Evidence map›Paper›PMID 40470719›Full record

Trial reportEuropean heart journal2025

Optical coherence tomography- vs angiography-guided coronary stent implantation in calcified lesions: the ILUMIEN IV trial.

Ziad A Ali, Doosup Shin, Rajesh Vijayvergiya, Atit A Gawalkar, Richard A Shlofmitz, Fernando Alfonso, Giuseppe Calligaris, Paolo Canova, Koshiro Sakai, Matthew J Price and 11 more

Abstract readRandomized Controlled TrialMulticenter StudyComparative Study
In one paragraph

Trial report in European heart journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. 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

21 authors.

Ziad A AliDepartment of Cardiology, St. Francis Hospital and Heart Center, Roslyn, NY, USA.ORCID 0000-0002-2482-3197
Doosup ShinDepartment of Cardiology, St. Francis Hospital and Heart Center, Roslyn, NY, USA.ORCID 0000-0003-4960-5732
Rajesh VijayvergiyaDepartment of Cardiology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.ORCID 0000-0001-5250-4735
Atit A GawalkarDepartment of Cardiology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Richard A ShlofmitzDepartment of Cardiology, St. Francis Hospital and Heart Center, Roslyn, NY, USA.
Fernando AlfonsoCardiology Department, Hospital Universitario de La Princesa, CIBERCV, IIS-IP, Madrid, Spain.ORCID 0000-0002-7480-2511
Giuseppe CalligarisCentro Cardiologico Monzino IRCCS, Milano, Italy.ORCID 0000-0001-8991-0956
Paolo CanovaCardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.ORCID 0000-0002-3594-2853
Koshiro SakaiDepartment of Cardiology, St. Francis Hospital and Heart Center, Roslyn, NY, USA.
Matthew J PriceDivision of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA, USA.
David LeistnerDepartment of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum Charité; Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-4351-420X
Francesco PratiCardiology, Saint Camillus International University of Health Sciences and CLI Foundation, Rome, Italy.
Gary MintzClinical Trial Center, Cardiovascular Research Foundation, New York, NY, USA.
Mitsuaki MatsumuraClinical Trial Center, Cardiovascular Research Foundation, New York, NY, USA.ORCID 0000-0002-2082-0247
Robert J McGreevyAbbott Vascular, Santa Clara, CA, USA.ORCID 0009-0009-9473-1798
Robert W McNuttAbbott Vascular, Santa Clara, CA, USA.
Hong NieAbbott Vascular, Santa Clara, CA, USA.
Jana BuccolaAbbott Vascular, Santa Clara, CA, USA.
Ulf LandmesserDepartment of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum Charité; Charité-Universitätsmedizin Berlin, Berlin, Germany.
Akiko MaeharaClinical Trial Center, Cardiovascular Research Foundation, New York, NY, USA.ORCID 0000-0002-1910-8447
Gregg W StoneThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Funding

Abbott Vascular
6 · The paper itself

Abstract

BACKGROUND AND

aimsThe large-scale, randomized ILUMIEN IV trial was examined to determine whether procedural guidance with optical coherence tomography (OCT) during percutaneous coronary intervention (PCI) of angiographically calcified lesions improves outcomes.

methodsPatients with a single PCI target lesion were included in the present analysis. The presence of none, mild, moderate or severe lesion calcification was determined by an angiographic core laboratory. The primary imaging endpoint was the post-PCI minimal stent area (MSA) assessed by OCT. The primary clinical endpoint was 2-year target-vessel failure (TVF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischaemia-driven target-vessel revascularization.

resultsIn the overall population (n = 2114), there was a significant interaction between the effect of randomization to OCT guidance vs angiography guidance in lesions with moderate/severe calcification (n = 1082) vs no/mild calcification (n = 1032) on the 2-year rate of TVF (Pinteraction = .01). The post-PCI MSA in moderately and severely calcified lesions was larger with OCT guidance (n = 544) compared with angiography guidance (n = 538) (5.57 ± 1.86 mm2 vs 5.33 ± 1.78 mm2; P = .03). In the moderate/severe calcified lesion cohort, TVF within 2 years occurred in 35 patients with OCT guidance and in 51 patients with angiography guidance (6.8% vs 9.7%; adjusted hazard ratio [aHR] 0.62; 95% confidence interval [CI] 0.40-0.96), whereas there was no significant difference in TVF in the no/mild calcified lesion cohort (7.7% vs 5.2%; aHR 1.48; 95% CI 0.90-2.44) (Pinteraction = .01). In moderately/severely calcified lesions, OCT-guided PCI also reduced the 2-year rates of serious major adverse cardiac events (2.8% vs 4.7%; aHR 0.49; 95% CI 0.25-0.95; P = .03), TV-MI (1.9% vs 4.0%; aHR 0.36; 95% CI 0.17-0.79; P = .01), and stent thrombosis (0.2% vs 1.5%; aHR 0.11; 95% CI 0.01-0.89; P = .04) compared with angiography-guided PCI.

conclusionsIn the ILUMIEN IV trial, OCT-guided PCI in patients with angiographically determined moderately or severely calcified lesions reduced the 2-year rate of TVF compared with angiography-guided PCI, an effect that was not seen in patients with lesions with no or mild angiographic calcium.

Indexed as

Coronary AngiographyCoronary Artery DiseasePercutaneous Coronary InterventionStentsTomography, Optical CoherenceVascular CalcificationAgedFemaleHumansMaleMiddle AgedMyocardial InfarctionTreatment OutcomeOptical coherence tomographyPercutaneous coronary interventionPrognosisStent

Identifiers

PMID40470719
PMCPMC12369818

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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.