Abstract
Purpose
The implantation of flow diverters requires administration of dual anti-platelet therapy, posing the potential for complications. The p48MW HPC (phenox, Bochüm, Germany) hydrophilic-coated flow diverting stent is designed to be anti-thrombotic, thus opening the potential for single anti-platelet therapy. We deploy a novel intravascular high-resolution imaging technique, high-frequency optical coherence tomography (HF-OCT), to study in an animal model the acute thrombus formation on coated p48MW devices versus uncoated control devices.
Methods
Three pigs were implanted with 4 flow diverters each, two test hydrophilic-coated devices, and two control uncoated devices (p48MW). Each pig was treated with a different anti-platelet regime: no anti-platelet therapy, aspirin only, aspirin and clopidogrel. Twenty minutes after the flow diverter was implanted, an HF-OCT data set was acquired. Acute clot formed on the flow diverter at each covered side branch was measured from the HF-OCT slices. Factors considered to be important were the device type (pHPC versus bare metal), aspirin, clopidogrel, and vessel location. A linear model was constructed from the significant factors.
Results
Both coating (p < 0.001) and aspirin (p = 0.003) were significantly related to reduction in clot burden, leading to an approximate 100-fold and 50-fold reduction in clot, respectively.
Conclusions
This study shows the power of HF-OCT not only in the detection of clot but also the quantification of clot burden. In an animal model, the pHPC-coated p48MW significantly reduced acute thrombus formation over jailed side branches as compared to the bare metal p48MW that was nearly eliminated when combined with aspirin administration.
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Notes
The anesthesiological protocol can be found in the online supplement of the article.
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Funding
This study was funded by phenox and the Massachusetts Life Sciences Center Bits-to-Bytes program.
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RMK performed the experiments, analyzed and interpreted the data, wrote the manuscript, and approved the final manuscript. ETL performed the experiments, analyzed the data, and approved the final manuscript. CMR performed the experiments and approved the final manuscript. GJU performed the experiments, interpreted the data, revised the manuscript, and approved the final manuscript. HH designed the study, revised the manuscript, and approved the final manuscript. ASP designed the study, revised the manuscript, and approved the final manuscript. MJG designed the study, designed and performed the experiments, analyzed and interpreted the data, drafted the manuscript, approved the final manuscript, and agrees to be accountable for the accuracy and integrity of the work.
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Robert M. King, Erin T. Langan, Chris M. Raskett declare that they have no conflicts of interest. Giovanni J. Ughi declares he is an employee of Gentuity LLC and holds stock. Hans Henkes declares he is a founder of phenox GmbH. Ajit S. Puri declares he has been a consultant for Stryker, Cerenovus, Medtronic, Cerevasc, and Microvention; holds stock in InNeuroCo; and has received research support from National Institutes of Health (NIH). Matthew J. Gounis declares he has been a consultant on a fee-per-hour basis for Cerenovus, Imperative Care, phenox, Medtronic Neurovascular, Route 92 Medical, Stryker Neurovascular; holds stock in Imperative Care and Neurogami; and has received research support from the National Institutes of Health (NIH), the United States – Israel Binational Science Foundation, Anaconda, ApicBio, Axovant, Cerenovus, Cook Medical, Gentuity, Imperative Care, InNeuroCo, Magneto, MicroVention, Medtronic Neurovascular, MIVI Neurosciences, Neuravi, Neurogami, Philips Healthcare, Rapid Medical, Route 92 Medical, Stryker Neurovascular, Syntheon, and the Wyss Institute.
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All procedures performed in this study were in accordance with ethical standards of the Institutional Animal Care and Use Committee (IACUC).
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King, R.M., Langan, E.T., Ughi, G.J. et al. Acute Thrombus Burden on Coated Flow Diverters Assessed by High Frequency Optical Coherence Tomography. Cardiovasc Intervent Radiol 43, 1218–1223 (2020). https://doi.org/10.1007/s00270-020-02482-w
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DOI: https://doi.org/10.1007/s00270-020-02482-w