TY - JOUR
T1 - Effects of the PCSK9 antibody alirocumab on coronary atherosclerosis in patients with acute myocardial infarction
T2 - a serial, multivessel, intravascular ultrasound, near-infrared spectroscopy and optical coherence tomography imaging study-Rationale and design of the PACMAN-AMI trial
AU - Zanchin, Christian
AU - Koskinas, Konstantinos C
AU - Ueki, Yasushi
AU - Losdat, Sylvain
AU - Häner, Jonas D
AU - Bär, Sarah
AU - Otsuka, Tatsuhiko
AU - Inderkum, Andrea
AU - Jensen, Maria Radu Juul
AU - Lonborg, Jacob
AU - Fahrni, Gregor
AU - Ondracek, Anna S
AU - Daemen, Joost
AU - van Geuns, Robert-Jan
AU - Iglesias, Juan F
AU - Matter, Christian M
AU - Spirk, David
AU - Juni, Peter
AU - Mach, Francois
AU - Heg, Dik
AU - Engstrom, Thomas
AU - Lang, Irene
AU - Windecker, Stephan
AU - Räber, Lorenz
N1 - Copyright © 2021. Published by Elsevier Inc.
PY - 2021/8
Y1 - 2021/8
N2 - BACKGROUND: 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 monoclonal 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.AIMS: To determine the effect of LDL-C lowering with alirocumab on top of high-intensity statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4 mm (maxLCBI4 mm) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI.METHODS: 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 maxLCBI4 mm, and OCT-derived minimal FCT, will be assessed 52 weeks post randomization.SUMMARY: 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.CLINICAL TRIAL REGISTRATION: NCT03067844.
AB - BACKGROUND: 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 monoclonal 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.AIMS: To determine the effect of LDL-C lowering with alirocumab on top of high-intensity statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4 mm (maxLCBI4 mm) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI.METHODS: 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 maxLCBI4 mm, and OCT-derived minimal FCT, will be assessed 52 weeks post randomization.SUMMARY: 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.CLINICAL TRIAL REGISTRATION: NCT03067844.
KW - Antibodies, Monoclonal, Humanized/administration & dosage
KW - Cholesterol, LDL
KW - Coronary Artery Disease/diagnostic imaging
KW - Double-Blind Method
KW - Drug Administration Schedule
KW - Endosonography
KW - Europe
KW - Humans
KW - Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use
KW - Myocardial Infarction/complications
KW - Non-ST Elevated Myocardial Infarction/complications
KW - Placebos/administration & dosage
KW - Plaque, Atherosclerotic/diagnostic imaging
KW - Proprotein Convertase 9/immunology
KW - Research Design
KW - Rosuvastatin Calcium/administration & dosage
KW - ST Elevation Myocardial Infarction/complications
KW - Spectroscopy, Near-Infrared
KW - Tomography, Optical Coherence
UR - http://www.scopus.com/inward/record.url?scp=85107049244&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2021.04.006
DO - 10.1016/j.ahj.2021.04.006
M3 - Journal article
C2 - 33951415
VL - 238
SP - 33
EP - 44
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -