Randomized Clinical Comparison of the Dual Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent with the Sirolimus-Eluting Orsiro Stent in Patients Treated with Percutaneous Coronary Intervention: The SORT OUT X Trial

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  • Lars Jakobsen
  • Evald H Christiansen
  • Phillip Freeman, Aalborg Psychiatric University Hospital, Aalborg, Denmark Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.
  • ,
  • Johnny Kahlert
  • Karsten Veien, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Michael Maeng
  • Bent Raungaard, Aalborg Psychiatric University Hospital, Aalborg, Denmark Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.
  • ,
  • Julia Ellert, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Anton B Villadsen, Aalborg Psychiatric University Hospital, Aalborg, Denmark Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.
  • ,
  • Steen D Kristensen
  • Ole Ahlehoff, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Martin K Christensen, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Christian J Terkelsen
  • Hans Erik Bøtker
  • Jens Aaroe, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Troels Thim
  • Leif Thuesen, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Ahmed Aziz, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Ashkan Eftekhari
  • Rebekka V Jensen
  • ,
  • Nicolaj B Støttrup
  • Jeppe G Rasmussen, Aalborg Psychiatric University Hospital, Aalborg, Denmark Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.
  • ,
  • Anders Junker, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Svend E Jensen, Aalborg Psychiatric University Hospital, Aalborg, Denmark Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark.
  • ,
  • Henrik S Hansen, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Lisette O Jensen, From the Heart Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: Target lesion failure remains an issue with contemporary drug eluting stents. Thus, the dual therapy sirolimus-eluting and CD34+ antibody coated Combo stent (DTS) was designed to further improve early healing. The aim of this study was to investigate whether the DTS is non-inferior to the sirolimus-eluting Orsiro stent (SES) in an all-comers patient population. Methods: The SORT OUT X trial, was a large-scale randomized, multicenter, single-blind, two-arm, non-inferiority trial with registry-based follow-up. The primary endpoint target lesion failure (TLF) was a composite of cardiac death, myocardial infarction or target lesion revascularization within 12 months, analyzed using intention to treat. The trial was powered for assessing TLF non-inferiority of the DTS compared with the SES with a predetermined non-inferiority margin of 0.021. Results: 3,146 patients were randomized to treatment with the DTS (1,578 patients, 2,008 lesions) or the SES (1,568 patients 1,982 lesions). At 12 months, intention-to-treat analysis showed that 100 patients (6.3%), who were assigned the DTS, and 58 patients (3.7%), who were assigned the SES, met the primary endpoint (absolute risk difference 2.6% [upper limit of one-sided 95% confidence interval (CI) 4.1%]; p(non-inferiority)=0.76). The SES was superior to the DTS (Incidence rate ratios (IRR) for target lesion failure=1.74 [95% CI, 1.26-2.41]; P=0.00086). The difference was mainly explained by a higher incidence of target lesion revascularization in the DTS group compared to the SES group (53 [3.4%] vs 24 [1.5%], IRR=2.22 [95% CI, 1.37-3.61]; P=0.0012). Conclusions: The DTS did not confirm non-inferiority to the SES for target lesion failure at 12 months in an all-comer population. The SES was superior to the DTS mainly because the DTS was associated with an increased risk of target lesion revascularization. However, rates of death, cardiac death, and myocardial infarction at 12 months did not differ significantly between the two stent groups. Clinical Trial Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03216733.

OriginalsprogEngelsk
TidsskriftCirculation
ISSN0009-7322
DOI
StatusE-pub ahead of print - 7 apr. 2021

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