ABSTRACT
Os stents eluidores de sirolimus (SES) reduaem significativamente a incidência de reestenose e de eventos cardíacos maiores em comparação a stents convencionais. O sirolimus A9 (BA9), um análogo do sirolimus, demosntrou eficácia e segurança simulares no estudo randomizado e controlado STEALTH I. O objetivo deste estudo é comparar a eficácia do stent eluidor de BA9 com os SES, assim como seu desempenho em relação ao respectivos grupos controle, utilizando a análise volumétrica pelo ultra-som intracoronário (3D-USIC). Método: No total, 45 pacientes foram randomizados 2:1 para o grupo submetido a implante de stents eluidores de BA9(n igual 30) ou para o grupo conrole (n igual 15). Os resultados de angiografia coronária quantitativa e 3D-USIC foram comparados a uma série histórica de pacientes submetidos a implante de SES (n igual 30) ou controle (n igual 15). As características clínicas e angiográficas foram semelhantes entre os grupos , exceto pela maior quantidade de lesões tipo C e mulheres no grupo dos stents eluidores de BA9. Resultados: Aos seis meses de seguimento, a perda tardia intra-stent foi significativamente inferior...
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 sirolimus-eluting (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.