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Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial.

Authors :
Jakobsen L
Christiansen EH
Freeman P
Kahlert J
Veien K
Maeng M
Raungaard B
Ellert J
Villadsen AB
Kristensen SD
Christensen MK
Terkelsen CJ
Aaroe J
Thim T
Lassen JF
Hougaard M
Eftekhari A
Jensen RV
Støttrup NB
Rasmussen JG
Junker A
Jensen SE
Hansen HS
Jensen LO
Source :
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology [EuroIntervention] 2023 Oct 23; Vol. 19 (8), pp. 676-683.
Publication Year :
2023

Abstract

Background: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing.<br />Aims: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention.<br />Methods: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR).<br />Results: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups.<br />Conclusions: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years.<br />Clinicaltrials: gov: NCT03216733.

Details

Language :
English
ISSN :
1969-6213
Volume :
19
Issue :
8
Database :
MEDLINE
Journal :
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Publication Type :
Academic Journal
Accession number :
37584207
Full Text :
https://doi.org/10.4244/EIJ-D-23-00330