A novel polymer-free drug-eluting stent coated with everolimus using nitrogen-doped titanium dioxide film deposition in a porcine coronary restenosis model

Sim, Doo Sun; Jeong, Myung Ho; Park, Dae Sung; Kim, Jung Ha; Lim, Kyung Seob; Bae, In Ho; Piao, Zhehao; Yang, Hong-Yeol; Lee, Jehoon; Hyun, Dae Young; Hong, Young Joon; Kang, Jung Chaee

doi:10.1016/j.ijcard.2016.07.275

Cited by 13 publications

(9 citation statements)

References 24 publications

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“…In another previous study, a polymer-free TiO 2 film-coated stent with everolimus showed superior biocompatibility and compared favorably to a polymer-based everolimus-eluting stent (Sim et al, 2016). As in previous preclinical studies, we established a polymer-free TiO 2 stent using the PECVD drug manufacturing method.…”

Section: Discussionmentioning

confidence: 95%

“…A mean 25 mg/ml of MPA was grafted onto the NTM. In vitro drug release kinetics were estimated using an ultraviolet-visible spectrophotometer as reported previously (Sim et al, 2016).…”

Section: Fabrication Of Everolimus-eluting Stent With Biodegradable Polymermentioning

confidence: 99%

“…We developed a non-polymer DES to solve the problems of the polymer-based DES. The titanium dioxide (TiO 2 ) film coating method using a plasma-enhanced chemical vapor deposition (PECVD) technique was applied to fabricate polymer-free DES in our previous studies (Lim et al, 2014;Sim et al, 2016). Mycophenolic acid (MPA), an immunosuppressive agent with several -limus derivatives (biolimus, sirolimus, everolimus, tacrolimus, etc.…”

Section: Introductionmentioning

confidence: 99%

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Effect of Novel Polymer-Free Nitrogen-Doped Titanium Dioxide Film–Coated Coronary Stent Loaded With Mycophenolic Acid

Shim

Kim

et al. 2021

Front. Bioeng. Biotechnol.

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Background: Titanium is commonly used in blood-exposed medical devices because it has superior blood compatibility. Mycophenolic acid inhibits the proliferation of vascular smooth muscle cells. This study examined the effect of a non-polymer TiO2 thin film–coated stent with mycophenolic acid in a porcine coronary overstretch restenosis model.Methods: Thirty coronary arteries in 15 pigs were randomized into three groups in which the coronary arteries were treated with a TiO2 film–coated stent with mycophenolic acid (NTM, n = 10), everolimus-eluting stent with biodegradable polymer (EES, n = 10), or TiO2 film–coated stent (NT, n = 10). A histopathologic analysis was performed 28 days after the stenting.Results: There were no significant intergroup differences in injury score, internal elastic lamina area, or inflammation score. Percent area stenosis was significantly smaller in the NTM and EES groups than in the NT group (36.1 ± 13.63% vs. 31.6 ± 7.74% vs. 45.5 ± 18.96%, respectively, p = 0.0003). Fibrin score was greater in the EES group than in the NTM and NT groups [2.0 (range, 2.0–2.0) vs. 1.0 (range, 1.0–1.75) vs. 1.0 (range, 1.0–1.0), respectively, p < 0.0001]. The in-stent occlusion rate measured by micro-computed tomography demonstrated similar percent area stenosis rates on histology analysis (36.1 ± 15.10% in NTM vs. 31.6 ± 8.89% in EES vs. 45.5 ± 17.26% in NT, p < 0.05).Conclusion: The NTM more effectively reduced neointima proliferation than the NT. Moreover, the inhibitory effect of NTM on smooth muscle cell proliferation was not inferior to that of the polymer-based EES with lower fibrin deposition in this porcine coronary restenosis model.

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Section: Discussionmentioning

confidence: 95%

“…A mean 25 mg/ml of MPA was grafted onto the NTM. In vitro drug release kinetics were estimated using an ultraviolet-visible spectrophotometer as reported previously (Sim et al, 2016).…”

Section: Fabrication Of Everolimus-eluting Stent With Biodegradable Polymermentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effect of Novel Polymer-Free Nitrogen-Doped Titanium Dioxide Film–Coated Coronary Stent Loaded With Mycophenolic Acid

Shim

Kim

et al. 2021

Front. Bioeng. Biotechnol.

