eISSN: 1897-4295
ISSN: 1734-9338
Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej
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1/2020
vol. 16
 
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Early scaffold strut coverage in ultra-high molecular weight amorphous PLLA sirolimus-eluting bioresorbable scaffolds: impact of strut thickness assessed in normal porcine coronary arteries

Paweł Gąsior
1, 2
,
Yanping Cheng
1
,
Marco Ferrone
1, 3
,
Jenn C. McGregor
1
,
Gerard B. Conditt
1
,
Juan F. Granada
1
,
Grzegorz L. Kaluza
1

  1. CRF-Skirball Center for Innovation, Orangeburg, NY, USA
  2. Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
  3. Federico II University, Naples, Italy
Adv Interv Cardiol 2020; 16, 1 (59): 102–106
Online publish date: 2020/04/03
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Introduction

The first FDA-approved bioresorbable scaffold (BRS) Absorb BVS (Abbott Vascular, USA) demonstrated a higher rate of scaffold thrombosis when compared to current-generation metallic drug-eluting stents (DES) [1]. It is believed that the bulky strut thickness of 156 µm, exceeding nearly twice that of contemporary metallic DES, is responsible for the higher thrombotic potential of this technology [2].
The speed and quality of stent/scaffold strut coverage by tissue are strongly impacted by strut thickness and shape, which influence shear stress and blood flow dynamics, affecting platelet accumulation and endothelial cell growth [3–5]. Regardless of strut height, non-streamlined scaffold struts influence blood flow recirculation and low flow shear rates and prolong particulate residence time [6]. Low endothelial shear stress influences endothelialization rates, and taller strut height induces an environment of procoagulant and pro­inflammatory elements, which can lead to a greater quantity of thrombus and also accelerate turnover of endothelial cells, making re­endothelialization more difficult [7, 8]. Preclinical studies demonstrated that strut thickness influences thrombogenicity, with struts that are < 100 µm having smaller thrombi than struts that are > 100 µm [9]. Therefore, the reduction in strut thickness resulting in improved vascular healing with neointimal strut coverage is a crucial concept in developing new BRS.
In this study we aimed to evaluate the short-term healing response using optical coherence tomography (OCT) following implantation of a new-generation sirolimus-eluting amorphous PLLA-based BRS (Amaranth Medical, USA) with ultra-thin strut (98-µm, AMA-98) and thin strut (115-µm, AMA-115) thickness in porcine coronary arteries.

Material and methods

Device description

Scaffolds used in this study have almost identical ring design and different strut thicknesses: the ultra-thin strut AMA-98, with strut thickness of 98 µm; and the thin strut AMA-115, with strut thickness of 115 µm. The only difference between the 2 versions is a slightly increased surface area coverage at rated burst pressure in AMA-98 when compared to AMA-115 (respectively: 22% vs. 21% for 3.0 mm scaffolds). Both scaffolds were manufactured by the same company (Amaranth Medical, USA) using an ultra-high molecular weight bioresorbable polylactide-based polymer. Devices are coated with a matrix consisting of a 1 :...


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