Early-Stage Vascular Response between Bare Metal Stent and Drug-Free Bioresorbable Vascular Scaffold in the Small-Sized Peripheral Artery: A Preclinical Study in Porcine Femoral Arteries

Abstract

Background: The clinical benefits and outcomes of the interventional treatment of small-sized infrapopliteal arteries using stent implantation remain uncertain. The aim of this study was to compare the safety and efficacy of drug-free bioresorbable vascular scaffold (BVS) with that of bare metal stent (BMS) in endovascular treatment of small-sized peripheral arteries. Methods: In this study, drug-free BVS and BMS were used in eight porcine models. We compared the angiographic and histomorphometric findings in the two groups at 4 weeks. In each pig, BVS and BMS of adequate sizes were implanted in the small branch (<3 mm) of the femoral artery. Angiography, intravascular ultrasound (IVUS), and histomorphometric analysis were performed at 4 weeks. Results: In the 4-week follow-up angiography and IVUS examination, the minimal luminal diameter was smaller and diameter stenosis was more severe in the BVS group. Histomorphometric findings indicated that the lumen area in the BVS group was smaller (0.34 +/- 0.28 mm(2) vs. 1.40 +/- 0.52 mm(2), P < 0.001), whereas the neointimal area (2.70 +/- 1.28 mm(2) vs. 1.76 +/- 0.66 mm(2), P = 0.013), area stenosis (85.18 +/- 13.14 % vs. 54.99 +/- 16.13 %, P < 0.001), inflammatory score (2.07 +/- 0.861 vs. 28 +/- 0.39, P = 0.003), and fibrin scores (1.24 +/- 0.70 vs. 0.79 +/- 0.72, P = 0.043) were significantly higher in the BVS group. The injury score was higher in the BMS group. In histopathologic findings, restenosis was mainly due to recoil and distortion of the scaffold in the BVS group. Conclusions: Compared with BMS, drug-free BVS was not feasible for small-sized peripheral arteries based on the angiographic, IVUS, and histomorphometric results primarily due to insufficient mechanical support.