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Published on: September 18, 2015
A novel stent flow chamber system demonstrates reduced thrombogenicity of bioresorbable magnesium scaffolds
Monja Müller1, Lars Ludwig1, Hanna Englert1
1Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Insights
A new stent flow chamber assesses thrombogenicity of coronary artery devices. Bioresorbable magnesium scaffolds (RMS) show reduced thrombogenicity versus traditional stents, with the DREAMS 3G prototype offering enhanced safety for coronary artery disease (CAD).
Area of Science:
- Biomaterials science
- Cardiovascular research
- Medical device engineering
Background:
- Coronary artery disease (CAD) necessitates advanced treatments like stents and scaffolds.
- Current in vitro models have limitations in analyzing device-material interactions and performance.
- Assessing thrombogenicity is crucial for clinical safety and efficacy of cardiovascular implants.
Purpose of the Study:
- To develop and validate a novel stent flow chamber for in vitro thrombogenicity assessment.
- To compare the thrombogenicity of a stainless steel stent with bioresorbable magnesium scaffolds (RMS).
- To evaluate the thrombogenicity of a third-generation RMS prototype (DREAMS 3G).
Main Methods:
- Establishment of a novel stent flow chamber system.
- In vitro assessment of platelet adhesion and coverage on different device materials under flow conditions.
- Comparative analysis of thrombogenicity between Magmaris-316L stainless steel stent, Magmaris RMS, and DREAMS 3G RMS prototype.
Main Results:
- The Magmaris RMS demonstrated significantly lower thrombogenicity compared to the Magmaris-316L stainless steel stent.
- The DREAMS 3G RMS prototype exhibited further reduced thrombogenicity compared to its predecessors.
- Platelet adhesion and coverage were reduced on RMS devices, particularly the DREAMS 3G prototype.
Conclusions:
- The novel stent flow chamber effectively assesses device thrombogenicity in vitro.
- Bioresorbable magnesium scaffolds, especially the DREAMS 3G prototype, offer improved thrombogenicity profiles over traditional stents.
- The DREAMS 3G prototype shows promise for enhanced clinical safety and efficacy in treating CAD, potentially reducing animal testing.
Abstract:
Coronary artery disease (CAD) is characterized by narrowing and subsequent blockade of coronary arteries, and imposes a significant health and economic burden. Stent and scaffold devices are introduced in advanced CAD to improve vascular stability and restore blood flow. Although in vitro flow systems like the Chandler loop have been developed to enhance the understanding of interactions between device materials, their coatings, and vascular cells, imaging-based in vitro analysis of device performance is limited. In this study, we established a novel stent flow chamber system designed to assess the thrombogenicity of bioresorbable magnesium scaffold (RMS) and stent materials in vitro. Additionally, we compared the thrombogenicity - an important clinical parameter in stent performance - of the Magmaris-316 L stainless steel stent with its predecessors, Magmaris RMS and a prototype of the third-generation RMS (DREAMS 3G). Analysis of platelet adhesion and coverage of the different devices under flow conditions demonstrated that the Magmaris RMS exhibits reduced thrombogenicity compared to the Magmaris-316 L stainless steel stent. Moreover, thrombogenicity of the DREAMS 3G prototype, composed of BIOmag material, is further decreased compared to its predecessors. The observed reduction in thrombogenicity of the DREAMS 3G prototype in vitro suggests additional improvements in clinical safety and efficacy, highlighting its promise for treating CAD. Future research on this prototype may thus open avenues for analyzing other blood components and patient-derived endothelial cells. In line with the 3R principles, this approach may also help reduce the need for animal testing.
