Jensen Lisette Okkels, Jakobsen Lars, Eftekhari Ashkan, Ellert-Gregersen Julia, Støttrup Nicolaj Brejnholt, Engstrøm Thomas, Kahlert Johnny, Freeman Philip, Veien Karsten Tange, Jensen Rebekka Vibjerg, Lassen Jens Flensted, Junker Anders, Christiansen Evald Høj
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
EuroIntervention. 2025 Jun 2;21(11):e617-e628. doi: 10.4244/EIJ-D-24-00586.
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.
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.
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.
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.
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.
在经皮冠状动脉介入治疗患者中使用无聚合物生物雷帕霉素洗脱BIOFREEDOM支架与可生物降解聚合物西罗莫司洗脱ORSIRO支架的随机对照（SORT OUT IX）试验中，与超薄支柱可生物降解聚合物西罗莫司洗脱支架相比，生物雷帕霉素A9涂层无聚合物支架在1年内的靶病变失败（TLF）方面并非不劣效。
我们旨在评估无聚合物药物涂层生物雷帕霉素洗脱支架与超薄支柱可生物降解聚合物西罗莫司洗脱支架的5年结局。
SORT OUT IX试验是一项基于注册的随机全人群试验。主要终点TLF定义为1年内心源性死亡、与靶病变以外任何节段无关的心肌梗死（MI）或靶病变血运重建（TLR）的复合终点。随访延长至5年。
共有3151例患者被随机分配接受无聚合物生物雷帕霉素涂层支架（1572例患者[1966处病变]）或超薄支柱可生物降解聚合物西罗莫司洗脱支架（1579例患者[1985处病变]）。仅0.3%的参与者失访，且均因移民。5年时，无聚合物生物雷帕霉素涂层支架组的TLF为14.1%，超薄支柱可生物降解聚合物西罗莫司洗脱支架组为12.0%（率比[RR]1.19，95%置信区间[CI]：0.97 - 1.44）。两组的心源性死亡、MI和明确的支架血栓形成无差异。临床驱动的TLR在5年时分别为7.6%和5.0%（RR 1.56，95%CI：1.17 - 2.07），无聚合物生物雷帕霉素涂层支架组更高，这归因于第一年更高的TLR风险。
药物涂层生物雷帕霉素洗脱支架组与超薄支柱可生物降解聚合物支架组的5年TLF无显著差异，但药物涂层生物雷帕霉素洗脱支架组的TLR风险更高。
