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Table 2 A comparison of the inclusion criteria of the EMPA-REG OUTCOMES trial with the nearest match available from routine UK primary care data

From: Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors: Comparing Trial and Real World Use (Study Protocol)

EMPA-REG OUTCOMES trial inclusion criteria Nearest match using routinely collected primary care data
History of myocardial infarction
History of myocardial infarction >2 months prior to informed consent Coding of a myocardial infarction or other definite indicator of a myocardial infarction
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 revascularisation (percutaneous transluminal coronary angioplasty ± stent or coronary artery bypass graft >2 months prior to consent
  The combination of revascularisation 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 re-vascularised, with at least 1 of the following:
  A positive non-invasive stress test for ischaemia
  Hospital discharge for unstable angina ≤12 months prior to consent
Evidence of coronary artery disease documented by any of the following:
  Coding of double coronary artery disease
  Previous revascularisation (percutaneous transluminal coronary angioplasty ± stent or coronary artery bypass graft) of the coronary arteries
NB. Coding of the precise percutaneous intervention performed in primary care is limited. Usually only a high level code is included to indicate the procedure has been undertaken. This coronary artery disease code search is therefore likely to slightly overestimate the number of people who meet the trial criteria
Unstable angina
Unstable angina >2 months prior to consent with evidence of single- or multi-vessel coronary artery disease Coding of unstable angina or code which indicates poor angina control
History of stroke
History of stroke (ischaemic or haemorrhagic) >2 months prior to consent Coding of stroke (ischemic or haemorrhagic)
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 haemodynamically significant via non-invasive methods) in 1 limb
  Ankle brachial index <0.9 in ≥1 ankle
Coding of peripheral artery disease documented by any of the following:
  Limb angioplasty, stenting or bypass surgery
  Limb or foot amputation
  Coding of peripheral arterial disease of the lower limb(s) including claudication, and peripheral gangrene
  A recorded ankle brachial index <0.9
  1. EMPA-REG OUTCOMES BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients
  2. Where specific disease information is not available from routine data (either due to coding limitations or due to limitations in non-specific data entry) we have used broader criteria, for example, percentage luminal narrowing is rarely recorded in primary care; we therefore include all people with coded coronary artery stenosis