Vascular responses to a biodegradable polymer (polylactic acid) based Biolimus A9-eluting stent in porcine models

Hagiwara, Hikoichi; Hiraishi, Yoshiaki; Terao, Hisako; Hirai, Toshiyuki; Sakaoka, Atsushi; Sasaki, Masashige; Murota, Satomi; Inoue, Katsumi; Kimura, Junji

doi:10.4244/eijv8i6a114

Cited by 17 publications

(6 citation statements)

References 22 publications

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“…Animal studies have shown significantly lower inflammatory responses in the stented segments, and the rapid recovery of endothelial function of peri-stent segments in the biodegradable polymer BES group compared with the durable polymer DES group at 1 month [33] . Also, the level of endothelial coverage in biodegradable polymer BES was comparable to BMS at four weeks, with no significant increase in inflammatory reactions up to 15 months [34] . These observations may explain why the biodegradable polymer BES may be associated with a lower risk of very late ST and a better long-term outcome in our meta-analysis.…”

Section: Discussionmentioning

confidence: 79%

Efficacy and Safety of Biodegradable Polymer Biolimus-Eluting Stents versus Durable Polymer Drug-Eluting Stents: A Meta-Analysis

Xie

Zeng

et al. 2013

PLoS ONE

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BackgroundsDrug-eluting stents (DES) with biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation DES. We aimed to determine the efficacy and safety of biodegradable polymer biolimus-eluting stents (BES) versus durable polymer DES.MethodsSystematic database searches of MEDLINE (1950 to June 2013), EMBASE (1966 to June 2013), the Cochrane Central Register of Controlled Trials (Issue 6 of 12, June 2013), and a review of related literature were conducted. All randomized controlled trials comparing biodegradable polymer BES versus durable polymer DES were included.ResultsEight randomized controlled trials investigating 11,015 patients undergoing percutaneous coronary interventions were included in the meta-analysis. The risk of major adverse cardiac events did not differ significantly between the patients treated with the biodegradable polymer BES and the durable polymer DES (Relative risk [RR], 0.970; 95% CI, 0.848–1.111; p = 0.662). However, biodegradable polymer BES was associated with reduced risk of very late ST compared with the durable polymer DES, while the risk of early or late ST was similar (RR for early or late ST, 1.167; 95% CI 0.755–1.802; p = 0.487; RR 0.273; 95% CI 0.115–0.652; p = 0.003; p for interaction = 0.003).ConclusionsIn this meta-analysis of randomized controlled trials, treatments with biodegradable polymer BES did not significantly reduce the risk of major adverse cardiac events, but demonstrated a significantly lower risk of very late ST when compared to durable polymer DES. This conclusion requires confirmation by further studies with long-term follow-up.PROSPERO register number http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004364#.UnM2lfmsj6J

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Section: Discussionmentioning

confidence: 79%

Efficacy and Safety of Biodegradable Polymer Biolimus-Eluting Stents versus Durable Polymer Drug-Eluting Stents: A Meta-Analysis

Xie

Zeng

et al. 2013

PLoS ONE

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“…Hagiwara reported that inflammatory score and injury score in BES were comparable to even bare metal stent at 30 days in histological analysis [17]. It is also reported that fibrin scores were significantly greater for both SES and paclitaxel-eluting stents (PES) compared with their respective bare metal stent controls at 30 days [18].…”

Section: Accepted Manuscriptmentioning

confidence: 94%

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

Gogas

Nagai

et al. 2015

Cardiovascular Revascularization Medicine

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“…Three to four months are required for complete endothelialization with BMS 28 , 29 , whereas with DES, more time is required 6 . At the same time, the level of endothelial coverage in BP- BES was comparable to that of BMS at four weeks, with no significant increase in inflammatory reactions up to 15 months 30 . Moreover, compared with DP-DES, BP-BES contains a biodegradable polymer that gradually dissolves into water and carbon dioxide, which are associated with a lower risk of inflammatory responses in animal studies 31 .…”

Section: Discussionmentioning

confidence: 65%

A comparison of the main outcomes from BP-BES and DP-DES at five years of follow-up: A systematic review and meta-analysis

Pan

Lü

et al. 2017

Sci Rep

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Biodegradable polymer biolimus-eluting stents (BP-BES) are third-generation drug-eluting stents (DES) composed of biodegradable polymers that may improve prognosis after percutaneous coronary intervention (PCI). After five years of follow-up, BP-BES showed conflicting results compared to durable polymer drug-eluting stents (DP-DES). We performed a meta-analysis of the outcomes of studies on BP-BES and DP-DES after percutaneous coronary intervention (PCI) at five years of follow-up. Eligible studies were retrieved from PubMed, Embase and the Cochrane Library and reported the results of all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis (ST) at five years of follow-up. Five studies of a total of 4687 patients were included in the meta-analysis. At five years of follow-up, BP-BES was associated with lower rates of major adverse cardiac events (MACE) (OR = 0.83, 95%CI = [0.71, 0.97]), TLR (OR = 0.77, 95%CI = [0.62, 0.96]) and ST (OR = 0.60, 95%CI = [0.43 to 0.84]), whereas no significant differences in mortality, MI, or TVR rates were detected. Our results demonstrated that at five years of follow-up, BP-BES can significantly reduce the risk of MACE, TLR and ST, which indicate that safety and efficacy were increased after PCI.

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Vascular responses to a biodegradable polymer (polylactic acid) based Biolimus A9-eluting stent in porcine models

Abstract: The level of endothelial coverage in BioPol-BES was comparable to BMS at four weeks, with no significant increase of inflammatory reaction up to 15 months.

Cited by 17 publications

References 22 publications

Efficacy and Safety of Biodegradable Polymer Biolimus-Eluting Stents versus Durable Polymer Drug-Eluting Stents: A Meta-Analysis

Efficacy and Safety of Biodegradable Polymer Biolimus-Eluting Stents versus Durable Polymer Drug-Eluting Stents: A Meta-Analysis

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

A comparison of the main outcomes from BP-BES and DP-DES at five years of follow-up: A systematic review and meta-analysis

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