Observational studyCardiovascular drugs and therapy2024
Third-Generation Sirolimus-Eluting Bioresorbable Tyrocore Scaffold Implantation in Patients with ST-Segment Elevation Myocardial Infarction: Baseline and 6-Month OCT and Clinical Outcomes-a FANTOM STEMI Pilot Study.
Observational study in Cardiovascular drugs and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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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
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Who cites it
2 citing papers in PubMed.
- Defining biomaterial-driven design principles for bioabsorbable flow diverters: current state and perspectives.Bioactive materials · 2027Review
- Antithrombotic Polymers: A Narrative Review on Current and Future Strategies for Their Design, Synthesis, and Application.International journal of molecular sciences · 2026Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this study was to evaluate the safety and efficacy of the Fantom BRS 6 months after implantation using the optical coherence tomography (OCT) imaging.
methodsTwenty STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into a prospective, single-arm, serial observational study. The scaffold sizing, positioning and optimisation were guided by OCT imaging. The primary endpoint was device-orientated composite endpoints (DOCE), comprised of cardiac death, target-vessel-related myocardial infarction and target lesion failure. To evaluate the device performance at the scaffold level, we performed a quantitative coronary angiography (QCA) and OCT imaging at 6 months.
resultsThe primary endpoint did not occur in any patient within the 6-month follow-up. There were no major adverse cardiac events (MACEs) or DOCEs, no cases of scaffold thrombosis, target lesion revascularization and no deaths. In QCA, we observed a decrease in the minimum and mean lumen diameter in the in-scaffold region and in the proximal and distal peri-scaffold region. Similarly, the minimum lumen area and reference vessel diameter had decreased in both QCA and OCT. The OCT imaging showed improvement in the expansion index and malposition rate.
conclusionA serial 6-month OCT imaging after implantation of a third-generation Tyrocore-based bioresorbable coronary scaffold indicated good coverage of the struts with excellent healing of the scaffold, low neointima growth and no signs of neoatherosclerosis.
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