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

Lars Jakobsen*, Evald H. Christiansen, Phillip Freeman, Johnny Kahlert, Karsten Veien, Michael Maeng, Bent Raungaard, Julia Ellert, Anton B. Villadsen, Steen D. Kristensen, Martin K. Christensen, Christian J. Terkelsen, Jens Aaroe, Troels Thim, Jens Flensted Lassen, Mikkel Hougaard, Ashkan Eftekhari, Rebekka V. Jensen, Nicolaj B. Støttrup, Jeppe G. RasmussenAnders Junker, Svend E. Jensen, Henrik S. Hansen, Lisette O. Jensen

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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. 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.

Original languageEnglish
JournalEuroIntervention
Volume19
Issue number8
Pages (from-to)676-683
ISSN1774-024X
DOIs
Publication statusPublished - Oct 2023

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Keywords

  • •clinical trials
  • •drug-eluting stent
  • •no specific risk

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