LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With Atherosclerotic Cardiovascular Disease (TARGET OLD)
To determine whether treating to an LDL-C target of 25 to \<70 mg/dL is superior to an LDL-C target of 70 to \<100 mg/dL with respect to major cardiovascular events (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization) in patients aged ≥75 years with atherosclerotic cardiovascular disease (ASCVD). To determine whether treating to an LDL-C target of 25 to \<70 mg/dL is non-inferior to an LDL-C target of 70 to \<100 mg/dL with respect to major safety events (hemorrhagic stroke, new-onset diabetes, muscle-related events, neurocognitive adverse events, new or recurrent cancer, cataract, or hepatic disorder \[Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) \>3× ULN, or total bilirubin \>2× ULN\]) in patients aged ≥75 years with ASCVD.
• Men or women ≥75 years of age
• Diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) with one or more of the following:
∙ Diagnosis of coronary heart disease (one or more of the following criteria must be satisfied):
⁃ Hospitalization for acute coronary syndrome
• Treatment or hospitalization for stable angina pectoris with documented ischemia on invasive or noninvasive testing
• History of myocardial infarction
• History of coronary revascularization procedure (eg, percutaneous coronary intervention \[PCI\] or coronary artery bypass graft surgery \[CABG\])
• Invasive diagnostic coronary angiography indicating \>50% stenosis in at least one major epicardial coronary artery or CT-imaging (eg, CCTA/MDCT) evidence of coronary atherosclerosis (\>50% stenosis in at least two major epicardial coronary artery)
‣ Diagnosis of atherosclerotic cerebrovascular or carotid disease (one or more of the following criteria must be satisfied):
⁃ History of ischemic stroke or transient ischemic attack (TIA) confirmed by symptoms with a documented ischemic lesion on CT or MRI in the cerebral regions corresponding to the symptoms;
• Documented intracranial atherosclerotic stenosis on the basis of conventional cerebral angiography, magnetic resonance angiography, CT angiography, transcranial doppler ultrasound, and high-resolution MRI;
• Symptomatic carotid artery disease with ≥50% carotid arterial stenosis;
• Asymptomatic carotid artery disease with ≥70% carotid arterial stenosis per angiography or duplex ultrasound;
• History of carotid revascularization (catheter-based or surgical).
‣ Diagnosis of atherosclerotic peripheral artery disease (one or more of the following criteria must be satisfied):
⁃ History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical).
• Prior non-traumatic amputation of a lower extremity due to peripheral artery disease
• History of intermittent claudication and one or more of the following:
∙ An ankle/arm blood pressure (BP) ratio \< 0.90, or
‣ Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound
• Baseline LDL-C level should be satisfied:
‣ Patients were required to have a baseline LDL-C level ≥100mg/dL (2.6mmol/L) if they were taking a regimen of lipid-lowering therapy \<4 weeks or they had not previously received lipid-lowering therapy.
⁃ Patients were required to have a baseline LDL-C level ≥70mg/dL (1.8mmol/L) if they were on stable treatment with lipid-lowering therapy ≥4 weeks
• Signed written informed consent.