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

Exclusion Criteria

• •1. Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate
• •2. Allergy to contrast dye
• •3. Known severe hepatic impairment (Childs-Pugh, Class C).
• •4. Known renal disease with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
• •5. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow)
• •6. Use of cholesterylester transfer protein (CETP) inhibition treatment within 12 months prior to randomization.
• •7. Current, prior within past year, or known planned use of PCSK9 inhibition treatment
• •8. Severe cardiovascular or concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 2 years
• •9. Major active infection, or major hematologic, renal, respiratory, metabolic, gastrointestinal or endocrine dysfunction
• •10. Women who are pregnant or breastfeeding
• •11. 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.
• •12. Known intolerance or allergy to evolocumab or other PCSK9 inhibitors.
• •13. Currently taking simvastatin \>40mg/day, niacin or bile acid sequestrants
• •14. Known latex allergy
• •15. Inability to comply with protocol-required study visits or procedures, including administration of study drug
• •16. 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)
• •17. 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
• •18. NYHA class IV
• •19. Pacemaker or other implantable device implanted within 30 days prior to screening
• •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