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BARI 2D methods/primary end points. Participants2368 with Type 2 diabetes and angiographically documented stable ischaemic heart diseaseMean age 62.4 years, 10.4 years average duration of diabetes, 32% with MI history, 30.7% with triple-vessel disease Randomization Either prompt revascularizati
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1. Evidence of the Month Comment on:
A randomized trial of therapies for type 2 diabetes and coronary artery disease
2. BARI 2D methods/primary end points Participants
2368 with Type 2 diabetes and angiographically documented stable ischaemic heart disease
Mean age 62.4 years, 10.4 years average duration of diabetes, 32% with MI history, 30.7% with triple-vessel disease
Randomization
Either prompt revascularization or intensive medical therapy alone (delayed revascularization could take place if needed during the trial) and
Either insulin-sensitizing therapy (mainly metformin and rosiglitazone) or insulin-providing therapy (sulfonylurea and insulin)
End points
Rate of death and major cardiovascular events (death, MI, or stroke) over 5 years
3. Enrollment and randomization
4. Survival outcomes: revascularization (CABG or PCI) vs medical therapy
5. Survival outcomes: insulin sensitization vs insulin provision
6. Freedom from major cardiovascular events: insulin sensitization vs insulin provision
7. Freedom from major cardiovascular events: CABG vs medical therapy
8. Clinical implications Prompt revascularization and intensive medical therapy alone offer comparable cardioprotection for individuals with Type 2 diabetes and stable ischaemic heart disease
Insulin-providing and insulin-sensitizing glucose control strategies offer comparable cardioprotection; however, insulin sensitization is associated with lower HbA1c, less hypoglycaemia, lower plasma insulin, less weight gain, and higher high-density lipoprotein cholesterol
Prompt CABG is associated with significantly greater cardioprotection than medical therapy alone, when CABG is needed; CABG/insulin-sensitizing therapy offers greatest protection
Initial treatment with medication alone is a safe and effective option for most Type 2 diabetes patients with stable ischaemic heart disease
BARI 2D reduces concerns about the cardiovascular safety of glucose control strategies and supports insulin sensitization and provision as reasonable treatment options