A comparison of drug eluting stent biocompatibility between third generation NOBORI biolimus A9-eluting stent and second generation XIENCE V everolimus-eluting stent in a porcine coronary artery model

Sumida, Arihiro; Gogas, Bill D.; Nagai, Hirokazu; Li, Jinsheng; King, Spencer B.; Chronos, Nicolas; Hou, Dongming

doi:10.1016/j.carrev.2015.06.009

Cited by 11 publications

(6 citation statements)

References 29 publications

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“…In line with our study, Nakamura et al demonstrated that a bioabsorbable‐polymer abluminal‐coated paclitaxel‐eluting stent had comparable vasomotor function to bare‐metal stent within 3 months after deployment in a rabbit iliac model 25 . Further, it was reported that the abluminal biodegradable polymer in a biolimus‐eluting stent with Biolimus A9 contributed to suppression of endothelial impairment after DES implantation 22 . Considering these results, the stent design of the bioabsorbable polymer, absence of a polymer, and use of Biolimus A9 may have protective effects on endothelial function after stent implantation.…”

Section: Discussionsupporting

confidence: 90%

“…Although the best method for evaluating re‐endothelialization after stent implantation is controversial, endothelial function after stenting is generally assessed by measuring the coronary vasomotor reactivity in response to Ach infusion 19,20 . Previous studies have reported that the coronary vasoconstrictive responses to Ach after the implantation of first‐generation DESs were strong, 19,20 and these responses were impaired after second‐ and third‐generation DES implantations 21,22 . As a significantly greater degree of endothelial dysfunction was described after DES implantation, the idea that other causes, including effects of the polymer, might play an important role was proposed 23 .…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Short‐ and mid‐term influence of drug‐coated stent implantation on structural and functional vascular healing response: An optical coherence tomography and acetylcholine testing study

Tamaru

Fujii

Otsuji

et al. 2020

Cathet Cardio Intervent

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Objective This study investigated the effect of a drug‐coated stent (DCS) that has a novel microporous abluminal surface without a polymer on 1‐month and 1‐year functional and morphological healing response as assessed using acetylcholine (Ach) testing and optical coherence tomography (OCT). Background DCS is expected to induce favorable morphological and physiological arterial healing after its implantation. Methods A total of 11 patients who underwent vascular response examinations 1‐month and 1‐year after the index PCI with DCS implantation were enrolled. The vascular response was evaluated by the functional response test by acetylcholine infusion, the morphological response test by OCT. Results Although 94.5% of the DCS struts were covered by homogeneous smooth neointima at 1 month, the percentage of neointimal coverage increased to 98.5% at 1 year (p = .02). Conversely, the proportion of uncovered struts and malapposed struts at 1 year were 1.2 and 0.7%, respectively. Furthermore, the coronary vasomotor response to incremental doses of Ach were impaired especially in the distal segments at each period, although the responses to Ach at 10−6 mol/L in the distal segment tended to improve over time from baseline to 1 month and 1 year later (−19 ± 20%, −9 ± 17%, and −5 ± 14%, respectively; p = .27). Conclusions The morphological assessment of DCS with OCT revealed a high degree of strut coverage and apposition at 4 weeks after implantation. The impaired endothelium‐dependent vasomotor response tended to improve chronologically from baseline to 1 month and 1 year later.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Short‐ and mid‐term influence of drug‐coated stent implantation on structural and functional vascular healing response: An optical coherence tomography and acetylcholine testing study

Tamaru

Fujii

Otsuji

et al. 2020

Cathet Cardio Intervent

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“…In many studies, several parameters have been studied which included degree and uniformity of neointimal coverage, presence of uncovered struts, thrombus formation, arterial healing, restenosis rate, external elastic lamina (EEL) area, internal elastic lamina (IEL) area, lumen area, neointimal area, medial area, lumen equivalent diameter, IEL equivalent diameters and percent area stenosis. [14][15][16] Neointimal hyperplasia is a post stent implantation response which is associated with vascular remodeling of coronary vessels. The incidence of remodeling of vessels is carried out by migration and proliferation of smooth muscle cells of vessels into tunica intima.…”

Section: Discussionmentioning

confidence: 99%

Preclinical Evaluation of the Vascular Effects of Rejuvenate® Cobalt Chromium Coronary Stent System Implanted in the Porcine Coronary in Stent Restenosis Model

