Long-Term Efficacy of Biodegradable Metal–Polymer Composite Stents After the First and the Second Implantations into Porcine Coronary Arteries

Li, Xin; Zhang, Wanqian; Lin, Woei; Qiu, Hong; Qi, Ying; Zhang, Fujun; Qi, Haiping; He, Yang; Zhang, Hongjie; Qian, Jie; Gui, Zhilun; Gao, Runlin; Zhang, Deyuan; Ding, Jiandong

doi:10.1021/acsami.0c00971

Cited by 56 publications

(29 citation statements)

References 70 publications

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“…To address these concerns, herein we tried to establish a semi-quantitative modality by OCT to evaluate the in vivo degradation of an iron based stent IBS, aiming to prepare for the follow-up of degradation of IBS in the future clinical trial. The sirolimus-eluting iron bioresorbable scaffold with the trademark name IBS was fabricated by employing a core technique called metal-polymer composite [ [37] , [38] , [39] ]. We also compared the endothelialization extents and endothelial function restoration between ultrathin IBS (73 μm in total, Biotyx, China) and a permanent thin-strut drug-eluting stent Xience (96 μm in total, Abbott, USA) after implanted in the rabbit iliac arteries.…”

Section: Introductionmentioning

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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Section: Introductionmentioning

confidence: 99%

In vivo degradation and endothelialization of an iron bioresorbable scaffold

Lin

Zhang

et al. 2021

Bioactive Materials

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“…A clinical application of high-strength resorbable Fe materials has been hindered by slow in vivo degradation due to formation of insoluble corrosion products [4]. However, there are some recent promising results for polymer-coated nitrided iron stents with enhanced degradation rate and corrosion product decomposition [5,6]. Bioresorbable Zn materials, whose mechanical properties and degradation rates are between those of Mg and Fe [7], are still afflicted with low ductility, strain rate-dependent mechanical properties and age-hardening effects [8].…”

Section: Introductionmentioning

confidence: 99%

Biocompatibility and Degradation Behavior of Molybdenum in an In Vivo Rat Model

et al. 2021

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The biocompatibility and degradation behavior of pure molybdenum (Mo) as a bioresorbable metallic material (BMM) for implant applications were investigated. In vitro degradation of a commercially available Mo wire (ø250 µm) was examined after immersion in modified Kokubo’s SBF for 28 days at 37 °C and pH 7.4. For assessment of in vivo degradation, the Mo wire was implanted into the abdominal aorta of female Wistar rats for 3, 6 and 12 months. Microstructure and corrosion behavior were analyzed by means of SEM/EDX analysis. After explantation, Mo levels in serum, urine, aortic vessel wall and organs were investigated via ICP-OES analysis. Furthermore, histological analyses of the liver, kidneys, spleen, brain and lungs were performed, as well as blood count and differentiation by FACS analysis. Levels of the C-reactive protein were measured in blood plasma of all the animals. In vitro and in vivo degradation behavior was very similar, with formation of uniform, non-passivating and dissolving product layers without occurrence of a localized corrosion attack. The in vitro degradation rate was 101.6 µg/(cm2·d) which corresponds to 33.6 µm/y after 28 days. The in vivo degradation rates of 12, 33 and 36 µg/(cm2·d) were observed after 3, 6 and 12 months for the samples properly implanted in the aortic vessel wall. This corresponds with a degradation rate of 13.5 µm/y for the 12-month cohort. However, the magnitude of degradation strongly depended on the implant site, with the wires incorporated into the vessel wall showing the most severe degradation. Degradation of the implanted Mo wire neither induced an increase in serum or urine Mo levels nor were elevated Mo levels found in the liver and kidneys compared with the respective controls. Only in the direct vicinity of the implant in the aortic vessel wall, a significant amount of Mo was found, which, however, was far below the amounts to be expected from degrading wires. No abnormalities were detected for all timepoints in histological and blood analyses compared to the control group. The C-reactive protein levels were similar between all the groups, indicating no inflammation processes. These findings suggest that dissolved Mo from a degrading implant is physiologically transported and excreted. Furthermore, radiographic and µCT analyses revealed excellent radiopacity of Mo in tissues. These findings and the unique combination with its extraordinary mechanical properties make Mo an interesting alternative for established BMMs.

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“…Polyesters constitute an important class of advanced materials, in particular, in the fields of biomaterials and eco‐friendly materials. [ 81‐83 ] Sn(Oct) 2 and ROH such as PEG are another functional chemicals applied in organic chemistry, polymer science, and biomedicine. [ 84 ] Most of biodegradable polyesters such as PLA and their copolymers are obtained via ring opening of cyclic esters assisted by Sn(Oct) 2 and ROH.…”

Section: Discussionmentioning

confidence: 99%

Coordination Insertion Mechanism of Ring‐Opening Polymerization of Lactide Catalyzed by Stannous Octoate^†

et al. 2021

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Main observation and conclusion Ring‐opening polymerization (ROP) of cyclic esters in the presence of stannous octoate (Sn(Oct)2) is the main way to obtain biodegradable aliphatic polyesters, an important family of biodegradable polymers which have been widely used and still rapidly developed in the fields of biomedical polymers and environment‐friendly materials. The underlying mechanism is thought via a coordination‐insertion way, but the pathway is still open owing to the absence of direct experimental evidence. Herein, we inquire this issue through density functional theory (DFT) calculations. According to our DFT calculations and the following Curtin‐Hammett evaluation, the carbonyl oxygen has a significant advantage over the ester oxygen, and thus the ring is opened mainly through pathway A instead of pathway B. The stannous octoate is identified as a catalyst rather than an initiator. We eventually summarize the main stages during the whole polymerization of lactide.

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Long-Term Efficacy of Biodegradable Metal–Polymer Composite Stents After the First and the Second Implantations into Porcine Coronary Arteries

Cited by 56 publications

References 70 publications

In vivo degradation and endothelialization of an iron bioresorbable scaffold

In vivo degradation and endothelialization of an iron bioresorbable scaffold

Biocompatibility and Degradation Behavior of Molybdenum in an In Vivo Rat Model

Coordination Insertion Mechanism of Ring‐Opening Polymerization of Lactide Catalyzed by Stannous Octoate^†

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Long-Term Efficacy of Biodegradable Metal–Polymer Composite Stents After the First and the Second Implantations into Porcine Coronary Arteries

Cited by 56 publications

References 70 publications

In vivo degradation and endothelialization of an iron bioresorbable scaffold

In vivo degradation and endothelialization of an iron bioresorbable scaffold

Biocompatibility and Degradation Behavior of Molybdenum in an In Vivo Rat Model

Coordination Insertion Mechanism of Ring‐Opening Polymerization of Lactide Catalyzed by Stannous Octoate†

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Coordination Insertion Mechanism of Ring‐Opening Polymerization of Lactide Catalyzed by Stannous Octoate^†