Everolimus-Eluting Biodegradable Abluminal Coating Stent versus Durable Conformal Coating Stent: Termination of the Inflammatory Response Associated with Neointimal Healing in a Porcine Coronary Model

Objectives We evaluated the effect of the different carrier systems on early vascular response through histological analysis and scanning electron microscopy using a porcine model. Background Although Synergy™ and Promus PREMIER™ share an identical stent material and drug elution (everolimus), they use different drug carrier systems: biodegradable abluminal coating polymer or durable conformal coating polymer, respectively. However, data regarding the impact of the different coating systems on vessel healing are currently limited. Methods Twelve Synergy™ and Promus PREMIER™ were implanted in 12 swine. Histopathological analysis of the stented segments was performed on the 2nd and 14th days after implantation. Morphometric analysis of the inflammation and intimal fibrin content was also performed. Results On the 2nd day, neointimal thickness, percentage of neointimal area, and inflammatory and intimal fibrin content scores were not significantly different between the two groups. On the 14th day, the inflammatory and intimal fibrin content scores were significantly lower in Synergy™ versus those observed in Promus PREMIER™. In Synergy™, smooth muscle cells were found and the neointimal layers were smooth. In contrast, inflammatory cells were observed surrounding the struts of Promus PREMIER™. Conclusions These results demonstrate that termination of reactive inflammation is accelerated after abluminal coating stent versus implantation of conformal coating stent.

[1]  S. Saito,et al.  Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. , 2019, Circulation. Cardiovascular interventions.

[2]  K. Hayashi,et al.  Acute Thrombogenicity and Vascular Response after Bioresorbable Vascular Scaffold Implantation: Evidenced from Porcine Coronary Model , 2018 .

[3]  I. Meredith,et al.  Final five-year clinical outcomes in the EVOLVE trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. , 2018, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[4]  Haichang Wang,et al.  A randomised comparison of biodegradable polymer- and permanent polymer-coated platinum-chromium everolimus-eluting coronary stents in China: the EVOLVE China study. , 2017, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[5]  D. Dudek,et al.  Comparative assessment of three drug eluting stents with different platforms but with the same biodegradable polymer and the drug based on quantitative coronary angiography and optical coherence tomography at 12-month follow-up , 2017, The International Journal of Cardiovascular Imaging.

[6]  K. Hayashi,et al.  Early endothelialization associated with a biolimus A9 bioresorbable polymer stent in a porcine coronary model , 2017, Heart and Vessels.

[7]  E. Toft,et al.  Solely abluminal drug release from coronary stents could possibly improve reendothelialization , 2016, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[8]  K. Hayashi,et al.  Short- and long-term benefits of drug-eluting stents compared to bare metal stents even in treatment for large coronary arteries , 2016, Heart and Vessels.

[9]  K. Dawkins,et al.  The SYNERGY biodegradable polymer everolimus eluting coronary stent: Porcine vascular compatibility and polymer safety study , 2015, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[10]  M. Yamagishi,et al.  Repeated occurrence of slow flow phenomenon during and late after sirolimus-eluting stent implantation , 2015, Heart and Vessels.

[11]  R. Virmani,et al.  Hypersensitivity reaction in the US Food and Drug Administration-approved second-generation drug-eluting stents: histopathological assessment with ex vivo optical coherence tomography. , 2015, Circulation.

[12]  T. Matsuda,et al.  Vascular endothelial growth factor-bound stents: application of in situ capture technology of circulating endothelial progenitor cells in porcine coronary model. , 2014, Journal of interventional cardiology.

[13]  P. Fitzgerald,et al.  Impact of Diabetes Mellitus on Vessel Response in the Drug-Eluting Stent Era: Pooled Volumetric Intravascular Ultrasound Analyses , 2012, Circulation. Cardiovascular interventions.

[14]  K. Dawkins,et al.  Comparison of the SYNERGY with the PROMUS (XIENCE V) and bare metal and polymer-only Element control stents in porcine coronary arteries. , 2012, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[15]  S. King,et al.  Nobori stent shows less vascular inflammation and early recovery of endothelial function compared with Cypher stent. , 2012, JACC. Cardiovascular interventions.

[16]  R. Virmani,et al.  Pathological Correlates of Late Drug-Eluting Stent Thrombosis: Strut Coverage as a Marker of Endothelialization , 2007, Circulation.

[17]  R. Virmani,et al.  Drug eluting stents: are human and animal studies comparable? , 2003, Heart.

[18]  P. Tsao,et al.  Stent-Based Delivery of Sirolimus Reduces Neointimal Formation in a Porcine Coronary Model , 2001, Circulation.

[19]  Bruce R. Brodie,et al.  Coronary Angioplasty with or without Stent Implantation for Acute Myocardial Infarction , 1999 .

[20]  L Chiariello,et al.  A comparison of coronary-artery stenting with angioplasty for isolated stenosis of the proximal left anterior descending coronary artery. , 1997, The New England journal of medicine.

[21]  R E Vlietstra,et al.  Restenosis and the proportional neointimal response to coronary artery injury: results in a porcine model. , 1992, Journal of the American College of Cardiology.

[22]  RussellAlexander,et al.  Hypersensitivity Reaction in the US Food and Drug Administration–Approved Second-Generation Drug-Eluting Stents , 2015 .

[23]  N. Combaret,et al.  Very late stent thrombosis related to incomplete neointimal coverage or neoatherosclerotic plaque rupture identified by optical coherence tomography imaging. , 2014, European heart journal cardiovascular Imaging.

[24]  Giuseppe Biondi-Zoccai,et al.  Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging. , 2012, JACC. Cardiovascular interventions.