Preclinical Evaluation of Drug-Eluting Stents for Peripheral Applications

Schwartz, Robert S.; Edelman, Elazer R.; Carter, Andrew; Chronos, Nicolas; Rogers, Campbell; Robinson, Keith A.; Waksman, Ron; Machan, Lindsay; Weinberger, Judah; Wilensky, Robert L.; Goode, Jennifer; Hottenstein, O.D.; Zuckerman, Bram; Virmani, Renu

doi:10.1161/01.cir.0000145164.85178.2e

Cited by 72 publications

(49 citation statements)

References 34 publications

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“…Although coronary and peripheral applications share several conceptual similarities in their preclinical evaluation, there are special considerations for peripheral devices with regard to model, anatomic location, and clinical application, for which supplementary references are provided. 41,98,161,208 Moreover, there is increasing complexity in the design of DES systems and the development of alternative endovascular treatments for ISR. Given that no set program or means for preclinical safety and efficacy evaluation can encompass all these endovascular technologies, this review seeks simplicity by focusing on DES systems commercially available or with published preclinical results.…”

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confidence: 99%

Preclinical Models of Restenosis and Their Application in the Evaluation of Drug-Eluting Stent Systems

Perkins

2010

Vet Pathol

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Coronary arterial disease (CAD) is the leading cause of death in the United States, the European Union, and Canada. Percutaneous coronary intervention (PCI) has revolutionized the treatment of CAD, and it is the advent of drug-eluting stent (DES) systems that has effectively allayed much of the challenge of restenosis that has plagued the success of PCI through its 30-year history. However, DES systems have not been a panacea: There yet remain the challenges associated with interventions involving bare metallic stents as well as newly arisen concerns related to the application of DES systems. To effectively address these novel and ongoing issues, animal models are relied on both to project the safety and efficacy of endovascular devices and to provide insight into the pathophysiology underlying the vascular response to injury and mechanisms of restenosis. In this review, preclinical models of restenosis are presented, and their application and limitation in the evaluation of device-based interventional technologies for the treatment of CAD are discussed.Keywords restenosis, stent, animal models, coronary artery disease Coronary artery disease (CAD) is the progressive accumulation of atherosclerotic plaque within the lumen of a coronary artery, with the typical result being luminal narrowing, reduced compliance of the vessel wall, and either a gradual reduction or a dramatic and sudden loss of blood supply to the myocardium. It is the leading cause of death in the United States, the European Union, and Canada, singly accounting for the death of 1 in 5 Americans. 117,185 In treatment options for symptomatic CAD, percutaneous coronary intervention (PCI) is the foremost modality, being based on the nonsurgical placement of a bare metallic scaffold, or stent, to prop open the artery to regain patency. However, there are drawbacks to coronary stenting, with restenosis being the Achilles' heel, accounting for a rate of failure up to 15 to 25%.18,124 Drug-eluting stents (DESs) have revolutionized PCI by effectively reducing restenosis rates to the single digits over standard bare metallic stents.DES systems combine mechanical and pharmacological approaches to assuage one or more events in the cascade that results in restenosis. These combination products consist of an intravascular scaffolding device that presents or releases single or multiple bioactive agents or pharmaceuticals into the bloodstream and arterial wall. Traditional DESs have consisted of a platform (stent), a carrier (usually a polymer), and an antirestenotic agent that is delivered locally to avert the need for high, systemically administered doses. The fundamental goal of the DES is to restore lumen patency while curtailing the diseased vessel's innate and often exuberant response to the implanted foreign material (stent) and to stent-induced injury. Despite the success of current DESs at achieving these goals, concerns have surfaced with their accruing clinical use. Such concerns pertain to vascular healing and late stent thrombosis, biocompat...

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confidence: 99%

Preclinical Models of Restenosis and Their Application in the Evaluation of Drug-Eluting Stent Systems

Perkins

2010

Vet Pathol

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“…Experience suggests that the coronary arteries in domestic swine and iliac arteries of rabbits are suitable in that their size, access, and injury response are similar to human vessels, and therefore allow assessment of devices that might be used in clinical evaluation 35 . Although armed with fewer collateral vessels, there are pertinent similarities between the pig and human cardiovascular system, including the distribution of epicardial coronary arteries.…”

Section: Large Animal Modelmentioning

confidence: 99%

“…Porcine coronary models using vascular injury methods are now accepted standards by which potential restenosis therapies are studied 35 .…”

Section: Technical Consideration Of Porcine Coronary Modelmentioning

confidence: 99%

Importância dos estudos pré-clínicos em animais de experimentação para a cardiologia intervencionista

Suzuki¹,

Yeung²,

Ikeno³

2008

Arq. Bras. Cardiol.

