Ikegami, Ryutaro; Piao, Zhonglie; Iglesias, Juan F; Pilgrim, Thomas; Ha, Khanh; McCarthy, Jason R; Castellanos, Maria I; Kassab, Mohamad B; Albagdadi, Mazen S; Mauskapf, Adam; Spicer, Graham; Kandzari, David E; Edelman, Elazer R; Libby, Peter; Heg, Dik; Joner, Michael; Tearney, Guillermo J; Jaffer, Farouc A (2024). Ultrathin-strut versus thin-strut stent healing and outcomes in preclinical and clinical subjects. EuroIntervention, 20(10), -e680. Europa Digital & Publishing 10.4244/EIJ-D-23-00563
Full text not available from this repository.BACKGROUND
Compared with thin-strut durable-polymer drug-eluting stents (DP-DES), ultrathin-strut biodegradable-polymer sirolimus-eluting stents (BP-SES) improve stent-related clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). Reduced stent strut thickness is hypothesised to underlie these benefits, but this conjecture remains unproven.
AIMS
We aimed to assess the impact of strut thickness on stent healing and clinical outcomes between ultrathin-strut and thin-strut BP-SES.
METHODS
First, we performed a preclinical study of 8 rabbits implanted with non-overlapping thin-strut (diameter/thickness 3.5 mm/80 μm) and ultrathin-strut (diameter/thickness 3.0 mm/60 μm) BP-SES in the infrarenal aorta. On day 7, the rabbits underwent intravascular near-infrared fluorescence optical coherence tomography (NIRF-OCT) molecular-structural imaging of fibrin deposition and stent tissue coverage, followed by histopathological analysis. Second, we conducted an individual data pooled analysis of patients enrolled in the BIOSCIENCE and BIOSTEMI randomised PCI trials treated with ultrathin-strut (n=282) or thin-strut (n=222) BP-SES. The primary endpoint was target lesion failure (TLF) at 1-year follow-up, with a landmark analysis at 30 days.
RESULTS
NIRF-OCT image analyses revealed that ultrathin-strut and thin-strut BP-SES exhibited similar stent fibrin deposition (p=0.49) and percentage of uncovered stent struts (p=0.63). Histopathological assessments corroÂborated these findings. In 504 pooled randomised trial patients, TLF rates were similar for those treated with ultrathin-strut or thin-strut BP-SES at 30-day (2.5% vs 1.8%; p=0.62) and 1-year follow-up (4.3% vs 4.7%; p=0.88).
CONCLUSIONS
Ultrathin-strut and thin-strut BP-SES demonstrate similar early arterial healing profiles and 30-day and 1-year clinical outcomes.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology |
UniBE Contributor: |
Pilgrim, Thomas |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1774-024X |
Publisher: |
Europa Digital & Publishing |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
23 May 2024 10:13 |
Last Modified: |
23 May 2024 10:30 |
Publisher DOI: |
10.4244/EIJ-D-23-00563 |
PubMed ID: |
38776143 |
URI: |
https://boris.unibe.ch/id/eprint/197032 |
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