Polymer-free biolimus-coated stents versus ultrathin-strut biodegradable polymer sirolimus-eluting stents: two-year outcomes of the randomised SORT OUT IX trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Julia Ellert-Gregersen
  • Lisette Okkels Jensen
  • Lars Jakobsen
  • Phillip Michael Freeman
  • Ashkan Eftekhari
  • Michael Maeng
  • Bent Raungaard
  • Engstrøm, Thomas
  • Johnny Kahlert
  • Henrik Steen Hansen
  • Evald Høj Christiansen

Background: For patients with high bleeding risk, the BioFreedom stent is safer and more effective than a bare metal stent. However, at the one-year follow-up of the SORT OUT IX trial, the BioFreedom stent did not meet the criteria for non-inferiority for target lesion failure (TLF) when compared with the Orsiro stent and had a higher incidence of target lesion revascularisation (TLR). Aims: The aim of the study was to compare the two-year outcomes following coronary implantation of the BioFreedom or the Orsiro stents in all-comer patients. Methods: The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX trial is a prospective, multicentre, randomised clinical trial comparing the BioFreedom and the Orsiro stents. The primary endpoint, TLF, was a composite of cardiac death, myocardial infarction (MI; not related to other lesions) and TLR. Results: A total of 1,572 patients were randomised to treatment with the BioFreedom stent and 1,579 patients with the Orsiro stent. At two-year follow-up, TLF was 7.8% in the BioFreedom and 6.3% in the Orsiro stent groups (rate ratio [RR] 1.23, 95% confidence interval [CI]: 0.94-1.61). Risks of cardiac death, MI and definite stent thrombosis did not differ significantly between the groups, whereas more patients in the BioFreedom group had TLR (5.1% vs 2.6%; RR 1.98, 95% CI: 1.26-2.89) attributable to a higher risk of TLR within the first year (3.5% vs 1.3%; RR 2.77, 95% CI: 1.66-4.62). Conclusions: At two years, there were no significant differences between the BioFreedom and Orsiro stents for TLF. TLR was significantly higher with the BioFreedom stent due to higher risk of TLR within the first year.

OriginalsprogEngelsk
TidsskriftEuroIntervention
Vol/bind18
Udgave nummer2
Sider (fra-til)E124-E131
Antal sider8
ISSN1774-024X
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
This study was an investigator-initiated study from the SORT OUT organisation. It was supported by equal, unrestricted grants from Biosensors and Biotronik. The two companies did not have access to the study database and were not involved in the study design, data collection, data analysis, or interpretation of results. Also, the companies did not have the opportunity to review the manuscript. The corresponding author had full access to all the data in the study and final responsibility to submit for publication.

Funding Information:
L.O. Jensen has received research grants from Biotronik, Biosensors and Orbush Neich for her institute. M. Maeng has received lecture and advisory board fees from Novo Nordisk. T. Engstrom has received speakers’ fees from Abbott. E.H. Christiansen has received grants from Biosensors and Biotronik for his institute. P.M. Freeman received honoraria from Edwards Lifesciences and Meril Lifesciences, and an educational grant from AstraZeneca. The other authors have no conflicts of interest to declare.

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