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Randomized Controlled Trial
. 2025 Jul 15;86(2):106-115.
doi: 10.1016/j.jacc.2025.05.012. Epub 2025 May 21.

Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in PCI: The SORT OUT XI Randomized Trial

Ashkan Eftekhari  1 , Lisette Okkels Jensen  2 , Karsten Veien  3 , Bent Raungaard  4 , Jeppe Grøndahl Rasmussen  4 , Michael Mæng  5 , Christian Juhl Terkelsen  5 , Julia Ellert-Gregersen  3 , Nicolaj Brejnholt Støttrup  5 , Jens Flensted Lassen  2 , Henrik Steen Hansen  3 , Troels Thim  5 , Rebekka Vibjerg Jensen  5 , Roni Nielsen  5 , Svend Eggert Jensen  4 , Steen Dalby Kristensen  5 , Mikkel Hougaard  3 , Anders Junker  3 , Martin Kirk Christensen  3 , Jens Aarøe  4 , Trine Frøslev  6 , Lars Jakobsen  5 , Evald Høj Christiansen  3
Affiliations
Randomized Controlled Trial

Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in PCI: The SORT OUT XI Randomized Trial

Ashkan Eftekhari et al. J Am Coll Cardiol. .

Abstract

Background: Percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES) is still associated with risk of target lesion failure (TLF). The biolimus A9-eluting Biomatrix Alpha stent (BES), with biodegradable polymer and thin struts, has not been compared head-to-head with another contemporary DES.

Objectives: This study compared 1-year TLF in BES vs dual therapy sirolimus-eluting Combo stent (DTS) in an all-comer population undergoing PCI.

Methods: The trial was conducted in the 3 Western Danish Heart centers (Aalborg, Aarhus, and Odense). The primary composite endpoint was 1-year TLF defined as a composite of cardiac death, target lesion myocardial infarction, or target lesion revascularization. The trial was designed as a noninferiority trial with a noninferiority margin of 2.1%. Data were analyzed by intention-to-treat.

Results: From August 14, 2019, to March 19, 2023, 3,136 patients were randomized 1:1 to BES (n = 1,566; 1,891 lesions) vs DTS (n = 1,570; 1,878 lesions). In the intention-to-treat analysis, TLF at 1-year follow-up occurred in 65 patients (4.2%) in the BES group and 82 patients (5.2%) in the DTS group: risk difference: -1.07% (upper limit of 1-sided 90% CI: 0.21%), (P for noninferiority = 0.00002); incidence rate ratio: 0.79 (95% CI: 0.57-1.09; P = 0.15). Cardiac death occurred in 18 patients (1.1%) in the BES group and 30 (1.9%) in the DTS group: incidence rate ratio: 0.60 (95% CI: 0.33-1.07; P = 0.08). Target lesion myocardial infarction occurred in 36 (2.3%) in the BES group and 33 (2.1%) in the DTS group: incidence rate ratio: 1.09 (95% CI: 0.68-1.75; P = 0.73). Definite stent thrombosis occurred in 21 patients (1.3%) in the BES group and 9 (0.6%) in the DTS group: incidence rate ratio: 2.33 (95% CI: 1.07-5.11; P = 0.034).

Conclusions: BES was noninferior to DTS at 1-year follow-up regarding the primary endpoint of TLF. However, BES was associated with significantly increased risk of definite stent thrombosis. (Combo Stent Versus Biomatrix Alpha Stent [SORT OUT XI] NCT03952273).

Keywords: coronary artery disease; drug-eluting stent; percutaneous coronary intervention; randomized controlled trial.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by unrestricted grants from Biosensors International and OrbusNeich Medical. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Dr Eftekhari has received unrestricted institutional grants from Biosensors and OrbusNeich; and has received a governmental institutional grant from the Independent Research Fund. Dr Lisette Okkels Jensen has received unrestricted institutional grants from Biosensors, Biotronik, and OrbusNeich. Dr Mæng has received institutional grants from Janssen, Novo Nordisk, and Philips; and has stock options with Eli Lilly, Novo Nordisk, and Verve Therapeutics. Dr Støttrup has received consultant fees from Boston Scientific and Novo Nordisk. Dr Lassen has received an institutional grant from Medtronic. Dr Kristensen has received a lecture fee from Chiesi. Dr Christiansen has received a travel grant from the Danish distributor of the Combo stent; and has received an institutional grant from Biosensors and OrbusNeich. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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