title: Risk factor control for coronary artery disease secondary prevention in large randomized trials.
abstract: OBJECTIVE
  This study evaluated data from 3 federally funded trials that focused on optimal medical therapy to determine if formalized attempts at risk factor control within clinical trials are effective in achieving guideline-driven treatment goals for diabetic patients with coronary artery disease (CAD).
  
  
  BACKGROUND
  Despite clear evidence of benefit for CAD secondary prevention, the level of risk factor control in clinical practice has been disappointing.
  
  
  METHODS
  We obtained data from the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) diabetes subgroup, (n = 766 of 2,287), the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial (n = 2,368), and the FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial (n = 1,900) to evaluate the proportion of patients achieving guideline-based, protocol-driven treatment targets for systolic blood pressure, low-density lipoprotein cholesterol, smoking cessation, and hemoglobin A1c. The primary outcome measure was the proportion of diabetic CAD patients meeting all 4 pre-specified targets at 1 year after enrollment.
  
  
  RESULTS
  The pooled data include 5,034 diabetic patients. The percentages of patients achieving the 1-year low-density lipoprotein cholesterol targets compared with baseline increased from 55% to 77% in COURAGE, from 59% to 75% in BARI 2D, and from 34% to 42% in FREEDOM. Although similar improved trends were seen for systolic blood pressure, glycemic control, and smoking cessation, only 18% of the COURAGE diabetes subgroup, 23% of BARI 2D patients, and 8% of FREEDOM patients met all 4 pre-specified treatment targets at 1 year of follow-up.
  
  
  CONCLUSIONS
  A significant proportion of diabetic CAD patients fail to achieve pre-specified targets for 4 major modifiable cardiovascular risk factors in clinical trials. We conclude that fundamentally new thinking is needed to explore approaches to achieve optimal secondary prevention treatment goals. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657) (Bypass Angioplasty Revascularization Investigation 2 Diabetes [BARI 2D]; NCT00006305) (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).
authors.affiliation: Mount Sinai School of Medicine, New York, New York 10029, USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Farkouh
authors.forename: William E
authors.initials: WE
authors.lastname: Boden
authors.forename: Vera
authors.initials: V
authors.lastname: Bittner
authors.forename: Victoria
authors.initials: V
authors.lastname: Muratov
authors.forename: Pamela
authors.initials: P
authors.lastname: Hartigan
authors.forename: May
authors.initials: M
authors.lastname: Ogdie
authors.forename: Marnie
authors.initials: M
authors.lastname: Bertolet
authors.forename: Shiny
authors.initials: S
authors.lastname: Mathewkutty
authors.forename: Koon
authors.initials: K
authors.lastname: Teo
authors.forename: David J
authors.initials: DJ
authors.lastname: Maron
authors.forename: Sanjum S
authors.initials: SS
authors.lastname: Sethi
authors.forename: Michael
authors.initials: M
authors.lastname: Domanski
authors.forename: Robert L
authors.initials: RL
authors.lastname: Frye
authors.forename: Valentin
authors.initials: V
authors.lastname: Fuster
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D002317:Cardiovascular Agents / Q000627:therapeutic use; D008078:Cholesterol, LDL / Q000097:blood; D015897:Comorbidity; D001026:Coronary Artery Bypass / Q000379:methods; D003324:Coronary Artery Disease / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control / Q000523:psychology / Q000628:therapy; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000453:epidemiology / Q000628:therapy; D015987:Effect Modifier, Epidemiologic; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D010043:Outcome and Process Assessment, Health Care; D017410:Practice Guidelines as Topic; D012307:Risk Factors; D040242:Risk Reduction Behavior; D055502:Secondary Prevention / Q000379:methods*; D016540:Smoking Cessation
chemical_list: D002317:Cardiovascular Agents; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents