Coronary interventions

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

EuroIntervention 2023;19:676-683. DOI: 10.4244/EIJ-D-23-00330

Lars Jakobsen
Lars Jakobsen1, MD, PhD; Evald H Christiansen1, MD, PhD; Phillip Freeman2, MD; Johnny Kahlert3, PhD; Karsten Veien4, MD; Michael Maeng1, MD, PhD; Bent Raungaard2, MD, PhD; Julia Ellert4, MD, PhD; Anton B. Villadsen2, MD; Steen D. Kristensen1, MD, DMSc; Martin K Christensen4, MD; Christian J. Terkelsen1, MD, DMSc; Jens Aaroe4, MD; Troels Thim1, MD, PhD; Jens Flensted Lassen4, MD, PhD; Mikkel Hougaard4, MD, PhD; Ashkan Eftekhari1, MD, PhD; Rebekka V. Jensen1, MD, PhD; Nicolaj B. Støttrup1, MD, PhD; Jeppe G. Rasmussen2, MD, PhD; Anders Junker4, MD, PhD; Svend E. Jensen2, MD, PhD; Henrik S. Hansen4, MD, DMSc; Lisette O. Jensen4, MD, DMSc
1. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; 2. Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark; 3. Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 4. Department of Cardiology, Odense University Hospital, Odense, Denmark

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.

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.

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).

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.

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. NCT03216733.

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