Trial reportJournal of the American Heart Association2025
Safety and Efficacy of Cobalt Chromium Everolimus-Eluting Stents for Treatment of In-Stent Restenosis: An ILUMIEN IV Substudy.
Trial report in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03507777 (OPtical Coherence Tomography), which is not on this map. Cited by 1 paper.
What it found
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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.
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.
OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe optimal management strategy for in-stent restenosis (ISR) remains unclear. We aimed to determine the safety and efficacy of percutaneous coronary intervention with XIENCE cobalt chromium everolimus-eluting stents (EES) for treatment of ISR.
methodsIn the ILUMIEN IV (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in Percutaneous Coronary Intervention) trial, the 1-year outcomes of all randomized patients with a single diffuse or multifocal single-layer ISR lesion treated with EES were compared with a performance goal. The primary end point was target lesion failure, the composite of cardiac death, target vessel-myocardial infarction, or ischemia-driven target lesion revascularization. Outcomes in patients with a single EES-treated ISR and non-ISR lesion were also compared.
resultsFrom May 2018 through December 2020, 247 patients with a single ISR lesion were treated with EES. Target lesion failure at 1 year occurred in 18 patients (7.4% [upper 1-sided 97.5% CI, 11.5%]), which was lower than the predefined performance goal of 20% (
conclusionsXIENCE EES was safe and effective for treatment of single-layer ISR. Compared with non-ISR lesions, ISR lesions treated with EES had a smaller postpercutaneous coronary intervention minimal stent area although stent expansion and 1-year target lesion failure rates were not different. REGISTRATION: URL: https://clinicaltrials.gov/; Unique identifier: NCT03507777.
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