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Randomized Controlled Trial
. 2022 Jul;15(7):1308-1321.
doi: 10.1016/j.jcmg.2022.03.002. Epub 2022 Mar 16.

Effect of Evolocumab on Coronary Plaque Phenotype and Burden in Statin-Treated Patients Following Myocardial Infarction

Stephen J Nicholls  1 , Yu Kataoka  2 , Steven E Nissen  3 , Francesco Prati  4 , Stephan Windecker  5 , Rishi Puri  3 , Thomas Hucko  6 , Daniel Aradi  7 , Jean-Paul R Herrman  8 , Renicus S Hermanides  9 , Bei Wang  6 , Huei Wang  6 , Julie Butters  10 , Giuseppe Di Giovanni  11 , Stephen Jones  11 , Gianluca Pompili  11 , Peter J Psaltis  12
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Free article
Randomized Controlled Trial

Effect of Evolocumab on Coronary Plaque Phenotype and Burden in Statin-Treated Patients Following Myocardial Infarction

Stephen J Nicholls et al. JACC Cardiovasc Imaging. 2022 Jul.
Free article

Abstract

Background: The proprotein convertase subtilisin kexin type-9 inhibitor evolocumab produced coronary atheroma regression in statin-treated patients.

Objectives: The purpose of this study was to determine the effect of evolocumab on optical coherence tomography (OCT) measures of plaque composition.

Methods: Patients with a non-ST-segment elevation myocardial infarction were treated with monthly evolocumab 420 mg (n = 80) or placebo (n = 81) for 52 weeks. Patients underwent serial OCT and intravascular ultrasound imaging within a matched arterial segment of a nonculprit vessel. The primary analysis determined the change in the minimum fibrous cap thickness and maximum lipid arc throughout the imaged arterial segment. Additional analyses determined changes in OCT features in lipid-rich plaque regions and plaque burden. Safety and tolerability were evaluated.

Results: Among treated patients (age 60.5 ± 9.6 years; 28.6% women; low-density lipoprotein cholesterol [LDL-C], 141.3 ± 33.1 mg/dL), 135 had evaluable imaging at follow-up. The evolocumab group achieved lower LDL-C levels (28.1 vs 87.2 mg/dL; P < 0.001). The evolocumab group demonstrated a greater increase in minimum fibrous cap thickness (+42.7 vs +21.5 μm; P = 0.015) and decrease in maximum lipid arc (-57.5o vs. -31.4o; P = 0.04) and macrophage index (-3.17 vs -1.45 mm; P = 0.04) throughout the arterial segment. Similar benefits of evolocumab were observed in lipid-rich plaque regions. Greater regression of percent atheroma volume was observed with evolocumab compared with placebo (-2.29% ± 0.47% vs -0.61% ± 0.46%; P = 0.009). The groups did not differ regarding changes in microchannels or calcium.

Conclusions: The combination of statin and evolocumab after a non-ST-segment elevation myocardial infarction produces favorable changes in coronary atherosclerosis consistent with stabilization and regression. This demonstrates a potential mechanism for the improved clinical outcomes observed achieving very low LDL-C levels following an acute coronary syndrome. (Imaging of Coronary Plaques in Participants Treated With Evolocumab; NCT03570697).

Keywords: PCSK9 inhibitor; acute coronary syndromes; atherosclerosis; clinical trials; lipid lowering.

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Conflict of interest statement

Funding Support and Author Disclosures This study was sponsored by Amgen Inc. Dr Nicholls is a recipient of a Principal Research Fellowship from the National Health and Medical Research Council of Australia; has received research support from AstraZeneca, Amgen, Anthera, CSL Behring, Cerenis, Eli Lilly, Esperion, Resverlogix, Novartis, InfraReDx, and Sanofi-Regeneron; and is a consultant for Amgen, Akcea, AstraZeneca, Boehringer Ingelheim, CSL Behring, Eli Lilly, Esperion, Kowa, Merck, Takeda, Pfizer, Sanofi-Regeneron, and Novo Nordisk. Dr Kataoka has received research support from Kowa; and has received speaker honoraria from Abbott Vascular, Amgen, CSL Behring, Daiichi Sankyo, Kowa, Nipro, and Takeda. Dr Nissen has reported that the Cleveland Clinic Center for Clinical Research has received funding to perform clinical trials from AbbVie, AstraZeneca, Amgen, Cerenis, Eli Lilly, Esperion, Medtronic, MyoKardia, Novartis, Pfizer, The Medicines Company, Silence Therapeutics, Takeda, and Orexigen; is involved in these clinical trials but receives no personal remuneration for his participation; and has served as a consultant for many pharmaceutical companies, but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction. Dr Prati has received consulting fees from Amgen and Abbott Vascular. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi-Aventis, Sinomed, Terumo, and V-Wave; has served as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, Terumo, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; and is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Puri has received speaker fees from Amgen and Sanofi; has served as a consultant for Cerenis, Medtronic, Philips, Boston Scientific, and Shockwave; has served on advisory boards for Centerline Biomedical, Medtronic, and Bioventrix; and holds minor equity in Centerline Biomedical. Drs Hucko, Wang, and Wang are employees of Amgen and hold Amgen stock/stock options. Dr Aradi has received speaker fees from AstraZeneca, Bayer, Pfizer, Merck Sharp & Dohme Pharma, Boehringer, Vascular Venture, and Amgen. Dr Psaltis is a recipient of a L2 Future Leader Fellowship from the National Heart Foundation of Australia (FLF102056) and a L2 Career Development Fellowship from the National Health and Medical Research Council of Australia (CDF1161506); has received research support from Abbott Vascular; has received consulting fees from Amgen and Esperion; and has received speaker honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Merck Schering-Plough, and Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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