Safety and efficacy of a novel 3D-printed bioresorbable sirolimus-eluting scaffold in a porcine model.

Abstract

Background: The effect of 3D-printed bioresorbable vascular scaffolds (BRS) in coronary heart disease has not been clarified.

Aims: We aimed to compare the safety and efficacy of 3D-printed BRS with that of metallic sirolimus-eluting stents (SES).

Methods: Thirty-two BRS and 32 SES were implanted into 64 porcine coronary arteries. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were performed at 14, 28, 97, and 189 days post-implantation. Scanning electron microscopy (SEM) and histopathological analyses were performed at each assessment.

Results: All stents/scaffolds were successfully implanted. All animals survived for the duration of the study. QCA showed the two devices had a similar stent/scaffold-to-artery ratio and acute percent recoil. OCT showed the lumen area (LA) and scaffold/stent area (SA) of the BRS were significantly smaller than those of the SES at 14 and 28 days post-implantation (14-day LA: BRS vs SES 4.52±0.41 mm² vs 5.69±1.11 mm²; p=0.03; 14-day SA: BRS vs SES 4.99±0.45 mm² vs 6.11±1.06 mm²; p=0.03; 28-day LA: BRS vs SES 2.93±1.03 mm² vs 4.82±0.74 mm²; p=0.003; 28-day SA: BRS vs SES 3.86±0.98 mm² vs 5.75±0.71 mm²; p=0.03). Both the LA and SA of the BRS increased over time and were similar to those of the SES at the 97-day and 189-day assessments. SEM and histomorphological analyses showed no significant between-group differences in endothelialisation at each assessment.

Conclusions: The novel 3D-printed BRS showed safety and efficacy similar to that of SES in a porcine model. The BRS also showed a long-term positive remodelling effect.