Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Jun 2;21(11):e617-e628.
doi: 10.4244/EIJ-D-24-00586.

Five-year outcomes of a drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent

Lisette Okkels Jensen  1 , Lars Jakobsen  2 , Ashkan Eftekhari  3 , Julia Ellert-Gregersen  1 , Nicolaj Brejnholt Støttrup  2 , Thomas Engstrøm  4 , Johnny Kahlert  5 , Philip Freeman  3 , Karsten Tange Veien  1 , Rebekka Vibjerg Jensen  2 , Jens Flensted Lassen  1 , Anders Junker  1 , Evald Høj Christiansen  2
Affiliations
Randomized Controlled Trial

Five-year outcomes of a drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent

Lisette Okkels Jensen et al. EuroIntervention. .

Abstract

Background: The biolimus A9-coated polymer-free stent was not non-inferior for target lesion failure (TLF) when compared with an ultrathin-strut biodegradable-polymer sirolimus-eluting stent within 1 year in the Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention (SORT OUT IX) trial.

Aims: We aimed to assess the 5-year outcomes of the drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent.

Methods: The SORT OUT IX trial was a registry-based, randomised, all-comer population trial. The primary endpoint, TLF, was defined as the composite of cardiac death, myocardial infarction (MI) not related to any segment other than the target lesion, or target lesion revascularisation (TLR) within 1 year. Follow-up was extended to 5 years.

Results: A total of 3,151 patients were randomly assigned to receive either the polymer-free biolimus-coated stent (1,572 patients [1,966 lesions]) or the ultrathin-strut biodegradable-polymer sirolimus-eluting stent (1,579 patients [1,985 lesions]). Only 0.3% of participants were lost to follow-up, and all of those were due to emigration. At 5 years, TLF was 14.1% in the polymer-free biolimus-coated stent group and 12.0% in the ultrathin-strut biodegradable-polymer sirolimus-eluting stent group (rate ratio [RR] 1.19, 95% confidence interval [CI]: 0.97-1.44). Cardiac death, MI and definite stent thrombosis did not differ between the two groups. Clinically driven TLR was 7.6% versus 5.0% (RR 1.56, 95% CI: 1.17-2.07) and was higher in the polymer-free biolimus-coated stent group at 5 years, attributable to a higher risk of TLR within the first year.

Conclusions: Five-year TLF did not differ significantly between the drug-coated biolimus-eluting stent group and the ultrathin-strut biodegradable-polymer stent group, but the risk of TLR was higher in the drug-coated biolimus-eluting stent group.

PubMed Disclaimer

Conflict of interest statement

L.O. Jensen has received research grants from Biotronik, Biosensors, and OrbusNeich, to her institution. E.H. Christiansen received institutional grants from Asahi Intecc, Philips, OrbusNeich, and Abbott. J. Ellert-Gregersen is on an advisory board for Boston Scientific. T. Engstrøm is on an advisory board for Novo Nordisk and Abbott; and he has received speaker fees from Abbott, Novo Nordisk, and Boston Scientific. J.F. Lassen has participated on a data safety monitoring board for B. Braun; has received travel grant from Terumo; and speaker fees from Medtronic and Boston Scientific. The other authors have no conflicts of interest to declare.

References

    1. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–80. - PubMed
    1. Pilgrim T, Heg D, Roffi M, Tüller D, Muller O, Vuilliomenet A, Cook S, Weilenmann D, Kaiser C, Jamshidi P, Fahrni T, Moschovitis A, Noble S, Eberli FR, Wenaweser P, Jüni P, Windecker S. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. Lancet. 2014;384:2111–22. - PubMed
    1. Smits PC, Hofma S, Togni M, Vázquez N, Valdés M, Voudris V, Slagboom T, Goy JJ, Vuillomenet A, Serra A, Nouche RT, den Heijer, van der. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013;381:651–60. - PubMed
    1. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario, Davies S, van Geuns, Eerdmans P, van Es, Meier B, Jüni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008;372:1163–73. - PubMed
    1. Jensen LO, Thayssen P, Maeng M, Ravkilde J, Krusell LR, Raungaard B, Junker A, Terkelsen CJ, Veien KT, Villadsen AB, Kaltoft A, Tilsted HH, Hansen KN, Aaroe J, Kristensen SD, Hansen HS, Jensen SE, Madsen M, Bøtker HE, Berencsi K, Lassen JF, Christiansen EH. Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT VII Trial. Circ Cardiovasc Interv. 2016;9:e003610. - PubMed

Publication types

LinkOut - more resources