First in human evaluation of a novel Sirolimus-eluting ultra-high molecular weight bioresorbable scaffold: 9-, 24-and 36-months imaging and clinical results from the multi-center RENASCENT study.

BACKGROUND: RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-µm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions. METHODS: FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months. RESULTS: A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months. CONCLUSIONS: In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up.

Magnesium versus poly-L-lactic acid bioresorbable scaffolds: in vivo optical coherence tomography comparison of mechanical performance / Andamiajes bioresorbibles de magnesio versus poliméricos: comparación in vivo de su comportamiento mecánico por OCT

Abstract Background: Different mechanical properties have been suggested for metallic bioresorbable vascular scaffolds (BVS) in comparison to polymeric BVS. We aim to evaluate the acute mechanical performance of Magmaris® scaffold in comparison to Absorb®. Materials and Methods: Two groups of 10 coronary lesions treated with Magmaris® and Absorb® 1.1 (20584 vs. 21016 struts) were compared. In all cases, optical coherence tomographic (OCT) images were acquired after scaffold deployment. Baseline clinical, angiographic, and procedural characteristics were compared, including OCT evaluations. Results: No baseline clinical or angiographic significant differences were found between groups. The most common indication for revascularization was effort angina (60% vs. 70% p = 0.45) with no ST-elevation myocardial infarction (MI) cases. Main target artery was left anterior descending, with a mean vessel diameter of 3.46 ± 0.23 in Absorb® and 3.52 ± 0.19mm in Magmaris® groups (p = 0.56). All cases underwent pre- and post-dilatation with a procedural success rate of 100%. OCT analyses showed larger scaffold and vessel diameters in Magmaris® group: 3.11 ± 0.38 mm versus 3.07 ± 0.36 mm, p = 0.03 and 4.12 ± 0.51 mm versus 4.04 ± 0.46 mm, p = 0.04. Despite the application of slightly higher postdilatation pressures to Magmaris® devices (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), significantly lower percentages of disrupted and malapposed struts were identified within Magmaris® scaffolds (0.15% vs. 0.27%, p = 0.03 and 1.06% vs. 1.46% p = 0.01). No cardiac death, target vessel-related MI, or clinically driven target lesion revascularization was reported in a 30-day follow-up. Conclusion: Mechanical properties of Magmaris® scaffold allow achieving larger vessel and scaffold diameters in a safe manner, with lower rates of malapposition and scaffold disruption.

Resumen Introducción: Se ha sugerido la presencia de un distinto comportamiento mecánico entre los dos grupos principales de dispositivos bioresorbibles: metálicos y poliméricos. En este estudio evaluamos el comportamiento mecánico agudo del andamiaje bioresorbible metálico Magmaris® frente al del polimérico Absorb®. Métodos: Se compararon dos grupos de 10 lesiones coronarias tratadas con Magmaris® y Absorb® 1.1 (20584 vs. 21016 struts). En todos los casos se realizó estudio postimplante del dispositivo mediante tomografia de coherencia óptica (OCT). Se compararon las características basales clínicas y angiográficas, así como aspectos del procedimiento (incluídos los estudios de OCT) entre ambos grupos. Resultados: No se encontraron diferencias clínicas o angiográficas estadísticamente significativas entre ambos grupos. La indicación más frecuente de revascularización coronaria fué la presencia de angina de esfuerzo (60% vs. 70% p = 0.45), sin incluirse casos de IAMCEST. La arteria descendente anterior fué el principal vaso diana, con un diámetro medio de 3.46 ± 0.23 mm en el grupo de Absorb® y de 3.52 ± 0.19mm en el grupo de Magmaris® (p = 0.56). En todos los casos se realizó pre y postdilatación, con una tasa de éxito del procedimiento del 100%. Los estudios mediante OCT demostraron un mayor diámetro de stent y del vaso en el grupo de Magmaris®: 3.11 ± 0.38mm versus 3.07 ± 0.36 mm, p = 0.03 y 4.12 ± 0.51mm versus 4.04 ± 0.46mm, p = 0.04. A pesar de someter a los dispositivos Magmaris® a presiones de postdilatación ligeramente superiores (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), se identificó un menor porcentaje estadísticamente significativo de struts rotos o malapuestos en dicho grupo (0.15% vs. 0.27 %, p = 0.03 y 1.06 % vs. 1.46% p = 0.01). En un seguimiento a 30 días no se registraron eventos mayores: muerte cardíaca, IM relacionado con vaso diana o TLR. Conclusión: Las propiedades mecánicas del scaffold metálico bioresorbible Magmaris® permiten alcanzar mayores diámetros de stent y vaso de forma segura tras su implante, con una baja tasa de malaposición y disrupción.

Magnesium versus poly-L-lactic acid bioresorbable scaffolds: in vivo optical coherence tomography comparison of mechanical performance.

