The risk for cardiovascular adverse events after acute myocardial infarction (AMI) remains high despite potent medical treatment including low-density lipoprotein cholesterol (LDL-C) lowering with statins. Proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies substantially reduce LDL-C when added to statin. Alirocumab, a momoclonal antibody to PCSK9, reduces major adverse cardiovascular events after AMI. The effects of alirocumab on coronary atherosclerosis including plaque burden, plaque composition and fibrous cap thickness in patients presenting with AMI remains unknown.
To determine the effect of LDL-C lowering with alirocumab on top of high-intensitv statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4mm (maxLCBI) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI.
In this multicenter, double-blind, placebo-controlled trial, 300 patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to receive either biweekly subcutaneous alirocumab (150 mg) or placebo beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg. Patients undergo serial IVUS, NIRS and OCT in the two non-infarct related arteries at baseline (at the time of treatment of the culprit lesion) and at 52 weeks. The primary endpoint, change in IVUS-derived PAV, and the powered secondary endpoints, change in NIRS-derived maxLCBI, and OCT-derived minimal FCT, will be assessed 52 weeks post randomization.
The PACMAN-AMI trial will determine the effect of alirocumab on top of high-intensity statin therapy on high-risk coronary plaque characteristics as assessed by serial, multimodality intracoronary imaging in patients presenting with AMI.
NCT03067844.
Copyright © 2021. Published by Elsevier Inc.
About The Expert
Christian Zanchin
Konstantinos C Koskinas
Yasushi Ueki
Sylvain Losdat
Jonas Häner
Sarah Bär
Tatsuhiko Otsuka
Andrea Inderkum
Maria Radu Juul Jensen
Jacob Lonborg
Gregor Fahrni
Anna S Ondracek
Joost Daemen
Robert-Jan van Geuns
Juan Iglesias
Christian M Matter
David Spirk
Peter Juni
Francois Mach
Dik Heg
Thomas Engstrom
Irene Lang
Stephan Windecker
Lorenz Räber
References
PubMed