At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus diagnosis
- ✓Coronary arteriogram showing ≥50% stenosis in ≥1 vessel amenable to revascularization
- ✓Objective documentation of ischemia (ST changes, perfusion defect, wall motion abnormality, CFR <2.0, or FFR <0.75) OR subjective typical angina with ≥70% stenosis in ≥1 artery
- ✓Suitable for coronary revascularization by ≥1 available method (does not require complete revascularization)
- ✕Definite need for urgent invasive intervention as determined by attending cardiologist
- ✕Prior CABG or catheter-based intervention within 12 months before study entry
- ✕NYHA Class III or IV congestive heart failure
- ✕Creatinine >2.0 mg/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Coronary Artery Bypass, and 3 other interventions for Coronary Disease and 5 related conditions. Completed, enrolled 2,368 participants.
Detailed Summary
The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients). SPECIFIC AIMS A. Primary Aim The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity: 1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone; 2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision. B. Secondary Aims The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.
Study Details
Timeline
Interventions
Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions
Coronary Artery Bypass
Biguanides, thiazolidinediones
Insulin, sulfonylurea
ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers