Thin, very thin, or ultrathin-strut biodegradable or durable polymer-coated drug-eluting stents

Buiten, Rosaly A.; Zocca, Paolo; Birgelen, Clemens von

doi:10.1097/hco.0000000000000786

Cited by 10 publications

(14 citation statements)

References 45 publications

(35 reference statements)

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“…Several studies have reported that the Orsiro stent shows excellent long-term outcomes, including a very low rate of stent thrombosis. 1,5,6 Nevertheless, a previous trial comparing the Orsiro stent with the BP thick-strut biolimus-eluting stent (BES) by Nobori (Terumo, Tokyo, Japan) only reported noninferiority of the Orsiro stent at 12 months. 7 In addition, we conducted the BIODEGRADE study (Biomatrix and Orsiro Drug-Eluting Stents in Angiographic Result in Patients With Coronary Artery Disease) to compare the performance of the Orsiro stent with that of the BP thick-strut BioMatrix stent (Biosensors Inc, Newport Beach, CA).…”

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confidence: 99%

BioMatrix Versus Orsiro Stents for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study

Yoon

Kwun

Choi

et al. 2023

Circ: Cardiovascular Interventions

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BACKGROUND: Comparative studies of ultrathin-strut biodegradable polymer sirolimus-eluting stent (BP-SES) have reported promising results and validated its excellent outcomes in terms of safety and efficacy. However, there are limited studies comparing BP drug-eluting stents with struts of different thicknesses. We compared the long-term clinical outcomes of patients treated with an ultrathin-strut BP-SES or a thick-strut biodegradable polymer biolimus-eluting stent (BP-BES). METHODS: The BIODEGRADE trial (Biomatrix and Orsiro Drug-Eluting Stents in Angiographic Result in Patients With Coronary Artery Disease) is a multicenter prospective randomized study comparing coronary revascularization in patients with ultrathin-strut BP-SES and thick-strut BP-BES with the primary end point of target lesion failure at 18 months posttreatment. We performed the prespecified analysis of 3-year clinical outcomes. RESULTS: In total, 2341 patients were randomized to receive treatment with ultrathin-strut BP-SES (N=1175) or thick-strut BP-BES (N=1166). The 3-year incidence rate of target lesion failure was 3.2% for BP-SES and 5.1% for BP-BES ( P =0.023). The difference was primarily due to differences in ischemia-driven target lesion revascularization (BP-SES, 1.5%; BP-BES, 2.8%; P =0.035) between groups. A landmark analysis of the late follow-up period showed significant differences in target lesion failure, with outcomes being better in BP-SES. Cardiac death and target lesion revascularization were significantly lower in the BP-SES group. CONCLUSIONS: In a large, randomized trial, the long-term clinical outcome of target lesion failure at 3 years was significantly better among patients treated with the ultrathin-strut BP-SES. The results indicate the superiority of the ultrathin-strut BP-SES compared with the thick-strut BP-BES. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT02299011.

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confidence: 99%

BioMatrix Versus Orsiro Stents for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study

Yoon

Kwun

Choi

et al. 2023

Circ: Cardiovascular Interventions

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“…It might because the bile is weakly alkaline, and bacteria could also play a role, which leads to the acceleration of self-degradation of the carrier. [30][31][32] We report a positive linear relationship between the concentration of PVBC-DGL in bile and the inhibition rate of β-glucuronidase activity. When the levels of PVBC-DGL reached 0.03, 0.05, and 0.08 mM, the inhibition rate of D-glucucaro-1,4-lactone on the activity of β-glucuronidase reached 30%, 60%, and 95%.…”

Section: Discussionmentioning

confidence: 74%

“…It might because the bile is weakly alkaline, and bacteria could also play a role, which leads to the acceleration of self-degradation of the carrier. 30–32…”

Section: Discussionmentioning

confidence: 99%

Studying in vivo and in vitro effects of a novel polyvinyl benzyl chloride-D-glucaro-1, 4-lactonate polymer-coated bile duct stent for anti-biliary mud deposition

