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J Am Coll Cardiol. 2018 Oct 23;72(17):2012-2021. doi: 10.1016/j.jacc.2018.06.078.

Effect of Evolocumab on Coronary Plaque Composition.

Author information

1
South Australian Health and Medical Research Institute, University of Adelaide, Adelaide, South Australia, Australia; Department of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio. Electronic address: stephen.nicholls@sahmri.com.
2
Department of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
3
Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
4
Section of Cardiovascular Research, Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center, Houston, Texas.
5
Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
6
Deutsches Herzzentrum München, Technische Universität München, Munich, DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Department of Internal Medicine, University of Ulm Medical Center, Ulm, Germany.
7
Amgen Inc., Thousand Oaks, California.
8
South Australian Health and Medical Research Institute, University of Adelaide, Adelaide, South Australia, Australia.

Abstract

BACKGROUND:

Incremental low-density lipoprotein (LDL) cholesterol lowering with the proprotein convertase subtilisin kexin type 9 inhibitor evolocumab regresses coronary atherosclerosis in statin-treated patients.

OBJECTIVES:

The purpose of this study was to evaluate the effect of adding evolocumab to statin therapy on coronary plaque composition.

METHODS:

A total of 968 statin-treated coronary artery disease patients underwent serial coronary intravascular ultrasound imaging at baseline and following 76 weeks of treatment with placebo or evolocumab 420 mg monthly. Plaque composition changes were determined in 331 patients with evaluable radiofrequency analysis of the ultrasound backscatter signal.

RESULTS:

Compared with statin monotherapy, evolocumab further reduced LDL cholesterol (33.5 mg/dl vs. 89.9 mg/dl; p < 0.0001) and induced regression of percent atheroma volume (-1.2% vs. +0.17%; p < 0.0001) and total atheroma volume (-3.6 mm3 vs. -0.8 mm3; p = 0.04). No difference was observed between the evolocumab and placebo groups in changes in calcium (1.0 ± 0.3 mm3 vs. 0.6 ± 0.3 mm3; p = 0.49), fibrous (-3.0 ± 0.6 mm3 vs. -2.4 ± 0.6 mm3; p = 0.49), fibrofatty (-5.0 ± 1.0 mm3 vs. -3.0 ± 1.0 mm3; p = 0.49), and necrotic (-0.6 ± 0.5 mm3 vs. -0.1 ± 0.5 mm3; p = 0.49) volumes. An inverse correlation was observed between changes in LDL cholesterol and plaque calcification (r = -0.15; p < 0.001).

CONCLUSIONS:

The addition of evolocumab to a statin did not produce differential changes in plaque composition compared with statin monotherapy. This suggests that evaluation of plaque morphology using virtual histology imaging may provide no incremental information about the plaque effects of evolocumab beyond measurement of plaque burden. (GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound [GLAGOV]; NCT01813422).

KEYWORDS:

PCSK9; atherosclerosis; clinical trial; imaging; lipids

PMID:
30336824
DOI:
10.1016/j.jacc.2018.06.078

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