西罗莫司洗脱与内皮祖细胞联合支架对比生物雷帕霉素洗脱可吸收聚合物涂层生物基质α支架用于经皮冠状动脉介入治疗患者的随机对照研究：斯堪的纳维亚临床结局随机试验组织（SORT OUT）XI试验的原理与研究设计

Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell combo Stent vs. biolimus eluting absorbable polymer coated biomatrix alpha stent in patients undergoing percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for randomized trials with clinical outcome (SORT OUT) XI trial.

作者信息

Eftekhari Ashkan, Christiansen Evald Høj, Lassen Jens Flensted, Raungaard Bent, Jakobsen Lars, Jensen Lisette Okkels

机构信息

Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

出版信息

Am Heart J. 2025 May;283:37-42. doi: 10.1016/j.ahj.2025.01.012. Epub 2025 Jan 25.

DOI:10.1016/j.ahj.2025.01.012

PMID:39870125

Abstract

RATIONALE

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).

HYPOTHESIS

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).

METHODS

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%.

RESULTS

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).

CONCLUSION

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.

CLINICALTRIALS

GOV: NCT03952273.

摘要

理论依据

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）。

假设

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。

方法

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%。