Evidence map›Paper›PMID 38840580›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024

Vulnerable plaque features and adverse events in patients with diabetes mellitus: a post hoc analysis of the COMBINE OCT-FFR trial.

David Del Val, Balazs Berta, Tomasz Roleder, Krzysztof Malinowski, Teresa Bastante, Renicus S Hermanides, Wojciech Wojakowski, Enrico Fabris, Javier Cuesta, Giuseppe De Luca and 3 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02989740 (Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients. COMBINE), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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.

NCT02989740 completednot on this map

Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients. COMBINE (OCT-FFR) Prospective Register

Typeobservational_patient_registrySponsorDiagram B.V.Ran2015 to 2021Enrolled550ConditionsDiabetes Mellitus, Coronary Artery Disease, Coronary AtherosclerosesArmsOptical Coherence Tomography
3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Outcomes of Patients With High-Risk Plaques Treated With a Bioresorbable Magnesium Scaffold: Insights From the BIOMAG-I Study.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
    Trial
  2. Review
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  14. Reply: Identifying vulnerable coronary atherosclerotic plaques: from theory to practice.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  15. Letter: Identifying vulnerable coronary atherosclerotic plaques: from theory to practice.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  16. Review
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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

13 authors.

David Del ValCardiology Department, Hospital Universitario de La Princesa, Madrid, Spain.
Balazs BertaHeart and Vascular Center, Semmelweis University, Budapest, Hungary.
Tomasz RolederDivision of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
Krzysztof MalinowskiDepartment of Bioinformatics and Telemedicine, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland.
Teresa BastanteCardiology Department, Hospital Universitario de La Princesa, Madrid, Spain.
Renicus S HermanidesIsala Hartcentrum, Zwolle, the Netherlands.
Wojciech WojakowskiDivision of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
Enrico FabrisCardiovascular Department, University of Trieste, Trieste, Italy.
Javier CuestaCardiology Department, Hospital Universitario de La Princesa, Madrid, Spain.
Giuseppe De LucaDivision of Cardiology, AOU "Policlinico G. Martino", Messina, Italy and Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Fernando RiveroCardiology Department, Hospital Universitario de La Princesa, Madrid, Spain.
Fernando AlfonsoCardiology Department, Hospital Universitario de La Princesa, Madrid, Spain.
Elvin KedhiDivision of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThin-cap fibroatheroma (TCFA) lesions are associated with a high risk of future major adverse cardiovascular events. However, the impact of other optical coherence tomography-detected vulnerability features (OCT-VFs) and their interplay with TCFA in predicting adverse events remains unknown.

aimsWe aimed to evaluate the individual as well as the combined prognostic impact of OCT-VFs in predicting the incidence of the lesion-oriented composite endpoint (LOCE) in non-ischaemic lesions in patients with diabetes mellitus (DM).

methodsCOMBINE OCT-FFR (ClinicalTrials.gov: NCT02989740) was a prospective, double-blind, international, natural history study that included DM patients with ≥1 non-culprit lesions with a fractional flow reserve>0.80 undergoing systematic OCT assessment. OCT-VFs included the following: TCFA, reduced minimal lumen area (r-MLA), healed plaque (HP), and complicated plaque (CP). The primary endpoint, LOCE - a composite of cardiac mortality, target vessel myocardial infarction, or clinically driven target lesion revascularisation up to 5 years - was analysed according to the presence of these OCT-VFs, both individually and in combination.

resultsTCFA, r-MLA, HP and CP were identified in 98 (25.3%), 190 (49.0%), 87 (22.4%), and 116 (29.9%) patients, respectively. The primary endpoint rate increased progressively from 6.3% to 55.6% (hazard ratio 15.2, 95% confidence interval: 4.53-51.0; p<0.001) in patients without OCT-VFs as compared to patients with concomitant HP, r-MLA, CP, and TCFA. The coexistence of TCFA with other OCT-VFs resulted in an increased risk of the LOCE at 5 years.

conclusionsIn DM patients with non-ischaemic lesions, TCFA was the strongest predictor of future LOCE events. However, lesions that present additional OCT-VFs are associated with a higher risk of adverse events than OCT-detected TCFA alone. Further randomised studies are warranted to confirm these findings and their potential clinical implications.

Indexed as

Coronary Artery DiseasePlaque, AtheroscleroticTomography, Optical CoherenceAgedCoronary VesselsDiabetes MellitusDouble-Blind MethodFemaleFractional Flow Reserve, MyocardialHumansMaleMiddle AgedPercutaneous Coronary InterventionPrognosisProspective StudiesRisk Factors

Identifiers

PMID38840580
PMCPMC11148652

What OpenQuestion holds

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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.