Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes

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.

Conditions

• Coronary Disease
• Cardiovascular Diseases
• Heart Diseases
• Insulin Resistance
• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent

Interventions

PROCEDURE

Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions

Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions

PROCEDURE

Coronary Artery Bypass

Coronary Artery Bypass

DRUG

Biguanides, thiazolidinediones

Biguanides, thiazolidinediones

DRUG

Insulin, sulfonylurea

Insulin, sulfonylurea

DRUG

ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers

ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Bernard Chaitman, MD · St. Louis University

• Robert L Frye, MD · Mayo Clinic

• Mark Hlatky · Stanford University

• Burton Sobel · University of Vermont & State Agricultural College

• Sheryl F. Kelsey, PhD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-09-30

Primary Completion

2008-11-30

Completion

2009-03-31