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. 2023 Sep 21;9(2):133-142.
doi: 10.4244/AIJ-D-22-00051. eCollection 2023 Sep.

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

Qiuping Shi  1 , Bin Zhang  1 , Xingang Wang  1 , Jintao Fei  1 , Qiao Qin  1 , Bo Zheng  1   2 , Ming Chen  1
Affiliations

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

Qiuping Shi et al. AsiaIntervention. .

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.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Configuration and structure of the AMSorb scaffold.
Figure 2
Figure 2. Performance of the BRS and SES at each optical coherence tomography assessment.
BRS: bioresorbable sirolimus-eluting scaffold (AMSorb); SES: metallic sirolimus-eluting stent
Figure 3
Figure 3. Lumen area and scaffold/stent area of the BRS and SES at each assessment time.
BRS: bioresorbable sirolimus-eluting scaffold (AMSorb); SES: metallic sirolimus-eluting stent
Figure 4
Figure 4. Histopathological findings for the BRS and SES at each assessment time (low magnification).
BRS: bioresorbable sirolimus-eluting scaffold (AMSorb); SES: metallic sirolimus-eluting stent
Figure 5
Figure 5. Histopathological findings for the BRS and SES at each assessment time (high magnification).
BRS: bioresorbable sirolimus-eluting scaffold (AMSorb); SES: metallic sirolimus-eluting stent
Figure 6
Figure 6. Findings on scanning electron microscopy for the BRS and SES at each assessment time (low magnification).
BRS: bioresorbable sirolimus-eluting scaffold (AMSorb); SES: metallic sirolimus-eluting stent
Figure 7
Figure 7. Findings on scanning electron microscopy for the BRS and SES at each assessment time (high magnification).
BRS: bioresorbable sirolimus-eluting scaffold (AMSorb); SES: metallic sirolimus-eluting stent
See this image and copyright information in PMC

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