Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: Rationale and design of the IRONMAN-II trial

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-06-04 DOI:10.1016/j.ahj.2024.05.019

Lei Song MD , Changdong Guan MSc , Mengyue Yu MD , Zhongwei Sun MSc , Guosheng Fu MD , Yong He MD , Shaobin Jia MD , Jiyan Chen MD , Feng Qi MD , Jie Bai MD , Wei li MD , Junbo Ge MD , Yaling Han MD , Runlin Gao MD

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Abstract

Background

The previous first-in-human study established the preliminary safety and effectiveness of the novel thin-strut iron bioresorbable scaffold (IBS). The current study aims to directly compare the imaging and physiological efficacy, and clinical outcomes of IBS with contemporary metallic drug-eluting stents (DES).

Methods

A total of 518 patients were randomly allocated to treatment with IBS (257 patients) or metallic DES (261 patients) from 36 centers in China. The study is powered to test noninferiority of the IBS compared with the metallic everolimus-eluting stent in terms of the primary endpoint of in-segment late lumen loss at 2 years, and major secondary endpoints including 2-year quantitative flow ratio and cross-sectional mean flow area measured by optical coherence tomography (OCT) (limited to the OCT subgroup, 25 patients in each group).

Conclusion

This will be the first powered randomized trial investigating the safety and efficacy of the novel thin-strut IBS compared to a contemporary metallic DES. The findings will provide valuable evidence for future research of this kind and the application of metallic bioresorbable scaffolds.

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在冠状动脉疾病患者中使用西罗莫司洗脱铁生物可吸收支架与钴铬依维莫司洗脱支架：IRONMAN-II 试验的原理与设计。

背景：之前的首次人体研究初步确定了新型薄支架铁生物可吸收支架（IBS）的安全性和有效性。目前的研究旨在直接比较 IBS 与当代金属药物洗脱支架（DES）的成像、生理疗效和临床结果：方法：来自中国 36 个中心的 518 名患者被随机分配接受 IBS（257 名）或金属 DES（261 名）治疗。该研究的主要终点是2年的节段内晚期管腔损失，主要次要终点是2年的定量血流比和光学相干断层扫描（OCT）测量的横截面平均血流面积（仅限于OCT亚组，每组25名患者）：这将是首个研究新型薄支架 IBS 与当代金属 DES 相比的安全性和有效性的有效随机试验。研究结果将为今后此类研究和金属生物可吸收支架的应用提供宝贵的证据。

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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.