title: Frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.
abstract: BACKGROUND
  In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, some patients with stable ischemic heart disease randomized to optimal medical therapy (OMT) crossed over to early revascularization. The predictors and outcomes of patients who crossed over from OMT to revascularization are unknown.
  
  
  RESULTS
  We compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire. To quantify the potential consequences of initiating OMT without percutaneous coronary intervention, we compared the outcomes of crossover patients with a matched cohort randomized to immediate percutaneous coronary intervention. Among 1148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline Seattle Angina Questionnaire scores and healthcare system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to percutaneous coronary intervention, rates of mortality (hazard ratio=0.51 [0.13-2.1]) and nonfatal myocardial infarction (hazard ratio=1.9 [0.75-4.6]) were similar, as were 1-year Seattle Angina Questionnaire scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (hazard ratio=2.8 [1.1-7.5]).
  
  
  CONCLUSIONS
  Among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment, and, to a lesser extent, their health system were associated with early revascularization. Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, these findings support an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657.
authors.affiliation: Department of Cardiovascular Research, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA. spertusj@umkc.edu
authors.forename: John A
authors.initials: JA
authors.lastname: Spertus
authors.forename: David J
authors.initials: DJ
authors.lastname: Maron
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Paul
authors.initials: P
authors.lastname: Kolm
authors.forename: Pam
authors.initials: P
authors.lastname: Hartigan
authors.forename: William S
authors.initials: WS
authors.lastname: Weintraub
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Berman
authors.forename: Koon K
authors.initials: KK
authors.lastname: Teo
authors.forename: Leslee J
authors.initials: LJ
authors.lastname: Shaw
authors.forename: Steven P
authors.initials: SP
authors.lastname: Sedlis
authors.forename: Merril
authors.initials: M
authors.lastname: Knudtson
authors.forename: Mihaela
authors.initials: M
authors.lastname: Aslan
authors.forename: Marcin
authors.initials: M
authors.lastname: Dada
authors.forename: William E
authors.initials: WE
authors.lastname: Boden
authors.forename: G B John
authors.initials: GB
authors.lastname: Mancini
mesh_terms: D000368:Aged; D000789:Angina, Unstable / Q000175:diagnosis / Q000209:etiology / Q000628:therapy; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D015897:Comorbidity; D023921:Coronary Stenosis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D018592:Cross-Over Studies; D005260:Female; D006304:Health Status; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009656:North America; D010343:Patient Admission; D017060:Patient Satisfaction; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000401:mortality; D016016:Proportional Hazards Models; D011788:Quality of Life; D012307:Risk Factors; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents
keywords: angina; chronic coronary artery disease; clinical trials; percutaneous coronary interventions; quality of life