Zhang

Kanwal

Batool

et al. 2022

Journal of Applied Biomaterials & Functional Materials

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Background: We aim to coat a novel polyvinyl benzyl chloride-D-glucaro-1, 4-lactonate polymer-coated bile duct stent for anti-biliary mud deposition and investigate its in vivo and in vitro impacts. Biliary mud deposition is a leading cause of plastic biliary stent obstruction after its placement. Orally administrated D-glucaro-1, 4-lactonate is a specific competitive inhibitor of β-glucuronidase that causes biliary mud deposition. Methods: In this study, the stents coated with polyvinyl benzyl chloride-D-glucaro-1,4-lactonate polymer (PVBC-DGL) were placed in an ex vivo bile duct model perfused with porcine bile and observed every week until completely blocked. Post establishing the model of bile duct stenosis in piglets, stents are observed through endoscopy, hematology, patency time, and pathological changes within 6 months. Results: The 70% PVBC-DGL stents achieved the highest percentage of the inhibitory effect when the drugs were completely released in vitro. Results were obtained from 14 pigs (5: no coating (original), 4: 0% coating, and 5: 70% coating). The overall patency time of the stents was prolonged in all groups; however, the group with 70% coated stents showed a significantly prolonged patency time as compared to no coating (original) and the 0% coating groups in pigs (23.4 ± 1.8 vs 11.2 ± 2.1 w ( p = 0.05); 23.4 ± 1.8 vs 10.5 ± 2.5 w ( p = 0.05), respectively). Conclusion: The stents with 70% PVBC-DGL better prevent and control the deposition of bile mud and prolong the patency time of stent placement in the subject animals and may be proposed for further clinical trials in patients.

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“…In addition to these, there are many studies demonstrating that biodegradable polymer coated sirolimus-eluting stents are both safe and feasible in preventing restenosis in human or experimental animal models (24)(25)(26)(27). The metal structure of Atlas drug-eluting stents enables the stent to be prepared with a very thin support structure and allows radioopacity (8,28). Its biodegradable and biocompatible PLGA polymer has been extensively studied for the controlled delivery of several drugs and its characteristics are well known (5).…”

Section: Discussionmentioning

confidence: 99%

“…Although more invasive CABG is superior in some groups of patients, they have become the preferred methods of revascularization (4)(5)(6). On the other hand, reocclusion of the coronary arteries due to thrombotic occlusion in acute stages or neointimal hyperplasia (NIH) in the longer periods following minimally invasive techniques has been a major problem after MIT, particularly after bare metal stents (BMS) (7)(8)(9). In the longer period re-occlusion process, multiple factors such as smooth muscle cell (SMC) migration, activation of some cytokines and growth factors, extracellular matrix formation, neutrophil/macrophage activation are involved.…”

Section: Introductionmentioning

confidence: 99%

Atlas drug-eluting coronary stents inhibits neointimal hyperplasia in sheep modeling

Dinc

Yerebakan

2023

Preprint

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Background: Coronary artery disease (CAD) is one of the leading causes of mortality and morbidity worldwide. Many patients with CAD require mechanical revascularization. However, restenosis after minimally invasive intervention is a major problem for these patients. Fortunately, due to the controlled drug delivery properties of drug-eluting stents (DES), this problem seems to be significantly overcome. In this study, the pharmacodynamic and pharmacokinetic properties of Atlas Drug-eluting Coronary Stents coated with PLGA were evaluated. Materials and Methods This study was carried out in 20 non-atherosclerotic female sheep, divided into four groups that included 4 study and 1 control randomly assigned to each group. The animals in the study groups were stented with Atlas Drug-eluting Coronary Stents and the pharmacodynamic and pharmacokinetic properties were evaluated. Results: A statistically important effectivity of sirolimus on the vascular endothelium was shown. With time, the decrease in sirolimus in blood samples was statistically significant. In the others, no clinically significant side effects were observed. Conclusions The results in this study showed a significant reduction in neointimal hyperplasia after experimental implantation of Atlas Drug-eluting Coronary Stents coated with PLGA polymer. Pharmacokinetic studies also showed that the stent did not release significant left sirolimus after 28 days.

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Thin, very thin, or ultrathin-strut biodegradable or durable polymer-coated drug-eluting stents

Cited by 10 publications

References 45 publications

BioMatrix Versus Orsiro Stents for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study

BioMatrix Versus Orsiro Stents for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study

Studying in vivo and in vitro effects of a novel polyvinyl benzyl chloride-D-glucaro-1, 4-lactonate polymer-coated bile duct stent for anti-biliary mud deposition

Atlas drug-eluting coronary stents inhibits neointimal hyperplasia in sheep modeling

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