Dataset Information

Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI.

ABSTRACT:

Aims

Randomised trials have demonstrated improvement in clinical outcomes with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI. The ILUMIEN III trial demonstrated non-inferiority of an optical coherence tomography (OCT)- versus IVUS-guided PCI strategy in achieving similar post-PCI lumen dimensions. ILUMIEN IV is a large-scale, multicentre, randomised trial designed to demonstrate the superiority of OCT- versus angiography-guided stent implantation in patients with high-risk clinical characteristics (diabetes) and/or complex angiographic lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes.

Methods and results

ILUMIEN IV is a prospective, single-blind clinical investigation that will randomise between 2,490 and 3,656 patients using an adaptive design to OCT-guided versus angiography-guided coronary stent implantation in a 1:1 ratio. The primary endpoints are: (1) post-PCI minimal stent area assessed by OCT in each randomised arm, and (2) target vessel failure, the composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation. Clinical follow-up will continue for up to two years. The trial is currently enrolling, and the principal results are expected in 2022.

Conclusions

The large-scale ILUMIEN IV randomised controlled trial will evaluate the effectiveness of OCT-guided versus angiography-guided PCI in improving post-PCI lumen dimensions and clinical outcomes in patients with diabetes and/or with complex coronary lesions.

Trial registration

NCT03507777.

SUBMITTER: Ali Z

PROVIDER: S-EPMC9725042 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI.

Ali Ziad Z Landmesser Ulf U Karimi Galougahi Keyvan K Maehara Akiko A Matsumura Mitsuaki M Shlofmitz Richard A RA Guagliumi Giulio G Price Matthew J MJ Hill Jonathan M JM Akasaka Takashi T Prati Francesco F Bezerra Hiram G HG Wijns William W Mintz Gary S GS Ben-Yehuda Ori O McGreevy Robert J RJ Zhang Zhen Z Rapoza Richard R RR West Nick E J NEJ Stone Gregg W GW

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20210101 13

<h4>Aims</h4>Randomised trials have demonstrated improvement in clinical outcomes with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI. The ILUMIEN III trial demonstrated non-inferiority of an optical coherence tomography (OCT)- versus IVUS-guided PCI strategy in achieving similar post-PCI lumen dimensions. ILUMIEN IV is a large-scale, multicentre, randomised trial designed to demonstrate the superiority of OCT- versus angiogra ...[more]

PMID: 32863246

Similar Datasets

Project description:BackgroundThe current advances in coronary imaging with the introduction of intravascular ultrasound (IVUS), and more recently, optical coherence tomography (OCT) have overcome the limitations of coronary angiography.ObjectiveThis study aimed to conduct a comprehensive network meta-analysis of randomized clinical trials to report clinical outcomes among patients undergoing drug-eluting stent (DES) implantation either by IVUS- or OCT-guided technique or angiography alone.MethodsPubMed/MEDLINE and EMBASE databases were searched systematically for all relevant published randomized clinical trials from the inception of the respective database to October 15th, 2021. The outcomes of interest assessed in this meta-analysis were major adverse cardiac events, myocardial infarction, target vessel revascularization, all-cause mortality, and cardiovascular mortality. All the endpoints were expressed as odds ratio (OR) with 95% CI. The network diagrams were computed using the OR as an effective measure. All statistical analyses were carried out in R statistical software version 4.0.3.ResultsA total of 14 randomized clinical trials were included in our meta-analysis. In patient undergoing DES implantation, angiography alone was associated with higher odds of major adverse cardiac events (OR, 1.62; 95% CI, 1.17-2.24), target vessel revascularization (OR, 1.60; 95% CI, 1.21-2.13) and cardiovascular mortality (OR, 1.97; 95% CI, 1.25-3.11). However, OCT demonstrated similar odds of major adverse cardiac events, cardiovascular mortality, and target vessel revascularization compared with IVUS. The odds of myocardial infarction and all-cause mortality were similar among all the 3 groups.ConclusionsAlthough angiography alone was associated with worse outcomes than IVUS in a patient undergoing DES implantation, no difference in outcome was noted between patients undergoing DES implantation with OCT compared with IVUS. Advanced intracoronary imaging use should be encouraged to prevent excess mortality and morbidity.

Project description:Importance:Whether optical coherence tomography angiography (OCT-A) outperforms OCT to detect glaucoma remains inconclusive. Objective:To compare (1) the diagnostic performance for detection of glaucoma and (2) the structure-function association between inner macular vessel density and inner macular thickness. Design, Setting, and Participants:This cross-sectional study included 115 patients with glaucoma and 35 healthy individuals for measurements of retinal thickness and retinal vessel density, segmented between the anterior boundary of internal limiting membrane and the posterior boundary of the inner plexiform layer, over the 3 × 3-mm2 macula using swept-source OCT. All participants were Chinese. Visual sensitivity corresponding to the 3 × 3-mm2 macular region was expressed in unlogged 1/lambert for investigation of the structure-function associations. Diagnostic performance was evaluated with area under the receiver operating characteristic curves (AUCs). The study was conducted between January 12, 2016, and December 12, 2016. Main Outcomes and Measures:Area under the receiver operating characteristic curve and R2 analysis. Results:Of the 115 patients with glaucoma, 42 (36.5%) were women (mean [SD] age, 53.5 [13.4] years); of the 35 individuals with healthy eyes, 25 (71.4%) were women (age, 60.6 [5.9] years). Inner macular vessel density and thickness were 4.3% (95% CI, 2.4%-6.1%) and 21.1 μm (95% CI, 17.4-24.9 μm) smaller, respectively, in eyes with glaucoma compared with healthy eyes. The AUC of mean inner macular thickness for glaucoma detection was greater than that of mean inner macular vessel density (difference, 0.17; 95% CI, 0.01-0.31; P = .03). At 90% specificity, the sensitivity of mean inner macular thicknesses for detection of glaucoma was greater than that of mean inner macular vessel densities (difference, 29.2%; 95% CI, 11.5%-64.6%; P = .02). The strength of the structure-function association was stronger for mean inner macular thickness than mean inner macular vessel density in the linear (difference in R2 = 0.38; 95% CI, 0.22-0.54; P < .001) and nonlinear (difference in R2 = 0.36; 95% CI, 0.21-0.51; P < .001) regression models. Conclusions and Relevance:In this study, OCT measurement of inner macular thickness shows a higher diagnostic performance to detect glaucoma and a stronger structure-function association than the currently used OCT-A measurement of inner macular vessel density. These findings may suggest that OCT-A of the macula has a limited role in the diagnostic evaluation of glaucoma.

Dataset Information

Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI.

Aims

Methods and results

Conclusions

Trial registration

Publications

Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets