Tratamento de reestenose intrastent com o novo stent farmacológico FirebirdTM, liberador de sirolimus: resultados angiográficos e ultrassonográficos de um ano de evolução

Background: Preliminary data have shown that the Firebird TM and the Cypher ® stents have similar safety and efficacy profiles. However, to date, no study has evaluated percutaneous coronary intervention (PCI) with the Firebird TM stent in diabetic patients. Methods: The performance of the Firebird TM stent in diabetic patients with multivessel coronary artery disease (CAD) (n = 100) was compared with that of the Cypher ® stent using historical data from the ARTS-II study (n = 159). One-year major adverse cardiovascular events (MACE) were compared. Results: Most of the patients in the Firebird TM group were male (65%), with a mean age of 63.3 ± 10.4 years, and 5% were on insulin. Stable coronary syndrome was prevalent (60%), and 45% of patients had three-vessel CAD with preserved ventricular function (56.6 ± 13.7%). In patients with three-vessel CAD, 135 lesions were treated with three or more stents in 78% of cases and with two stents in the remainder. In patients with two-vessel CAD, 110 lesions were treated with two or more stents in 80% of the cases and with one stent in the remainder. The one-year incidence of MACE with the Firebird TM stent was 21%. Mortality occurred in 3% of the patients, myocardial infarction in 2%, and a new revascularisation procedure in 18%, predominantly a new PCI (14% of cases). Comparison with the Cypher ® group did not show differences for any of the evaluated endpoints. Conclusions: In the present study, the use of the Firebird TM stent showed similar results to those of the patients in the ARTS-II study, demonstrating its suitability for use in the complex scenario of diabetic patients with multivessel CAD.

Section: Discussionsupporting

confidence: 76%

Desempenho do stent farmacológico firebird em diabéticos portadores de doença coronária multiarterial

Osterne¹,

Filho²,

Custódio³

et al. 2012

“…12 Em resumo, o stent eluidor de sirolimus Firebird TM consiste em uma plataforma metálica balão-expansível, de aço inox 316L, com células abertas e um sistema matricial de polímero EVAC (Ethylene Vinyl Acetate Copolymer) e sirolimus, que reveste as hastes dos stents. A concentração de sirolimus no stent é de 9 µg/mm² e a dose liberada varia de acordo com o diâmetro e o comprimento do dispositivo.…”

Section: Características Do Stentunclassified

“…[7][8][9] Esses dois fatores, reestenose e trombose, ainda presentes na evolução dos pacientes tratados com SFs, são motivo para o desenvolvimento de novos stents, com o propósito de superar as atuais limitações da geração mais antiga de SFs. O SF Firebird TM (Microport Co. Ltd., Xangai, China) mostrou resultados clínicos promissores no tratamento de lesões de novo 10,11 e da reestenose intrastent 12 , mas são escassas na literatura informações sobre sua evolução a longo prazo.…”

Section: Introductionunclassified

Análise ultrassonográfica tardia do stent eluidor de sirolimus FirebirdTM

Costantini¹,

Costantini²,

Denk³

et al. 2011

“…In this issue of the Revista Brasileira de Cardiologia Invasiva, Freitas et al 12 presented their one year angiographic and ultrasonographic follow-up results of treating in-stent restenosis with the Firebird TM sirolimus eluting stent. This study show that the late luminal loss was 0.30 ± 0.24 mm, and no case of binary restenosis was identified at 12 months.…”

mentioning

confidence: 99%

Qual stent utilizar na reestenose de stent não-farmacológico?

Yan¹,

Xu²

2010

Management of in-stent restenosis remains a problem.1-3 Although bare-metal stents provide excellent angiographic results, high restenosis rates still shadow these results. The superiority of drug-eluting stents compared with balloon angioplasty and vascular brachytherapy for the treatment of patients with in-stent restenosis has been shown in randomized trials. [4][5][6] . At present, drug-eluting stents represent the therapy of choice for in-stent restenosis. 1-6The Firebird TM sirolimus eluting stent (Microport Co. Ltd., Shanghai, China) combines a stainless steel platform (L316) of thin struts (0.0040"), a powerful antiproliferative agent (sirolimus, at a dose of 9 µg/mm²) and a coating that includes three layers of a durable polymer, that controls drug release. Since the Firebird TM drug-eluting stent was approved by Chinese SDA (State Drug Administration) for commercial use in the beginning of 2005, the penetration of this drug-eluting stent use accounted for 28%-30% (personal communication) in China because of promising clinical results from using this drug-eluting stents.7-11 However, no published data appeared regarding its performance in treating in-stent restenosis.In this issue of the Revista Brasileira de Cardiologia Invasiva, Freitas et al. 12 presented their one year angiographic and ultrasonographic follow-up results of treating in-stent restenosis with the Firebird TM sirolimus eluting stent. This study show that the late luminal loss was 0.30 ± 0.24 mm, and no case of binary restenosis was identified at 12 months. And on intravascular ultrasound, the percentage of in-stent volumetric obstruction was 2.6 ± 1.9%. Accordingly, the authors concluded that the Firebird TM sirolimus eluting stent showed favorable angiographic and ultrasound results for the treatment of bare metal in-stent restenosis at 1 year follow-up. More recently, Liistro et al.6 confirmed 4-year effectiveness and safety of sirolimus eluting stent implantation for coronary in-stent restenosis. Therefore, See related article in this issuesirolimus eluting stents are currently considered the best possible care in the treatment of in-stent restenosis, especially in patients with bare-metal stents.However, this study is inherently limited by a lack of valid control groups which did not enable a direct comparison with another drug-eluting stents. Another major limitation is small cohort of patients and relative shorter clinical follow-up, which did not allow a real estimation of the late catch-up phenomenon with drugeluting stents in in-stent restenosis lesions.Finally, two points are worth to be noted. First, although drug-eluting stents have dramatically reduced the rates of in-stent restenosis compared with baremetal stents, a low rate of in-stent restenosis after drugeluting stents still exists, and its prevalence is not negligible because the population treated with drug-eluting stents is large. Second, drug-eluting stents implantation after in-stent restenosis may further reduce the flexibility of the vessel and limit the repea...