title: Clinical and angiographic risk stratification and differential impact on treatment outcomes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.
abstract: BACKGROUND
  The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial assigned patients with type 2 diabetes mellitus to prompt coronary revascularization plus intensive medical therapy versus intensive medical therapy alone and reported no significant difference in mortality. Among patients selected for coronary artery bypass graft surgery, prompt coronary revascularization was associated with a significant reduction in death/myocardial infarction/stroke compared with intensive medical therapy. We hypothesized that clinical and angiographic risk stratification would affect the effectiveness of the treatments overall and within revascularization strata.
  
  
  RESULTS
  An angiographic risk score was developed from variables assessed at randomization; independent prognostic factors were myocardial jeopardy index, total number of coronary lesions, prior coronary revascularization, and left ventricular ejection fraction. The Framingham Risk Score for patients with coronary disease was used to summarize clinical risk. Cardiovascular event rates were compared by assigned treatment within high-risk and low-risk subgroups. Overall, no outcome differences between the intensive medical therapy and prompt coronary revascularization groups were seen in any risk stratum. The 5-year risk of death/myocardial infarction/stroke was 36.8% for intensive medical therapy compared with 24.8% for prompt coronary revascularization among the 381 coronary artery bypass graft surgery-selected patients in the highest angiographic risk tertile (P=0.005); this treatment effect was amplified in patients with both high angiographic and high Framingham risk (47.3% intensive medical therapy versus 27.1% prompt coronary revascularization; P=0.010; hazard ratio=2.10; P=0.009). Treatment group differences were not significant in other clinical-angiographic risk groups within the coronary artery bypass graft surgery stratum, or in any subgroups within the percutaneous coronary intervention stratum.
  
  
  CONCLUSIONS
  Among patients with diabetes mellitus and stable ischemic heart disease, a strategy of prompt coronary artery bypass graft surgery significantly reduces the rate of death/myocardial infarction MI/stroke in those with extensive coronary artery disease or impaired left ventricular function.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.
authors.affiliation: Department of Epidemiology, University of Pittsburgh, GSPH, A530 Crabtree Hall/130 DeSoto St, Pittsburgh, PA 15261, USA. mbrooks@pitt.edu
authors.forename: Maria Mori
authors.initials: MM
authors.lastname: Brooks
authors.forename: Bernard R
authors.initials: BR
authors.lastname: Chaitman
authors.forename: Richard W
authors.initials: RW
authors.lastname: Nesto
authors.forename: Regina M
authors.initials: RM
authors.lastname: Hardison
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Gersh
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Krone
authors.forename: Edward Y
authors.initials: EY
authors.lastname: Sako
authors.forename: William J
authors.initials: WJ
authors.lastname: Rogers
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Garber
authors.forename: Spencer B
authors.initials: SB
authors.lastname: King
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Davidson
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Ikeno
authors.forename: Robert L
authors.initials: RL
authors.lastname: Frye
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D017023:Coronary Angiography / Q000379:methods; D001026:Coronary Artery Bypass / Q000379:methods; D003924:Diabetes Mellitus, Type 2 / Q000000981:diagnostic imaging* / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods; D012307:Risk Factors; D016896:Treatment Outcome