1-Year Results of the Hydroxyapatite Polymer-Free Sirolimus-Eluting Stent for the Treatment of Single De Novo Coronary Lesions

Costa, J. Ribamar; Abizaid, Alexandre; Costa, Ricardo; Feres, Fausto; Tanajura, Luiz Fernando; Abizaid, Andréa; Maldonado, Galo; Staico, Rodolfo; Siqueira, Dimytri; Sousa, Amanda G.M.R.; Bonan, Raoul; Sousa, J. Eduardo

doi:10.1016/j.jcin.2009.02.009

Cited by 89 publications

(55 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However, its clinical effectiveness was lower than that reported for other DES, with and without polymers. [1][2][3][7][8][9][10][11][24][25][26][27][28] Notably, the angiographic findings in the long-term follow-up of the PAX-B study are similar to results reported with other previously tested non-polymeric paclitaxel-releasing stents, 6 which also confirms that the Amazonia PAX ® stent is less effective than the Taxus ® Liberté paclitaxel-releasing stent with durable polymer at suppressing neointimal proliferation. 19 In general, first-generation DES, such as Cypher ® (Cordis -Miami Lakes, USA) and Taxus ® , demonstrated remarkable and sustained clinical effectiveness.…”

Section: Discussionsupporting

confidence: 68%

Seguimento angiográfico e clínico tardio do novo stent farmacológico não-polimérico liberador de paclitaxel para o tratamento de lesões coronárias de novo: resultados do estudo PAX-B

Abreu-Silva¹,

Costa²,

Abizaid³

et al. 2012

Rev. Bras. Cardiol. Invasiva

Self Cite

View full text Add to dashboard Cite

Background: Compared with the Taxus ® stent, the nonpolymeric paclitaxel-eluting Amazonia ® PAX stent shows no differences in the occurrence of coronary restenosis or clinical events after four months of follow-up. However, the performance of the Amazonia ® PAX stent in more complex cases and with longer angiographic follow-up has not been demonstrated. Methods: The PAX-B study was a prospective, non-randomised, multicentre study assessing the long-term follow-up of patients treated with the Amazonia ® PAX stent. The primary outcome was late in-stent lumen loss. Results: The study included 103 patients with a mean age of 61.3 ± 11.4 years; 26.2% were diabetics, 24.3% had acute coronary syndromes, and 71.6% had type B2/C lesions. Multiple stents were implanted in 4.7% of the patients, and angiographic success was achieved in 100% of the cases. During hospitalisation, the periprocedural acute myocardial infarction rate was 3.9%, and one of these events led to target-lesion revascularisation (TLR). At the nine-month angiographic follow-up, the median late in-stent lumen loss was 0.91 [0.50; 1.21] mm. The cumulative rates of major adverse cardiac events at the six-month, nine-month, and 12-month follow-ups were 7.8%, 18.5%, and 21.3%,

show abstract

Section: Discussionsupporting

confidence: 68%

Seguimento angiográfico e clínico tardio do novo stent farmacológico não-polimérico liberador de paclitaxel para o tratamento de lesões coronárias de novo: resultados do estudo PAX-B

Abreu-Silva¹,

Costa²,

Abizaid³

et al. 2012

Rev. Bras. Cardiol. Invasiva

Self Cite

View full text Add to dashboard Cite

show abstract

“…20 There was a mild, nonsignificant increase in both surrogates at 9 months (0.36Ϯ0.23 mm and 4.0Ϯ2.2%). 21 Of note, there was no case of late incomplete stent apposition. Up to 24 months of clinical follow-up, none of these patients presented any MACE, including death, myocardial infarction, and target lesion revascularization.…”

