联合西罗莫司洗脱和内皮祖细胞combtm支架与生物莫司洗脱可吸收聚合物涂层BioMatrix AlphaTM支架在经皮冠状动脉介入治疗中的随机比较斯堪的纳维亚临床结果随机试验组织（SORT OUT） XI试验的基本原理和研究设计：SORT OUT XI试验设计。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-01-25 DOI:10.1016/j.ahj.2025.01.012

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

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引用次数: 0

摘要

原理：生物可降解聚合物BioMatrix Alpha™支架含有生物莫司A9药物，该药物是西罗莫司衍生物，可提高脂性。可生物降解聚合物西罗莫司洗脱复合支架是一种双重治疗西罗莫司洗脱和CD34+抗体包被支架捕获内皮祖细胞（EPCs）。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莫司A9 BioMatrix Alpha™支架不低于可生物降解聚合物西罗莫司洗脱Combo™支架。方法：SORT OUT XI研究是一项随机、多中心、单盲、全角、双组、非效性试验，在丹麦西部的三所丹麦大学医院中比较了可生物降解聚合物生物莫司A9 BioMatrix Alpha™支架和可生物降解聚合物西罗莫司洗脱Combo™支架。复合主要终点为12个月内靶病变失败（TLF）。TLF定义为心源性死亡、心肌梗死与指标病变或靶病变血运重建无关的复合。采用临床驱动事件检测，未进行计划随访。每个治疗组的样本量为1,564例患者，单侧显著性水平为5%的两组大样本比例正态近似检验将具有90%的检测非劣效性的能力，预定的非劣效性裕度为2.1%。结果：试验时间为2019年8月14日至2023年3月19日。共有3141名患者入组，并以1:1的比例随机分配到Combo™支架（n=1,573）和biommatrix Alpha™支架（n=1,568）。SORT OUT XI试验将评估biolimus A9洗脱BioMAtrix Alpha™支架在靶病变失败方面是否优于双疗法Combo™支架。(ClinicalTrials.gov NCT03952273)。

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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

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.

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.