Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

Buszman, Piotr P.; Michalak, Magdalena; Pruski, Maciej; Fernández, Carlos; Jelonek, Michał; Janas, Adam; Savard, Claudine; Gwiazdowska-Nowotka, Beata; Żurakowski, Aleksander; Wojakowski, Wojciech; Milewski, Krzysztof

doi:10.5603/cj.2016.0108

Cited by 11 publications

(10 citation statements)

References 22 publications

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“…The findings comparing SS‐SESs with CoCr‐EESs are consistent with previous pathological studies . Our study reveals, for the first time, that CoCr‐EESs show less inflammatory reaction than CoCr‐BMSs, a trend that was also observed in an animal study . Meta‐analyses and some clinical trials have suggested lower rates of stent thrombosis and target lesion revascularization with CoCr‐EESs versus BMSs or BP‐DESs .…”

Section: Discussionsupporting

confidence: 91%

Very Late Pathological Responses to Cobalt–Chromium Everolimus‐Eluting, Stainless Steel Sirolimus‐Eluting, and Cobalt–Chromium Bare Metal Stents in Humans

Mori

Atmakuri

Torii

et al. 2017

JAHA

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BackgroundThe “very late” clinical outcomes for durable polymer drug‐eluting stents and bare metal stents (BMSs) have been shown to be dissimilar in clinical studies. Conceptually, the long‐term vascular compatibility of BMSs is still regarded to be superior to drug‐eluting stents; however, no pathologic study to date has specifically addressed this issue. We evaluated the very late (≥1 year) pathologic responses to durable polymer drug‐eluting stents (cobalt–chromium [CoCr] everolimus‐eluting stents [EESs] and stainless steel sirolimus‐eluting stents [SS‐SESs]) versus BMSs (CoCr‐BMSs).Methods and ResultsFrom the CVPath stent registry, we studied a total of 119 lesions (40 CoCr‐EESs, 44 SS‐SESs, 35 CoCr‐BMSs) from 92 autopsy cases with a duration ranging from 1 to 5 years. Sections of stented coronary segments were pathologically analyzed. Inflammation score and the percentage of struts with giant cells were lowest in CoCr‐EESs (median inflammation score: 0.6; median percentage of struts with giant cells: 3.8%) followed by CoCr‐BMSs (median inflammation score: 1.3 [P<0.01]; median percentage of struts with giant cells: 8.9% [P=0.02]) and SS‐SESs (median inflammation score: 1.7 [P<0.01]; median percentage of struts with giant cells: 15.3% [P<0.01]). Polymer delamination was observed exclusively in SS‐SESs and was associated with increased inflammatory and giant cell reactions. The prevalence of neoatherosclerosis with CoCr‐EESs (50%) was significantly less than with SS‐SESs (77%, P=0.02) but significantly greater than with CoCr‐BMSs (20%, P<0.01).ConclusionsCoCr‐EESs, SS‐SESs, and BMSs each demonstrated distinct vascular responses. CoCr‐EESs demonstrated the least inflammation, near‐equivalent healing to BMSs, and lower neointimal formation. These results challenge the belief that BMSs have superior biocompatibility compared with some polymeric coated drug‐eluting stents and may have implications for future stent design.

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Section: Discussionsupporting

confidence: 91%

Very Late Pathological Responses to Cobalt–Chromium Everolimus‐Eluting, Stainless Steel Sirolimus‐Eluting, and Cobalt–Chromium Bare Metal Stents in Humans

Mori

Atmakuri

Torii

et al. 2017

JAHA

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“…Nevertheless, preclinical work in the most preferred large animal model, that is, the porcine coronary artery model remains of vital interest during the earlier DES development process. 5,6 In addition, today’s intravascular imaging techniques do not allow a differentiation between endothelial cells and fibrin coating of the stent struts in the clinical setting. Therefore, the time course of endothelialization in the porcine model is a major indicator in preclinical DES research.…”

Section: Introductionmentioning

confidence: 99%

Comparative preclinical evaluation of a polymer-free sirolimus-eluting stent in porcine coronary arteries

