BARI 2D Trial BARI 2D Trial Presented at the American Diabetes Association (ADA) Annual Scientific Sessions 2009 in New Orleans The Bypass Angioplasty Revascularization Investigation 2 DiabetesTrial The Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial Copyleft Clinical Trial Results. You Must Redistribute Slides

BARI 2D Trial: Background Patients with Type 2 diabetes have an increased risk of suffering a cardiovascular event over non-diabetic patients.Patients with Type 2 diabetes have an increased risk of suffering a cardiovascular event over non-diabetic patients. The success of coronary revascularization in reducing myocardial infarction and death in diabetic patients with chronic stable angina has not been established.The success of coronary revascularization in reducing myocardial infarction and death in diabetic patients with chronic stable angina has not been established. Similarly, it is unclear if insulin sensitization therapy offers benefits over insulin provision therapy in reducing cardiovascular events.Similarly, it is unclear if insulin sensitization therapy offers benefits over insulin provision therapy in reducing cardiovascular events. BARI 2D Study Group, NEJM 2009

Copyleft Clinical Trial Results. You Must Redistribute Slides PCI Stratum (N= 1605) CABG Stratum (N= 763) BARI 2D Trial: Study Design OMT alone (N= 385) CABG +OMT (N= 378) 2368 patients with mild to moderate CAD and Type 2 diabetes prior to randomization. Prospective. Randomized. Mean follow-up 5.3 years  Primary Endpoint: Death (from any cause)  Secondary Endpoint: Composite of Death, MI, or Stroke R R R BARI 2D Study Group, NEJM 2009 OMT alone (N= 807) PCI +OMT (N= 798) Provision (N= 194) Sensitization (N= 191) Provision (N= 190) Sensitization (N= 188) Provision (N= 399) Provision (N= 402) Sensitization (N= 408) Sensitization (N= 396) RRR R

CharacteristicRevasc (CABG + OMT or PCI + OMT) (n=1176) OMT (n=1192) Age (yrs  SD) 62.3   9.0 Male (%) HbA1c (% mean  SD) 7.6   1.6 Duration of diabetes (years mean  SD) 10.2   8.8 History of MI (%) History of CHF (%) Cerebrovascular event (%) Peripheral artery disease (%) Prior revascularization (%) BARI 2D Trial: Baseline Characteristics BARI 2D Study Group, NEJM 2009 Copyleft Clinical Trial Results. You Must Redistribute Slides

Characteristic Insulin Sensitization (n=1183) Insulin Provision (n=1185) Age (yrs  SD) 62.3   8.7 Male (%) HbA1c (% mean  SD) 7.6   1.6 Duration of diabetes (years mean  SD) 10.1   8.9 History of MI (%) History of CHF (%) Cerebrovascular event (%) Peripheral artery disease (%) Prior revascularization (%) BARI 2D Trial: Baseline Characteristics BARI 2D Study Group, NEJM 2009 Copyleft Clinical Trial Results. You Must Redistribute Slides

The 5-year death rate for the group receiving revascularization plus optimal medical therapy was 13.2% vs. 13.5% in the group receiving optimal medical therapy alone.The 5-year death rate for the group receiving revascularization plus optimal medical therapy was 13.2% vs. 13.5% in the group receiving optimal medical therapy alone. The difference between the two treatment groups did not reach statistical significance.The difference between the two treatment groups did not reach statistical significance. Death (%) Death (%) BARI 2D Trial: Primary Endpoint n =155 n =161 p = 0.97 BARI 2D Study Group, NEJM 2009 Copyleft Clinical Trial Results. You Must Redistribute Slides

The 5-year death rate for the group receiving insulin sensitization therapy was 13.2% vs. 13.5% in the group receiving insulin provision therapy.The 5-year death rate for the group receiving insulin sensitization therapy was 13.2% vs. 13.5% in the group receiving insulin provision therapy. The difference between the two treatment groups did not reach statistical significance.The difference between the two treatment groups did not reach statistical significance. Death (%) Death (%) BARI 2D Trial: Primary Endpoint n =156 n =160 p = 0.89 BARI 2D Study Group, NEJM 2009 Copyleft Clinical Trial Results. You Must Redistribute Slides

BARI 2D Trial: Secondary Endpoint The rates of MI, stroke and the combined secondary endpoint of death, MI, and stroke were similar between the group receiving revascularization plus optimal medical therapy vs. the group receiving optimal medical therapy alone.The rates of MI, stroke and the combined secondary endpoint of death, MI, and stroke were similar between the group receiving revascularization plus optimal medical therapy vs. the group receiving optimal medical therapy alone. The difference between the two treatment groups for the combined secondary endpoint of death, MI, and stroke did not reach statistical significance (p=0.70)The difference between the two treatment groups for the combined secondary endpoint of death, MI, and stroke did not reach statistical significance (p=0.70) n=118 BARI 2D Study Group, NEJM 2009 Cardiovascular Event (%) n=138 n=30 n=33 n=266 n=283

Copyleft Clinical Trial Results. You Must Redistribute Slides BARI 2D Trial: Secondary Endpoint The rates of MI, stroke and the combined secondary endpoint of death, MI, and stroke were similar between the group insulin sensitization therapy vs. the group receiving insulin provision therapy.The rates of MI, stroke and the combined secondary endpoint of death, MI, and stroke were similar between the group insulin sensitization therapy vs. the group receiving insulin provision therapy. The difference between the two treatment groups for the combined secondary endpoint of death, MI, and stroke did not reach statistical significance (p=0.13)The difference between the two treatment groups for the combined secondary endpoint of death, MI, and stroke did not reach statistical significance (p=0.13) n=118 BARI 2D Study Group, NEJM 2009 Cardiovascular Event (%) n=138 n=27 n=36 n=261 n=288

Copyleft Clinical Trial Results. You Must Redistribute Slides BARI 2D Trial: Limitations Patients who are at high risk for MI and, therefore, stand to benefit the most from revascularization were excluded from the trial.Patients who are at high risk for MI and, therefore, stand to benefit the most from revascularization were excluded from the trial. The broad applicability of BARI 2D is limited by the fact that the patient population selected represents only a small subset of patients with diabetes and coronary artery disease.The broad applicability of BARI 2D is limited by the fact that the patient population selected represents only a small subset of patients with diabetes and coronary artery disease. BARI 2D Study Group, NEJM 2009

Copyleft Clinical Trial Results. You Must Redistribute Slides BARI 2D Trial: Summary Neither revascularization nor optimal medical therapy demonstrated a significant reduction in the occurrence of death or major cardiovascular events at 5 years.Neither revascularization nor optimal medical therapy demonstrated a significant reduction in the occurrence of death or major cardiovascular events at 5 years. Likewise, there was no demonstrated difference between a strategy of insulin sensitization and insulin provision.Likewise, there was no demonstrated difference between a strategy of insulin sensitization and insulin provision. Further research into defining optimal medical therapy for this group of patients is needed, as evidenced by the fact that 42.1% of patients in the optimal medical therapy alone treatment group eventually required revascularization within 5 years.Further research into defining optimal medical therapy for this group of patients is needed, as evidenced by the fact that 42.1% of patients in the optimal medical therapy alone treatment group eventually required revascularization within 5 years. BARI 2D Study Group, NEJM 2009