Novel fully bioabsorbable salicylate-based sirolimus-eluting stent

Jabara, Refat; Pendyala, Lakshmana; Geva, Sarah; Chen, Jack; Chronos, Nicolas; Robinson, Keith A.

doi:10.4244/eijv5ifa10

Cited by 54 publications

(30 citation statements)

References 20 publications

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“…Unfortunately, insufficient neointimal suppression has been demonstrated. 82 This is likely to be the consequence of inadequate drug dosing, particularly considering that the surface area dose of sirolimus is only a quarter of that found on the Cypher stent. The rapid elution of sirolimus may also be a contributing factor.…”

Section: Poly (Anhydride Ester) Salicylic Acid: the Ideal Stentmentioning

confidence: 99%

“…Furthermore, the promising mechanical properties of the stent were confirmed, with well-apposed stent struts observed at follow-up. 82 In July 2009, the 11 patients enrolled in the multicenter first-inhumans Whisper trial completed their 12 month follow-up. Primary results have shown stent safety and confirmed structural integrity of the stent with no evidence of acute or chronic recoil.…”

Section: Poly (Anhydride Ester) Salicylic Acid: the Ideal Stentmentioning

confidence: 99%

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Bioresorbable Scaffold

Onuma¹,

Serruys²

2011

Circulation

393

151

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T he invention of balloon angioplasty as a percutaneous treatment for obstructive coronary disease by Andreas Gruntzig in 1977 was a huge leap forward in cardiovascular medicine and undoubtedly will always be remembered as a revolution in the field of revascularization. However, this technique was plagued by multiple problems, including the risk of acute vessel closure secondary to occlusive coronary dissection, sometimes necessitating emergency coronary artery bypass surgery. 1-3 Although late luminal enlargement and vascular remodeling could take place, more often restenosis 4 -8 would occur instead. The restenosis would essentially be caused by constrictive remodeling 9 -13 and, to a lesser extent, by elastic recoil 14 or the neointimal hyperplastic healing response. [15][16][17] The advent of bare metal stenting (BMS) and the landmark Belgian-Netherlands Stent Study (BENESTENT) and Stent Restenosis Study (STRESS) trials have established BMS as the second revolution in interventional cardiology. 18,19 This technology provided a solution to acute vessel occlusion by sealing the dissection flaps and preventing recoil. The rate of subacute occlusion was reduced to 1.5%, making emergency bypass surgery a rare occurrence. Restenosis rates were further reduced from 32% to 22% at 7 months, but this rate was still high, and neointimal hyperplasia inside the stent was even more prominent than with angioplasty, necessitating repeat treatment in numerous patients. 18 Because the vessel was now caged with metal, late luminal enlargement and advantageous vascular remodeling could no longer occur. Another problem, namely late stent thrombosis (ST), was also first described. 20 To solve the problem of in-stent restenosis, after the historic failure of brachytherapy to resolve this problem, 21,22 drug-eluting stents (DES) were introduced. The first 45 patients implanted with the sirolimuseluting Bx velocity stent (Cordis, Johnson & Johnson, Warren, NJ) were found to have negligible neointimal hyperplasia at follow-up. 23,24 This was confirmed in the randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization (RAVEL) study. 25,26 The introduction of DES was thus dubbed the third revolution in interventional cardiology. Both large-scale randomized trials and all-comer registries showed excellent results in terms of the need for repeat revascularization. However, the early enthusiasm has been tempered in recent years after widespread concerns about the increased risk of late and very late ST. [27][28][29][30][31] Registries of all comers treated with DES showed late ST rates of 0.53%/y, with a continued increase to 3% over 4 years. 32,33 In the Arterial Revascularization Therapies Study II (ARTS II) trial, which enrolled patients with complex multivessel disease, the rate of combined definite, probable, and possible ST was as high as 9.4% at 5 years, accounting for 32% of major adverse cardiovascular events (MACEs). 34 In addition, postmortem pathological specimens of DES revealed sig...

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Section: Poly (Anhydride Ester) Salicylic Acid: the Ideal Stentmentioning

confidence: 99%

Section: Poly (Anhydride Ester) Salicylic Acid: the Ideal Stentmentioning

confidence: 99%

Bioresorbable Scaffold

Onuma¹,

Serruys²

2011

Circulation

393

151

View full text Add to dashboard Cite

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“…La dégradation complète est observée en 12-15 mois. La première étude montrant de bons résultats a démontré que l'hyperplasie néo-intimale n'a pas été suffisamment supprimée [19]. Une seconde …”

