Serial intravascular ultrasound evaluation of the DESolveTM novolimus-eluting bioresorbable coronary scaffold system

INTRODUCTION: Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolveTM novolimus-eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions. Methods: Single-center, prospective, non-randomized study involving 17 consecutive patients submitted to implantation of the DESolveTM scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months. RESULTS: Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 6 1.35 mm2 vs. 7.35 6 1.53 mm2, P < 0.002; and 101.19 6 20.9 mm3 vs. 118.51 6 26.6 mm 3, P 5 0.001). Late lumen loss was 0.22 6 0.30 mm at 6 months and 0.33 6 0.44 mm at 18 months. No major adverse cardiac events occurred. At late follow-up (18 months) the scaffold was not visualized by IVUS; therefore the evaluation was restricted to lumen and vessel at that time point. CONCLUSIONS: IVUS serial evaluation of the novel DESolve BRS showed an increase in the device dimensions between baseline and 6 months, with concomitant enlargement of lumen dimensions and effective suppression of neointimal proliferation. At 18 months, no footprint of the scaffold was detected and the initial lumen enlargement was sustained.

Serial intravascular ultrasound evaluation of the DESolve™ novolimus-eluting bioresorbable coronary scaffold system.

INTRODUCTION: Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolve™ novolimus-eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions. METHODS: Single-center, prospective, non-randomized study involving 17 consecutive patients submitted to implantation of the DESolve™ scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months. RESULTS: Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 ± 1.35 mm2 vs. 7.35 ± 1.53 mm2 , P < 0.002; and 101.19 ± 20.9 mm3 vs. 118.51 ± 26.6 mm3 , P = 0.001). Late lumen loss was 0.22 ± 0.30 mm at 6 months and 0.33 ± 0.44 mm at 18 months. No major adverse cardiac events occurred. At late follow-up (18 months) the scaffold was not visualized by IVUS; therefore the evaluation was restricted to lumen and vessel at that time point. CONCLUSIONS: IVUS serial evaluation of the novel DESolve BRS showed an increase in the device dimensions between baseline and 6 months, with concomitant enlargement of lumen dimensions and effective suppression of neointimal proliferation. At 18 months, no footprint of the scaffold was detected and the initial lumen enlargement was sustained.

Implante de stents com ou sem pré-dilatação em pacientes com síndrome coronária aguda sem supradesnivelamento do segmento ST / Stent implantation with or without pre-dilatation in non-ST-segment-elevation acute coronary syndrome patients

INTRODUÇÃO: O benefício do implante direto de stent não está bem estabelecido na síndrome coronária aguda sem supradesnivelamento do segmento ST (SCASST). Comparamos aqui o implante de stent, com ou sem pré-dilatação (stent direto) da lesão-alvo nessa população. MÉTODOS: Registro unicêntrico, retrospectivo, que incluiu pacientes com SCASST tratados entre 2009 a 2010. Foram excluídas lesões reestenóticas, lesões em enxertos de safena ou em bifurcações. O desfecho primário foi a comparação de eventos cardíacos adversos maiores (ECAM) hospitalares e tardios. RESULTADOS: Do total de 182 pacientes avaliados, 42,3% foram tratados com stent direto. A idade da população foi de 61,1 ± 11,0 anos, sendo 67% do sexo masculino e 33,5% diabéticos. Os pacientes do grupo pré-dilatação apresentaram mais lesões do tipo C (37,1% vs. 18,2%; P <0,01), menor diâmetro de referência do vaso (2,3 [2,0-2,7] mm vs. 2,7 [2,2-3,1] mm; P <0,01) e menor diâmetro luminal mínimo pré-intervenção (0,5 [0,1-0,7] mm vs. 0,6 [0,4-1,0] mm; P < 0,01). Calcificação moderada/grave foi evidenciada em 13,2% dos casos, igualmente distribuídos entre os grupos. Não foram observadas diferenças na ocorrência de complicações angiográficas periprocedimento (3,9% vs. 4,8%; P > 0,99). As taxas de ECAM hospitalar não diferiram entre os grupos, embora os pacientes submetidos ao implante direto tenham apresentado metade dos eventos (2,6% vs. 5,7%; P = 0,47). Ao final de 1 ano, os ECAM foram semelhantes entre os grupos (6,5% vs. 5,7%; P > 0,99 ). CONCLUSÕES: Nesta série de pacientes com SCASST, o implante direto de stent não esteve associado a melhores resultados angiográficos ou clínicos. Contudo, a complexidade da lesão permanece como fator determinante na escolha da estratégia de pré-dilatação na prática diária.

BACKGROUND: The benefits of direct stenting in non-ST-segment-elevation acute coronary syndromes (NSTE ACS) are not clearly established. We compared stenting with or without pre-dilatation (direct stenting) of the target lesion in this population. METHODS: Single center, retrospective registry including NSTE ACS patients treated from 2009 to 2010. Stenting for bifurcations, saphenous vein grafts, and in-stent restenosis were excluded. The primary endpoint was the comparison of in-hospital and late major adverse cardiac events (MACE). RESULTS: Of a total of 182 patients, 42.3% were treated by direct stenting. Mean age was 61.1 ± 11.0 years, 67% were male and 33.5% were diabetics. Patients in the pre-dilatation group had more type C lesions (37.1% vs. 18.2%; P = 0.01), smaller reference vessel diameter (2.3 [2.0-2.7] mm vs. 2.7 [2.2-3.1] mm; P = 0.01) and smaller preintervention minimal luminal diameter (0.5 [0.1-0.7] mm vs. 0.6 [0.4-1.0] mm; P < 0.01). Moderate/severe calcification was observed in 13.2% of the cases, and was equally distributed in both groups. There were no differences in the occurrence of periprocedural angiographic complications (3.9% vs. 4.8%; P = 0.99). In-hospital MACE was not different between groups, although patients submitted to direct stenting have shown half of the events (2.6% vs. 5.7%; P = 0.47). At the end of 1 year, the MACE rate was similar for the two groups (6.5% vs. 5.7%; P > 0.99). CONCLUSIONS: In this series of NSTE ACS patients, direct stenting was not associated with better angiographic or clinical outcomes. However, lesion complexity remains a determinant factor in the choice of the pre-dilatation strategy in daily practice.