Evidence mapPaperPMID 33708484Full record

ArticleCardiovascular diagnosis and therapy2021

Assessing the impact of PCSK9 inhibition on coronary plaque phenotype with optical coherence tomography: rationale and design of the randomized, placebo-controlled HUYGENS study.

Stephen J Nicholls, Steven E Nissen, Francesco Prati, Stephan Windecker, Yu Kataoka, Rishi Puri, Thomas Hucko, Helina Kassahun, Jason Liao, Ransi Somaratne and 4 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Cardiovascular diagnosis and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03570697. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
11.5field-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.

NCT03570697 phase3completed

High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS)

Ran2018Enrolled164Registered outcomes7Posted comparisons7ConditionsCoronary Artery Disease (CAD)ArmsEvolocumab, Placebo, Statin therapy
PMID 33355725other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Observational
  4. Review
  5. Cardiovascular risk management beyond statins: review of new therapies available in Italy.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2025
    Review
  6. PCSK9 Monoclonal Antibodies Have Come a Long Way.Current atherosclerosis reports · 2024
    Review
  7. Article
  8. Tandem lesions associate with angiographic progression of coronary artery stenoses.International journal of cardiology. Heart & vasculature · 2024
    Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Stabilization of vulnerable plaque in the ACS patient: evidence from HUYGENS studies.European heart journal supplements : journal of the European Society of Cardiology · 2023
    Article
  15. Review
  16. Acute coronary syndromes: hospital management of dyslipidaemia with proprotein convertase subtilisin/kexin 9 inhibitors: time to act.European heart journal supplements : journal of the European Society of Cardiology · 2023
    Article
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Stephen J NichollsMonash Cardiovascular Research Centre, Clayton, Australia.
Steven E NissenMonash Cardiovascular Research Centre, Clayton, Australia.
Francesco PratiMonash Cardiovascular Research Centre, Clayton, Australia.
Stephan WindeckerMonash Cardiovascular Research Centre, Clayton, Australia.
Yu KataokaMonash Cardiovascular Research Centre, Clayton, Australia.
Rishi PuriMonash Cardiovascular Research Centre, Clayton, Australia.
Thomas HuckoMonash Cardiovascular Research Centre, Clayton, Australia.
Helina KassahunMonash Cardiovascular Research Centre, Clayton, Australia.
Jason LiaoMonash Cardiovascular Research Centre, Clayton, Australia.
Ransi SomaratneMonash Cardiovascular Research Centre, Clayton, Australia.
Julie ButtersMonash Cardiovascular Research Centre, Clayton, Australia.
Giuseppe Di GiovanniMonash Cardiovascular Research Centre, Clayton, Australia.
Stephen JonesMonash Cardiovascular Research Centre, Clayton, Australia.
Peter J PsaltisMonash Cardiovascular Research Centre, Clayton, Australia.
Monash Medical Centre · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTechnological advances in arterial wall imaging permit the opportunity to visualize coronary atherosclerotic plaque with sufficient resolution to characterize both its burden and compositional phenotype. These modalities have been used extensively in clinical trials to evaluate the impact of lipid lowering therapies on serial changes in disease burden. While the findings have unequivocally established that these interventions have the capacity to either slow disease progression or promote plaque regression, depending on the degree of lipid lowering achieved, their impact on plaque phenotype is less certain. More recently optical coherence tomography (OCT) has been employed with a number of studies demonstrating favorable effects on both fibrous cap thickness (FCT) and the size of lipid pools within plaque in response to statin treatment.

methodsThe phase 3, multi-center, double-blind HUYGENS study will assess the impact of incremental lipid lowering with the proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, evolocumab, on plaque features using serial OCT imaging, in statin-treated patients following an acute coronary syndrome (ACS). Subjects with non-ST-elevation ACS (n=150) will be randomized 1:1 into two groups to receive monthly injections of evolocumab 420 mg or placebo.

resultsThe primary endpoint is the effect of evolocumab on coronary atherosclerotic plaques will be assessed by OCT at baseline and at week 50.

conclusionsThe HUYGENS study will determine whether intensified lipid lowering therapy with evolocumab in addition to maximally tolerated statin therapy will have incremental benefits on high-risk features of coronary artery plaques.

trial registrationThis study was registered on Clinicaltrials.gov (NCT03570697).

Indexed as

clinical trialsImaginglipidsproprotein convertase subtilisin kexin type 9 (PCSK9)risk factors

Identifiers

PMID33708484
PMCPMC7944215
OpenAlexW3127847696

What Socratic 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 Socratic graph.