Use of PCSK9 Inhibitor Therapy in a Small Cohort of Heart Transplant Recipients with Statin Intolerance or Refractory Hyperlipidemia

Abstract

Purpose Use of statin therapy in heart transplant (HT) recipients offers the dual benefits of lipid control and as an anti-rejection agent. It is unknown whether PCSK9 inhibitors are safe and effective in transplant recipients and whether there might be similar anti-rejection or anti-inflammatory benefits in this patient population. Methods We identified eight patients in our outpatient HT clinic who were either statin intolerant (defined by myositis or transaminitis) or with refractory hyperlipidemia (defined as LDL > 80 in patients with cardiac allograft vasculopathy [CAV] or LDL > 120 in patients without prior CAV). Baseline demographics including lipid parameters and presence or absence of CAV were collected. Descriptive statistical analysis were performed in Excel. Results The mean age was 54 years. The average time after HT to PCSK9 initiation ranged from one month to 28 years. Two patients were treated for refractory hyperlipidemia, while the remaining were statin intolerant. All patients tolerated evolocumab 140 mg subcutaneously every two weeks, with no reported side effects. The average time on PCSK9 inhibitor therapy was 14 months. Six patients have follow up LDL values at 3 months after starting therapy. In this group the LDL decreased from a mean of 146.2 mg/ dL prior to therapy to 78.1 mg/ dL after 1-3 months of treatment (p = 0.016). One patient was intolerant to both statin therapy and everolimus. In this patient we saw an improvement in CAV at 1 year angiographic follow up. Conclusion Use of PCSK9 inhibitors in this small single-center cohort appears to be safe and effective. While this therapy has known benefit for atherosclerosis, additional research is needed to understand whether there are anti-inflammatory properties that may stabilize or improve CAV in a larger cohort of HT recipients.