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 - 16/08/24

Doi : 10.1016/j.ahj.2024.05.019

Lei Song, MD ^a,^b,^c, Changdong Guan, MSc ^c, Mengyue Yu, MD ^a,^d, Zhongwei Sun, MSc ^c, Guosheng Fu, MD ^e, Yong He, MD ^f, Shaobin Jia, MD ^g, Jiyan Chen, MD ^h, Feng Qi, MD ^d, Jie Bai, MD ^d, Wei li, MD ⁱ, Junbo Ge, MD ^j, Yaling Han, MD ^k, Runlin Gao, MD ^a,^d,^⁎
^a Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
^b National Clinical Research Center for Cardiovascular Diseases, Beijing, China
^c Catheterization Laboratories, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
^d Department of Cardiology, Fuwai Yunan hospital, Chinese Academy of Medical Sciences, Kunming, China
^e Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China
^f Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China
^g Department of Cardiology, General Hospital of Ningxia Medical University, Yinchuan, China
^h Department of Cardiology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China
ⁱ Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China
^j Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Disease, Shanghai, China
^k Cardiovascular Research Institute and Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China

^⁎Reprint requests: Runlin Gao, Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, A 167 Beilishi Road, Xicheng District, Beijing 100037, China.Department of CardiologyFuwai HospitalNational Center for Cardiovascular DiseasesChinese Academy of Medical Sciences and Peking Union Medical CollegeA 167 Beilishi Road, Xicheng DistrictBeijing100037China

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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Vol 275

P. 53-61 - septembre 2024 Retour au numéro

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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 - 16/08/24

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