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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.
- 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.
- Subjects :
- Humans
Male
Middle Aged
Female
Aged
Treatment Outcome
Prospective Studies
Coronary Artery Disease therapy
Myocardial Infarction
Drug-Eluting Stents
Percutaneous Coronary Intervention methods
Percutaneous Coronary Intervention adverse effects
Percutaneous Coronary Intervention instrumentation
Sirolimus therapeutic use
Sirolimus administration & dosage
Antigens, CD34 immunology
Subjects
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