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. ClinicalTrials.gov: NCT03216733.

Sign in to read and download 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

clinical trialsdrug-eluting stentno specific risk
Read next article
A sham-controlled randomised trial of pulmonary artery denervation for Group 1 pulmonary arterial hypertension: one-year outcomes of the PADN-CFDA trial

Latest news