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Doctoral Thesis
DOI
https://doi.org/10.11606/T.98.2018.tde-08042022-113346
Document
Author
Full name
Cleverson Neves Zukowski
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2018
Supervisor
Committee
Costa, Ricardo Alves da (President)
Campos, Carlos Augusto Homem de Magalhães
Cantarelli, Marcelo José de Carvalho
Feres, Fausto
Title in Portuguese
Stent dedicado para bifurcação BIOSS LIM: análise comparativa de imagem com angiografia quantitativa, tomografia de coerência ótica e ultrassom intracoronário
Keywords in Portuguese
Angioplastia transluminal percutânea
Aterosclerose coronária
Lesão em bifurcação coronária
Stents farmacológicos
Tomografia
Ultrassonografia
Abstract in Portuguese
Os métodos de imagem de angiografia coronária quantitativa (ACQ), tomografia de coerência óptica (TCO) e ultrassom intracoronário (USIC), são comumente utilizados na avaliação do desempenho e eficácia de dispositivos coronários. Entretanto, eles diferem grandemente em relação ao modo de aquisição das imagens, perfil, resolução, método de análise e interpretação, e custos. O objetivo desta análise foi avaliar a correlação e a concordância dos métodos de imagem de avaliação de eficácia tardia em lesões de bifurcação coronária tratadas com um stent farmacológico (SF) liberador de sirolimus BiOSS LIM dedicado para bifurcação. A hipótese testada foi que as dimensões luminais tardias, conforme determinado pelas análises de ACQ, TCO e USIC, apresentariam alta correlação e concordância em termos de métricas de eficácia na avaliação subsegmentar do vaso principal de lesões de bifurcação coronária tratadas com estratégia provisional com um SF dedicado. Entre Janeiro de 2016 e Fevereiro de 2017, 35 pacientes (36 lesões) portadores de lesões de bifurcação coronária de novo (excluindo tronco de coronária esquerda) foram submetidos a tratamento de intervenção coronária percutânea com estratégia provisional com SF dedicado para bifurcação. Cerca de 41% das lesões apresentavam morfologia complexa, com comprometimento significativo dos dois ramos. Durante o procedimento, 25% receberam stent no ramo lateral (RL), e fluxo final TIMI 3 foi obtido no 2 ramos em todos os casos. No reestudo protocolar aos 9 meses, realizado em 100% dos casos, a perda tardia do lúmen (PTL) no VP e RL foram, respectivamente, 0,29 mm e 0,18 mm. Considerando os subsegmentos intra-stent proximal, carina e intra-stent distal no VP, a PTL foi 0,23 mm, 0,29 mm e 0,33 mm, respectivamente; já a área mínima do lúmen (AML) pelo TCO e USIC foram, respectivamente, 8,60 mm2 e 5,68 mm2, 8,18 mm2 e 5,32 mm2, e 6,29 mm2 e 3,99 mm2. Pelo método de Pearson, a TCO e o USIC demonstraram correlação para as medidas de AML (r = 0,75; p < 0,05; concordância pelo coeficiente de Lin = 0,38) no segmento intra-stent e área mínima do stent (r = 0,79; concordância = 0,77). Já a ACQ não demonstrou correlação significativa com os métodos invasivos na avaliação de dimensões luminais coronárias tardias em lesões de bifurcação tratadas com SF dedicado.
Title in English
BiOSS LIM Dedicated Stent for Bifurcation: Comparative Imaging Analysis between Quantitative Angiography, Optical Coherence Tomography and Intravascular Ultrassound
Keywords in English
Coronary atherosclerosis
Coronary bifurcation lesions
Percutaneous transluminal coronary angioplasty
Stents farmacológicos
Tomography
Ultrassonography
Abstract in English
Imaging methods such as quantitative coronary angiography, optical coherence tomography (OCT) and intravascular ultrasound (IVUS), are commonly used for the evaluation of performance and efficacy of coronary devices. However, they differ greatly in relation to imaging aquisition protocol, profile, resolution, analysis and interpretation method, and costs. The objetive of this analysis was to evaluate the correlation and agreement of imaging methods for late efficacy evaluation in coronary bifurcation lesions treated with the BiOSS LIM dedicated bifurcation drug-eluting stent (DES) coated with sirolimus. The tested hypothesis was that late luminal dimensions, as determined by QCA, OCT and IVUS analysis, would present high correlation and agreement in terms of efficacy metrics in the subsegmental evaluation of the main vessel (MV) of coronary bifurcation lesions treated by provisional strategy with a dedicated DES. Between January 2016 and February 2017, 35 patients (36 lesions) with de novo coronary bifurcation lesions (excluding left main) underwent percutaneous coronary intervention treatment with provisional strategy with dedicated bifurcation DES. About 41% of lesions presented with complex morphology, with significant compromise of both branches. During procedure, 25% received stent in the side branch (SB), and final TIMI 3 flow was obtained in both branches in all cases. At the protocol-mandated re-evaluation at 9 months, performed in 100% of cases, late lumen loss (LLL) at MV and SB were, respectively, 0.29 mm e 0.18 mm. Considering the MV proximal instent, carina and distal in-stent subsegments, LLL was 0.23 mm, 0.29 mm and 0.33 mm, respectively; as for minimum lumen area (MLA) by OCT and IVUS, results were 8.60 mm2 and 5.68 mm2, 8.18 mm2 and 5.32 mm2, and 6.29 mm2 and 3.99 mm2, respectively. By Pearson method, OCT and IVUS demonstrated high correlation for MLA (r = 0.75; p < 0.05; agreement by the Lin coefficient = 0.38) at the in-stented segment and minimum stent area (r = 0.79; agreement = 0,77). As for QCA, there was no significant correlation with invasive methods for the evaluation of coronary luminal dimensions in bifurcation lesions treated with dedicated DES.
 
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Publishing Date
2023-10-06
 
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