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“…/ Ago. 2008 neurológicas), a trombose do Stent; o infarto, a isquemia distal, a inflamação peri-Stent; a perda do endotélio; fibrina em quantidade e a estenose do vaso são complicações encontradas na literatura 14 . No nosso estudo não ocorreu nenhuma morte precoce, as complicações clínicas ocorreram em 60% dos casos, sendo que relacionadas diretamente ao ato cirúrgico, só uma, a liberação inadequada de um Stent no sistema venoso.…”

Section: Figura 3 -Discreta Estenose Na Projeção Do Local De Implanteunclassified

Endoprótese revestida de jugular preservada de bovino: estudo comparativo da resposta tecidual em aorta torácica descendente e veia cava inferior de suínos

Chouin

Pinto

Lopez

2008

Rev. Col. Bras. Cir.

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;Gaudencio Espinosa Lopez, TCBC-RJ 3 RESUMO: Objetivo: Avaliar e comparar a resposta tecidual de uma endoprótese biosintetica implantada na aorta torácica descendente e veia cava inferior de suínos. Método: Foi implantada uma endoprótese auto-expansível composta de aço inoxidável, revestida por veia jugular de bovino, processada pelo método L-hydro, com auxilio de uma bainha de liberação Taheri-Leonhardt (Flórida, EUA) na aorta torácica descendente, e a veia cava infra-renal de 10 suínos. Sessenta dias após, as endopróteses foram retiradas e analisadas sob o ponto de vista macro e microscópicos. Foram observados: perviedade, grau de incorporação a parede do vaso, tipo de reação inflamatória, e local de maior resposta, tanto em relação a camada do vaso quanto ao local de contato com o anel de aço Resultados: Todas as endopróteses encontravam-se pérvias, e incorporadas à parede. No setor venoso, seis apresentaram traves fibrosas em sua luz, e quatro apresentaram fibrose perivascular. No setor arterial somente uma prótese apresentou discreta estenose, sem fibrose perivascular. A reação inflamatória crônica tipo corpo estranho ocorreu em 100% das peças, a camada média foi a mais acometida no setor venoso, enquanto a íntima foi mais constante na artéria, o grau de incorporação foi mais firme na veia em comparação a artéria. A reação tecidual mostrou maior tendência nas áreas em intimo contato com o anel de aço (intraanelar), mais intensa na artéria do que na veia. Conclusão: A prótese apresentou baixa trombogenicidade em ambos os sistemas, houve maior reação tecidual e baixa biocompatibilidade no setor venoso (Rev. Col. Bras. Cir. 2008; 35(4): 252-258 INTRODUÇÃOO objetivo de promover a revascularização efetiva, ou temporária até a neovascularização na área além do processo obstrutivo levou a elaboração de novas e revolucioná-rias técnicas. Entre estas fazemos referencia especial às técni-cas minimamente invasivas, os procedimentos intraluminais de angioplastia por balão e os implantes de stent, que ofereceram alternativas mais seguras aos pacientes com graves comprometimentos clínicos. As vantagens indiretas dos Stents são: pouca invasividade, baixo período de internação, melhora clínica imediata, ampla utilização em pacientes de alto risco cirúrgico, além de permitir re-intervenções. As vantagens diretas são: evita o trauma direto no vaso envolvido, menor perda de sangue, previne o hematoma perivascular e a síntese acontece em locais não comprometidos do vaso [1][2][3][4] . No circuito venoso a angioplastia percutanea pode ser eficaz durante alguns meses, porém geralmente as estenoses são muito resistentes e há um alto índice de reestenose a curto prazo de tempo 5. A maior parte dos pacientes, com exceção dos casos de tratamento paliativo em doença neoplásica, terá de se submeter a vários procedimentos endoluminais e, mesmo assim, os resultados ainda são inferiores aos do circuito arterial 5,6 . Alguns autores propuseram uma cobertura sob ou sobre as estruturas metálicas, entretanto, não há ainda um tipo de materia...

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Preclinical Evaluation of Drug-Eluting Stents for Peripheral Applications

Cited by 72 publications

References 34 publications

Preclinical Models of Restenosis and Their Application in the Evaluation of Drug-Eluting Stent Systems

Preclinical Models of Restenosis and Their Application in the Evaluation of Drug-Eluting Stent Systems

Importância dos estudos pré-clínicos em animais de experimentação para a cardiologia intervencionista

Endoprótese revestida de jugular preservada de bovino: estudo comparativo da resposta tecidual em aorta torácica descendente e veia cava inferior de suínos

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