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“…[23,24] We previously investigated the efficacy of a polymer-free everolimus-eluting stent with N-TiO 2 film deposition in a pig coronary model of ISR with a 4-week follow-up. [24] Furthermore, we also performed an OCT-based preclinical comparative study between the TIGEREVOLUTION and XIENCE Alpine ® stents, which demonstrated comparable efficacy and safety outcomes. [8] On the basis of this preclinical evidence, the use of the TIGEREVOLUTION stent in human beings was approved by the Korean Food and Drug Administration on July 31, 2020.…”

Section: Discussionmentioning

confidence: 99%

Successful implantation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film with good patency on follow-up angiography: A case report

Jeong

Park

et al. 2022

Medicine

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Rationale: Despite technological advances in interventional cardiology during the last decades, many concerns remain regarding the narrowing and occlusion of the in-stent area. Particularly, polymer materials pose several problems, including chronic arterial inflammation, impaired arterial healing, and stent thrombosis. To avoid these complications, we invented the TIGEREVOLUTION stent with a cobalt–chromium alloy-based stent platform deposited with N-TiO2 film, which has demonstrated good biocompatibility. As this stent is not coated with polymer, it is expected to have decreased risk of stent thrombosis. Patient concerns: A 62-year-old Korean man visited our department because of angina. We commenced coronary angiography (CAG). Diagnosis: CAG revealed critical stenosis in the mid-portion of the right coronary artery, with a minimum lumen area of 1.08mm2 on optical coherence tomography (OCT). Intervention: Percutaneous coronary intervention was performed with implantation of a novel 3.5 × 26-mm polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film (TIGEREVOLUTION® stent). Post-percutaneous coronary intervention OCT showed good stent expansion and apposition, and the patient was discharged successfully and uneventfully. Outcomes: Eight months later, follow-up coronary angiography demonstrated good stent patency with no definitive evidence of in-stent restenosis, with thin stent strut coverage demonstrated on OCT. Lessons: We report the first case of TIGEREVOLUTION stent implantation with follow-up OCT at 8 months.

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“… 27 Polymer-free DESs coated with everolimus using nitrogen-doped TiO2 film deposition were tested in vitro and in vivo in a porcine restenosis model. 28 Electro-spinning coating with TiO2 film was used and this coating technique showed a rate of cumulative drug release to that of bioabsorbable polymer [poly lactic-co-glycolic acid (PLGA)] coating on the release kinetics. Coating thickness of everolimus-coated TiO2 film was 50 nm, which is the thinnest coating technology so far developed ( Fig.…”

Section: Polymer-free Desmentioning

confidence: 99%

Development of Novel Drug-Eluting Stents for Acute Myocardial Infarction

Sim

Jeong

2017

Chonnam Med J

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Delayed arterial healing at culprit sites after drug-eluting stent (DES) placement for acute myocardial infarction (AMI) is associated with increased risk of late stent thrombosis. The Korea Acute Myocardial Infarction Registry was established in commemoration of the 50th anniversary of Korea Circulation Society. Between November 2005 and December 2016, more than 62,000 patients were registered from 50 primary percutaneous coronary intervention (PCI) centers in Korea. DES in AMI may be safe and effective, however, there is concern about increased stent thrombosis after DES implantation in AMI patients, requiring longer-term dual anti-platelet therapy to reduce the risk of late stent thrombosis. Device innovation is needed to overcome issues such as stent thrombosis and restenosis by using new coating materials with biocompatible polymers, different coating methods using non-polymer techniques, bioabsorbable stents and pro-healing stents. In this review article, we describe the current usage of DES in AMI in Korea and introduce novel DES uses in development for patients with AMI. We have developed many types of DES in our research laboratory. Abciximab-coated stents inhibited platelet thrombi and restenosis. Furthermore, anti-oxidants (carvedilol, probucol and alpha-lipoic acid) were used for stent coating. Currently we are developing novel DESs using polymer-free and natural binding techniques, peptide coating stents, gene-and-drug delivery, bioabsorbable stents using 3D printing, endothelial progenitor cell capturing stents to promote reendothelialization and reduce stent thrombosis. New DESs in development may be safe and effective in preventing late stent thrombosis and restenosis in patients with AMI.

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A novel polymer-free drug-eluting stent coated with everolimus using nitrogen-doped titanium dioxide film deposition in a porcine coronary restenosis model

Cited by 13 publications

References 24 publications

Effect of Novel Polymer-Free Nitrogen-Doped Titanium Dioxide Film–Coated Coronary Stent Loaded With Mycophenolic Acid

Effect of Novel Polymer-Free Nitrogen-Doped Titanium Dioxide Film–Coated Coronary Stent Loaded With Mycophenolic Acid

Successful implantation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film with good patency on follow-up angiography: A case report

Development of Novel Drug-Eluting Stents for Acute Myocardial Infarction

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