Patients with atherosclerotic peripheral artery disease often have combined coronary artery disease or cerebral artery disease and show high rates of cardiovascular mortality and morbidities. Therefore, secondary prevention for these patients is of great clinical importance. Currently, Korean, US, and European guidelines recommend different LDL cholesterol target goals in patients with peripheral artery disease. In recent clinical trials, combination therapy of statin plus ezetimibe demonstrated improved cardiovascular outcomes compared with statin monotherapy. Thus, the purpose of the CARE-PVD study is to investigate whether the combination therapy of high intensity rosuvastatin 20 mg plus ezetimibe 10 mg can improve cardiovascular outcomes in patient with peripheral artery disease or polyvascular artery disease in comparison with rosuvastatin treat-to-target (LDL cholesterol \<70 mg/dL) monotherapy.
Ages 19-80
Patient with arteriosclerotic lower extremity artery disease or multivessel disease 1) Arteriosclerotic lower extremity artery disease: If any of the following applies
Ankle-brachial index <0.85 with symptoms of intermittent claudication
Lower extremity artery stenosis of more than 50% on imaging tests
Chronic limb threatening ischemia (Rutherford 4~6)
History of acute coronary syndrome or stroke/TIA or lower extremity amputation within 6 months
Acute liver disease or persistent unexplained elevation of serum AST or ALT more than twice the upper limit of normal
Severe renal dysfunction (eGFR <30 mL/min/1.73m2) or dependancy on dialysis
Parallel
Combination therapy of high-intensity dose rosuvastatin and ezetimibe
DrugCombination therapy of rosuvastatin 20 mg and ezetimibe 10 mg
Rosuvastatin monotherapy for treat-to-target
DrugRosuvastatin monotherapy for treat-to-target (LDL cholesterol \<70 mg/dL)
Composite of Major cardiovascular event or major adverse limb event
Composite of Major cardiovascular event (MACE) or major adverse limb event (MALE) at 3-year follow-up MACE includes death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure. MALE includes acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries.
Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)
Major cardiovascular event(death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina or heart failure)
Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)
Major adverse limb event(acute lower extremity ischemia, major lower extremity amputation, and revascularization of lower extremity arteries)
discontinuation of lipid lowering therapy
Intolerance of lipid lowering therapy
adverse clinical events related to lipid lowering therapy
adverse clinical events related to lipid lowering therapy
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