Preclinical Evaluation of a Novel Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold in Porcine Coronary Artery at 6 Months

Zheng, Jianfeng; Qiu, Hong; Tian, Yanhua; Hu, Xiaoying; Luo, Tong; Wu, Chao; Tian, Yantao; Tang, Yue; Song, Li; Li, Li; Xu, Liang; Xu, Bo; Gao, Runlin

doi:10.1016/j.jcin.2018.10.020

Cited by 34 publications

(34 citation statements)

References 28 publications

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“…In total, 48 swines that received IBS were assessed by QCA, OCT, and histology, and their results were compared to the same number of subjects receiving Xience (Abbott Vascular, Santa Clara, CA, USA) at 7 days to 6 months follow-up. IBS results showed no significant difference in area of stenosis compared to Xience up to 6 months, while scaffold or stent thrombosis was observed during the study [45].…”

Section: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold (Ibs)mentioning

confidence: 75%

“…Pure iron devices are highly biocompatible and structurally sturdy, however, they present a long corrosion period and slow clearance from the vessel up to 18 months from implantation [45]. However, iron-alloy processed with nitriding technology, a thermochemical heat treatment with nitrogenation of the iron piece, adds more reliability to corrosion rate when associated with PLLA coating as seen in porcine models at 13 months [45,46].…”

Section: Iron Alloy Platform Degradationmentioning

confidence: 99%

“…The major difference of this device compared to the pure iron-devices is the nitriding technology and the Zinc buffer covering the whole strut before the sirolimus-eluted PLLA coating, conferring a more reliable corrosion rate to the device and maintaining structural integrity up to 4-6 months and complete corrosion of the struts at 13 months in the pre-clinical rabbit models [45,48]. IBS (Lifetech Scientific, Shenzhen, Guangdong, China) presented a strut thickness of 70 µm, density of 115 µg/cm 2 , diameters of 2.75-3.0 mm and 15 mm in length.…”

Section: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold (Ibs)mentioning

confidence: 99%

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The Development of Magnesium-Based Resorbable and Iron-Based Biocorrodible Metal Scaffold Technology and Biomedical Applications in Coronary Artery Disease Patients

et al. 2019

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In the treatment of atherosclerotic disease patients, the adoption of second-generation drug-eluting stents (DES) in percutaneous coronary intervention reduced the occurrence of in-stent restenosis (ISR) and acute stent thrombosis (ST) when compared to bare metal stents and 1st generation DES. However, the permanent encaging of the vessel wall by any of the metallic stents perpetuates the inflammation process and prevents vasomotion in the treated segment. Aiming to overcome this issue, the bioresorbable scaffold (BRS) concept was developed by providing transient vascular radial support to the target segment during the necessary time to heal and disappearing after a period of time. Close to 20 years since BRS technology was first reported, the interventional cardiology field saw the rise and fall of several BRS devices. Although iron-based BRS is an emerging technology, currently, magnesium-alloy resorbable scaffolds devices are supported with the most robust data. This manuscript aims to review the concept of magnesium-based BRS devices, as well as their bioresorption mechanisms and the status of this technology, and the clinical outcomes of patients treated with magnesium BRS and to review the available evidence on iron-based BRS technology.

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Section: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold (Ibs)mentioning

confidence: 75%

Section: Iron Alloy Platform Degradationmentioning

confidence: 99%

Section: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold (Ibs)mentioning

confidence: 99%

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The Development of Magnesium-Based Resorbable and Iron-Based Biocorrodible Metal Scaffold Technology and Biomedical Applications in Coronary Artery Disease Patients

et al. 2019

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“…S1 ). It has comparable low crossing-profile, 5 French guiding catheter compatibility, mechanical strength, specification range, endothelialization, safety and effectiveness to state-of-the-art permanent drug-eluting stents [ 36 , 48 ] in vitro and in animal models. As presented in Fig.…”

Section: Discussionmentioning

confidence: 99%

In vivo degradation and endothelialization of an iron bioresorbable scaffold

Lin

Zhang

et al. 2021

Bioactive Materials

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Detection of in vivo biodegradation is critical for development of next-generation medical devices such as bioresorbable stents or scaffolds (BRSs). In particular, it is urgent to establish a nondestructive approach to examine in vivo degradation of a new-generation coronary stent for interventional treatment based on mammal experiments; otherwise it is not available to semi-quantitatively monitor biodegradation in any clinical trial. Herein, we put forward a semi-quantitative approach to measure degradation of a sirolimus-eluting iron bioresorbable scaffold (IBS) based on optical coherence tomography (OCT) images; this approach was confirmed to be consistent with the present weight-loss measurements, which is, however, a destructive approach. The IBS was fabricated by a metal-polymer composite technique with a polylactide coating on an iron stent. The efficacy as a coronary stent of this new bioresorbable scaffold was compared with that of a permanent metal stent with the name of trade mark Xience, which has been widely used in clinic. The endothelial coverage on IBS was found to be greater than on Xience after implantation in a rabbit model; and our well-designed ultrathin stent exhibited less individual variation. We further examined degradation of the IBSs in both minipig coronary artery and rabbit abdominal aorta models. The present result indicated much faster iron degradation of IBS in the rabbit model than in the porcine model. The semi-quantitative approach to detect biodegradation of IBS and the finding of the species difference might be stimulating for fundamental investigation of biodegradable implants and clinical translation of the next-generation coronary stents.

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“…No ScT was observed within 180 days after implantation. Tissue coverage of the IBS was more complete compared with that of the CoCr-EES at the 14 day follow-up ( 25 ). Interestingly, the IBS shows good device performance comparable to a current mainstream DES.…”

Section: Current Status Of Brssmentioning

confidence: 99%

Bioresorbable Scaffolds: Contemporary Status and Future Directions

Xiang

Jia

et al. 2020

Front. Cardiovasc. Med.

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Percutaneous coronary intervention, which is safe, effective, and timely, has become an important treatment for coronary artery diseases and has been widely used in clinical practice. However, there are still some problems that urgently need to be solved. Permanent vessel caging through metallic implants not only prevents the process of positive vessel remodeling and the restoration of vascular physiology but also makes the future revascularization of target vessels more difficult. Bioresorbable scaffolds (BRSs) have been developed as a potential solution to avoid the above adverse reactions caused by permanent metallic devices. BRSs provide temporary support to the vessel wall in the short term and then gradually degrade over time to restore the natural state of coronary arteries. Nonetheless, long-term follow-up of large-scale trials has drawn considerable attention to the safety of BRSs, and the significantly increased risk of late scaffold thrombosis (ScT) limits its clinical application. In this review, we summarize the current status and clinical experiences of BRSs to understand the application prospects and limitations of these devices. In addition, we focus on ScT after implantation, as it is currently the primary drawback of BRS. We also analyze the causes of ScT and discuss improvements required to overcome this serious drawback and to move the field forward.

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Preclinical Evaluation of a Novel Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold in Porcine Coronary Artery at 6 Months

Cited by 34 publications

References 28 publications

The Development of Magnesium-Based Resorbable and Iron-Based Biocorrodible Metal Scaffold Technology and Biomedical Applications in Coronary Artery Disease Patients

The Development of Magnesium-Based Resorbable and Iron-Based Biocorrodible Metal Scaffold Technology and Biomedical Applications in Coronary Artery Disease Patients

In vivo degradation and endothelialization of an iron bioresorbable scaffold

Bioresorbable Scaffolds: Contemporary Status and Future Directions

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