Exequibilidade, eficácia e segurança do sistema de stent cardioMind tm no tratamento de lesões em vasos de fino calibre. Um estudo seriado com angiografia e ultra-som intracoronariano / Feasibility, efficacy and safety of the CardioMind tm stent system in the treatment of small coronary vessels: a serial angiography and intravascular ultrasound study

RESUMO

Introdução: A intervenção coronária percutânea em vasos de fino calibre está associada a piores resultados imediatos e tardios, com elevadas taxas de reestenose, motivando o desenvolvimento de novos instrumentais para tal finalidade. Objetivo: Avaliar a exequibilidade, a eficácia e a segurança do novo sistema de stent CardioMind tm para o tratamento de lesões em vasos de fino calibre. Método: Dez pacientes portadores de lesões únicas, de novo, menor 14 mm, em artérias coronárias nativas menor 2,5 mm de diâmetro foram submetidos a implante de stent CardioMind tm. Todos os pacientes foram submetidos a angiografia e ultra-sonografia intracoronária (USIC) pós-procedimento e aos seis meses, com o desfecho primário de eficácia avaliada pela perda luminal tardia (PT) à angiografia e porcentagem de obstrução do stent à USIC. Resultados: A média das idades foi de 63 mais ou menos 10,6 anos 60 por cento dos pacientes eram do sexo feminino e 60 por cento, diabéticos...

ABSTRACT

Background: Percutaneous coronary intervention in small vessels is associated to poor short and long-term results with high rates of restenosis, inducing the development of newer devices for this purpose. Objective: To assess the feasibility, efficacy and safety of the new CardioMind™ stent system in the treatment of small vessel coronary artery disease (CAD). Methods: Ten patients presenting a single, de novo lesion in a native coronary artery < 2.5 mm in diameter were assigned to receive the CardioMind™ stent. All patients were submitted to angiography and intravascular ultrasound (IVUS) evaluation immediately post-procedure and at 6 months. The primary end-point of efficacy was assessed by the late lumen loss at angiography and percentage (%) of neointimal obstruction at IVUS at 6 months. Results: Mean age was 63 ± 10.6 years, 60% were female and 60% diabetics. Reference vessel diameter and lesion length were 2.06 mm ± 0.27 mm and 9.35 mm ± 1.39 mm, respectively. Device and procedure success were obtained in all patients. At 6-month, late loss was 0.53 mm ± 0.60 mm and % of neointimal obstruction by IVUS was 24.1% ± 8.7%. One patient presented binary restenosis requiring repeat percutaneous intervention. There were no cases of cardiac death and/or myocardial infarction. Conclusions: The CardioMind™ stent system showed to be viable and safe in this "First-In-Man" study of the use of this novel device in the treatment of small vessel CAD, with encouraging results in the reduction of in-stent late loss and neointimal formation. The clinical impact of these findings should be assessed in a larger cohort of patients.