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Polymer free biolimus coated stents to treat acute ST-elevation myocardial infarction in Asian patients.

Authors :
Ong PJL
Chui SF
Tam FC
Nguyen QT
Tsai CT
Kang WC
Nuruddin AA
Singh R
Chotinaiwattarakul C
Lee M
Source :
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2024 Oct 21. Date of Electronic Publication: 2024 Oct 21.
Publication Year :
2024
Publisher :
Ahead of Print

Abstract

Background: Patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment-elevation myocardial infarction (STEMI) have a high thrombotic burden and often have a high bleeding risk (HBR). Asian patients have different patterns of thrombotic and bleeding risk from other populations which may be particularly relevant in the setting of PPCI for STEMI.<br />Objectives: To assess the safety and efficacy of the polymer free biolimus coated coronary stent (PF-BCS, BioFreedom <superscript>TM</superscript> , Biosensors International) in Asian STEMI patients.<br />Methods: Patients with acute STEMI who received at least one PF-BCS were invited to participate after their index procedure. Follow-up was performed at 1, 4, and 12 months. The primary endpoint was the rate of target lesion failure (TLF) at 1 year. A performance goal was derived from the biolimus eluting stent arm of the COMFORTABLE AMI study which was the only prior dedicated study of biolimus eluting stents in patients with STEMI.<br />Results: A total of 914 patients with STEMI were enrolled. Mean patient age was 60 ± 13 years, diabetes was present in 23.2% and 43% were active smokers. According to the ARC definition, 12.4% of the patients were HBR. TLF rate was 2.54% [95% CI: 1.52-3.56], p-value for non-inferiority <0.0001, p-value for superiority = 0.0004). The rate of definite/probable stent thrombosis was 0.44% [95% CI: 0.16-1.16]. There was a trend toward more BARC 3 to 5 bleeding in ARC-HBR patients (3.69% vs 1.46%, HR = 2.74, [95% CI: 0.87-8.62], p = 0.07).<br />Conclusions: In Asian patients undergoing PPCI for STEMI and treated with variable durations of DAPT, the use of a PF-BCS was associated with low rates of TLF and stent thrombosis (NCT03609346).<br /> (© 2024 Wiley Periodicals LLC.)

Details

Language :
English
ISSN :
1522-726X
Database :
MEDLINE
Journal :
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Publication Type :
Academic Journal
Accession number :
39434554
Full Text :
https://doi.org/10.1002/ccd.31263