Section: Vestasync (Miv Therapeutics)mentioning

confidence: 98%

New Drug-Eluting Stents

Abizaid

Costa

2010

Circ: Cardiovascular Interventions

Self Cite

151

View full text Add to dashboard Cite

D rug-eluting stents (DES)were primarily conceived to reduce in-stent neointimal formation and therefore minimize the occurrence of restenosis, the major drawback of percutaneous coronary interventions with bare-metal stents (BMS).The development of DES has been pioneered through a combination of the increased understanding of the biology of restenosis, the selection of drugs that target 1 or more pathways in the restenotic process, controlled-release drug delivery strategies, and the use of the stent as a delivery platform.Although first-generation DES Cypher (sirolimus-eluting stent; Cordis Corporation, Johnson & Johnson, Warren, NJ) and Taxus (paclitaxel-eluting stent; Boston Scientific Corporation, Natick, Mass) have effectively achieved their main goal, reducing restenosis across virtually all lesion and patient subsets, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization leading to late and very late thrombosis, and local drug toxicity. [1][2][3][4][5][6][7][8][9] Both Cypher and Taxus use durable thick polymers to carry and control the release of their antiproliferative agents. The permanent presence of these polymers has been correlated to inflammatory responses and local toxicity in preclinical analysis. 10 -13 Furthermore, durable polymers used in first-generation DES have been associated with mechanical complications (eg, polymer delamination and "webbed" polymer surface leading to stent expansion issues) 14 and nonuniform coating resulting in erratic drug distribution. As a consequence, in recent years, the focus of clinical research has been on the development of novel drug carrier systems including absorbable (or biodegradable) polymers and nonpolymeric stent surfaces. Additional improvements include the development of more modern platforms (eg, better deliverability, radiopacity, flexibility, and radial strength) as well as the use of novel antiproliferative agents or reduced doses of current approved antiproliferative drugs.This review focuses on describing next-generation drugeluting stent systems based on the use of novel coatings and carrier systems developed to enhance DES safety. Initially, we will address the issue of how to plan and conduct first-in-man studies to evaluate efficacy of novel devices for coronary intervention. After this brief introduction, we will discuss the next-generation DES systems and for didactic purpose the text will be divided into 2 parts, focusing on programs with biodegradable polymers and finally moving to nonpolymeric DES. First-in-Man StudiesA lot has changed since our institution conducted the firstever successful in-human DES evaluation, the CypherSirolimus-eluting stent first-in-man (FIM) trial. At that time, 10 years ago, with 15 patients receiving the slow-release formulation and 15 patients receiving the moderate-release version, we were able to show the impressive power of the novel technology in reducing neointimal proliferation by means of surrogate end points: in-stent late luminal loss and intravas...

show abstract

“…In clinical trials the HA coated stent was effective in reducing lumen loss and neointimal hyperplasia at 4 and 9 months with no incomplete stent apposition [Costa, 2009].…”

Section: Biodegradable Stentsmentioning

confidence: 99%

On the Design of a Biodegradable POC-HA Polymeric Cardiovascular Stent

Ponkala

Rizwan

Shiakolas

2012

Volume 2: Biomedical and Biotechnology

View full text Add to dashboard Cite

The current state of the art in coronary stent technology, tubular structures used to keep the lumen open, is mainly populated by metallic stents coated with certain drugs to increase biocompatibility, even though experimental biodegradable stents have appeared in the horizon. Biodegradable polymeric stent design necessitates accurate characterization of time dependent polymer material properties and mechanical behavior for analysis and optimization. This manuscript presents the process for evaluating material properties for biodegradable biocompatible polymeric composite poly(diol citrate) hydroxyapatite (POC-HA), approaches for identifying material models and three dimensional solid models for finite element analysis and fabrication of a stent. The developed material models were utilized in a nonlinear finite element analysis to evaluate the suitability of the POC-HA material for coronary stent application. In addition, the advantages of using femtosecond laser machining to fabricate the POC-HA stent are discussed showing a machined stent. The methodology presented with additional steps can be applied in the development of a biocompatible and biodegradable polymeric stents.

show abstract

1-Year Results of the Hydroxyapatite Polymer-Free Sirolimus-Eluting Stent for the Treatment of Single De Novo Coronary Lesions

Abstract: The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.

Cited by 89 publications

References 11 publications

Seguimento angiográfico e clínico tardio do novo stent farmacológico não-polimérico liberador de paclitaxel para o tratamento de lesões coronárias de novo: resultados do estudo PAX-B

Seguimento angiográfico e clínico tardio do novo stent farmacológico não-polimérico liberador de paclitaxel para o tratamento de lesões coronárias de novo: resultados do estudo PAX-B

New Drug-Eluting Stents

On the Design of a Biodegradable POC-HA Polymeric Cardiovascular Stent

Contact Info

Product

Resources

About