Vascular response after implantation of biolimus A9-eluting stent with bioabsorbable polymer and everolimus-eluting stents with durable polymer. Results of the optical coherence tomography analysis of the BIOACTIVE randomized trial

BackgroundIn BIOACTIVE study, we evaluated vascular responses after the implant of biolimus A9-eluting stent (BES; BioMatrixTM) and the everolimus-eluting stent (EES; XIENCE VTM). In this study, we present the optical coherence tomography analysis (OCT) 6 months post-intervention.MethodsPatients were randomized to treatment with BES (n = 22) or EES (n = 18). The primary outcome was the frequency of non-covered, poorly positioned struts by OCT.ResultsOCT was performed in 26 patients (BES: n = 15; EES: n = 11) and 749 tomographic images and 7,725 stent struts were analyzed. BES and EES showed similar luminal and stent areas. Neointimal hyperplasia area, neointimal thickness and the percentage of in-stent obstruction (8.44 ± 5.10% vs. 9.21 ± 6.36%; p = 0.74) were similar. The rates of not covered struts (BES: 2.10 ± 3.60% vs. ESS: 2.46 ± 2.15%, p = 0.77) and poorly positioned struts (BES: 0.48 ± 1.48% vs. EES 0.44 ± 1.05%, p = 0.94) were similarly low. The frequency of frames with signs consistent with peri-strut inflammatory infiltrate was low and similar between BES (15.53 ± 20.77%) and EES (11.70 ± 27.51%; p = 0.68).ConclusionsThe second-generation drug-eluting stents BES and EES were equally effective at suppressing the neointimal formation after 6 months, with favorable vascular responses. The frequency of frames with peri-strut infiltrate signals per patient was low, and lower than that observed historically with first-generation drug-eluting stents.

ResumoIntroduçãoNo estudo BIOACTIVE, avaliamos as respostas vasculares após implante do stent eluidor de biolimus A9 (SEB; BioMatrixTM) e o stent eluidor de everolimus (SEE; XIENCE VTM). Apresentamos a análise de tomografia de coerência óptica (OCT) 6 meses pós-intervenção.MétodosOs pacientes foram randomizados para tratamento com SEB (n = 22) ou SEE (n = 18). O desfecho primário foi a frequência de hastes não cobertas e mal apostas pela OCT.ResultadosA OCT foi realizada em 26 pacientes (SEB: n = 15; SEE: n = 11) e foram analisadas 749 imagens tomográficas e 7.725 hastes de stent. SEB e SEE apresentaram áreas luminais e dos stents semelhantes. A área de hiperplasia neointimal, a espessura neointimal e o porcentual de obstrução intra-stent (8,44 ± 5,10% vs. 9,21 ± 6,36%; p = 0,74) foram similares. As taxas de hastes não cobertas (SEB: 2,10 ± 3,60% vs. SEE: 2,46 ± 2,15%; p = 0,77) e mal apostas (SEB: 0,48 ± 1,48% vs. SEE 0,44 ± 1,05%; p = 0,94) foram baixas e semelhantes. A frequência de frames com sinais compatíveis com infiltrado inflamatório peri-haste foi baixa e similar entre SEB (15,53 ± 20,77%) e SEE (11,70 ± 27,51%; p = 0,68).ConclusõesStents farmacológicos de segunda geração SEB e SEE se mostraram igualmente eficientes em suprimir a formação neointimal aos 6 meses, com respostas vasculares favoráveis. A frequência de frames com sinais de infiltrado peri-haste por paciente foi baixa, e menor do que a historicamente observada com os stents farmacológicos de primeira geração.