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Randomized Controlled Trial
. 2024 Sep-Oct;21(5):14791641241283939.
doi: 10.1177/14791641241283939.

Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial

Jens Trøan  1 , Evald Høj Christiansen  2 , Kirstine Nørregaard Hansen  1 , Ashkan Eftekhari  3 , Lars Jakobsen  2 , Michael Mæng  2 , Phillip Freeman  3 , Rebekka Vibjerg Jensen  2 , Martin Kirk Christensen  3 , Manijeh Noori  1 , Julia Ellert-Gregersen  1 , Nicolaj Brejnholt Støttrup  2 , Johnny Kahlert  4 , Karsten Tange Veien  1 , Lisette Okkels Jensen  1
Affiliations
Randomized Controlled Trial

Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial

Jens Trøan et al. Diab Vasc Dis Res. 2024 Sep-Oct.

Abstract

Background: Diabetes mellitus is associated with higher risk of target lesion failure (TLF) after percutaneous coronary intervention. We studied the 5-year outcome in patients with diabetes mellitus treated with biodegradable polymer stents.

Methods: The SORT OUT VII was a randomised trial comparing the ultrathin sirolimus-eluting Orsiro stent (O-SES) and the biolimus-eluting Nobori stent (N-BES) in an all-comer setting. Patients (n = 2525) were randomised to receive O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). Endpoints were TLF (a composite of cardiac death, target-lesion myocardial infarction (MI), target lesion revascularization (TLR)), definite stent thrombosis and a patient related outcome (all-cause mortality, MI and revascularization) within 5 years.

Results: Patients with diabetes mellitus had higher TLF (20.6% vs 11.0%, (Rate ratio (RR) 1.85 95% confidence interval (CI): (1.42-2.40) and patient related outcome (42.0% vs 31.0%, RR 1.43 95% CI: (1.19-1.71)) compared to patients without diabetes. Among patients with diabetes mellitus, TLF after 5 years did not differ between O-SES and N-BES (21.2% vs 20.0%), RR 1.05 95% CI: (0.70-1.58), p = 0.81). Cardiac death, MI, TLR, and definite stent thrombosis did not differ between the groups.

Conclusion: In patients with diabetes mellitus, 5-year outcomes were similar among patients treated with biodegradable polymer O-SES or N-BES.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01879358.

Keywords: Drug-eluting stent; biodegradable polymer; diabetes mellitus; target lesion failure.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: LOJ has received research grants from Biotronik and Biosensor to her institution, MKC has received both educational and research grants from Biotronik and Terumo. MM is supported by a grant from the Novo Nordisk Foundation (grant number NNF22OC0074083); has received lecture and/or advisory board fees from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Novo Nordisk, has received a travel grant from Novo Nordisk, has received institutional research grants from Philips, Bayer and Novo Nordisk, has ongoing research contracts with Janssen, Novo Nordisk, and Philips, and equity in Novo Nordisk, Eli Lilly & Company, and Verve Therapeutics. JT, EHC, KNH, AE, LJ, MM, PF, RVJ, MN, JEG, NBS, JK and KTV declare they have no conflicts of interest.

Figures

Figure 1.
Figure 1.
CONSORT diagram for the scandinavian organization for randomized trails with clinical outcome (SORT OUT) VII trail.
Figure 2.
Figure 2.
Time to event curves for endpoints at 5-year. (A): Patient related composite endpoint in patients with or without diabetes. (B): Target lesion failure in patients with diabetes treated with O-SES and N-BES. (C): Cardiac death in patient with diabetes treated with O-SES and N-BES. (D): Target lesion revascularization in patients with diabetes treated with O-SES and N-BES. E: Definite stent thrombosis in patients with diabetes treated with O-SES and N-BES.
See this image and copyright information in PMC

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