Análise volumétrica tardia após implante de stents eluidores de sirolimus versus biolimus A9

Abstract

Introduction: Sirolimus-eluting stents (SES) significantly reduce restenosis and major adverse cardiac events (MACE) compared to bare metal stents (BMS). The novel sirolimus analog, Biolimus A9T (BA9), presented similar safety and efficacy in the randomized, controlled STEALTH I trial. This study compared the efficacy of a BA9-eluting stent versus sirolimus-eluting and bare metal control stents. Methods: Forty-five patients with de novo coronary lesions were randomly assigned in a 2:1 basis to receive either BA9-eluting (n = 30) or bare metal (n=15) S-stents. Quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS), at 6 months, were then compared to a matched series of patients who received either sirolimuseluting (n = 30) or bare metal (n = 15) Bx Velocity stents. Baseline clinical and angiographic characteristics were similar among all groups, except for a significantly higher percentage of females and Class C lesions in the BA9-eluting stent group. Results: At 6 month follow-up, there was no significant difference in clinical outcomes between any of the groups. QCA revealed significantly lower late loss in both drug-eluting stents (DES) groups compared to bare metal controls, but no significant difference between BA9 and SES groups was observed (0.24 ± 0.39mm vs. 0.15 ± 0.38mm, p = NS). Obstruction volume measured by 3D IVUS was significantly reduced in both DES groups compared to bare metal controls, but did not differ between the BA9 and SES groups (2.23% vs. 3.30%, BA9 vs. SES, p=NS). Conclusions: BA9-eluting stents reduce neointimal hyperplasia, safely and effectively, compared to BMS, and the magnitude of this inhibition is similar to that of SES.

Avaliação pela tomografia de coerência óptica de stent nacional recoberto com polímero biodegradável eluidor de sirolimus vs. stent eluidor de biolimus A9 em artérias coronárias porcinas

“…O stent BioMatrix TM (Biosensors International, Cingapura) é um stent de aço inoxidável inspirado no S-Stent TM (Biosensors International), recoberto com polímero biodegradável (PLA), exclusivamente em sua face abluminal, e que libera biolimus A9. 10,11 Está em desenvolvimento em nosso meio o stent Inspiron TM (Scitech Produtos Médicos Ltda., Goiânia, Brasil), um stent nacional metálico de cobaltocromo recoberto com uma mistura de polímeros bioabsorvíveis [poli(ácido láctico) e poli(ácido láctico-co-ácido glicólico)] também exclusivamente em sua face abluminal e com liberação de sirolimus. [12][13][14] Este estudo teve como objetivo comparar, em um modelo experimental, os achados da tomografia de coerência óptica dos stents Inspiron TM e BioMatrix TM , similares por serem revestidos em sua face abluminal por polímero biodegradável, diferenciando-se pela liga metálica e por liberarem sirolimus ou biolimus A9, respectivamente.…”