Sperling

Waliszewski

Kherad

et al. 2019

Therapeutic Advances in Cardiovascular Disease

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Background:Polymer-free drug-eluting stents (DES) without permanent-polymer coating may be associated with rapid vessel healing, providing a rationale to reduce dual-antiplatelet therapy (DAPT). The aim of the current study was to compare vessel healing of a polymer-free sirolimus-eluting stent (PF-SES), its bare metal stent (BMS) analogue to a permanent polymer-based sirolimus-eluting stent (SES) with proven effectiveness in porcine coronary arteries.Material and methods:An ultrathin-strut cobalt–chromium PF-SES, its BMS analogue and an SES with a permanent polymer were used to study vessel healing and their antistenotic potential. Stents were implanted in porcine coronary arteries for histopathologic analysis at 7, 28 and 180 days.In an additional in vitro study, the thrombogenicity of PF-SES was compared with a fluoropolymer-coated everolimus-eluting stent (EES) which demonstrated low stent thrombosis rates in numerous studies.Results:In the animal study, neointimal growth and injury scores were minimal and inflammation scores were low in the neointima and adventitia in all study groups. After 28 days, neointimal area was lowest in PF-SES when compared with SES and BMS (1.48 ± 0.55 mm² versus 2.43 ± 0.69 mm² versus 1.90 ± 0.85 mm², respectively, p < 0.05) and endothelialization of luminal surfaces was nearly complete in all groups, though SES show the least coverage with occasional adherent luminal inflammatory cells (p > 0.05). At 180 days, neointimal area and thickness were most pronounced in SES (p < 0.05) and comparable with BMS implantations, which were characterized by nearly completed vessel healing. PF-SES and BMS had complete endothelialization, absence of fibrin and sustained low inflammatory reaction when compared with the permanent polymer-based SES (inflammation score: PF-SES 0.41 ± 0.74 versus SES 2.52 ± 1.72 versus BMS 0.30 ± 0.65, respectively, p < 0.05 BMS versus SES). Granuloma formation and fibrin accumulation were most pronounced in SES but did not reach statistical significance, p > 0.05). In the in vitro thrombogenicity study, the PF-SES confirmed comparable antithrombogenic properties with regard to the parameters fibrin and platelet binding, and platelet aggregation when compared with the EES.Conclusions:As compared with BMS, the ultrathin-strut cobalt–chromium PF-SES showed similar endothelialization at 28 days and comparable healing characteristics at 180 days efficacious inhibition of neointimal proliferation in porcine coronary arteries with low inflammation responses and a BMS-like endothelialization at 180 days. In addition, in an in vitro model, the PF-SES also confirmed low thrombogenicity as compared with the EES.

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“…OCT demonstrated an optimal reconstruction of the lumen in absence of any dissection and in absence of any in-stent thrombotic or plaque material ( Figures 1 H–J ), and it showed fully preserved side-branch access ( Figure 1 K ). Indeed, this stent has overall similar acute procedural results compared to other best-in-class stents [ 12 – 15 ], while optimal healing [ 16 ] and clinical outcomes of the device in all types of PCI including primary PCI in STEMI [ 13 ], are consistent with Alex Plus use as a modern workforce stent [ 14 , 15 ]. Alex Plus is a Cobalt-Chromium new generation coronary stent with an innovative coating for a consistent and controlled drug delivery.…”

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confidence: 89%

“…nitroglycerin administration, optical coherence tomography (OCT, Ilumien Optis Imaging System, Abbott) run was employed to understand [11] the residual thrombotic material and plaque (Figures 1 D-F). A novel thin-strut bioresorbable-polymer sirolimus-eluting stent (Alex Plus 3.0 × 18 mm, Balton, Poland) [12][13][14][15] was implanted (direct stenting, 10-12 atm/30 s). Control angiography (Figure 1 J) showed lack of any residual stenosis and lack of distal embolism; there was TIMI-3 (TIMI Myocardial Perfusion Grade 2/3) [3].…”

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confidence: 99%

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Thin-strut bioresorbable-polymer sirolimus-eluting stent use for an optimal result of rescue coronary angioplasty in acute myocardial infarction failed thrombolytic therapy: the Bangladesh National Heart Foundation Annual Conference OCT-assisted live case

Malik¹,

Dutta²,

Banik³

et al. 2021

pwki

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Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model

Cited by 11 publications

References 22 publications

Very Late Pathological Responses to Cobalt–Chromium Everolimus‐Eluting, Stainless Steel Sirolimus‐Eluting, and Cobalt–Chromium Bare Metal Stents in Humans

Very Late Pathological Responses to Cobalt–Chromium Everolimus‐Eluting, Stainless Steel Sirolimus‐Eluting, and Cobalt–Chromium Bare Metal Stents in Humans

Comparative preclinical evaluation of a polymer-free sirolimus-eluting stent in porcine coronary arteries

Thin-strut bioresorbable-polymer sirolimus-eluting stent use for an optimal result of rescue coronary angioplasty in acute myocardial infarction failed thrombolytic therapy: the Bangladesh National Heart Foundation Annual Conference OCT-assisted live case

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