Coronary interventions - Mini focus on bioresorbable scaffolds

First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial

EuroIntervention 2023;19:222-231. DOI: 10.4244/EIJ-D-22-00919

Run-Lin Gao
Run-Lin Gao1, MD; Bo Xu1,2, MBBS; Zhongwei Sun1, MSc; Changdong Guan1, MSc; Lei Song1, MD; Lijian Gao1, MD; Chongjian Li1, MD; Jingang Cui1, MD; Yin Zhang2, MD; Kefei Dou1, MD; Jue Chen1, MD; Chaowei Mu1, MD; Haibo Liu1, MD; Ang Li1, BS; Zihao Li1, MSc; Lihua Xie1, MSc; Yuejin Yang1, MD; Shubin Qiao1, MD; Yongjian Wu1, MD; Gregg W. Stone3, MD
1. Department of Cardiology, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People’s Republic of China; 2. National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, People’s Republic of China; 3. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA

Background: The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes.

Aims: We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions.

Methods: The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months.

Results: A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%.

Conclusions: In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.

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bioresorbable scaffoldsintravascular ultrasoundoptical coherence tomographyPrior percutaneous interventionqca
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