Evidence map›Paper›PMID 30336824›Full record

Trial reportJournal of the American College of Cardiology2018

Effect of Evolocumab on Coronary Plaque Composition.

Stephen J Nicholls, Rishi Puri, Todd Anderson, Christie M Ballantyne, Leslie Cho, John J P Kastelein, Wolfgang Koenig, Ransi Somaratne, Helina Kassahun, Jingyuan Yang and 8 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03067844. Cited by 68 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 2 pooled it
13.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03067844 phase3completed

Effects of the PCSK9 Antibody AliroCuMab on Coronary Atherosclerosis in PatieNts With Acute Myocardial Infarction: A Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Optical Coherence Tomography Imaging Study

Ran2017Enrolled294Registered outcomes16Posted comparisons0ConditionsAtheroma; Myocardial, Coronary Circulation, Coronary VesselArmsAlirocumab
PMID 25687353PMID 25773378PMID 25182248PMID 22019821PMID 22421222PMID 22421299PMID 23871513PMID 24239923PMID 24631113PMID 26330422PMID 26655874PMID 27846344other papers from this trial
Open the trial in the graph
NCT01813422 phase3completednot on this map

A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization

TypeinterventionalSponsorAmgenRan2013 to 2016Enrolled970ConditionsHypercholesterolemiaArmsEvolocumab, Placebo
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 2 syntheses or guidelines pooled it, 134 citations in OpenAlex.

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  2. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2020 · on this map
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8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 5 countries.

Stephen J NichollsSouth 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.
Rishi PuriDepartment of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
Todd AndersonLibin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Christie M BallantyneSection of Cardiovascular Research, Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center, Houston, Texas.
Leslie ChoDepartment of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
John J P KasteleinDepartment of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Wolfgang KoenigDeutsches 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.
Ransi SomaratneAmgen Inc., Thousand Oaks, California.
Helina KassahunAmgen Inc., Thousand Oaks, California.
Jingyuan YangAmgen Inc., Thousand Oaks, California.
Scott M WassermanAmgen Inc., Thousand Oaks, California.
Satoshi HondaSouth Australian Health and Medical Research Institute, University of Adelaide, Adelaide, South Australia, Australia.
Daisuke ShishikuraSouth Australian Health and Medical Research Institute, University of Adelaide, Adelaide, South Australia, Australia.
Daniel J SchererSouth Australian Health and Medical Research Institute, University of Adelaide, Adelaide, South Australia, Australia.
Marilyn BorgmanDepartment of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
Danielle M BrennanDepartment of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
Kathy WolskiDepartment of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
Steven E NissenDepartment of Cardiovascular Medicine and Cleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
Cleveland Clinic · USAmgen (United States) · USSouth Australian Health and Medical Research Institute · AUAmsterdam UMC Location University of Amsterdam · NLGerman Centre for Cardiovascular Research · DEHouston Methodist · USUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

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

methodsA 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.

resultsCompared 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 mm

conclusionsThe 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).

Indexed as

Coronary Artery DiseasePCSK9 InhibitorsPlaque, AtheroscleroticAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLDrug MonitoringDrug Therapy, CombinationFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedProprotein Convertase 9Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLevolocumabHydroxymethylglutaryl-CoA Reductase InhibitorsPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9atherosclerosisclinical trialimaginglipidsPCSK9

Identifiers

PMID30336824
OpenAlexW2897540422

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.