Evidence map›Paper›PMID 32540793›Full record

Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2021

Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial.

Ziad A Ali, Keyvan Karimi Galougahi, Akiko Maehara, Richard A Shlofmitz, Franco Fabbiocchi, Giulio Guagliumi, Fernando Alfonso, Takashi Akasaka, Mitsuaki Matsumura, Gary S Mintz and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02471586 (ILUMIEN III), which is not on this map. Cited by 55 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 10 pooled it
–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.

NCT02471586 nacompletednot on this map

ILUMIEN III: OPTIMIZE PCI: OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in Percutaneous Coronary Intervention (PCI)

TypeinterventionalSponsorAbbott Medical DevicesRan2015 to 2017Enrolled450ConditionsCoronary Artery DiseaseArmsCoronary PCI guided by IVUS, Coronary PCI guided by OCT, Coronary PCI guided by Angiography
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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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

15 authors.

Ziad A AliCenter for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA.
Keyvan Karimi Galougahi
Akiko Maehara
Richard A Shlofmitz
Franco Fabbiocchi
Giulio Guagliumi
Fernando Alfonso
Takashi Akasaka
Mitsuaki Matsumura
Gary S Mintz
Ori Ben-Yehuda
Zhen Zhang
Richard R Rapoza
Nick E J West
Gregg W Stone

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsIn the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact on clinical outcomes is unknown. The aim of the present study was to report the 12-month clinical follow-up data from the ILUMIEN III study. METHODS AND

resultsOCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes among the groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT.

conclusionsIn this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12 months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit of OCT-guided PCI.

trial registrationNCT02471586.

Indexed as

Coronary Artery DiseasePercutaneous Coronary InterventionCoronary AngiographyHumansStentsTomography, Optical CoherenceTreatment OutcomeUltrasonography, Interventional

Identifiers

PMID32540793
PMCPMC9724851

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.