Impact of diabetes on clinical outcomes after revascularization with the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent

Lars Jakobsen*, Evald H. Christiansen, Phillip Freeman, Johnny Kahlert, Karsten Veien, Michael Maeng, Bent Raungaard, Julia Ellert, Steen D. Kristensen, Martin K. Christensen, Christian J. Terkelsen, Troels Thim, Ashkan Eftekhari, Rebekka V. Jensen, Nicolaj B. Støttrup, Anders Junker, Henrik S. Hansen, Lisette O. Jensen

*Corresponding author for this work

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Abstract

Objectives: To compare the efficacy and safety of the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study. Background: The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown. Methods: In total 3146 patients were randomized to stent implantation with DTS (n = 1578; DM: n = 279) or SES (n = 1568; DM: n = 271). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year. Results: At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02–3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15–2.42). The differences were mainly explained by higher rates of TLR. Conclusion: Compared to the SES, the DTS was associated with an increased risk of TLF at 12 months in patients with and without DM. The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without DM.

Original languageEnglish
JournalCatheterization and Cardiovascular Interventions
Volume99
Issue number7
Pages (from-to)1965-1975
ISSN1522-726X
DOIs
Publication statusPublished - Jun 2022

Keywords

  • diabetes
  • randomized controlled trial
  • stent comparison
  • target lesion failure
  • Percutaneous Coronary Intervention/adverse effects
  • Sirolimus/adverse effects
  • Antigens, CD34/immunology
  • Coronary Artery Disease/drug therapy
  • Humans
  • Treatment Outcome
  • Diabetes Mellitus/diagnosis
  • Prosthesis Design
  • Absorbable Implants
  • Myocardial Infarction/etiology
  • Death
  • Stents

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