Early administration of a PCSK9 inhibitor in addition to a statin may provide a feasible and safe therapeutic approach for patients with acute myocardial infarction (AMI) undergoing primary PCI, according to a study simultaneously published in JACC: Cardiovascular Interventions and presented as a poster during ESC Congress 2020.

Tomoaki Okada, MD, et al., assessed the four-week efficacy of PCSK9 inhibitor therapy combined with a statin in patients who underwent primary PCI for AMI in a single center, prospective open-label randomized trial. A total of 102 Japanese patients (88% male, 26% previously treated with a statin) participated in the trial and they all received pitavastatin (2 mg/day). Of the 102 patients, 52 received evolocumab (140 mg) subcutaneously within 24 hours after the indexed PCI and two weeks later, and 50 patients did not (control group).

Baseline LDL-C levels were 120.8 mg/dL and 124.7 mg/dl in the treatment and control groups, respectively.

Results showed the change in LDL-C levels from baseline to four weeks was –76.1% and –33.1% in the evolocumab and control groups, respectively (mean difference, –43.9%; 95% confidence interval, –52.1 to –35.6 mg/dL; p<0.001). LDL-C levels of <70 mg/dL at four weeks were achieved in 100% and 27% of the patients in the evolocumab and control groups, respectively. In the evolocumab group, researchers also found that LDL levels of <55 mg/dL were achieved in 92% of patients at two weeks and 96% of patients at four weeks.

In the evolocumab and control groups, the change in non–HDL-C was –66.2% and –26%, respectively; the change in HDL-C was 2.8% and –0.7%, respectively; and the change in small dense LDL was –67.3% and –13.8%, respectively. Lipoprotein(a) levels decreased by –2.7% in the evolocumab group and increased by 82% in the control group. The number of adverse events and serious adverse events in the evolocumab and control groups did not differ significantly.

"Notably, this study demonstrated that evolocumab with pitavastatin substantially reduced small dense LDL levels and mitigated lipoprotein(a) increase in patients after AMI compared to statin alone," write the authors of the study. "Statin therapy significantly increased lipoprotein(a) levels by 10-20%. Here, lipoprotein(a) levels increased in the control but not in the evolocumab group, suggesting the benefit of including evolocumab for managing residual risk in patients with high lipoprotein(a) levels after AMI."

Clinical Topics: Cardiovascular Care Team, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Lipid Metabolism, Nonstatins, Novel Agents, Statins

Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors, Lipoproteins, PCSK9 protein, human, Proprotein Convertase 9, Cholesterol, LDL, Percutaneous Coronary Intervention, Antibodies, Monoclonal, Quinolines, Myocardial Infarction, ESC Congress, ESC20

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