Impact of bioresorbable versus permanent polymer on longterm vessel wall inflammation and healing: a comparative drug-eluting stent experimental study

Wilson, Gregory J.; McGregor, Jennifer; Conditt, Gerard; Shibuya, Masabumi; Sushkova, Natalia; Eppihimer, Michael J.; Hawley, Steve; Rouselle, Serge D.; Huibregtse, Barbara; Dawkins, Keith D.; Granada, Juan F.

doi:10.4244/eij-d-17-00332

Cited by 11 publications

(3 citation statements)

References 20 publications

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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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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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“…After that, the polymer was completely dissolved, and the less inflammatory bare metal surface came into direct contact with the vascular wall, accommodating relatively healthy and homogeneous neointimal tissue growth for the remainder. In addition, Wilson et al [23] demonstrated that the use of a bioresorbable-polymer coating as a method for drug elution results in lower long-term inflammation compared to durable polymer DES. Furthermore, Itoh et al [24] showed that qualitatively and quantitatively consistent neointimal stent coverage was achieved by the 12-month time point by optical frequency-domain imaging.…”

Section: Discussionmentioning

confidence: 99%

Five-year clinical outcomes of a 2.25 mm sirolimus-eluting stent in Japanese patients with very small coronary artery disease: final results of the CENTURY JSV study

Shishido

Ando

Ito

et al. 2022

Cardiovasc Interv and Ther

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The aim of this study is to evaluate the long-term safety and efficacy of the 2.25 mm bioresorbable-polymer sirolimus-eluting Ultimaster stent in a Japanese patient population. Treatment of coronary artery disease in very small vessels is associated with an increased risk for cardiac events. The CENTURY JSV study is a prospective, multicenter, single-arm study. Seventy patients with stable and unstable coronary artery disease with a coronary lesion eligible for implantation with a 2.25 mm stent were enrolled in this study. Patients underwent clinical follow-up through 5-year after the PCI procedure. The mean age was 70.4 ± 9.2 years. The prevalence of diabetes mellitus was 37.1%, all not insulin dependent. The incidence of major adverse cardiac events, defined as cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (CD-TLR) at 5 years was 5.7%. A non-Q wave MI was noted in 1.4% and 4.3% underwent a CD-TLR. There was no stent thrombosis during the entire follow-up period. No cardiac events were reported between 2 and 5 years. This is the first study to demonstrate safety and effectiveness for 5 years after treatment of very small coronary disease with 2.25 mm-diameter DES.Clinical trial registration: UMIN000012928

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“…PF-DES were introduced with the aim to overcome the risks of late safety and efficacy outcomes associated with the preceding generations of devices. The polymer coating used in DP-DES has been shown to cause chronic inflammation and delayed vascular healing [ 30 ]. A meta-analysis [ 31 ] of 6575 patients reported that PF-DES had a significantly reduced risk of all-cause death compared with DP-DES (OR, 0.77; 95% CI, 0.61–0.98; P = 0.03).…”

Section: Discussionmentioning

confidence: 99%

Polymer-free versus durable polymer drug-eluting stents in patients with coronary artery disease: A meta-analysis

Way

Kritharides

et al. 2019

Annals of Medicine and Surgery

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BackgroundPolymer-free drug-eluting stents (PF-DES) were introduced with the aim of reducing the risk of stent thrombosis associated with durable polymer drug-eluting stents (DP-DES). The comparison of safety and efficacy profiles between these two stent platforms remains unclear.Materials and methodsWe conducted electronic database searches for randomized controlled trials (RCTs) comparing patients treated with either PF-DES or DP-DES. Outcomes included definite or probable stent thrombosis (ST), myocardial infarction (MI), cardiac death, all-cause death, target lesion revascularization (TLR), and target vessel revascularization (TVR). A random-effects model was used to derive risk ratios (RRs) with 95% confidence intervals (CIs). Subgroup analyses based on different variables were also performed. After screening a total of 1026 articles, the present meta-analysis included 13 RCTs comprising 8021 patients.ResultsNo significant differences were found for the risks of definite or probable ST (RR, 0.94; 95% CI, 0.62–1.43; P = 0.77), MI (RR, 1.06; 95% CI, 0.85–1.33; P = 0.61), cardiac death (RR, 0.98; 95% CI, 0.80–1.21; P = 0.88), all-cause death (RR, 0.87; 95% CI, 0.76–1.00; P = 0.06), TLR (RR, 1.12; 95% CI, 0.94–1.33; P = 0.22), and TVR (RR, 1.18; 95% CI, 0.87–1.61; P = 0.29). Similarly, no significant differences were found for all outcomes regardless of anti-proliferative drug, except for an increased risk of TLR for polymer-free paclitaxel-eluting stents compared with DP-DES (RR, 2.32, 95% CI, 1.30–4.14; P = 0.005).ConclusionsOur findings showed that PF-DES and DP-DES confer equivalent safety and efficacy profiles, with similar rates of stent thrombosis.

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Impact of bioresorbable versus permanent polymer on longterm vessel wall inflammation and healing: a comparative drug-eluting stent experimental study

Abstract: BP-EES resulted in a lower net long-term reduction in neointimal formation and inflammation compared to permanent polymer DES in an animal model. Further study of the long-term neointima formation deserves study in human clinical trials.

Cited by 11 publications

References 20 publications

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

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

Five-year clinical outcomes of a 2.25 mm sirolimus-eluting stent in Japanese patients with very small coronary artery disease: final results of the CENTURY JSV study

Polymer-free versus durable polymer drug-eluting stents in patients with coronary artery disease: A meta-analysis

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