Original Research

DOI: 10.4244/EIJ-D-23-00563

Ultrathin-strut versus thin-strut stent healing and outcomes in preclinical and clinical subjects

Ryutaro Ikegami1,2, MD, PhD; Zhonglie Piao3, PhD; Juan F. Iglesias4, MD, PhD; Thomas Pilgrim5, MD; Khanh Ha6,7, PhD; Jason R. McCarthy6,7, PhD; Maria I. Castellanos8,9, PhD; Mohamad B. Kassab1, MD; Mazen S. Albagdadi1,10, MD, MSc; Adam Mauskapf1, BS; Graham Spicer3, PhD; David E. Kandzari11, MD; Elazer R. Edelman12,13,14, MD, PhD; Peter Libby14, MD; Dik Heg15, PhD; Michael Joner8,9, MD; Guillermo J. Tearney3,12, MD, PhD; Farouc A. Jaffer1,3, MD, PhD

Abstract

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.

Sign in to read
the full article

Forgot your password?
No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

Volume 20 Number 10
May 20, 2024
Volume 20 Number 10
View full issue


Key metrics

Suggested by Cory

10.4244/EIJV14I12A224 Dec 20, 2018
Covering our tracks – optical coherence tomography to assess vascular healing
Ali ZA et al
free
Trending articles
152.9

Clinical research

10.4244/EIJ-D-20-01125 Oct 20, 2021
An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation
Costa G et al
free
47.8

NEW INNOVATION

10.4244/EIJ-D-15-00467 Feb 20, 2018
Design and principle of operation of the HeartMate PHP (percutaneous heart pump)
Van Mieghem NM et al
free
39.1

Clinical research

10.4244/EIJ-D-22-00558 Feb 6, 2023
Permanent pacemaker implantation and left bundle branch block with self-expanding valves – a SCOPE 2 subanalysis
Pellegrini C et al
free
38.95

State-of-the-Art

10.4244/EIJ-D-23-00912 Oct 7, 2024
Optical coherence tomography to guide percutaneous coronary intervention
Almajid F et al
free
X

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

EuroPCR EAPCI
PCR ESC
Impact factor: 7.6
2023 Journal Citation Reports®
Science Edition (Clarivate Analytics, 2024)
Online ISSN 1969-6213 - Print ISSN 1774-024X
© 2005-2024 Europa Group - All rights reserved