article67

BARI 2D

"Intensive Medical Therapy for Type 2 Diabetes and Stable Ischemic Heart Disease".The New England Journal of Medicine. 2009. 362:1575-1585.PubMed•Full text•PDF

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcome
8.2 Secondary Outcomes
9 Funding
10 Further Reading

Clinical Question

In patients with type 2 diabetes and stable ischemic heart disease, is there a significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization with intensive medical therapy or intensive medical therapy alone, and between strategies of insulin sensitization and insulin provision?

Bottom Line

In patients with type 2 diabetes and stable ischemic heart disease receiving intensive medical therapy, there was no significant difference in the rates of death and major cardiovascular events between those undergoing prompt revascularization and those undergoing medical therapy alone, or between strategies of insulin sensitization and insulin provision over a 5-year period.

Major Points

Guidelines

As of August 2021, no guidelines have been published that reflect the results of this trial.

Design

Multicenter, randomized, controlled trial with a 2-by-2 factorial design
N=2,368 patients with type 2 diabetes and stable ischemic heart disease

Interventions:

Prompt revascularization with intensive medical therapy (n=1,187)
Intensive medical therapy alone (n=1,181)
Insulin-sensitization therapy (n=1,192)
Insulin-provision therapy (n=1,176)
Mean follow-up: 5.3 years
Analysis: Intention-to-treat
Primary endpoint: Death from any cause
Principal secondary endpoint: Composite of death, myocardial infarction, or stroke (major cardiovascular events)

Population

Inclusion Criteria: Diagnosed with both type 2 diabetes and coronary artery disease; eligible for elective percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG)
Exclusion Criteria: Immediate revascularization required, left main coronary disease, creatinine >2.0 mg/dL, glycated hemoglobin >13.0%, class III or IV heart failure, hepatic dysfunction, PCI or CABG within previous 12 months
Baseline Characteristics: Symptomatic myocardial ischemia in 82.1% of patients, mean duration of diabetes 10.4 years

Interventions

Patients randomized to one of four groups combining revascularization and insulin therapy strategies:
1. Prompt revascularization + insulin sensitization
2. Prompt revascularization + insulin provision
3. Medical therapy alone + insulin sensitization
4. Medical therapy alone + insulin provision

Outcomes

Primary Outcome: Rates of death from any cause did not differ significantly between the revascularization group and the medical-therapy group, or between the insulin-sensitization group and the insulin-provision group over 5 years.
Secondary Outcomes: Rates of freedom from major cardiovascular events did not differ significantly among the groups.
In the CABG stratum, prompt revascularization significantly reduced major cardiovascular events compared with medical therapy. No significant difference in primary endpoints between groups in the PCI stratum.

Funding

Supported by grants from the National Institutes of Health, with additional support from various industry sponsors.