{"id":"cabcfc78e503","type":"article","url":"https://hartvaat.nl/2025/07/15/sort-out-xi-biomatrix-versus-duale-therapie-sirolimus-eluting-stent-bij-pci/","title":"SORT OUT XI: biomatrix versus duale-therapie sirolimus-eluting stent bij PCI","title_en":"Biolimus-Eluting Biomatrix Stent vs a Dual-Therapy Sirolimus-Eluting Stent in PCI: The SORT OUT XI Randomized Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2025.05.012","source_url":"https://doi.org/10.1016/j.jacc.2025.05.012","authors":["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"],"significance":6,"published":"2025-07-15","source_date":"2025-07-15","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"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.","created":"2026-07-03T10:31:44Z","updated":"2026-07-03T13:30:44Z","licence":"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.","body_markdown":"De SORT OUT XI trial vergeleek twee stentplatforms bij PCI. Beide waren vergelijkbaar in effectiviteit en veiligheid, wat de stentevolutie naar biocompatibele platforms bevestigt.","abstract_original":"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)."}