Author + information
- Pawel Gasior1,
- Yanping Cheng1,
- Lijie Wang1,
- Gaoke Feng1,
- Gerard B. Conditt1,
- Jenn McGregor1,
- Frank D. Kolodgie2,
- Renu Virmani2,
- Juan Granada1 and
- Greg L. Kaluza1
The first-in-class and most widely commercially available bioresorbable scaffold (BRS) Absorb has strut thickness of 150 microns, far exceeding those of contemporary drug-eluting stents. As such, it has potential for delivery challenges and higher thrombogenicity. As such, decreasing the BRS strut thickness with no adverse effect on its biomechanics seems desirable. The aim of the study was to assess safety and efficacy of a novel thin strut (100 μm) sirolimus eluting BRS (MeRes100, Meril Life Sciences, Gujarat, India) in porcine coronary arteries.
A total of 34 coronary segments of 14 healthy swine were implanted with 24 thin strut sirolimus eluting MeRes100 BRS and 10 Absorb scaffolds at 110% overstretch. To date, angiographic and optical coherence tomography (OCT) imaging were performed after 1 and 3 months (MeRes100 n=19 and Absorb n=8 at each time point). Of the entire cohort, 3 animals were euthanized at each time point and coronary segments were harvested for histological evaluation.
The animals in both groups were comparable with regard to weight, clinical status, baseline vessel size and procedural characteristics. All procedures were completed with no complications. At the implantation procedure there was no statistical difference in angiographic, minimal lumen diameter (MLD)-based percent acute recoil between MeRes100 and Absorb (respectively: 13% ± 7% vs. 10% ± 5% p=0.18). OCT evaluation demonstrated no differences in metrics of neointimal proliferation in MeRes100 when compared to Absorb at 1- and 3-month follow up. Angiographic results corresponded to OCT and showed similar results without statistical differences in MLD and late loss at both time points. OCT and angiographic results are summarized in the table. Histological analysis at 1-month follow up revealed comparable results in MeRes100 and Absorb in % area stenosis (respectively: 28.7 ± 12.6% vs. 27.3±2.5% p=0.86), neointimal area (respectively 1.77±0.82 vs. 1.95±0.35 mm2; p=0.22) and in qualitative parameters of vascular healing. Three-month histological results will be available by the time of the meeting.
|1 month||3 months|
|QCA||Minimal Lumen Diameter(mm)||1.98±0.32||2.20±0.22||0.07||2.02±0.32||2.24±0.26||0.11|
|OCT||% Area Stenosis||22.4±8.2||22.6±7.1||0.96||29.2±11.6||23.6±5.3||0.11|
The novel sirolimus-eluting BRS with thinner struts and hybrid cell design showed similar radial strength and equivalent inhibition of neointimal proliferation when compared to the benchmark Absorb BVS up to 90 days in normal porcine coronary arteries.
CORONARY: Stents: Bioresorbable Vascular Scaffolds
Animal model, Bioresorbable scaffold, Optical coherence tomography