Table 1.

Inclusion criteria for the EMPA-REG trial

Excerpted from the supplementary material included in the EMPA-REG trial manuscript by Zinman et al. [1]

Inclusion criteria
History of myocardial infarction
History of myocardial infarction >2 months prior to informed consent
Coronary artery disease
Evidence of multi-vessel coronary artery disease, i.e., in ≥2 major coronary arteries or the left main coronary artery, documented by any of the following:
Presence of significant stenosis: ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography)
Previous revascularization (percutaneous transluminal coronary angioplasty ± stent or coronary artery bypass graft >2 months prior to consent
The combination of revascularization in one major coronary artery and significant stenosis (≥50% luminal narrowing) in another major coronary artery
Evidence of single-vessel coronary artery disease, ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography) not subsequently successfully revascularized, with at least 1 of the following:
A positive non-invasive stress test for ischemia
Hospital discharge for unstable angina ≤12 months prior to consent
Unstable angina
Unstable angina >2 months prior to consent with evidence of single- or multi-vessel coronary artery disease
History of stroke
History of stroke (ischemic or hemorrhagic) >2 months prior to consent
Peripheral artery disease
Occlusive peripheral artery disease documented by any of the following:
Limb angioplasty, stenting, or bypass surgery
Limb or foot amputation due to circulatory insufficiency
Evidence of significant peripheral artery stenosis (>50% on angiography, or >50% or hemodynamically significant via non-invasive methods) in 1 limb
Ankle brachial index <0.9 in ≥1 ankle