# SORT OUT XI: biomatrix versus duale-therapie sirolimus-eluting stent bij PCI

*geplaatst 2025-07-15 · Algemeen · Journal of the American College of Cardiology · doi 10.1016/j.jacc.2025.05.012 · https://hartvaat.nl/2025/07/15/sort-out-xi-biomatrix-versus-duale-therapie-sirolimus-eluting-stent-bij-pci/*

De SORT OUT XI trial vergeleek twee stentplatforms bij PCI. Beide waren vergelijkbaar in effectiviteit en veiligheid, wat de stentevolutie naar biocompatibele platforms bevestigt.

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

The SORT OUT XI trial confirmed comparable efficacy and safety between two contemporary DES platforms (biolimus-eluting BioMatrix vs dual-therapy sirolimus-eluting stent), demonstrating therapeutic equivalence in modern stent technology.

## Abstract (original, from the publication)

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).

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

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Bron: Journal of the American College of Cardiology, https://doi.org/10.1016/j.jacc.2025.05.012. Bijgewerkt 2026-07-03T13:30:44Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.