2021

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Objectives: The main objective of the study was to evaluate the implantation, safety, and vascular tissue effects of REJUVENATE® Cobalt Chromium Bare Metal Stent in the Porcine Coronary Restenosis model at short, mid and long-term follow up. Methodology: A total of 18 REJUVENATE® bare metal stents (CoCr, 95 µm strut thickness) were implanted into the coronary arteries (RCA, LCX and LAD) of the six pigs. Throughout the study period, stent patency, vascular response, percent stenosis, late lumen loss and performance of stent were evaluated by angiography, optical coherence tomography (OCT), and Histopathology (includes both Histopathology and histomorphometry) at 30, 90, and 180 days and compared with the results of control Bare Metal Stent Coflexus®. The mean, variance and standard deviation was analyzed using SPSS software. Results: OCT and QCA analysis demonstrated two cases of binary restenosis at 30 days follow-up and two at 90 days follow-up (33%). The mean area stenosed for Rejuvenate® was 34% as compared to 24% of Coflexus® and at 180 days follow up, it decreased to 21%. The histopathology analysis demonstrated favorable safety with acceptable levels of neointimal formation, with decreased levels of inflammation and complete endothelialization in 180 days. Conclusion: This study proved the potential safety of REJUVENATE® in porcine model and supports that this stent can move forward for the human trials.

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“…25,57 However, in a porcine coronary model, thickstrut BP-BES revealed less inflammation and foreign-body immunoreaction than thin-strut PP-EES. 58 In the Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography (TEST-6-OCT) trial, thickstrut BP-BES stent showed similar stent coverage and vascular healing response with thin-strut PP-EES ≤9 months after implantation. 59 The results of the Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent (COMPARE II) trial, in which patients randomly received thick-strut BP-BES or thin-strut fluoropolymer-based EES, the current standardbearer among DESs, support the animal and intracoronary imaging data.…”

Section: Bp-based Dessmentioning

confidence: 99%

Stent Polymers

Rizas

Mehilli

2016

Circ: Cardiovascular Interventions

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W ith drug-eluting stent (DES) platforms representing the concept of combined mechanical stenosis repair and localized drug delivery, percutaneous coronary intervention became a pharmacomechanical therapy option for coronary artery disease. The concept of drug coating of metallic scaffolds is ≈20 years old and started with the aim to increase the hemocompatibility of metallic scaffolds. 1 In the era when plain balloon angioplasty was the default percutaneous coronary intervention option and the incidence of acute ischemic events was at double-digit levels, heparin-coated stents have been shown effective in reducing stent thrombosis without any measurable effect on neointimal formation.1,2 Development of heparin-coated stent platforms revealed the difficulties of producing a stable system able to deliver the needed amount of the active drug without compromising its chemical sequence. Different from physical adsorption and ionic binding techniques, copolymerization of heparin with a variety of polymers provided stable heparin binding on the stent surface. This experience, among others, explained later in this review, served as a prerequisite for development of various DES platforms, which have revolutionized the percutaneous coronary intervention field. Advantages With Nonbiodegradable PolymersSuccess of DES platforms in reduction of neointimal hyperplasia depends on the amount and kinetics of drug released. The experience with various formulations of polymer-free paclitaxel-eluting stents 4,5 or polymer-free sirolimus-eluting stents (SESs) 6 loaded with different increasing drug amounts demonstrated the importance of the drug amount for effective inhibition of neointima proliferation at an acceptable safety profile. The amount of drug loading through direct drug adsorption on the metallic surface is limited. Furthermore, most of the drugs are not able to adhere appropriately on the stent surface to insure controlled release. Therefore, polymer coating has become a key component of different DES platforms. Various permanent (biostable) and biodegradable polymers (BPs) have been used on DES platforms (Table 1). [7][8][9][10][11][12] Polymers selected to be used as a drug carrier should share following features: be biocompatible; do not interact with the active drug; provide a platform for appropriate drug-eluting kinetics; behave biologically inert after the drug has been completely eluted, and be mechanically stable at long-term in the dynamics of coronary circulation milieu.Poly-(n)-butyl methacrylate, an inert synthetic polymer, has been used as a drug carrier on the first-generation SES, Cypher stent (Cordis, Johnson & Johnson, Miami Lakes, FL). The complex drug-polymer matrix on the Cypher stent (Table 2) allows a slow sirolimus release resulting in elution of 80% of drug within the first 30 days after DES implantation.3 In contrast to this, the drug-polymer system of the paclitaxel-eluting stent, Taxus stent (Boston Scientific Corp, Natick, MA), based on a single layer of Translute (Table 1) polymer allows th...

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A comparison of drug eluting stent biocompatibility between third generation NOBORI biolimus A9-eluting stent and second generation XIENCE V everolimus-eluting stent in a porcine coronary artery model

Cited by 11 publications

References 29 publications

Short‐ and mid‐term influence of drug‐coated stent implantation on structural and functional vascular healing response: An optical coherence tomography and acetylcholine testing study

Short‐ and mid‐term influence of drug‐coated stent implantation on structural and functional vascular healing response: An optical coherence tomography and acetylcholine testing study

Preclinical Evaluation of the Vascular Effects of Rejuvenate® Cobalt Chromium Coronary Stent System Implanted in the Porcine Coronary in Stent Restenosis Model

Stent Polymers

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