Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery

Open to people ages 18 years and up

• To be considered eligible for participation in this study, a participant must satisfy each of the following criteria:
• Age ≥ 18 years
• Scheduled to undergo coronary artery bypass graft (CABG) surgery (with or without cardiopulmonary bypass (CPB); with or without single valve repair/replacement)
• CABG procedure included/planned to include at least two saphenous vein grafts
• CABG procedure occurred within the past 21 days, or is planned within the next 60 days
• On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mg daily, rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, or another statin or non-statin therapy is clinically justified

• A participant will be ineligible for participation in this study if he or she satisfies any one or more of the following criteria:
• Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate
• Allergy to contrast dye
• Known severe hepatic impairment (Childs-Pugh, Class C).
• Known renal disease with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
• Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow)
• Use of cholesterylester transfer protein (CETP) inhibition treatment within 12 months prior to randomization.
• Current, prior within past year, or known planned use of PCSK9 inhibition treatment
• Severe cardiovascular or concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 2 years
• Major active infection, or major hematologic, renal, respiratory, metabolic, gastrointestinal or endocrine dysfunction
• Women who are pregnant or breastfeeding
• Women of child bearing potential who are unwilling to use proper family planning or birth control methods to avoid pregnancy. Women are considered post-menopausal and not of childbearing potential after 12 months of natural (spontaneous) amenorrhea or have had a surgical procedure such as hysterectomy which makes pregnancy impossible.
• Known intolerance or allergy to evolocumab or other PCSK9 inhibitors.
• Currently taking simvastatin >40mg/day, niacin or bile acid sequestrants
• Known latex allergy
• Inability to comply with protocol-required study visits or procedures, including administration of study drug
• Known history of cancer within the past 5 years (except for carcinoma in-situ of the cervix, stage 1 prostate cancer or adequately treated non-melanoma carcinomas of the skin)
• Participation in another investigational device or drug study which is likely to affect the primary outcome, within 30 days of planned initiation of study drug
• NYHA class IV
• Pacemaker or other implantable device implanted within 30 days prior to screening

Additional postoperative exclusion criteria:

1. Received only <2 vein grafts
2. Major peri-operative complications following CABG surgery (e.g. stroke, MI, renal failure requiring dialysis, or postoperative ICU stay > 5 days) prior to randomization