Eftekhari Ashkan, Christiansen Evald Høj, Lassen Jens Flensted, Raungaard Bent, Jakobsen Lars, Jensen Lisette Okkels
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Am Heart J. 2025 May;283:37-42. doi: 10.1016/j.ahj.2025.01.012. Epub 2025 Jan 25.
The biodegradable polymer Biomatrix Alpha stent contains biolimus A9 drug which is a sirolimus derivative increased in lipophicity. The biodegradable polymer sirolimus eluting Combo stent is a dual-therapy sirolimus-eluting and CD34+ antibody coated stent capturing endothelial progenitor cells (EPCs).
The main hypothesis of the SORT OUT XI trial was that the biodegradable polymer biolimus A9 Biomatrix Alpha stent is noninferior to the biodegradable polymer sirolimus eluting Combo stent in an all-comers population with coronary artery disease undergoing percutaneous coronary intervention (PCI).
The SORT OUT XI study was a randomized, multicenter, single blinded, all-comer, 2-arm, noninferiority trial comparing the biodegradable polymer biolimus A9 Biomatrix Alpha stent to the biodegradable polymer sirolimus eluting Combo stent in 3 Danish University Hospitals in Western Denmark. The composite primary endpoint was target lesion failure (TLF) within 12 months. TLF was defined as composite of cardiac death, myocardial infarction not related to other than index lesion or target lesion revascularization. Clinically driven event detection was used and no planned follow up was performed. With a sample size of 1,564 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level had a 90% power to detect noninferiority with a predetermined noninferiority margin of 2.1%.
The trial ran from August 14, 2019 to March 19, 2023. A total of 3141 patients were enrolled and randomized 1:1 to Combo stent (n = 1,573) and Biomatrix Alpha stent (n = 1,568).
The SORT OUT XI trial will assess if the biolimus A9 eluting Biomatrix Alpha stent is noninferior to the dual-therapy Combo stent with respect to target lesion failure.
GOV: NCT03952273.
可生物降解聚合物Biomatrix Alpha支架含有生物雷帕霉素A9药物，它是一种亲脂性增加的西罗莫司衍生物。可生物降解聚合物西罗莫司洗脱组合支架是一种双重治疗的西罗莫司洗脱且包被有CD34 +抗体的支架，可捕获内皮祖细胞（EPC）。
SORT OUT XI试验的主要假设是，在接受经皮冠状动脉介入治疗（PCI）的所有冠状动脉疾病患者中，可生物降解聚合物生物雷帕霉素A9 Biomatrix Alpha支架不劣于可生物降解聚合物西罗莫司洗脱组合支架。
SORT OUT XI研究是一项随机、多中心、单盲、全人群、双臂、非劣效性试验，在丹麦西部的3家大学医院中，比较可生物降解聚合物生物雷帕霉素A9 Biomatrix Alpha支架与可生物降解聚合物西罗莫司洗脱组合支架。复合主要终点是12个月内的靶病变失败（TLF）。TLF被定义为心源性死亡、与靶病变无关的心肌梗死或靶病变血运重建的复合终点。采用临床驱动的事件检测，未进行计划随访。每个治疗组样本量为1564例患者，采用两组大样本比例正态近似检验，单侧5%显著性水平，有90%的把握度检测非劣效性，预定非劣效界值为2.1%。
该试验从2019年8月14日持续至2023年3月19日。共纳入3141例患者，按1:1随机分为组合支架组（n = 1573）和Biomatrix Alpha支架组（n = 1568）。
SORT OUT XI试验将评估生物雷帕霉素A洗脱的Biomatrix Alpha支架在靶病变失败方面是否不劣于双重治疗的组合支架。
政府注册号：NCT03952273
