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Efficacy and safety of oral sirolimus to inhibit in-stent intimal hyperplasia.
Brito, Fábio S; Rosa, Werther C M; Arruda, J Airton; Tedesco, Hélio; Pestana, Jose O M; Lima, Valter C.
Afiliação
  • Brito FS; Hospital São Paulo and Hospital do Rim e Hipertensão, Federal University of São Paulo, Brazil.
Catheter Cardiovasc Interv ; 64(4): 413-8, 2005 Apr.
Article em En | MEDLINE | ID: mdl-15789385
Sirolimus systemic administration has shown marked inhibition of neointimal hyperplasia (NIH) after balloon angioplasty in porcine models. In this pilot study, we tested the hypothesis that oral sirolimus is safe and effective to inhibit in-stent NIH and therefore to prevent and treat in-stent restenosis (ISR). Twelve patients (18 lesions) with high risk for ISR, including 8 ISR lesions, were admitted. One day before the procedure, patients were given a 15 mg loading dose of oral sirolimus, followed by 5 mg daily for 28 days, with weekly whole blood level measurements. The daily dose was adjusted to keep the concentration at 10-15 ng/ml. Sirolimus was well tolerated by all patients but one, who died at the end of the third week of treatment. The 4- and 8-month follow-up revealed an angiographic late loss of 0.40 +/- 0.24 and 0.67 +/- 0.45 mm (P < 0.01), respectively. At the same time points, the intravascular ultrasound in in-stent relative volumetric obstruction was 14.4% +/- 9.1% and 23.2% +/- 10.1% (P < 0.01), respectively. At 24-month clinical follow-up, adverse events were one (8.3%) death, two (11.1%) target lesion, and four (22.2%) target vessel revascularizations. In conclusion, in this small group of high-risk ISR patients, oral sirolimus inhibited NIH and therefore may be an effective strategy for the prevention and treatment of ISR.
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Angioplastia Coronária com Balão / Stents / Sirolimo / Estenose Coronária / Reestenose Coronária Tipo de estudo: Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Catheter Cardiovasc Interv Assunto da revista: CARDIOLOGIA Ano de publicação: 2005 Tipo de documento: Article País de afiliação: Brasil País de publicação: Estados Unidos
Buscar no Google
Adicionar na Minha BVS
Imprimir
XML
PubMed Links

Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Angioplastia Coronária com Balão / Stents / Sirolimo / Estenose Coronária / Reestenose Coronária Tipo de estudo: Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Catheter Cardiovasc Interv Assunto da revista: CARDIOLOGIA Ano de publicação: 2005 Tipo de documento: Article País de afiliação: Brasil País de publicação: Estados Unidos