Performance of the Firebird™ Drug-eluting Stent in Diabetic Patients with Multivessel Coronary Artery Disease

Abstract

Preliminary data have shown the Firebird™ and the Cypher® stents have similar safety and efficacy profiles. However, to date, no study has evaluated the percutaneous coronary intervention (PCI) with the Firebird™ stent in diabetic patients. The performance of the Firebird™ stent in diabetic patients with multivessel coronary artery disease (CAD) (n = 100) was compared to that of the Cypher® stent, using historical data from the ARTS-II study (n = 159). We compared the major adverse cardiovascular events (MACE) at one year. Most of the patients in the Firebird™ group were male (65%), with mean age of 63.3 ± 10.4 years and 5% were receiving insulin. Stable coronary syndromes were prevalent (60%), 45% had three-vessel CAD and ventricular function was preserved (56.6 ± 13.7%). In patients with three-vessel CAD, 135 lesions were treated with ≥ 3 stents in 78% of the cases and 2 stents in the remaining ones. In patients with two-vessel CAD, 110 lesions were treated with ≥ 2 stents in 80% of the cases and 1 stent in the remaining ones. The incidence of MACE at one year of the Firebird™ stent was 21%, death was observed in 3% of the patients, myocardial infarction in 2% and a new revascularization procedure in 18%, predominantly at the expense of a new PCI in 14% of the cases. Comparison with the Cypher® group did not show differences for any of the evaluated endpoints. In our study, the use of the Firebird™ stent showed similar results to those of patients in the ARTS-II study, which makes it attractive for use in the complex scenario of diabetic patients with multivessel CAD. Desempenho do Stent Farmacológico Firebird™ em Diabéticos Portadores de Doença Coronária Multiarterial Dados preliminares têm demonstrado que o perfil de segurança e eficácia do stent Firebird™ é semelhante ao do stent Cypher®. No entanto, até o presente momento, nenhum estudo avaliou a intervenção coronária percutânea (ICP) com o Firebird™ em diabéticos. Comparamos, em diabéticos portadores de doença arterial coronária (DAC) multiarterial, o desempenho do Firebird™ (n = 100) ao do Cypher®, utilizando os dados históricos do estudo ARTS-II (n = 159). Foram comparados os eventos cardiovasculares adversos maiores (ECAM) em um ano. A maioria dos pacientes do grupo Firebird™ era do sexo masculino (65%), com média de idade de 63,3 ± 10,4 anos e 5% estavam em uso de insulina. Predominaram os quadros clínicos estáveis (60%), 45% eram portadores de DAC triarterial e a função ventricular era preservada (56,6 ± 13,7%). Nos pacientes com DAC triarterial, foram tratadas 135 lesões, com 3 ou mais stents em 78% dos casos e 2 stents nos demais. Nos pacientes com DAC biarterial, foram tratadas 110 lesões com 2 ou mais stents em 80% dos casos e 1 stent nos demais. A incidência de ECAM em um ano do Firebird™ foi de 21%, óbito ocorreu em 3% dos pacientes, infarto do miocárdio em 2%, e novo procedimento de revascularização miocárdica em 18%, predominantemente à custa de nova ICP em 14% dos casos. A comparação com o grupo Cypher® não mostrou diferenças para nenhum dos desfechos avaliados. Em nosso estudo, o uso do stent Firebird™ apresentou resultados similares aos dos pacientes do estudo ARTS-II, o que o torna atrativo para ser utilizado no complexo cenário de pacientes diabéticos portadores de DAC multiarterial.