Section: Avantages Des Stents De Nouvelles Générationsunclassified

Stentscoronaires

et al. 2014

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> Les révolutions successives ont marqué l'histoire de la cardiologie interventionnelle. La première fut l'introduction de l'angioplastie percutanée par ballonnet, utilisée en alternative à la chirurgie pour la revascularisation coronaire, suivie de l'invention des premiers stents métalliques nus (bare metal stent ou BMS) et leur amélioration en stents dits actifs à élution de médicaments (drug-eluting stent ou DES), réduisant drastiquement le taux de re-sténoses observé avec les BMS. L'amélioration des plates-formes et des polymères des stents (biocompatibles ou résorbables) a permis de réduire le taux de thromboses tardives de stent à des niveaux extrêmement bas. Le développement de stents auto-expansibles est actuellement proposé pour lutter contre le problème de mauvaise apposition tardive aux parois du vaisseau dans l'infarctus du myocarde. Enfin, les nouveaux stents intégralement biorésorbables, pouvant être combinés à des molécules actives antiprolifératives, deviendront très probablement les stents de choix pour la revascularisation coronaire dans un futur proche. < été reconnue par le magazine anglais Intellectual property international magazine comme l'une des dix inventions qui ont changé le monde lors du siècle dernier. La troisième révolution a été l'arrivée, en 2002, du stent dit actif ou à élution de médicaments (DES ou drug-eluting stent), développé avec succès par les laboratoires Johnson & Johnson, pour réduire le risque de re-sténose observé avec les BMS. Ce risque obligeait a une ré-intervention dans 10 à 20 % des cas et, parfois, conduisait à proposer une revascularisation chirurgicale en cas de re-sténose diffuse ou itérative. Le principe du stent actif à élution de médicament antiprolifératif incorporé au sein d'un polymère le recouvrant a entraîné, de manière parallèle, une augmentation des thromboses tardives de stent, observées avec la première génération de DES, et attribuées à un retard ou à un défaut d'endothélisation du stent. L'amélioration des plates-formes des DES de nouvelle génération a permis de réduire ce taux de thrombose de stent au même niveau que celui du BMS. La diminution de la taille des mailles, et le caractère biocompatible ou résorbable des polymères les recouvrant ont permis de réduire le taux de thromboses tardives de stent à moins de 1 %. L'utilisation de stents auto-expansibles est actuellement proposée pour éviter la mal-apposition tardive dans l'infarctus du myocarde 2 . La dernière révolution est le stent biorésorbable, qui peut être combiné à des molécules antiprolifératives. Ce concept, encore au stade de validation chez l'homme, va possiblement devenir un standard pour la revascularisation coronaire. Ces stents ont le potentiel théorique de permettre la réduction de la durée de la bithérapie anti-agrégante plaquettaire 3 et, donc, des complications hémorragiques potentielles 2 On appelle mal-apposition le fait que le stent n'est pas parfaitement apposé aux parois du vaisseau, laissant un espace. 3 Association de 2 antiagrégants plaquettaires : acide acétyl...

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“…For all pharmaceuticals, the in vivo environment appears to provide a slower metabolic rate than the in vitro environment. 29 This phenomenon may explain why the effective period of in vivo drug release is longer than it is in vitro. In addition, the in vivo antiplatelet property of acetylsalicylic acid is known to continue for some time after discontinuation of therapy.…”

Section: Endothelial Coverage and Adhesion Of Blood Cellsmentioning

confidence: 99%

Local sustained delivery of acetylsalicylic acid via hybrid stent with biodegradable nanofibers reduces adhesion of blood cells and promotes reendothelialization of the denuded artery

Liu¹,

Lee²,

Lin³

et al. 2014

IJN

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Incomplete endothelialization, blood cell adhesion to vascular stents, and inflammation of arteries can result in acute stent thromboses. The systemic administration of acetylsalicylic acid decreases endothelial dysfunction, potentially reducing thrombus, enhancing vasodilatation, and inhibiting the progression of atherosclerosis; but, this is weakened by upper gastrointestinal bleeding. This study proposes a hybrid stent with biodegradable nanofibers, for the local, sustained delivery of acetylsalicylic acid to injured artery walls. Biodegradable nanofibers are prepared by first dissolving poly(D,L)-lactide-co-glycolide and acetylsalicylic acid in 1,1,1,3,3,3-hexafluoro-2-propanol. The solution is then electrospun into nanofibrous tubes, which are then mounted onto commercially available bare-metal stents. In vitro release rates of pharmaceuticals from nanofibers are characterized using an elution method, and a highperformance liquid chromatography assay. The experimental results suggest that biodegradable nanofibers release high concentrations of acetylsalicylic acid for three weeks. The in vivo efficacy of local delivery of acetylsalicylic acid in reducing platelet and monocyte adhesion, and the minimum tissue inflammatory reaction caused by the hybrid stents in treating denuded rabbit arteries, are documented. The proposed hybrid stent, with biodegradable acetylsalicylic acid-loaded nanofibers, substantially contributed to local, sustained delivery of drugs to promote re-endothelialization and reduce thrombogenicity in the injured artery. The stents may have potential applications in the local delivery of cardiovascular drugs. Furthermore, the use of hybrid stents with acetylsalicylic acid-loaded nanofibers that have high drug loadings may provide insight into the treatment of patients with high risk of acute stent thromboses.

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Novel fully bioabsorbable salicylate-based sirolimus-eluting stent

Cited by 54 publications

References 20 publications

Bioresorbable Scaffold

Bioresorbable Scaffold

Stentscoronaires

Local sustained delivery of acetylsalicylic acid via hybrid stent with biodegradable nanofibers reduces adhesion of blood cells and promotes reendothelialization of the denuded artery

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