ABSTRACT
No estudo BIOACTIVE, avaliamos as respostas vasculares após implante do stent eluidor de biolimus A9 (SEB; BioMatrix®) e o stent eluidor de everolimus (SEE; XIENCE V®). Apresentamos a análise detomografia de coerência óptica (OCT) 6 meses pós-intervenção. Métodos: Os 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. Resultados: A 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).Conclusões: Stents farmacológicos de segunda geração SEB e SEE se mostraram igualmente eficientes emsuprimir a formação neointimal aos 6 meses, com respostas vasculares favoráveis. A frequência de framescom sinais de infiltrado peri-haste por paciente foi baixa, e menor do que a historicamente observada comos stents farmacológicos de primeira geração...
In 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. Methods: Patients 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.Results: OCT was performed in 26 patients (BES: n = 15; EES: n = 11) and 749 tomographic images and 7,725stent 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). Conclusions: The 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 frameswith peri-strut infiltrate signals per patient was low, and lower than that observed historically with firstgenerationdrug-eluting stents...
Subject(s)
Humans , Male , Female , Middle Aged , Coronary Disease/physiopathology , Coronary Disease/therapy , Drug-Eluting Stents , Tomography, Optical Coherence/methods , Data Interpretation, Statistical , Prospective Studies , Percutaneous Coronary Intervention/methods , Polymers/therapeutic use , Treatment Outcome , Thrombosis/complications , Thrombosis/diagnosisABSTRACT
Introdução: A incidência de dissecções de borda, após o implante de suportes vasculares biorreabsorvíveis (SVBs), ainda não foi investigada. Esses suportes têm hastes mais espessas e requerem pré-dilatação mais agressiva no implante. Avaliamos a incidência de dissecções de borda após implante de SVBs, seus aspectos morfométricos e o processo de cicatrização, com imagens de tomografia de coerência óptica (OCT) seriadas. Métodos: Incluímos pacientes consecutivos, que foram tratados com SVBs polimérico, e que possuíam avaliação com OCT após o procedimento e aos 6 meses de evolução. Dissecções de borda foram definidas como rupturas da superfície luminal nos 5 mm distais ou proximais ao SVB. Resultados: Das 96 bordas de 48 SVB implantados em 48 lesões de 48 pacientes, 91 bordas estavam disponíveis para a análise. Dissecções foram detectadas pela OCT em 28 bordas (30,7%) de 22 lesões (45,8%), com igual distribuição entre as bordas distais e proximais. Todas as dissecções apareceram como flaps e não foram visualizadas pela angiografia. Doença aterosclerótica esteve presente em 96,4% das bordas dissecadas; a maioria era fibrocalcificada (40,8%) e mais de um terço era rica em lipídio. O comprimento médio das dissecções foi 1,80 mm e a área média dos flaps tinha 0,30 mm. A maioria ...
Background: The incidence of edge dissections after the coronary implantation of bioresorbable scaffolds (BRS) has not been investigated. BRS have thicker struts and require more aggressive pre-dilation for implantation. The incidence of edge dissections after BRS implantation, their morphological aspects and healing process were evaluated using serial optical coherence tomography (OCT) images. Methods: Consecutive patients treated with a polymeric BRS, who had an OCT evaluation after the procedure and at 6-month follow-up, were included in the current analysis. Edge dissections were defined as luminal surface ruptures, 5-mm distally or proximally to the BRS edges. Results: Out of 96 edges from 48 BRS implanted in 48 lesions of 48 patients, 91 edges were available for analysis. Dissections were detected by OCT in 28 edges (30.7%) and in 22 lesions (45.8%), with equal distribution between distal and proximal edges. All dissections appeared as flaps and none were visible by angiography. Atherosclerotic disease was present in 96.4% of all dissected edges; most were fibrocalcific (40.8%), and more than one-third were lipid-rich. Mean dissection length was 1.80 mm, and the mean flap area was 0.30 mm. Most dissections (89.3%) were superficial and restricted to the intima/atheroma layer. At the 6-month follow-up 92.8% of all dissections healed completely, and there was no significant reduction in the luminal dimensions at the edge segments, with only one case of restenosis. ...