RESUMO
OBJECTIVES: The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention. BACKGROUND: Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications. METHODS: Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis. RESULTS: At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P=0.02), and MACE rate was 10% in PES and 19% in BMS arm (P=0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms. CONCLUSIONS: The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Estenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Stents , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Argentina , Distribuição de Qui-Quadrado , Angiografia Coronária , Reestenose Coronária/etiologia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Feminino , Glicocálix , Humanos , Estimativa de Kaplan-Meier , Ácido Láctico , Modelos Logísticos , Masculino , Metais , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Ácido Poliglicólico , Copolímero de Ácido Poliláctico e Ácido Poliglicólico , Modelos de Riscos Proporcionais , Estudos Prospectivos , Desenho de Prótese , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Trombose/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
Se analizaron 602 pacientes con angina inestable tratados con angioplastia coronaria e incluídos en el Registro de Angioplastia en la Angina Inestable. Se relacionaron variables clínicas y angiográficas previas a la angioplastia con la aparición de complicaciones mayores intrahospitalarias (muerte, infarto de miocardio tipo Q, cirugía de revascularización de urgencia). La edad promedio de los pacientes fue de 61,3 años, 78 por ciento eran hombres y el 70,3 por ciento del total recibió un stent. Se registraron 14 (2,34 por ciento) complicaciones mayores (IAM 1,17 por ciento, muerte 0,5 por ciento y cirugía 1,17 por ciento). En el análisis multivariado, las variables relacionadas en forma significativa con las complicaciones mayores fueron la angina refractaria, el sexo femenino y las lesiones complejas