Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)

Inclusion Criteria

• •Systolic Blood Pressure (SBP) between 130 and 180 mm Hg:
• •* 130 to 150 mm Hg (if on 0-4 medications)
• •* 130 to 160 mm Hg (if on 0-3 medications)
• •* 130 to 170 mm Hg (if on 0-2 medications)
• •* 130 to 180 mm Hg (if on 0-1 medications)
• •Type 2 diabetes
• •To be considered as having a high cardiovascular risk, including AT LEAST ONE of the following factors:
• •1. Established cardiovascular disease (CVD), including:
• •* Coronary artery disease: previous myocardial infarction, previous acute coronary syndrome, previous percutaneous coronary intervention, previous coronary artery bypass graft surgery, or at least 50% stenosis in a main coronary artery associated with typical angina pectoris; or
• •* Cerebrovascular disease: previous stroke (except those events caused by intracranial aneurysm or arteriovenous malformation) or previous transient ischemic attack (TIA), stable for at least 2 weeks preceding inclusion in the study; or
• •* Carotid artery disease: previous carotid endarterectomy, previous percutaneous intervention with carotid stent implantation, or stenosis of at least 50% in a carotid shown by the Doppler ultrasonography, CT angiography or MR angiography; or
• •* Peripheral artery disease: prior surgical or percutaneous revascularization of a peripheral artery, limb amputation due to vascular cause, abdominal aortic aneurysm ≥ 5 cm (with or without prior surgical or percutaneous repair), or stenosis of at least 50% in a peripheral artery associated to intermittent claudication.
• •2. Subclinical CVD, including:
• •* Coronary calcium score ≥ 300 Agatston units; or
• •* Ankle-brachial index ≤ 0.90 in the last two years; or
• •* Left ventricular hypertrophy on the electrocardiogram, echocardiogram or other cardiac imaging exam in the last two years.
• •3. Chronic kidney disease (CKD):
• •▪ Definition of CKD: glomerular filtration rate (GFR) between 20 and 59 ml/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
• •4. Additional cardiovascular risk factors, including:
• •* Active smoking: Defined as regular use of cigarettes or other tobacco products, such as cigars and pipe, in the last six months;
• •* Dyslipidemia: Defined as LDL cholesterol \> 70 mg/dL or non-HDL cholesterol \> 100 mg/dL in patients with previous CVD; or LDL cholesterol \> 100 mg/dL or non-HDL cholesterol \> 130 mg/dL in patients without previous CVD; or Triglycerides \> 200 mg/dL or HDL \< 40 mg/dL regardless of treatment; or use of statins or other lipid lowering medication; or
• •* Age ≥ 75 years