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

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)