Effect of Alirocumab Added to High-Intensity Statin on Platelet Reactivity and Noncoding RNAs in Patients with AMI: A Substudy of the PACMAN-AMI Trial

Thromb Haemost. 2024 Jun;124(6):517-527. doi: 10.1055/a-2156-7872. Epub 2023 Aug 18.

Abstract

Objective: The effect of the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor alirocumab on platelet aggregation among patients with acute myocardial infarction (AMI) remains unknown. We aimed to explore the effect of alirocumab added to high-intensity statin therapy on P2Y12 reaction unit (PRU) among AMI patients receiving dual antiplatelet therapy (DAPT) with a potent P2Y12 inhibitor (ticagrelor or prasugrel). In addition, we assessed circulating platelet-derived noncoding RNAs (microRNAs and YRNAs).

Methods: This was a prespecified, powered, pharmacodynamic substudy of the PACMAN trial, a randomized, double-blind trial comparing biweekly alirocumab (150 mg) versus placebo in AMI patients undergoing percutaneous coronary intervention. Patients recruited at Bern University Hospital, receiving DAPT with a potent P2Y12 inhibitor, and adherent to the study drug (alirocumab or placebo) were analyzed for the current study. The primary endpoint was PRU at 4 weeks after study drug initiation as assessed by VerifyNow P2Y12 point-of-care assays.

Results: Among 139 randomized patients, the majority of patients received ticagrelor DAPT at 4 weeks (57 [86.4%] in the alirocumab group vs. 69 [94.5%] in the placebo group, p = 0.14). There were no significant differences in the primary endpoint PRU at 4 weeks between groups (12.5 [interquartile range, IQR: 27.0] vs. 19.0 [IQR: 30.0], p = 0.26). Consistent results were observed in 126 patients treated with ticagrelor (13.0 [IQR: 20.0] vs. 18.0 [IQR: 27.0], p = 0.28). Similarly, platelet-derived noncoding RNAs did not significantly differ between groups.

Conclusion: Among AMI patients receiving DAPT with a potent P2Y12 inhibitor, alirocumab had no significant effect on platelet reactivity as assessed by PRU and platelet-derived noncoding RNAs.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Blood Platelets* / drug effects
  • Blood Platelets* / metabolism
  • Double-Blind Method
  • Drug Therapy, Combination
  • Dual Anti-Platelet Therapy
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / therapeutic use
  • Male
  • Middle Aged
  • Myocardial Infarction* / blood
  • Myocardial Infarction* / drug therapy
  • PCSK9 Inhibitors
  • Percutaneous Coronary Intervention
  • Platelet Aggregation / drug effects
  • Platelet Aggregation Inhibitors* / therapeutic use
  • Prasugrel Hydrochloride / therapeutic use
  • Proprotein Convertase 9
  • Purinergic P2Y Receptor Antagonists / therapeutic use
  • Ticagrelor* / therapeutic use
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • alirocumab
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Ticagrelor
  • Platelet Aggregation Inhibitors
  • Purinergic P2Y Receptor Antagonists
  • Prasugrel Hydrochloride
  • PCSK9 Inhibitors
  • PCSK9 protein, human
  • Proprotein Convertase 9