84, P < .001 for women and HR, 0.86; 95% CI, 0.74-1.01, P = .47 for men; P for interaction = .02). Both sexes randomized to PCI experienced significantly reduced need for subsequent revascularization (HR, 0.72; 95% CI, 0.62-0.83, P < .001 for women; HR, 0.84; 95% CI, 0.79-0.89, P < .001 for men; P for interaction = .02) with evidence of a sex-based differential treatment effect.
  
  
  CONCLUSIONS
  In this adjusted analysis of the COURAGE trial, there were no significant differences in treatment effect on major outcomes between men and women. However, women assigned to PCI demonstrated a greater benefit as compared to men, with a reduction in heart failure hospitalization and need for future revascularization. These exploratory observations require further prospective study.
authors.affiliation: Einstein Medical Center Philadelphia, Philadelphia, PA.
authors.forename: Subroto
authors.initials: S
authors.lastname: Acharjee
authors.affiliation: Hamilton General Hospital/Master University, Hamilton, Canada.
authors.forename: Koon K
authors.initials: KK
authors.lastname: Teo
authors.affiliation: Boston Medical Center, Boston, MA.
authors.forename: Alice K
authors.initials: AK
authors.lastname: Jacobs
authors.affiliation: VA Connecticut Healthcare System, West Haven, CT.
authors.forename: Pamela M
authors.initials: PM
authors.lastname: Hartigan
authors.affiliation: Geisinger Medical Center, Danville, PA.
authors.forename: Kulpreet
authors.initials: K
authors.lastname: Barn
authors.affiliation: Montreal Heart Institute/Université de Montréal, Montreal, QC, Canada.
authors.forename: Gilbert
authors.initials: G
authors.lastname: Gosselin
authors.affiliation: Montreal Heart Institute/Université de Montréal, Montreal, QC, Canada.
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Tanguay
authors.affiliation: Vanderbilt University Medical Center, Nashville, TN.
authors.forename: David J
authors.initials: DJ
authors.lastname: Maron
authors.affiliation: London Health Science Centre, London, ON, Canada.
authors.forename: William J
authors.initials: WJ
authors.lastname: Kostuk
authors.affiliation: Saint Louis University School of Medicine, St. Louis, MT.
authors.forename: Bernard R
authors.initials: BR
authors.lastname: Chaitman
authors.affiliation: Vancouver Hospital and Health Science Centre, Vancouver, BC, Canada.
authors.forename: G B John
authors.initials: GB
authors.lastname: Mancini
authors.affiliation: Mid America Heart Institute, Kansas City, MO.
authors.forename: John A
authors.initials: JA
authors.lastname: Spertus
authors.affiliation: Hartford Hosp, Hartford, CT.
authors.forename: Marcin R
authors.initials: MR
authors.lastname: Dada
authors.affiliation: University of Michigan, Ann Arbor, MI.
authors.forename: Eric R
authors.initials: ER
authors.lastname: Bates
authors.affiliation: University of Kentucky Med Center, Lexington, KY.
authors.forename: David C
authors.initials: DC
authors.lastname: Booth
authors.affiliation: Christiana Healthcare System and Center for Outcomes Research, Newark, DE.
authors.forename: William S
authors.initials: WS
authors.lastname: Weintraub
authors.affiliation: South Texas Veterans Health Care System-Audie Murphy Campus, San Antonio, TX.
authors.forename: Robert A
authors.initials: RA
authors.lastname: O'Rourke
authors.affiliation: Stratton VA Medical Center, Albany Medical College, Albany, NY. Electronic address: william.boden@va.gov.
authors.forename: William E
authors.initials: WE
authors.lastname: Boden
mesh_terms: D000368:Aged; D002170:Canada / Q000453:epidemiology; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002423:Cause of Death / Q000639:trends; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011379:Prognosis; D011446:Prospective Studies; D012189:Retrospective Studies; D018570:Risk Assessment; D012737:Sex Factors; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D002317:Cardiovascular Agents