Efficacy of Factor Xa Anticoagulant Monotherapy after Drug-Eluting Stent Implantation in a Human-Like Coronary Atherosclerotic Porcine Model

2021 Fiscal Year Final Research Report

• Project/Area Number: 19K16621
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 49030:Experimental pathology-related
• Research Institution: Nihon University
• Principal Investigator: KITANO Daisuke 日本大学, 医学部, 助教 (40815495)
• Project Period (FY): 2019-04-01 – 2022-03-31
• Keywords: 直接作用型経口抗凝固薬 / 薬剤溶出性ステント / 冠動脈狭窄症 / 大動物モデル / 血管内イメージング / 抗血栓療法

Outline of Final Research Achievements

Background: We evaluated the safety and efficacy of factor Xa inhibitor, edoxaban monotherapy in a low-density lipoprotein receptor knockout (LDLR-/-) miniature pig with human-like unstable coronary plaques compared to conventional dual-antiplatelet therapy (DAPT).
Methods & results: Drug-eluting stents (DES) were implanted in LDLR-/- pigs with unstable coronary plaque. The pigs were given a DAPT comprising of aspirin and clopidogrel or an edoxaban orally 3 days before DES implantation and then daily throughout the follow-up period. One month after DES implantation, optical coherence tomography assessment showed the neointima in the edoxaban was thinner than that in the DAPT. Histological analysis revealed fibrin deposits and inflammatory cells infiltration in the peri-strut region were similar in both groups. No instent thrombi were observed.
Conclusion: Our results showed that the edoxaban monotherapy was non-inferior to DAPT after DES implantation in terms of safety and efficacy.

Free Research Field

循環器内科学

Academic Significance and Societal Importance of the Research Achievements

ヒトに類似した大動物モデルを用いた本研究の成果は、薬剤溶出性ステント留置時から直性作用型経口抗凝固薬単剤でも安全性に寄与するだけでなく、ステント再狭窄の抑制に繋がる可能があり、今後実臨床においてより少ない抗血栓薬の投与で十分な冠動脈ステント留置治療を行うことができることを支持するという重要な意義を持つ。