Background: Different mechanical properties have been suggested for metallic bioresorbable vascular scaffolds (BVS) in comparison to polymeric BVS. We aim to evaluate the acute mechanical performance of Magmaris® scaffold in comparison to Absorb®. Materials and Methods: Two groups of 10 coronary lesions treated with Magmaris® and Absorb® 1.1 (20584 vs. 21016 struts) were compared. In all cases, optical coherence tomographic (OCT) images were acquired after scaffold deployment. Baseline clinical, angiographic, and procedural characteristics were compared, including OCT evaluations. Results: No baseline clinical or angiographic significant differences were found between groups. The most common indication for revascularization was effort angina (60% vs. 70% p = 0.45) with no ST-elevation myocardial infarction (MI) cases. Main target artery was left anterior descending, with a mean vessel diameter of 3.46 ± 0.23 in Absorb® and 3.52 ± 0.19mm in Magmaris® groups (p = 0.56). All cases underwent pre- and post-dilatation with a procedural success rate of 100%. OCT analyses showed larger scaffold and vessel diameters in Magmaris® group: 3.11 ± 0.38 mm versus 3.07 ± 0.36 mm, p = 0.03 and 4.12 ± 0.51 mm versus 4.04 ± 0.46 mm, p = 0.04. Despite the application of slightly higher postdilatation pressures to Magmaris® devices (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), significantly lower percentages of disrupted and malapposed struts were identified within Magmaris® scaffolds (0.15% vs. 0.27%, p = 0.03 and 1.06% vs. 1.46% p = 0.01). No cardiac death, target vessel-related MI, or clinically driven target lesion revascularization was reported in a 30-day follow-up. Conclusion: Mechanical properties of Magmaris® scaffold allow achieving larger vessel and scaffold diameters in a safe manner, with lower rates of malapposition and scaffold disruption.

Introducción: Se ha sugerido la presencia de un distinto comportamiento mecánico entre los dos grupos principales de dispositivos bioresorbibles: metálicos y poliméricos. En este estudio evaluamos el comportamiento mecánico agudo del andamiaje bioresorbible metálico Magmaris® frente al del polimérico Absorb®. Métodos: Se compararon dos grupos de 10 lesiones coronarias tratadas con Magmaris® y Absorb® 1.1 (20584 vs. 21016 struts). En todos los casos se realizó estudio postimplante del dispositivo mediante tomografia de coherencia óptica (OCT). Se compararon las características basales clínicas y angiográficas, así como aspectos del procedimiento (incluídos los estudios de OCT) entre ambos grupos. Resultados: No se encontraron diferencias clínicas o angiográficas estadísticamente significativas entre ambos grupos. La indicación más frecuente de revascularización coronaria fué la presencia de angina de esfuerzo (60% vs. 70% p = 0.45), sin incluirse casos de IAMCEST. La arteria descendente anterior fué el principal vaso diana, con un diámetro medio de 3.46 ± 0.23 mm en el grupo de Absorb® y de 3.52 ± 0.19mm en el grupo de Magmaris® (p = 0.56). En todos los casos se realizó pre y postdilatación, con una tasa de éxito del procedimiento del 100%. Los estudios mediante OCT demostraron un mayor diámetro de stent y del vaso en el grupo de Magmaris®: 3.11 ± 0.38mm versus 3.07 ± 0.36 mm, p = 0.03 y 4.12 ± 0.51mm versus 4.04 ± 0.46mm, p = 0.04. A pesar de someter a los dispositivos Magmaris® a presiones de postdilatación ligeramente superiores (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), se identificó un menor porcentaje estadísticamente significativo de struts rotos o malapuestos en dicho grupo (0.15% vs. 0.27 %, p = 0.03 y 1.06 % vs. 1.46% p = 0.01). En un seguimiento a 30 días no se registraron eventos mayores: muerte cardíaca, IM relacionado con vaso diana o TLR. Conclusión: Las propiedades mecánicas del scaffold metálico bioresorbible Magmaris® permiten alcanzar mayores diámetros de stent y vaso de forma segura tras su implante, con una baja tasa de malaposición y disrupción.

Bioresorbable Coronary Scaffolds: Deployment Tips and Tricks and the Future of the Technology.

Bioresorbable scaffolds (BRS) were developed as an alternative to drug-eluting stents (DES) to facilitate vessel restoration and reduce the risk of future adverse events. However, recent meta-analyses and "real-world" registries have raised some concern about the safety of this novel technology, especially due to an increased risk of thrombosis within the first weeks of scaffold implantation. These devices appear to be less forgiving to poor implantation strategies when compared to contemporary DES. Moreover, problems with the first generation of these devices-bulky struts and high crossing prolife, prolonged resorption time, lack of x-ray visibility, and limited tolerance to postdilation-have restricted their clinical application and negatively impacted their short- to mid-term safety performance. However, the potential for long-term improvements has encouraged further research into strategies to overcome these limitations, and potentially safer next-generation devices are already undergoing in-human clinical evaluations. Based on the current literature and our center's experience with these devices, this review discusses various approaches to optimize BRS implantation, drawbacks related to current-generation BRS, and potentially advantageous features of three next-generation scaffold systems.

Role of invasive imaging in acute and long-term assessment of bioresorbable scaffold technology.

Fully bioresorbable scaffolds (BRS) represent a novel approach for the percutaneous treatment of coronary artery stenosis, providing temporary vessel scaffolding with drug-eluting capability during the restenosis-prone phase of the vascular healing. Beyond this initial critical period, when mechanical scaffolding support is no longer necessary, the device is bioresorbed, restoring the normal vascular physiology with the aim to eliminate the long-term safety concerns related to permanent metallic implants. Nonetheless, current BRS technology suffers from limited mechanical properties as compared to available metallic platforms, requiring careful attention to lesion preparation, accurate vessel sizing, and implantation technique. Intravascular imaging has played an important role in providing knowledge on the acute effects after BRS deployment, and it helped refine the current technique of BRS implantation. In addition, extensive work with multiple intravascular imaging modalities have also contributed to the understanding of the unique dynamic vascular changes that are experienced in the treated segment from post-implantation up to complete device bioresorption. In this manuscript, we review the role of invasive imaging modalities-from angiography to sound- and light-based techniques-to guide BRS implantation procedures, to assess its acute results postimplantation, and the changes experienced in the long-term until complete bioresorption has ensued. © 2016 Wiley Periodicals, Inc.