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. Rasmussen; Anders Junker; Svend E. Jensen; Henrik S. Hansen; Lisette O. Jensen

doi:10.4244/EIJ-D-23-00330

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

Clinical research

DOI: 10.4244/EIJ-D-23-00330

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 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

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...

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