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Randomized Controlled Trial
. 2022 Jun 3;18(2):e124-e131.
doi: 10.4244/EIJ-D-21-00874.

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

Julia Ellert-Gregersen  1 , Lisette Okkels Jensen  1 , Lars Jakobsen  2 , Phillip Michael Freeman  3 , Ashkan Eftekhari  3 , Michael Maeng  2 , Bent Raungaard  3 , Thomas Engstroem  4 , Johnny Kahlert  5 , Henrik Steen Hansen  1 , Evald Høj Christiansen  2
Affiliations
Randomized Controlled Trial

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

Julia Ellert-Gregersen et al. EuroIntervention. .

Abstract

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.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1. Time-to-event curve for the composite endpoint target lesion failure at two-year follow-up.
CI: confidence interval; RR: rate ratio
Figure 2
Figure 2. Time-to-event curves for the individual components of the primary endpoint at two-year follow-up.
A) Cardiac death. B) Myocardial infarction. C) Definite stent thrombosis. D) Definite or probable stent thrombosis. CI: confidence interval; RR: rate ratio
Central illustration
Central illustration. Time-to-event curves for the target lesion revascularisation.
A) Target lesion revascularisation at two years of follow-up B) Landmark analysis of the cumulative incidence of target lesion revascularisation up to two years. A landmark was set at one year. CI: confidence interval; RR: rate ratio
Figure 3
Figure 3. Pre-specified stratified analysis for the primary endpoint at two-year follow-up.
P-values in the Forest plot are all two-sided for interaction. BES: biolimus-eluting stent; CI: confidence interval; LAD: left anterior descending artery; MI: myocardial infarction; PCI: percutaneous coronary intervention; SES: sirolimus-eluting stent; STEMI: ST-segment-elevation myocardial infarction
See this image and copyright information in PMC

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