Evidence map›Paper›PMID 40828313›Full record

Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2025

Changes in non-culprit coronary lesions with PCSK9 inhibitors: the randomised, placebo-controlled FITTER trial.

Frans B Mensink, Jonathan Los, Mohamed M Reda Morsy, Rohit M Oemrawsingh, Clemens von Birgelen, Alexander J J Ijsselmuiden, Martijn Meuwissen, Jin M Cheng, Diederik F van Wijk, Pieter C Smits and 13 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. "He who has eyes to see, let him see".EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
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

23 authors.

Frans B MensinkDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Jonathan LosDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Mohamed M Reda MorsyDepartment of Cardiology, Faculty of Medicine, Assiut University, Asyut, Egypt.
Rohit M OemrawsinghDepartment of Cardiology, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands.
Clemens von BirgelenDepartment of Cardiology, Medisch Spectrum Twente, Enschede, the Netherlands.
Alexander J J IjsselmuidenDepartment of Cardiology, Amphia Hospital, Breda, the Netherlands.
Martijn MeuwissenDepartment of Cardiology, Amphia Hospital, Breda, the Netherlands.
Jin M ChengDepartment of Cardiology, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands.
Diederik F van WijkDepartment of Cardiology, Noordwest ziekenhuisgroep locatie Alkmaar, Alkmaar, the Netherlands.
Pieter C SmitsDepartment of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
Valeria ParadiesDepartment of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
Dirk J van WijkDepartment of Cardiology, Haaglanden Medisch Centrum, the Hague, the Netherlands.
Himanshu RaiSchool of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
Tim J F Ten CateDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Cyril CamaroDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Peter DammanDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Lokien X van NunenDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Aukelien C Dimitriu-LeenDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Marleen H van WelyDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Aysun Cetinyurek-YavuzDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Robert A ByrneSchool of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland.
Niels van RoyenDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Robert-Jan M van GeunsDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProlonged lipid-lowering therapy has demonstrated its ability to induce plaque regression and improve the plaque morphology of mild atherosclerotic lesions.

aimsThis trial aimed to assess the short-term effect of evolocumab in addition to high-intensity statin therapy (HIST) on relevant non-culprit coronary artery lesions using fractional flow reserve (FFR) measurements and multimodality intracoronary imaging.

methodsPatients with an acute coronary syndrome (ACS) and relevant multivessel disease were randomised to receive either evolocumab or placebo for 12 weeks in addition to HIST. Patients underwent serial FFR and intravascular ultrasound (IVUS)-near-infrared spectroscopy imaging of a non-culprit vessel. The primary endpoints were the differences in the change in FFR and in the maximum lipid core burden index within any 4 mm segment (maxLCBI

resultsAmong 150 patients (mean age 64.2±8.5 years; 27 [18.0%] female) randomised to evolocumab (n=74) or placebo (n=76), 143 underwent follow-up coronary angiography. After 12 weeks of treatment, the adjusted mean change in FFR was 0.00 (95% confidence interval [CI]: -0.02 to 0.02) with evolocumab versus 0.01 (95% CI: -0.01 to 0.03) with placebo (adjusted mean difference: -0.01, 95% CI: -0.03 to 0.01; p=0.6). The adjusted mean change in the maxLCBI

conclusionsIn patients with ACS and relevant non-culprit coronary artery lesions, the addition of evolocumab to HIST for 12 weeks, compared to placebo, did not result in improvement of FFR or maxLCBI

Indexed as

Acute Coronary SyndromeAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCoronary Artery DiseasePCSK9 InhibitorsPlaque, AtheroscleroticAgedCoronary AngiographyCoronary VesselsFemaleFractional Flow Reserve, MyocardialHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedProprotein Convertase 9Antibodies, Monoclonal, HumanizedAnticholesteremic AgentsevolocumabHydroxymethylglutaryl-CoA Reductase InhibitorsPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9

Identifiers

PMID40828313
PMCPMC12337765

What OpenQuestion holds

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Registered trials

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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.